cyrilzakka/clinical-trials huggingface dataset:
A Quality of Life Study of Peginterferon-Alfa-2a Plus Ribavirin in Participants With Chronic Hepatitis C and Persistently Normal Alanine Transaminase (ALT) Levels

Participants with Chronic Hepatitis C (CHC) and normal ALT, who have been under treatment with peginterferon alfa-2a and ribavirin for at least 4 weeks, will be enrolled into this non-interventional, open-label study. The primary aim is to evaluate quality of life according to the 36-Item Short-Form Health Survey (SF-36) questionnaire, modified for the Greek population.


Eligibility Criteria:
Inclusion Criteria:

* Serological confirmation of chronic infection by anti-hepatitis C virus (HCV) assay
* HCV ribonucleic acid (RNA) positive
* CHC with normal transaminases
* Compensated liver disease
* Non-pregnant and willing to use two contraceptive methods (if fertile)
* At least 4 weeks of prior treatment with peginterferon alfa-2a and ribavirin

Exclusion Criteria:

* Pregnant or lactating women
* Co-infection with hepatitis A or B, or human immunodeficiency virus (HIV)
* History of seizures or depression
* History of autoimmune disease, severe heart or lung disease, or renal failure with reduced creatinine clearance
* Uncontrolled thyroid disease
* Severe retinopathy
* Leukopenia or thrombocytopenia
* Bleeding esophageal varices or other evidence of hepatic decompensation
Revive Toric RWE Study

This is a post-market observational clinical investigation. The objective of this observational study is to evaluate the visual performance and HCP satisfaction of REVIVE samfilcon B custom toric contact lenses.


Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years or older on the date the ICF is signed
2. Have the capacity to read, understand, and provide written voluntary informed consent
3. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings
4. Have no active ocular disease or allergic conjunctivitis
5. Not be using any topical ocular medications
6. Be willing and able to follow instructions
7. Have signed a statement of informed consent
8. Be an experienced soft contact lens wearer (have previously used soft contact lenses)
9. Meet the indications per the Instructions for Use (IFU) and have a suitable prescription for treatment with the device

Exclusion Criteria:

1. Is participating in another research study
2. Is considered by the Investigator to not be a suitable candidate for participation
3. Is not eligible for treatment with the study lens per the IFU (contraindicated)
4. Has had previous ocular surgery
5. Is taking/using ocular, systemic, or topical medications that, in the Investigator's opinion, could potentially affect ocular physiology or lens/solution performance
Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children

The goal of CPP-EDG 01 study is to assess possible genetic and/or environmental parameters which may influence the growth rate of children affected by precocious puberty. In this view, we are collecting clinical data and biological samples of children attended as outpatients at the Pediatric Endocrine Center of Pisa from 1998 to present (the study is still open). From biological (blood) samples, gene polymorphisms such as endocrine disruptor levels are determined and compared to different growth pattern of pediatric patients treated with different GnRH agonists.


Eligibility Criteria:
Inclusion Criteria:

* Clinica diagnosis of central precocious puberty
* Diagnosis is based on growth spurt, bone age advancement, positive GnRH agonist stimulating test, pubertal sex steroid levels before 8 years of age for female and 9 years for male, respectively

Exclusion Criteria:

* Thyroid disorders
* Peripheric diagnosis of precocious puberty
* Genetic disorders
Quantification of Upper Trapezius Muscle Stiffness Using Supersonic Shear Wave Imaging: Efficacy of Workplace-based Exercise Programme to Reduce Neck and Shoulder Disorders in Working Population

Objectives: (1) To examine the upper trapezius muscle stiffness using SSI in workers with and without neck/shoulder disorders; and (2) to develop a workplace-based exercise programme to reduce upper trapezius muscle stiffness and to enhance shoulder function and work ability in the working population.

Hypotheses to be tested: (1) Workers with neck/shoulder disorders demonstrate increase upper trapezius muscle stiffness when compared to healthy control; and a cutoff value of the upper trapezius stiffness was established for early identification of individuals at risk of having neck/shoulder disorders in the working population; (2) Workplace-based exercise programme can reduce upper trapezius muscle stiffness and enhance shoulder function and work ability in the working population.

Design: Part A study: Cross-sectional study; Part B study: randomized controlled trial

Subjects: One-hundred office computer workers with or without neck/shoulder pain

Study instruments: Supersonic shear wave imaging

Main outcome measures: Upper trapezius muscle stiffness, Shoulder Pain and Disability Index (SPADI), Neck Disability Index, Disability of the Arm, Shoulder and Hand (DASH), work ability index (WAI).

