cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke

This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Acute ischemic stroke with limb weakness
* Onset of symptoms within 6 hours
* Full functional independence prior to the present stroke

Exclusion Criteria:

* Unconsciousness
* Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.
* Severe illness with life expectancy less than 6 months.
* Known severe kidney disorder.
* Current known alcohol or illicit drug abuse or dependence.
* Pregnant or breast-feeding.
* Treatment with acetazolamide and methotrexate is not permitted during the infusion
* Participation in a previous clinical study within 30 days.
* Meets all other exclusion criteria.
Metformin and Furosemide Drug-Drug Interaction Study

This study will assess the potential effects of lesinurad on the pharmacokinetics (PK) of metformin and furosemide in healthy, adult male subjects.

Leinurad is a weak in vitro inhibitor of the hepatic transporter OCT1 and the renal transporters OAT1 and OAT3 (OAT1/3). To assess the clinical relevance of these in vitro findings, this clinical study will evaluate the effect of lesinurad on the PK of metformin (OCT1 substrate) and furosemide (OAT1/3 substrate).

Eligibility Criteria:
Inclusion Criteria:

* Subject has a body weight ≥ 50 kg (110 lbs) and body mass index ≥ 18 and ≤ 30 kg/m2.
* Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion Criteria:

* Subject has a history or suspicion of kidney stones, prostatic hyperplasia, or urinary stricture.
* Subject has undergone major surgery within 3 months prior to Screening.
* Subject donated blood or experienced significant blood loss (\>450 mL) within 12 weeks prior to Screening or gave a plasma donation within 4 weeks prior to Screening.
* Subject has inadequate venous access or unsuitable veins for repeated venipuncture.
Effects of Traditional Greek Meals on Glycemic Responses

This study investigated the effects of Greek traditional meals in dehydrated form consumed after reconstitution with water on glycemic responses

This study aimed at 1. to determined the glycemic index and glycemic load of three mixed meals and 2. to investigate the effects of these mixed meals on postprandial glycemic response in healthy subjects

Eligibility Criteria:
Inclusion Criteria:

* healthy
* non-smoking
* non-diabetic men and women
* normal body mass index (BMI; between 18.5 and 25 kg/m2)

Exclusion Criteria:

* severe chronic disease (e.g. coronary heart disease, diabetes mellitus, kidney or liver conditions, endocrine conditions)
* gastrointestinal disorders
* pregnancy
* lactation
* competitive sports
* alcohol
* drug dependency
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a premenopausal female at the time of Screening.
* Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound).
* Subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by menstrual blood loss \> 80 mL during each of two screening menses as measured by the alkaline hematin method.
* Subject has negative urine and/or serum pregnancy test in Screening and just prior to first dose.
* Subject has an adequate endometrial biopsy performed during Screening, the results of which show no clinically significant endometrial pathology.

Exclusion Criteria:

* Subject has screening pelvic ultrasound or saline infusion sonohysterography results that show a clinically significant gynecological disorder.
* Subject has history of osteoporosis or other metabolic bone disease.
* Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
* Subject has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
* Subject is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over the counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.
A Study of Medical Records From Children With Central Precocious Puberty (CPP) in China

The main purpose is to describe how many children were treated during 24 months or less because of CPP and how treatment worked for them.

There are no participants in this trial, the study only involves reviewing participants medical past and current records and collecting information.

This is an observational, non-interventional, retrospective study to evaluate the participants characteristics, current treatment patterns and resource usage in Chinese pediatric participants diagnosed with CPP.

This study will enroll approximately 1000 participants.

The data available in an existing data source the Chinese CPP Big Data Platform database will be analyzed. All the participants will be assigned to a single observational cohort:

• Pediatric Participants With CPP

This multi-center trial will be conducted in China. The overall duration of the study will be approximately 3 years.

Eligibility Criteria:
Inclusion Criteria:

• Participants diagnosed with CPP and treated with GnRHa from the centers participating in this study within the Chinese CPP Big Data Platform database since 2015 to 2024.

CPP diagnosis is based on the clinical assessment and description by CPP specialized doctors.

