cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Switching From Sitagliptin to Liraglutide in Subjects With Type 2 Diabetes Not Achieving Adequate Glycaemic Control on Sitagliptin and Metformin

This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the efficacy and safety of switching from sitagliptin to liraglutide in subjects with type 2 diabetes not achieving adequate glycaemic control on sitagliptin and metformin.


Eligibility Criteria:
Inclusion Criteria:

* - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* - Subjects diagnosed with type 2 diabetes and treated with metformin equal to or above 1500 mg/day (or maximum tolerated dose equal to or above 1000 mg/day) and sitagliptin 100 mg/day, both at a stable dose for at least 90 days prior to screening. Stable is defined as unchanged medication and dose
* - HbA1c 7.5% - 9.5% (58 mmol/mol - 80 mmol/mol) (both inclusive)
* - Body mass index equal to or above 20 kg/m\^2

Exclusion Criteria:

* - Any chronic disorder or severe disease which at the discretion of the investigator might jeopardise subject's safety or compliance with the protocol
* - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days prior to screening. An exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with intercurrent illness
* - Female who is pregnant, breast-feeding, intends to become pregnant or of child-bearing potential not using adequate contraceptive methods (adequate contraceptive measures as required by local regulations or practice)
* - History of chronic pancreatitis or idiopathic acute pancreatitis
* - Screening calcitonin value equal to or above 50 ng/L
* - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
* - Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
* - Impaired liver function, defined as alanine aminotransferase equal to or above 2.5 times upper normal limit
* - Impaired renal function defined as estimated glomerular filtration rate 60 mL/min/1.73 m\^2 per modification of diet in renal disease formula
* - Any episode of unstable angina, acute coronary event, cerebral stroke/transient ischemic attack or other significant cardiovascular event as judged by the investigator within 90 days prior to screening
* - Heart failure, New York Heart Association class IV
* - Uncontrolled treated or untreated hypertension (systolic blood pressure equal to or above 180 mmHg and/or diastolic blood pressure equal to or above 100 mmHg)
The Effects of Sevoflurane and Desflurane Used in Low-Flow Anesthesia on Thiol Disulfide Homeostasis

This study aimed to compare the effects of sevoflurane and desflurane used in low-flow anesthesia on thiol-disulfide homeostasis of patients undergoing general anesthesia.

Fifty patients were included who were scheduled to undergo elective total thyroidectomy operation under general anesthesia. The patients were assigned to one of 2 groups. Group S was the low-flow sevoflurane anesthesia group and Group D was the low-flow desflurane group. Blood samples were collected to evaluate thiol disulfide homeostasis preoperatively and postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were scheduled to undergo elective total thyroidectomy under general anesthesia

Exclusion Criteria:

* Patients with diabetes mellitus, alcohol or drug addiction, smoking habits, expected difficult intubation, morbid obesity, chronic obstructive pulmonary disease, cardiovascular disease and those in pregnancy or lactation period were excluded from the study.
Drug Interaction Between CKD-501 and Metformin

The purpose of this study is to evaluate safety, tolerance by comparing availability and the pharmacokinetic drug interaction between the CKD-501 and metformin when administered alone and combination to healthy male volunteers.

Volunteers doses three times over the period of CKD-501 0.5mg and metformin 1000mg alone, repeated doses are five days.

In addition, the CKD-501 0.5mg and metformin 1000mg are administered simultaneously be used repeatedly to five days.

Every time before and after each medication safety and drug absorption, distribution, metabolism and excretion rate, and is expected to conduct some tests.

Eligibility Criteria:
Inclusion Criteria:

* Between 20 aged and 45 aged in healthy males
* Weight more than 55kg, IBW 20% within the range
* FPG 70\~125 mg/dL
* Agreement with written informed consent

Exclusion Criteria:

