cyrilzakka/clinical-trials huggingface dataset:
Molecular Classifier for the Fine Needle-based Assessment of Malignancy Risk in Thyroid Nodules

This study evaluates the usefulness of molecular classifier to aid the diagnosis of malignancy in the material obtained by fine-needle aspiration biopsy (FNAB) of thyroid nodule. All participants will undergo FNAB with routine cytological assessment and molecular testing. Patients will undergo surgery or be followed-up, according to the clinical guidelines. The diagnostic power of combined molecular/clinical classifier will be compared to prediction based on clinical features only, by investigators blinded to the final diagnosis of surgical assessment.

Currently, the diagnosis of malignancy of thyroid nodule is based on cytological assessment of fine-needle aspiration biopsy (FNAB) classified according to the Bethesda System for Reporting of Thyroid Cytopathology. This does not allow for the definitive diagnosis of cancer in significant proportion of tumors, so called indeterminate nodules (Bethesda class III, IV and V). These patients require surgery to establish a definitive diagnosis, leading to unnecessary operating procedures in at least 2/3 of subjects.

Molecular classifiers could significantly improve thyroid preoperative diagnostics, although they are not optimal and provide either high specificity to the detriment of low sensitivity or conversely, relatively low specificity with high sensitivity. The classifiers could be based on gene expression or mutations present in FNAB specimen.

In the present study the investigators plan to assess the improvement of classification power by molecular gene-expression-based multi-feature classifier when added to standard clinical parameters indicating the risk of malignancy (Bethesda class, tumor size, patient age and sex). Participants will undergo FNAB with prospective collection of material for molecular testing and simultaneous preoperative recording of all clinical parameters. The patients will be operated on or followed-up according to the clinical guidelines. The comparison of a predictive power of clinical criteria to the combined clinical-molecular classifier will be carried out by the group of investigators blinded to the results of final surgery.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of thyroid nodule
* considerable chance for surgical procedure following biopsy result
* patient's consent for collection of material during routine fine needle aspiration biopsy

Exclusion Criteria:

* age below 18 years
* the presence of contraindications that make surgical treatment impossible
* prior diagnosis of thyroid cancer
* antithrombotic treatment except of acetylsalicylic acid or low molecular weight heparin at a prophylactic dose
Impact of Grape Powder Consumption on Eye Health and Glycemic Status in Singapore Older Adults

The purpose of this study is to understand the impacts of regular consumption of freeze-dried table grape powder on eye health and regulation of advanced glycation end products in Singapore older adults. The investigators hypothesize that regular consumption of freeze-dried table grape powder will promote improvements in eye health and lower levels of advanced glycation end products when compared to the placebo group.

The study will be a 16-week, double-blind, randomized, placebo-controlled trial using a parallel study design. 46 adults (aged 60 - 85) will be recruited and randomly assigned to the intervention or placebo group to investigate whether regular consumption of freeze-dried table grape powder (46g/d) can improve eye health parameters, blood/skin AGE and glycemic status, and reduce inflammation and oxidative stress. This study will consist of 1 screening visit and 5 study visits with 4-week intervals.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants, aged between 60 and 85 years old inclusive
2. English-literate and able to give informed consent in English

Exclusion Criteria:

1. Smokers
2. Allergy to grapes or food dyes/additives, or had serious food allergies in the past
3. Known eye diseases (macular degeneration, cataracts, retinopathy or glaucoma), blindness in at least one eye or have had eye surgery
4. Unable to view bright lights or flashing lights
5. Has Type 1 or 2 diabetes, uremia, cardiovascular disease, abnormal kidney and liver function
6. Taking eye medication and/or dietary supplements for the eyes for the past 3 month
7. Taking supplements containing carotenoids (e.g. Vitamin A, lutein, zeaxanthin) for past 3 months
8. Currently on a specialised diet (e.g. vegetarian, vegan, weight loss diet, low fat diet
9. Consumes more than 2 alcoholic drinks per day i.e. one drink is defined as either 150ml of wine,340ml of beer/cider or 45ml of distilled spirit
10. Significant change in weight (≥ 3 kg body weight) in the past 3 months
11. Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week
12. Currently on anti-hypertensive, cholesterol-lowering or psychoactive drugs
13. Scored ≤ 7 on the abbreviated mental test
14. Poor peripheral venous access based on past experiences with blood draw
15. Participating in another clinical study
The Effect of Whole Body Vibration in Individuals With Parkinson's Disease