Exclusion Criteria:

* Not received GnRHa as the treatment for CPP.
* No available data for analysis.
Effects of Jacobson's Progressive Muscular Relaxation Technique in Hypertensive Patients

Effects of Jacobson's progressive muscular relaxation technique on blood pressure regulation and activity of daily living in hypertensive patient

Hypertension is a disease that becomes a major problem of health. In 2008, 40% of adults aged 25 years above were diagnosed with hypertension. The mortality rate of the complications of hypertension reaches 9.4 million deaths worldwide each year. Hypertension is often called a ''silent killer'' because it often appears without symptoms until it becomes severe and impacts on other organs. Hypertension affects both on physical and psychological. Several studies have found that hypertension can cause anxiety. Hypertension requires comprehensive pharmacological and non-pharmacological treatment. Since 1983, the World Health Organization has suggested the use of the non-pharmacological approach in hypertension treatment. Progressive Muscle Relaxation (PMR) is one of the therapies that is mostly used in complementary therapy and alternative medication. PMR is a technique developed by Edmund Jacobson in 1920. This technique is designed to create a state of physiological and psychological relaxation in patients. It requires the patient to tense and relax various muscle groups while focusing awareness on proprioceptive and interceptive sensations. Several studies have found that PMR exercise helps to reduce blood pressure. Besides, PMR exercise can also reduce anxiety in various diseases.

Study design will be randomized controlled trial. Study will be conducted at Life care Hospital Gujranwala. Written informed consent will be obtained. Patients will be allocated randomly. Subjects meeting the predetermined inclusion and exclusion criteria . Questionnaire will be used as subjective measurements of activity of daily living and Bp will be monitored for initial readings.subjects will be divided into two groups both groups will perform 30 minutes walk as baseline treatment. only one group will receive Jacobsons muscle relaxation technique. Patients will be demonstrated with the technique to contract and relax various groups of muscles, to coordinate contractions and relaxations with deep breaths and to perform the entire procedure with eyes closed in supine lying down position. Every subject will perform this supervised relaxation for 6 repetitions during a single session on once a day basis for four weeks. At the end of 4 weeks of treatment session blood pressure will be recorded questionnaire will be filled. The data thus obtained will be considered for statistical analysis

Eligibility Criteria:
Inclusion Criteria:

* Age: 35 to 55 years
* Ambulatory male and female
* Mentally fitted
* Diagnosed with grade 2 and grade 3 hypertension(3)

Exclusion Criteria:

* Subjects who are not regular in taking medications and who reported about aggravation of any symptoms due to exercise.(7)
* Subjects who fall in grade1 hypertension
* Subjects below the age of 30.
* History of cardiac, renal and liver diseases
* History of recent fracture or surgery.
Assessment of Renal Function in Cirrhotic Patients

The purpose of this study is to help determine whether cystatin C is a more sensitive laboratory measurement for renal function in cirrhotic patients.

Serum cystatin C, creatinine clearance based calculations, and 125I-Iothalamate clearance (Glofil) will be obtained in 220 patients with cirrhosis. Utilizing this information, the correlation between cystatin C and 125I-Iothalamate clearance will be obtained. In addition, the current serum creatinine based calculations and true creatinine clearance will also be correlated with 125I-Iothalamate clearance. The results of this study should help to determine whether serum cystatin C is a more sensitive laboratory measurement of renal function in patients with cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* over 18 undergoing evaluation for a liver transplant

Exclusion Criteria:

* known allergy or sensitivity to 125I-Iothalamate
Outcomes and Perceptions of the Implementation of the JADA Device in a Stage II Postpartum Hemorrhage Management Protocol in Referral Hospitals of the Colombian Pacific Region

This study focuses on postpartum hemorrhage (PPH), a condition that stands out as the leading cause of global maternal mortality. Annually, about 14 million women experience PPH, resulting in approximately 70,000 deaths. This condition presents a higher risk in low- and middle-income countries (LMICs), particularly where access to quality care is limited. Recognizing the urgency of addressing this public health problem, the Colombian Ministry of Health and Social Protection has implemented the Maternal Mortality Reduction Acceleration Plan (PARE) to improve maternal mortality indicators and meet the Sustainable Development Goals (SDGs).

The project will evaluate the results and perception of a new device in the management of stage II PPH in referral hospitals in the department of Valle del Cauca, integrated in the Hospital Padrino strategy. This initiative seeks not only to improve the understanding and treatment of PPH, but also to strengthen institutional capacities through education, creation of telecare networks and care services adapted to local needs.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who are admitted to the obstetrics service scheduled for vaginal delivery in any of the participating hospitals: Fundación Valle del Lili, Hospital Universitario del Valle and Hospital Luis Ablanque de la Plata.
* Patient admitted during the shift of one of the gynecologists trained in the use of the JADA device in the context of the research project.

Criteria for the use of JADA device:

* Pregnant women over or equal to 18 years of age.
* Gestational age of pregnancy greater than 32 weeks of gestation.
* Pregnant with vaginal delivery.
* Pregnant with postpartum hemorrhage due to uterine atony that does not respond to treatment with uterotonics and uterine massage.
* Postpartum hemorrhage uterine stage/stage II.
* Vaginal delivery attended in a health institution in the context of the Hospital Padrino strategy (Fundación Valle del Lili or Hospital Universitario del Valle or Hospital Luis Ablanque de la Plata).

