cyrilzakka/clinical-trials huggingface dataset:
Functional Proteins in Polycystic Ovary Syndrome

The concentration of functional proteins: kisspeptin, ghrelin, zonulin will be measured and compared in women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), in women with PCOS without IR, and in women without PCOS.

Polycystic Ovary Syndrome (PCOS) is currently the most common endocrine disorder in women of reproductive age with an unknown etiology. A predominant metabolic feature of PCOS is insulin resistance (IR), which contributes to the pathogenesis and expression of other symptoms of the syndrome, such as hyperandrogenism. The metabolic disturbances in women with PCOS result in a higher incidence of cardiovascular diseases and endometrial cancer in the premenopausal age. The gold standard for assessing peripheral tissue sensitivity to insulin is the hyperinsulinemic-euglycemic clamp technique; however, this method is not commonly used in clinical practice due to its complexities. Instead, simpler tests, such as the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and fasting insulin measurements along with glucose tolerance tests, are employed. These methods are utilized for diagnosing insulin resistance rather than identifying predispositions. Therefore, there is an urgent need to identify more precise markers of IR that could be used in routine early-stage assessments. Given the long-term complications associated with PCOS, which can shorten life expectancy, early diagnosis and treatment of IR are crucial. Furthermore, such studies may contribute to exploring the etiopathogenesis of the syndrome. The discovery of "markers" that can predict or diagnose metabolic abnormalities at an early stage, prior to the onset of clinical symptoms, would facilitate early intervention and treatment, thus preventing a decline in quality of life associated with PCOS.

This study will measure and compare the concentrations of locally acting hormones: ghrelin, kisspeptin, and zonulin in three research groups: women with polycystic ovary syndrome (PCOS) and insulin resistance (IR), women with PCOS without IR, and women without PCOS. Measurements will be performed using immunoenzymatic methods (ELISA) and the Erba XL biochemical analyzer. Statistical calculations will be conducted using SPSS Statistics software.

Eligibility Criteria:
Inclusion Criteria:

* women aged 18-45 years

Exclusion Criteria:

* removal of at least one ovary
* treated diabetes of any type
* diagnosed and treated metabolic diseases
* diagnosed and treated autoimmune diseases
* diagnosed and treated autoinflammatory diseases
A Pilot Study of Neuro Hand Orthosis Program In Stroke Upper Limb Rehabilitation

The implementation of Neuro Hand Orthosis Upper Limb Program can significantly improve the severe stroke paralytic arm in subacute rehabilitation as compared with the use of conventional therapy.

The neuro hand orthosis is based on a design of dynamic hand orthosis for orthopaedic patients. We attempt to apply such an orthosis on stroke patients to aid in regaining movement from severe paralytic arm by helping the patients to support their wrist and finger in a functional position for grasping. The patient is then encouraged to produce voluntary movement from the severe paralytic arm to transport an object (ball) from place to place either in sitting or standing position.

Since intensive arm usage is associated with neuro reorganisation, we propose designing a program with the neuro hand to encourage usage of the paralysed hand and help overcome the barriers of poor motivation and lack of arm usage through self practice program.

Eligibility Criteria:
Inclusion Criteria:

* Post stroke between one week to three months and medically stable
* Right Hemiplegia with right hand dominant
* Able to stand with minimum assistance
* AMT score not lesser then 7/10
* Motricity Index Arm Score \<36/100

Exclusion Criteria:

* Unable to commit to the Neuro Hand Orthosis Program (either as in or out patients) for 10 weeks according to the program regime or unable to follow the control group regime for 10 weeks
* Pre-existence shoulder or upper limb pain
* Pre-existence moderate or severe hand oedema
* Patients with terminal disease
* Resident of Institution (eg, Nursing home etc prior to admission)
* Pre-existing upper limb disability on affected arm
* Psychiatric problem
A Pilot Methodology Study To Evaluate Changes In Bone Quality Parameters Following Therapy With Forteo

This methodology trial will be conducted in patients with osteoporosis and will measure the changes in bone quality parameters, micro- and macroarchitecture, bone biomarkers and bone density following therapy with the approved drug, Forteo.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with osteoporosis

Exclusion Criteria:

* Any therapies or products affecting bone turnover within 12 months of Screening.
* Bisphosphonate treatment \>1 month in total duration at any time in the past.
* In addition, patients must be bisphosphonate-treatment-free for at least 12 months prior to Screening.
Sequent Extended Study

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Sequent Please Neo to meet EU Medical Device regulation (MDR) requirements in all the consecutive patients treated with Sequent Please Neo.