Data analysis: Between-group comparisons to show differences in the outcome measures will be analyzed using Independent t-test. To compare the treatment effects, repeated-measures analysis of variance test (between-group factor: intervention vs control; within-subject factor: time (baseline, 6 week and 1 year)).

Expected results: Workers with neck/shoulder disorders demonstrate increase upper trapezius muscle stiffness when compared to healthy control. Workplace-based exercise programme can reduce upper trapezius muscle stiffness and enhance shoulder function and work ability in the working population.


Eligibility Criteria:
Inclusion Criteria:

* Office computer workers who worked for a minimum of four hours per day using a computer
* With or without neck/shoulder pian

Exclusion Criteria:

* Involved regular strength training of the neck/upper extremities within the past 12 months;
* history of whiplash, neck/upper limb fractures, previous surgery and previous clinical treatment for a neck/upper limb injury within the last 12 months;
* Fibromyalgia;
* Pregnancy;
* Neurological disorders.
Methodological Developments for Magnetic Resonance Imaging (MRI)

The purpose of this study is to optimize clinical MR protocols and to validate MR acquisition parameters.


Eligibility Criteria:
Inclusion Criteria:

* to be over 18 year-old,
* to be able to give an informed consent,
* to have underwent a pre-inclusion medical examination,
* to present no contraindication to MR examination,
* to be enrolled in a social security plan.

Exclusion Criteria:

* subject refusal,
* subject under a measure of legal protection,
* any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, ... ).
Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear

Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant. Recent findings in hearing technology allow for people to either use a hearing aid or a Contralateral Routing of Signal (CROS) device on the non-implanted ear. Differences in speech understanding may result depending on the device chosen by a person, and these differences may be measureable through speech discrimination measurement methods.

This study intends to determine whether or not a CROS device improves speech perception in noise when the source of the speech of interest originates from the side of the head opposite to the implant.


Eligibility Criteria:
Inclusion Criteria\*:

* An Advanced Bionics cochlear implant recipient with at least 6 months of listening experience
* Low frequency Pure Tone Audiometry (PTA)

Exclusion Criteria\*:

* Non-English speakers

  * Additional Inclusion and Exclusion criteria apply
Telehealth Interventions for Cardiac Surgery

The goal of this clinical trial is to compare telehealth monitoring at home against usual care in patients undergoing planned heart surgery. The main questions it aims to answer are:

1. Can telehealth improve quality of life prior to surgery
2. Can telehealth prevent serious deterioration requiring hospital or primary care attendance

Participants awaiting heart surgery will be randomly allocated to either telehealth remote monitoring of symptoms, blood pressure, heart rate, oxygen levels and activity levels or they will be allocated to usual care which is unmonitored on the waiting list for surgery.

Researchers will compare telehealth to usual care to see if it improves quality of life or prevents deteriorations on the waiting list.

Patients on elective cardiac surgery waiting lists can deteriorate, presenting via acute services as urgent inpatients as a result of their decompensation and facing increased surgical risk. With increases in waiting times prevalent through the country, and healthcare resources under pressure from Covid-related backlogs, it is imperative to find ways to monitor and escalate the most vulnerable patients and to provide safe methods of providing healthcare interventions outside conventional hospital settings. Remote monitoring identifies patients at need, and allows tertiary-care led interventions to prevent deterioration in the first instance. Such facilities could also enhance recovery following treatment and reduce the risks of complications and readmissions post-operatively.

The benefits and risks of such programmes is, however, not well understood: additional monitoring may increase the burden of responsibility on patients or monitoring facilities without providing additional safeguards to the patient. The advantages of early detection may not translate into improved outcomes and the onus on the patient to report in may reduce quality of life rather than enhance it.

The researchers therefore seek to identify if telehealth monitoring can improve health related quality of life, reduce unplanned admissions and healthcare resource utilisation and enhance pre-habilitation using protocolised patient engagement facilities to reduce complications and improve risk-stratification metrics such as smoking status, diabetic control and BMI.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients over 18y referred and accepted for cardiac surgery
2. Able to consent to participate

Exclusion Criteria:

1. Urgent or emergent surgery
2. Surgery planned within 3 weeks of first cardiac surgery outpatient review
Endometrial Local Injury Before First IVF : Evaluation of Pregnancy Rate

In spite of all progress realized in the field of assisted reproduction the pregnancy rate by In vitro fertilization (IVF) in France, across indications, is only 23% after IVF cycle.

Different causes may account for these failures and that, during all stages of pregnancy.