Exclusion Criteria:

* Patients who, according to the attending physician's criteria, are not candidates for vaginal delivery.
* Abnormality of the normal uterine anatomy.
* Placental abnormalities.
* Maternal anemia with hemoglobin less than 7 mg/dl prior to delivery.
* Those who do not sign informed consent.
Evaluation of Treatment Predictors Reflecting Beta-catenin Activation in Hepatocellular Carcinoma

This prospective clinical trial will evaluate PET/CT and genomic liquid biopsy based biomarkers as predictors of clinical therapeutic response to immune-checkpoint inhibitor (ICI) therapy for patients with inoperable hepatocellular carcinoma (HCC). The primary objective of this diagnostic trial is to assess the accuracy of pre-treatment fluorine-18 (18F-) fluorocholine (FCH) PET/CT for predicting a lack of objective response (LOR) after 16 weeks of ICI therapy.

This is a prospective open-label single-arm diagnostic clinical trial evaluating fluorine-18 fluorocholine (FCH) PET/CT and cell-free DNA mutation profiling (also referred to as genomic liquid biopsy) as diagnostic tools for predicting therapeutic response in advanced HCC patients receiving immune-checkpoint inhibitor (ICI) therapy. All enrolled subjects will undergo diagnostic testing with FCH PET/CT and genomic liquid biopsy before ICI treatment. A fluorine-18 fluorodeoxyglucose (FDG) PET/CT may also be performed before treatment and after 8 weeks if the pre-treatment FCH PET/CT shows low or heterogeneous tumor uptake. The accuracy of tumor biomarkers based on PET/CT and liquid biopsy for predicting therapeutic outcome and disease progression will be determined using objective clinical endpoints based on the radiographic classification of treatment response by RECIST v1.1 applied to CT or MRI performed after 16 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older (no upper limit of age)
* Hepatocellular carcinoma diagnosis made histologically or radiographically in accordance to National Comprehensive Cancer Network guidelines (3.2019 version or higher)
* Does not qualify for surgical resection or locoregional therapy alone or has disease that has progressed after surgical resection and/or locoregional therapy
* Has measurable disease defined as at least one tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 on CT/MRI completed within past 6 weeks of eligibility screening
* Under the care of a licensed medical oncologist
* Life expectancy \> 6 months
* Deemed eligible for treatment with an immune checkpoint inhibitor agent based on the treating medical oncologist's assessment of previous treatment failure, clinical/performance/virology status, and liver/renal/hematologic function.
* Child-Pugh score of 9 or less
* Creatinine clearance ≥ 40 mL/min, measured or calculated using the Cockcroft-Gault formula
* ALT and AST ≤7x upper limit of normal
* Total bilirubin ≤4 mg/dL
* Albumin ≥2.8 g/dL

Exclusion Criteria:

* Weight \> 500 lbs (PET/CT limit)
* Pregnant or lactating female (those of child-bearing potential must be re-screened within 7 days prior to PET/CT imaging)
* Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure
* Concurrent treatment with a non-targeted therapeutic agent. Concurrent enrollment in an ICI-treatment trial and combination ICI treatment are allowed.
The Effect of External Diaphragmatic Pacemaker on the Patients With Chronic Cor Pulmonale

This study evaluates the effect of external diaphragmatic pacemaker on the patients with chronic cor pulmonale. Half of participants will receive external diaphragmatic pacemaker, while the other half will receive routine therapy.

Investigate the effect of external diaphragmatic pacemaker on chronic cor pulmonale, the indicators include: respiratory muscle force, diaphragmatic degree of excursion and thickness, pulmonary artery pressure, respiratory distress, feeling of fatigue and quality of life, pulmonary function,NT-proBNP,PaO2 and PaCO2.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic cor pulmonale and admit to hospital

Exclusion Criteria:

* pneumothorax or mediastinal emphysema
* active tuberculosis
* install a cardiac pacemaker
* acute cardiocerebrovascular events: acute myocardial infarction, acute myocarditis, severe arrhythmia, severe cerebrovascular accidents.
* pregnancies
* end-stage patients (expected survival time less than 6 months)
Automated Robotic TCD in Traumatic Brain Injury

This study's objective is to determine the safety, feasibility and efficacy of prolonged automated robotic TCD monitoring in critically ill patients with severe TBI across multiple clinical sites with varying levels of TCD availability and experience

Upon informed consent, patients will undergo daily automated robotic TCD monitoring sessions for up to 4 hours a day for a total duration of at least 3 days and up to 5 days whenever clinically feasible. TCD monitoring of bilateral middle cerebral artery cerebral blood flow velocity (MCA CBFV) will be performed using a robotic TCD system equipped with bilateral 2-MHz Doppler probes. This system allows for continuous bilateral extended duration recording of MCA CBFV, using robotically controlled TCD probes that allow automated angle correction to maintain optimal MCA insonation.