The objective of this multicenter, prospective, non-randomized, postmarket clinical follow-up(PMCF) study is to confirm and support the clinical safety and performance of the Sequent Please Neo in a NON-SELECTED, Real Word population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device Regulation requirements for post-market clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Sequent please neo according to routine hospital practice and following instruction for use.
* Informed Consent Signed.

Exclusion Criteria:

* Patient life expectancy less than 12 months.
* Contraindication for antiplatelet therapy.
* Not meet inclusion criteria.
Developing Culturally-Tailored Information-Based Support Groups for Chinese Immigrants With Breast Cancer

There are few breast cancer support groups that focus on the specific needs of Chinese women. The purpose of this study is to learn about two different ways of providing support groups to help women of Chinese descent cope with the difficulties of a diagnosis of breast cancer and its treatment. The investigators want to learn about how best to support Chinese women with breast cancer by providing two different types of groups: an in-person support group and a virtual (online/phone) support group.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Non-US born
* Resident in the US \< 20 years
* Of Chinese descent
* Age 21 years through 80 years
* Language spoken: Mandarin
* Diagnosis of breast cancer within 3 months prior to recruitment

  \*Not required that breast cancer is the patients' first and/or only cancer diagnosis
* Currently receiving cancer treatment;
* Will be living continuously in the US for the next year
* Has a telephone that he/she is willing to use for the study

Exclusion Criteria:

* Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
* Another household member is already enrolled.
* Prior participation in a cancer support group
Visceral Fat and Cardiometabolic Risk

The present study showed that the 75th percentile of visceral fat area in boys and girls is the optimal cutoff for screening cardiometabolic risk and its clustering, but the 80th percentile is the optimal cutoff for hyperglycemia screening in girls. The investigators proposed simplified cutoffs of 37.19 cm2 and 31.09 cm2 aged 6 to 8 years, 56.76 cm2 and 39.51 cm2 aged 9 to 11 years, 57.03 cm2 and 38.33 cm2 aged 12 to 15 years, and 58.32 cm2 and 53.91 cm2 aged 16 to 18 years for boys and girls, respectively. Both the optimal and simplified methods were verified in a 2-year longitudinal cohort. An improved understanding of the importance of visceral fat to cardiometabolic risk and its clustering in children may yield insight into the risks associated with child obesity and the initial phases of cardiovascular disease development, especially in normal-weight boys.


Eligibility Criteria:
Inclusion Criteria:

Healthy children and adolescents aged 6-18 years

Exclusion Criteria:

Heart disease Kidney disease Thyroid disease Individuals who take hormone medication Missing data for anthropometry
High Cessation Rates in Smokers Using Personal Vaporizers

E-cigarettes are proving to be an attractive long-term alternative to conventional cigarettes. Although they may also help smokers to remain abstinent during their quit attempt, recent clinical trials with first generation e-cigarettes have shown only modest quit rates. Second generation devices may result in much higher quit rates. Their efficacy and safety in long-term smoking cessation and/or smoking reduction studies have never been investigated.

In this prospective proof-of-concept study we monitored modifications in smoking habits of 50 regular smokers (unwilling to quit) who were asked to switch to a second generation device focusing on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product usage, number of cigarettes smoked, and exhaled carbon monoxide (eCO) levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and participants' opinions of these products were also reviewed.


Eligibility Criteria:
Inclusion Criteria:Healthy smokers 18-60 years old, smoking ≥15 conventional cigarettes per day (cig/day) for at least 10 years were recruited using anti-smoking leaflets and by an approved kiosk located in the atrium of the university hospital (AOU 'Policlinico-V. Emanuele') promoting the smoking cessation services of the CPCT (Centro per la Prevenzione e Cura del Tabagismo, Università di Catania, Italy).

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Exclusion Criteria:history of alcohol and illicit drug use, major depression or other psychiatric conditions. We also excluded subjects who reported recent myocardial infarction, angina pectoris, essential hypertension (\>140mmHg systolic and/or \>90mmHg diastolic), diabetes mellitus, severe allergies, poorly controlled asthma or other airways diseases

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Pancreatitis - Microbiome As Predictor of Severity

This study is a multicentric prospective study initiated and coordinated from the University Medical Centre Goettingen. The study aims to evaluate the orointestinal microbiome as a potential biomarker for the course, severity and outcome of patients with acute pancreatitis.