* Clinically significant disease(liver, heart, immune system, Respiratory system, Endocrine system, blood tumor disease, Mental illness)or a history that has learned
* Test drug may affect the absorption of the gastrointestinal disease or a history that has learned
* Hypersensitivity reactions to drugs or Clinically significant hypersensitivity reactions in the history of party
* AST, ALT level over to 1.5 times and creatinine clearance less 80mL/min
* systolic blood pressure less than 100mmHg or 150mmHg, diastolic blood pressure less than 60mmHg or greater than 95mmHg
* Substance abuse, or a history of drug abuse showed a positive for the party
* Medication within 2 weeks in the first professional medical, medicine, OTC, vitamins taking
* Previously participated in other trial within 2 months
* Medication within 2 months make whole blood donation or medication within 1 month in component blood donation
* Continued to be drunk or during clinical trials can not be drunk
* 10 cigarettes a day for the last 3 months than the average smoker or during clinical trials can not be smoke
* Containing grapefruit foods ingested during clinical trials or can not be ingested
* Containing caffeine foods ingested during 24 hours before admission to hospital of can not be ingested
Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia

Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates treated with the state of the art therapy (induced systemic hypothermia) have normal outcomes. Therefore, other promising therapies that potentially work in synergy with hypothermia to improve neurologic outcomes need to be tested. One potential agent is melatonin. Melatonin is a naturally occurring substance produced mainly from the pineal gland. Melatonin is widely known for its role in regulating the circadian rhythm, but it has many other effects that may benefit infants with HI injury. Melatonin serves as a free radical scavenger, decreases inflammatory cytokines, and stimulates anti-oxidant enzymes. Therefore, melatonin may interrupt several key components in the pathophysiology of HIE, in turn minimizing cell death and improving outcomes. The research study will evaluate the neuroprotective properties and appropriate dose of Melatonin to give to infants undergoing therapeutic hypothermia for hypoxic ischemic encephalopathy.

Thirty subjects will be enrolled in a dose escalation study. Subjects 1-10 will receive melatonin (0.5 mg/kg). If that dose proves to be safe, subjects 11-20 will receive an increased dose of melatonin (3 mg/kg). Subjects 21-30 will receive a dose increased to the targeted projected therapeutic dose (5 mg/kg).

The serum concentration of melatonin and capture adverse event reports during this dose escalation study in neonates undergoing hypothermia and the long-term safety and potential efficacy via developmental follow-up performed at 18-22 months of age. In addition, this study will determine the effect of melatonin on the inflammatory cascade, oxidative stress, free radical production, and serum biomarkers of brain injury in neonates undergoing hypothermia.

Eligibility Criteria:
Inclusion Criteria:

* Eligible infants are \>36 0/7th weeks gestation,
* pH (cord or neonatal) \<7.0,
* base deficit \>16 mEq/L,
* no available blood gas,
* a cord blood/first hour of life blood gas with pH \> 7.0 and \< 7.15,
* base deficit between 10 and 15.9 mEq/L,
* infants must have a history of an acute perinatal event,
* either a 10-minute Apgar \< 5 or a continued need for ventilation,
* All infants must have signs of encephalopathy within 6 hours of age using the modified Sarnat scoring system,
* neonates cooled within 6 hours of birth will be included in the study.

Exclusion Criteria:

* suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia,
* clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation,
* a diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and/or chromosomal abnormalities.
Evaluation of Tc 99m Tilmanocept Localization in Primary Cutaneous Kaposi's Sarcoma and Lymphatic Drainage by SPECT/CT

The purpose of this study (NAV3-12) is to determine the dissemination and localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with confirmed cutaneous KS. This is a single center, open-label, within-subject study.


Eligibility Criteria:
Inclusion Criteria:

1. The subject has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before the initiation of any study-related procedures.
2. The subject is at least 18 years of age at the time of consent.
3. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 2.
4. The subject has a KS stage of T(0), I(0), S(0).
5. The subject has a marker lesion with a confirmed diagnosis of KS (CD 206-expressing cutaneous KS) via punch biopsy. The location of the marker KS lesion will be limited to locations on the extremities: from the shoulder to the metacarpal region or from the groin to the metatarsal region.
6. The subject has a marker KS lesion that is ≥ 1cm in diameter.

Exclusion Criteria:

1. The subject is pregnant or lactating.
2. The subject has had prior chemotherapy, immunotherapy, or radiation therapy to the local KS site or regional lymphatic system within one year of enrollment.
3. The subject has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the marker KS lesion.
4. The subject has known sensitivity to dextran.
Evaluation and Optimization of Hearing Devices in 3-D Complex Audio Environments

A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and assess strengths and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at the University Hospital of Zürich.