Recent studies have investigated an essential step in fecundation : uterine receptivity. Some teams have shown that a lot of immunological factors would have very significant in this step, by them possible expression in this process. Other studies looked at genes modulation, essential to implantation, with endometrium manipulation, simple, such as endometrial biopsy (EB). The last findings published on this subject, but after 2 IVF failures, are most encouraging because the pregnancy rate for these teams after just endometrial local injury (EB after 2 IVF failures) is well above their usual pregnancy rate. Some teams have focused on immunoassay of endometrial biopsy, in order to profile uterine receptivity and suggest with results, suitable treatment for each patient (ongoing study).

EB is quick, easy, make in a simple consultation and with a low cost, contrary to immunological study, which depend of ultra-specialized laboratories and therefore with an important cost.


Eligibility Criteria:
Inclusion Criteria:

* Only first IVF
* Acceptance of protocol by patient after free and complete information and signature of consent.
* Anti-Mullerian Hormone (AMH ) greater than 1
* Member or eligible to social security system
* Availabilities for a follow up 2 or 12 months.

Exclusion Criteria:

* Known intolerance of proposed treatment
Sonographic Evaluation of Patients With Carpal Tunnel Syndrome Following Steroid Injection

The objective of this study was to assess sonographic changes of the median nerve after steroid injection for carpal tunnel syndrome.

Patients with CTS were recruited. The Boston Questionnaire (BQ) was administered and ultrasonographic and electrophysiological examinations were performed before and at two, six, and 12 weeks after steroid injection. Cross sectional area (CSA) was measured at 2 levels: at the tunnel inlet and in the mid-carpal tunnel. Flattening ratio (FR) was measured only in the mid-carpal tunnel. Correlation analyses between baseline ultrasonography, BQ, and electrophysiological measures were performed.

Eligibility Criteria:
Inclusion Criteria:

1. clinical diagnosis of CTS
2. The diagnosis of CTS was confirmed by electrophysiological tests.

Exclusion Criteria:

1. neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome
2. history of distal radius fracture
3. pregnancy or lactation
4. regular use of systemic NSAIDs or corticosteroids
5. known allergy to corticosteroids and local anesthetics.
Remote Monitoring Use In Cases Of Suspected COVID-19 (Coronavirus)

The study aims to see if participant deterioration due to suspected coronavirus in a designated location (e.g. hotel) can be identified sooner by wearing the sensor. If sick patients can be identified early, participants are more likely to have better outcomes; the study believes that the sensor can help us do this. The sensor measures heart rate, respiratory rate and temperature every 2 minutes and this can be reviewed by the clinical team looking after the participants.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over.
* Able to provide written consent.

Exclusion Criteria:

* Any participants that withdraw their consent.
* A skin condition/reaction preventing wearing the wearable sensor.
* The presence of a permanent pacemaker or cardiac defibrillator.
* Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team.
* Inability to cooperate or communicate with the research team.
Preventing Chemotherapy-induced Peripheral Neuropathy Using PRESIONA Exercise Program

The aim of this study is to determinate if therapeutic exercise with blood flow restriction (BFR) during neoadjuvant chemotherapy potentialy neurotoxic could prevent the onset of chemotherapy induced peripheral neuropathy (CIPN) comparing to usual care.

CIPN is a side effect of cancer therapies that nowadays has no solution, so our intention is to carry out a preventive therapy against the onset of CIPN. The nature of the studies that try to prevent is very diverse, but one of the wide tools is therapeutic exercise. In this case we intend to combine therapeutic exercise with BFR to obtain a pre-conditioning effect that protects intraepidermal fibers from exposure to the chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* HER2+ breast cancer diagnosis
* On the waiting list to anticancer medical treatment (taxanes-based neoadjuvant chemotherapy)

Exclusion Criteria:

* Previous diagnosis of cancer
* Pregnant
* Cardiac pathology
* No symptoms or pathology that could be confused with neuropathy or related to diabetes
* No recommendation from oncologist for therapeutic exercise practice
A Study of the Effects of Ketoconazole Taken Orally Has on the PK Profiles of a Dose of GSK189075 in Healthy Volunteers

The purpose of this research study is to evaluate the effect of several daily doses of ketoconazole (a medication used to treat fungal infections like athlete's foot) on a single dose of GSK189075 (an experimental diabetes drug), and also to evaluate the safety and tolerability of GSK189075 in healthy volunteers. The study will see whether ketoconazole causes GSK189075 to stay in your bloodstream for a longer period of time. It will also examine whether GSK189075 causes any changes in the amount of glucose you have in your urine.