This prospective translational study aims to evaluate the orointestinal microbiome as a potential biomarker for the course, severity and outcome of patients with acute pancreatitis. From each patient one buccal and rectal swab is collected within 72 h after hospital admission. Microbial composition will be determined by 16S and metagenomics Oxford Nanopore Sequencing (ONT) and correlated with the revised Atlanta classification as the primary endpoint. Secondary endpoints are the correlation of microbiome signatures with the length of hospital stay, numbers of interventions and mortality. To this end, alpha and beta diversity of microbiota are determined and compared between mild, moderately severe and severe acute pancreatitis.

Eligibility Criteria:
Inclusion Criteria:

Patients with acute pancreatitis (2 out of 3 following diagnostic criteria: lipase \>3x of upper limit, abdominal pain, and imaging modalities (computed tomography, magnetic resonance imaging or ultrasound).

\< 72 hours after hospital admission.

Exclusion Criteria:

Pregnant women Patients \< 18 years; Patients who are incapable of giving consent
Enhanced Recovery After Cardiac Surgery

Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide. The principles of Enhanced Recovery Protocols are those of early mobilization and restoration of normal function as soon as possible after surgery. These principles are achieved by use of alternate pain control regimens and removing invasive lines and drains as soon as possible. The benefits of ERPs are improved patient experience, earlier return to normal function and reduced length of stay. Enhanced recovery protocols for cardiac surgery have been published by the Enhanced Recovery After Cardiac Surgery Society.

The current study will investigate whether it is possible to utilise ERP bundles in the population of cardiac surgery patients at James Cook Hospital, with a view to rolling out a full ERP service. Secondary study outcomes will be patient-centred, including; pain scores, nausea and vomiting rates and time taken to return to normal function.

Why? Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide. The principles of Enhanced Recovery Protocols are those of early mobilization and restoration of normal function as soon as possible after surgery. These principles are achieved by use of alternate pain control regimens and removing invasive lines and drains as soon as possible. The benefits of ERPs are improved patient experience, earlier return to normal function and reduced length of stay. Enhanced recovery protocols for cardiac surgery have been published by the Enhanced Recovery After Cardiac Surgery Society. These protocols have been demonstrated as safe, though have yet to make it into mainstream practice in the UK. The use of ERPs in Cardiac Surgery has the potential to greatly improve the patient journey and hospital efficiency.

What? The current study will investigate whether it is possible to utilise ERP bundles in the population of cardiac surgery patients at James Cook Hospital, with a view to rolling out a full ERP service. Secondary study outcomes will be patient-centred, including; pain scores, nausea and vomiting rates and time taken to return to normal function.

Who? All adult patients over the age of 18 years and listed for cardiac surgery will be considered for inclusion in this study.

Where? The study population will be comprised of patients undergoing cardiac surgery at the James Cook University Hospital in Middlesbrough.

How? Study duration will be 6 months, with 80 patients (comprising a control and intervention group)

Eligibility Criteria:
Inclusion Criteria:

* Having Cardiac Surgery
* Aged 18 years or older at the time of consent
* Deemed appropriate for ERAS by Surgeon and Anaesthetist
* Able and willing to provide written informed consent

Exclusion Criteria:

* Aged 18 years or under
* Deemed not suitable for ERAS by Surgeon and/or Anaesthetist
A Smartphone Application for Neurology and Telemedicine

This observational research study is designed to assess the feasibility of developing a new software application that can be used in the home using a commercially available camera to measure abnormal body movements associated with Parkinson's disease (PD). The goal of this study is to validate the motor outcomes derived from a consumer camera observing a sub-set of standardized assessment tasks with respect to the reference motion capture system.

The long-term goal of this project is to develop a new software application (NeuroVision App) for a smartphone or tablet that can be used in the home to measure abnormal body movements associated with Parkinson's disease (PD). The outcomes are intended to enhance PD symptom monitoring in the context of telehealth videoconferences with a clinician. Typical abnormal body movements that can be assessed with the proposed solution include uncontrolled shaking of hands and limbs (tremor) or spastic movements (dyskinesia) while at rest; abnormally slow movements when reaching or walking (bradykinesia); or inability to initiate a movement (akinesia) using 5 standardized motor assessment tasks (sitting at rest, walking, finger tapping, foot tapping, and foot stomping) derived from the Unified Parkinsons Disease Rating Scale (UPDRS). The proposed solution will make it easier for the doctor to periodically assess the motor signs of PD during remote telehealth appointments which may be more convenient and safer for the patient. Current reliance on videoconferencing apps make it difficult to record and measure such symptoms accurately in a telehealth setting.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female;
* 35 years of age or older;
* Physician-diagnosed Parkinson's disease or other movement disorder such as Essential Tremor or Dystonia;
* One or more mild to moderate motor symptoms of PD (tremor, bradykinesia, akinesia, Parkinsonian gait);
* Hohn and Yahr (Stage I-III);
* Independent ambulator - walker or cane allowed;
* Referring neurologist indicates that prospective subject is not at high fall risk and can safely participate in the study;
* Have participated in prior telehealth visits using videoconferencing app;
* Have used a smartphone in past to record videos;
* Able to provide his/her written informed consent to participate in the study as stated in the informed consent document;
* American-English speaking; able to follow directions in English;
* Normal hearing.