Eligibility Criteria:
Inclusion Criteria:

* Adult normal hearing persons (minimum age: 18 years)
* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders
Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

Study Design : multi-center, double-blind, placebo-controlled, randomized,

parallel group, fixed dose design

Phase : Phase III


Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 20 years or more diagnosed with ED

Exclusion Criteria:

* Had uncontrolled blood pressure
* Had hepatic or renal dysfunction
* Was currently under anticancer chemotherapy
* Had a treatments for ED using other PDE-5 inhibitors
Carboplatin in Patients With Progressive Gliomas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of carboplatin in patients with progressive glioma.

OBJECTIVES: I. Assess the response to carboplatin (CBDCA) in patients with progressive low-grade gliomas. II. Assess the activity of CBDCA in stabilizing the growth of these tumors.

OUTLINE: Single-Agent Chemotherapy. Carboplatin, CBDCA, NSC-241240.

PROJECTED ACCRUAL: A total of 25 evaluable patients will be entered if there is at least 1 response in the first 9 patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed primary intracranial low-grade glioma (i.e., astrocytoma or oligodendroglioma) No more than 2 years since tissue diagnosis Biopsy not required for intrinsic chiasmatic mass or tumor infiltration along the posterior optic tracts Evidence of progressive disease by at least one of the following: Papilledema or other clinical sign of increased intracranial pressure Documented change in neuroimaging studies, e.g.: Hydrocephalus 25% increase in product of maximum perpendicular diameters of tumor The following are required in patients with optic pathway gliomas: Progressive loss of vision documented by an ophthalmologist, i.e.: Doubling of octaves (e.g., 20/20 to 20/40 or 20/40 to 20/80) on 2 successive visits Loss of visual acuity not explainable by other causes, e.g., media abnormalities or amblyopia Greater than 3 mm increase in proptosis At least 2 mm increase in diameter of optic nerve on neuroimaging Increase in distribution of tumor involving the optic tracts or optic radiations demonstrated by CT or MRI using T1 (with or without contrast) or T2 imaging

PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70%-100% Life expectancy: At least 12 weeks Hematopoietic: ANC at least 1,500 Platelets at least 100,000 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin less than 1.5 times normal ALT less than 1.5 times normal Renal: Creatinine less than 1.5 mg/dL Other: Negative pregnancy test required of fertile women Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY: At least 12 weeks since radiotherapy (4 weeks since other therapy) and recovered Prior chemotherapy allowed with subsequent disease progression
Patient-Reported Outcome Measures in Lower Extremity Rehabilitation Program PROM_R: Impact on Health Care

Different musculoskeletal conditions affect people all over the world and were considered by the WHO to be the leading cause of disability in 4 out of 6 regions in 2017, with an increase in the associated burden and impact on society expected in the coming years.

The knee is a complex joint, vulnerable to various types of injury. The most common are ligament, meniscus and cartilage injuries of different etiologies.

After surgery, as a result of the reflex inhibition of motor neurons and immobilization, there is rapid atrophy and weakness in the different associated muscles, affecting proprioception, muscle strength and extension, clearly compromising health-related quality of life.

Through partnership and collaboration between health institutions and academia, the rehabilitation program will take place on an outpatient basis in a supervised manner, allowing its effectiveness to be assessed using Patient-Reported Outcome Measures. These instruments are a rapidly developing topic and it is essential to understand whether the Patient-Reported Outcome Measures used are sufficient to measure the results perceived by patients with lower limb pathology who take part in rehabilitation programs.

The different Patient-Reported Outcome Measures will be applied before and after the program.

The study design is a clinical trial with longitudinal assessment, with a convenience sample. Participants who meet the inclusion criteria are invited to take part and sign an informed consent form. All participants' data is encrypted and stored with password protection, and will be deleted once the results of the study have been published.

The experimental group followed the program for 4 weeks with a treatment frequency of 5 sessions per week, performed and supervised by the same specialist physiotherapist at every session.

For the statistical analysis of the data in this study, we used the Statistical Package for Social Sciences (SPSS®) 29 software.

Eligibility Criteria:
Inclusion Criteria:

* Patients with knee and ankle pathology, undergoing surgery;
* That they are going to start a rehabilitation program in two Rehabilitation Clinics in coastal and inland regions of Portugal;
* Aged between 18 and 80;
* Have signed an informed consent form.