Eligibility Criteria:
Inclusion Criteria:

* Are a healthy, non-smoking male or female.
* Are 18 to 55 years old, inclusive.
* Have a body weight of \> or equal to 110 pounds.
* Are a female who is unable to have any more children and have a negative pregnancy test.
* Are willing and able to provide written informed consent before the start of any study-related procedures.
* Are able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions.

Exclusion Criteria:

* Smoke or use any tobacco products.
* Have a known allergic reaction to ketoconazole or study drug.
* Have a history of regular alcohol consumption greater than 7 drinks per week for females or greater than 14 drinks per week for males.
* Have a positive drug or alcohol or smoking test at screening or check-in to the clinic.
* Have participated in another clinical trial within 30 days prior to screening in which you have received an investigational drug.
* Have donated a pint of blood within 56 days before the first dose of study drug.
* Have any known or suspected stomach condition (or stomach surgery within the 6 months prior to dosing).
* Have abnormal liver test results.
* Have a documented history or diagnosis of cirrhosis.
* Have positive results for hepatitis C or B, or HIV at screening.
* Have blood pressure outside of the normal range.
* Are a male subject who is unwilling to either abstain from sexual activity or unwilling to use birth control during the course of the study.
* Are using non-prescription drugs, vitamins, herbal or dietary supplements (including St John's Wort) within 7 days before the first dose of study medication,
* Have any abnormality identified on the screening physical or laboratory examination that the study physician feels would make it inappropriate for you to participate in the study.
A Comparative Study of the Effect of Ayurvedic Drugs and Metformin in the Management of Diabetes Mellitus (Type II)

Present study entitled "A Comparative Study of the Effect of "Chhinnavahni Kashaya Vati" along with "Agnimantha Kwatha" \& Metformin in the management of Madhumeha w.s.r. to Diabetes mellitus (Type II)" is a small effort to find out an effective remedy for Madhumeha i.e. Diabetes Mellitus Type-2

Single centered, randomized clinical trial of Chhinnavahni Kashaya Vati along with Agnimantha Kwatha was carried out on total of 60 registered patients. They were randomly classified in two groups, where in Group-A received Chhinnavahni Kashaya Vati with Agnimantha Kwatha and Group-B received Metformin for 12 weeks. Out of these, 12 patients did not complete the full course of the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of either sex aged between 20 to 60 years.
2. If yes in any two of the four:

   * Blood sugar -fasting \> 126 and ≤ 250 mg/dl.
   * PP \> 200 mg/dl and ≤350 mg/dl.
   * Glycosylated Haemoglobin (HbA1c) \> 6.5% and \< 9%.
   * Subjects having classical symptoms of diabetes with random glucose levels ≥200mg/dl (≤350mg/dl).
3. Diagnosed cases of Type II Diabetics having Glycosylated Haemoglobin (HbA1c) between 6.5-9% without or {with metformin in a dose1g-1.5g/day (for Group-B)}.
4. Subjects who are able to come for follow up on fixed visits and are well aware about the treatment plan.
5. Subjects willing to participate and able to provide written informed consent.

Exclusion Criteria:

1. Age below 20 and above 60yrs.
2. Subject of Type-I DM (insulin dependent DM) or Type-II DM on insulin/OHA's other than metformin/ any other AYUSH medication for glucose control.
3. Subjects suffering from the complications of Diabetes mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy etc. which require an urgent treatment.
4. Uncontrolled Hypertensive subjects (BP with or without medication \>140/90 mmHg after 5 mins of rest).
5. Subjects with any unstable Heart disease or known cases of MI, unstable angina or CHF.
6. Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT \> 2 times of the upper normal limit) or Renal Dysfunction, uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects).
7. Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years).
8. Subjects who have a recent history or who are currently known to abuse of alcohol or drugs.
9. Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, TB, AIDS etc).
10. Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
11. Pregnant / Lactating women.
12. Subject on systemic or oral steroids, oral contraceptive pills or estrogen replacement therapy.
13. Subjects having hypersensitivity to any of the trial drug.
14. Subjects who have completed participation in any other clinical trial during the past six (06) months.
Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches

The RA patients receiving leflunomide for more than one month, and not receiving other DMARDs (except hydroxychloroquine), will be enrolled to assess their disease activity. Blood samples will be collected for genetic studies and pharmacokinetic assay of the blood levels of the drug and its active metabolite.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis patients already receiving leflunomide with or without Hydroxychloroquine but without other Disease modifying agents

Exclusion Criteria:

* Those diagnosed with other rheumatic diseases or Rheumatoid patients receiving disease modifying agents other than leflunomide