Exclusion Criteria:

* Inability to understand spoken English or follow simple instructions;
* Inability to provide written informed consent.
Supine Versus Prone PNL in Pediatric

To Compare the safety and efficacy of PNL in a modified flank-free supine position versus prone position in pediatric patients

Incidence of pediatric urolithiasis varies from 5%-15% in developing countries to 1%-5% in the developed ones. The 5-year recurrence rate of about55% (range, 38%-70%). Fernstrom and Johansson first introduced percutaneous nephrolithotomy (PNL) in 1976. Since that PNL has become widely used for multiple indications. Pediatric PNL was done in the prone position with more rapid and easy puncture point determination, wider field for renal puncture, free application of multiple accesses, and avoidance of visceral injuries, especially the colon. PNL in the supine position has several advantages as, similar success rate and a shorter operative time than conventional PNL. The Amplatz sheath is oriented downward, maintaining a low pressure in the renal pelvis and reducing the fluid absorption with rapid drainage of the fragmented stones. Furthermore, it's easier for the anesthesiologist to control the airway and reduce the neural and ophthalmologic pressure lesions than the prone position. Desoky et al in 2012 described the flank-free modified supine position (FFMSP) and claimed that this position overcomes the mechanical limitation of ordinary supine position because of ample space for puncture, dilatation, multiple tracts, and maneuverability of the system with the nephoscope. Moreover, the surgeon can comfortably sit during the operation, and X-ray exposure is reduced because puncture and dilatation are quite perpendicular to the body, and the operator's hands are outside the fluoroscopic field. it's better to do supine PNL in case of retro renal colon. as we see the supine position in pediatric is still under research and few trials about it had been done with no clear recommendation, so we will compare PNL in pediatric age group in modified free flank supine position versus prone position.

Eligibility Criteria:
Inclusion Criteria:

Age ≤ 18 years old. Renal stones are amenable for PNL with Guy's stone score 1-2.

Exclusion Criteria:

congenital anomalies. skeletal anomalies. bleeding diathesis. active urinary tract infection. Patient refusing participation. Patients with PCN.
CH1701 for Prevention and Treatment of Radiation Burns

A combined Phase I\&II, randomized, double-blind, placebo-controlled clinical trial to evaluate efficacy and safety for prevention and treatment of radiation therapy burn of CH1701


Eligibility Criteria:
\*Phase I:

Inclusion Criteria:

* Healthy volunteers, aged 18 and older at the time of enrollment
* Voluntarily participate in the study by signing a consent form to participate in the study
* Ability to adhere to treatment according to researchers' assessment

Exclusion Criteria:

* Subjects with other acute or chronic diseases need to be treated
* It is not possible to comply with the research or studied drug treatment process in the opinion of the researcher

  * Phase II:

Inclusion Criteria:

* Female patient, aged 18 to 60 years old
* Having been diagnosed with breast cancer with axillary lymph node metastasis, having radiation therapy for radiation therapy in the range of 45-50 Gy for a period of 5-6 weeks
* Treatment can be started within 3 days of signing the consent to participate in the study
* Agree to voluntarily sign the consent form to participate in the study

Exclusion Criteria:

* The available skin lesions in the breast and chest and according to the researchers' judgment will affect the assessment of inflammation caused by radiation
* The patient had radiation therapy before the breast area
* History of connective tissue disorders
* The patient is incapable of complying with the research procedures or is unable to ensure compliance with the study medication as assessed by the researcher
* Participate in other clinical trial studies within 1 month before joining this study
A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 474121 in the Blood

The main objective of this trial is to investigate the effect on the exposure of BI 474121 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
* Age of 18 to 50 years (inclusive)
* BMI of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including blood pressure, pulse rate or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Further exclusion criteria apply