Exclusion Criteria:

* Unconsolidated fractures;
* Previous surgeries in the ipsilateral knee;
* Partial or total amputation in upper or lower limbs;
* Permanent or temporary dysfunctions of the central or peripheral nerve system.
Prevention of Anhedonia in Children

This trial will test the effects of a positive emotion-focused preventive intervention on reward responsiveness in children of mothers with histories of depression and anhedonia.

This study will test the effects of a dyadic preventive intervention, Family Promoting Positive Emotion (F-PPE), for 8- to 12-year-old children of mothers with a history of major depressive disorder (MDD) with anhedonia. The study will first test F-PPE effects on child reward responsiveness (R61), and pending evidence of target engagement, effects on real-world experience of interest/pleasure and clinical symptoms of anhedonia will be evaluated in a second, larger clinical trial (R33). F-PPE was designed to increase child positive valence systems function through mother-child training in behavioral and cognitive skills to increase pleasant activities and attention towards/savoring the positive, individual and dyadic goals, and skills practice. For the R61 phase, eligible child participants (N=60 intervention completers) will complete an EEG assessment of neural reward responsiveness, as well as halfway through the intervention (4 weeks) to determine dose effects. Children and their biological mothers will be randomly assigned to 8 sessions of F-PPE or a psychoeducation comparison condition (groups will be matched on child sex and baseline RewP). Both interventions will be administered through individual telehealth sessions with a masters- or doctoral-level clinician under the supervision of the PIs. To ensure treatment fidelity, videotaped sessions will be reviewed for adherence to the protocol, clinicians will participate in weekly group supervision, and supervisors will randomly review recorded sessions for ratings of treatment adherence.

Eligibility Criteria:
Inclusion Criteria:

* Biological mothers with past or current MDD with anhedonia and their 8- to 12-year-old children
* Child and biological mother can read and speak fluently in English
* Child and mother have access to a computer or tablet and internet for videoconferencing
* For compensation purposes, child and biological mothers must be U.S. citizens

Exclusion Criteria:

* Children with past or current major depressive disorder (MDD) and/or anhedonia lasting most of the day, nearly every day for at least 2 weeks based on semi-structured interviews will be excluded
* Mothers or children with intellectual or developmental disabilities
* Mothers with past 6 months substance use disorder with moderate or greater severity
* Children or mothers with a lifetime history of a manic or hypomanic episode/bipolar disorder
* Children or mothers with a psychotic disorder (e.g., schizophrenia)
* Children or mothers with visual or hearing impairments that interfere with completing study measures and sessions
* Child offspring of a mother who has previously participated in the study with another biological child
* Children taking medications for emotional or behavioral problems other than SSRIs (stable dose for 6 weeks before time of enrollment) or psychostimulants
Preventing Loss of Independence Through Exercise (PLIÉ) - Pilot

The primary goal of this study is to perform a 36-week pilot study with a cross-over design to study the safety and efficacy of a novel integrative exercise program called PLIÉ (Preventing Loss of Independence through Exercise). PLIÉ integrates elements of Eastern and Western exercise traditions and is specifically designed to target the muscles and movements needed to help individuals with mild-to-moderate dementia maintain physical function and independence.


Eligibility Criteria:
Inclusion Criteria - Primary Participant:

* Current participant in the Irene Swindells Center for Adult Day Services in San Francisco, CA
* Recommended by Swindells staff
* mild-to-moderate dementia
* caregiver consent

Inclusion Criteria - Caregiver:

* Provide care to primary participant in the Irene Swindells Center for Adult Day Services in San Francisco, CA
* can provide information about the primary participant's physical functioning, behaviors, falls, quality of life and own level of stress.

Exclusion Criteria - Primary Participant:

* major current psychiatric illness (e.g., schizophrenia, bipolar disorder)
* life expectancy \< 1 year (e.g., metastatic cancer)
* inability to assent to study procedures

Exclusion Criteria - Caregiver:

* Any major neurologic disease (e.g., dementia, stroke, Parkinson's disease, ALS)
* major current psychiatric illness (e.g., schizophrenia, bipolar disorder)
* life expectancy \< 1 year (e.g., metastatic cancer)
* evidence of cognitive impairment
* inability to consent to study procedures.