Safety measures: patient discomfort, device dislodgement or skin lesion at the site of insonation Feasibility: feasibility of using bilateral automated robotic TCD monitoring device on severe TBI patients for \>= 4 hrs per day that can provide clinically useful/meaningful data for over 50% of the total monitoring period

Additionally, a 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived safety and feasibility of protocol implementation.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18
* Blunt TBI with Glasgow Coma Score (GCS) ≤8
* Injury within 72 hours
* Adequate TCD windows
* Ability to obtain informed consent from a Legally Authorized Representative (LAR)

Exclusion Criteria:

* Catastrophic brain injury with grim prognosis (e.g.: GCS 3 with bilateral mid-position pupil)
* C- spine fracture with evidence of spinal cord injury
* Severe skull or scalp injury precluding device placement
* Planned decompressive hemicraniectomy
* Continuous fever for \>6 hours at the time of enrollment (despite treatment)
* Lack of TCD window
Quality in Patients With Permanent Hypoparathyroidism After Total Thyroidectomy

Quality of life study. The study with include all patients operated with total thyroidectomy between 2005-2015 in Uppsala-Örebro healthcare region, Sweden. The study population has been identified in a previous study and includes close to 1700 patients, of which about 200 developed permanent hypoparathyroidism after surgery.

Quality of Life will be assessed using SF-36 Health Surgery and the outcome for patients with and without permanent hypoparathyroidism will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Total thyroidectomy between 2005-2015 in Uppsala-Orebro healthcare region.

Exclusion Criteria:

* Malignancy
* Sternotomy
* Previous thyroid surgery
* Previous or concurrent parathyroidectomy
Impact of Breast Magnetic Resonance Imaging (MRI) on Mastectomy Rates

The primary goal of this study is to determine if preoperative breast MRI findings resulted in more extensive surgery, i.e., mastectomy than breast conserving surgery, i.e., lumpectomy in early stage breast cancers at Summa Akron City Hospital. Early stage breast cancer is defined as breast tumor size less than 5 cm.

The objectives are to:

* Review early stage breast cancer patient cases treated at Summa Akron City Hospital between 2006 and 2009 to evaluate clinical and pathological staging
* Determine the results of preoperative breast MRI and the impact on type of surgery performed
* Evaluate the decision to have mastectomy rather than lumpectomy, i.e., physician or patient decision and if this decision was based on breast MRI findings

Early stage breast cancer cases between 2006 and 2009 will be identified by the Summa Akron City Hospital cancer registry. The cases will be reviewed and abstracted. The abstracted data will include results of physical breast examinations, mammograms, sonograms, breast MRI reports, biopsy procedure notes and pathology reports to illustrate the clinical stage. Definitive surgical pathology reports will be included in the abstracted data to demonstrate the final pathologic stage of the breast cancer.

A database will be developed to capture the abstracted data. Outcomes will be determined based on final pathology reports.

Eligibility Criteria:
Inclusion Criteria:

* early stage breast cancer between 2006-2009
* preoperative MRI

Exclusion Criteria:

-
Analgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain

The analgesic effects of ultrasound-guided dry-needling therapy will be evaluated in the management of head and neck pain.

The analgesic effects of ultrasound-guided dry-needling therapy will be evaluated in the management of head and neck pain by myofascial active and latent trigger point.

The myofascial pain control will be assessed for the superficial and deep posterolateral muscle complex of neck. The analgesic request, Range Of Motion (ROM), Motion Related Pain (MRP) and the quality of life, will be also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Chronic neck pain
* Chronic head pain

Exclusion Criteria:

* previous surgery of neck and head
* Body Mass Index \> 39,99
* politrauma patients
* pregnancy
* neck and head infections
Screening of ATTRwt in Patient With Advanced AV-Block Undergoing Pacemaker Implantation

The investigators will nationally investigate the prevalence of Transthyretin Amyloidosis wildtype (ATTRwt) in patients of ≥ 65 years with left ventricular hypertrophy who present with high degree atrioventricular block (AV-block) and are admitted for pacemaker implantation. The investigators aim to characterize the group of patients with positive screening of ATTR and compare the ATTRwt disease stage at time of diagnosis for patients identified with ATTR at screening with a control group of routinely clinically diagnosed ATTRwt patients.


Eligibility Criteria:
Inclusion Criteria:

* Men ≥65years or women ≥75years with unexplained AV-block with pacemaker indication, as decided per treating physician and presence of left ventricular hypertrophy ≥12mm.

Exclusion Criteria:

* Reversible causes for AV-block, som as AV-node disturbing medicament, ion-disturbances, hypothyroidism, hypoxia, ischemia, new heart surgery \<1month, endocarditis.