Previous studies reported that whole body vibration has the potential impact on balance and walking abilities in individuals with Parkinson's disease; however, the inconsistent treatment protocols and different experimental designs lead to inconclusive results. Therefore, the purpose of this study is to investigate the short term and long term effect of whole body vibration on sensorimotor function in individuals with Parkinson's disease. The experimental design will be randomized double-blinded controlled trial. Sixty individuals with idiopathic Parkinson's disease will be randomly assigned to two groups and they are non-random whole body vibration group and conventional therapy group. Each participant will receive the treatment about one hour after the administration of medicine. For non-random whole body vibration group, participants will be required to maintain the erect standing position on the vibratory platform and the frequency and amplitude of vibratory stimuli will be 6Hz and 3mm respectively. Each treatment includes five sessions and each session is composed of one minute whole body vibration and one minute rest. For the conventional therapy group, participants will receive the occupational therapy including dynamic balance training and functional ambulatory training. Each session is 10 minutes in both groups and all participants will receive one and twelve treatment sessions for short-term and long-term effect respectively. Outcome measures include proprioceptive sensitivity threshold of upper limb, position sense test of the knee joint, Unified Parkinson's disease rating scale-motor (UPDRS motor), functional reach, and time up and go test (TUG). Specifically, the investigators want to answer the following four questions: 1) Is there any difference in proprioceptive sensitivity, motor performance and balance before and after treatment in individuals with Parkinson's disease? 2) Is there any difference in short-term and long term effect of whole body vibration in individuals with Parkinson's disease? 3) Is there any difference in treatment effect in individuals with Parkinson's disease in Taiwan?


Eligibility Criteria:
Inclusion Criteria:

* agree to sign the informed consent form.
* diagnosed with idiopathic Parkinson's disease with Hoehn and Yahr stage 2\~3
* cognitive impairment (Mini-Mental State Examination \[MMSE\] score greater than 24 points
* no depression as evaluated by the Beck Depression Inventory
* no severe arm injuries or shoulder dislocation which might interfere with proprioceptive function
* can perform reaching movement
* no diagnosed peripheral nerve disorders or other neurologic conditions
* no severe tremor which might interfere with the measurement proprioceptive function

Exclusion Criteria:

* diagnosed with other central nervous system diseases, ex: stroke
* had surgeries in head or arms
* unable to sit for assessment
Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-5552 monotherapy in adult participants with relapsed/refractory solid tumors and to identify the recommended Phase 2 dose (RP2D).

This is an open-label, multicenter, Phase 1/1b study of RMC-5552 monotherapy in participants with advanced relapsed or refractory solid tumors. The study will include 2 components: 1) a Dose-Escalation Component for participants with relapsed or refractory solid tumors and 2) a Dose-Expansion Component for participants with relapsed or refractory solid tumors harboring certain specific mutations/rearrangements that result in hyperactivation of the mTOR pathway. Participants will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* Participants (male or female) ≥18 years of age
* Participants who have advanced solid tumors that have failed, are intolerant to, or are considered ineligible for standard of care anticancer treatments including approved drugs for oncogenic drivers in their tumor type
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Participants in the Dose-Expansion Component must have molecular aberrations in the mTOR pathway
* Adequate hematologic, hepatic and renal function

Exclusion Criteria:

* Known or suspected leptomeningeal or brain metastases or spinal cord compression
* Primary central nervous system (CNS) tumors
* Clinically significant cardiac disease
* Active, clinically significant interstitial lung disease or pneumonitis
* Subjects with abnormal fasting glucose, type 1 diabetes, or uncontrolled type 2 diabetes are excluded.
* Subjects with stomatitis or mucositis of any grade
Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme

This pilot clinical trial studies the feasibility of palliative 4pi radiotherapy in treating patients with glioblastoma multiforme that has come back after standard chemoradiation. A new radiotherapy delivery planning system, called 4pi radiotherapy, may help improve radiation delivery by improving dose coverage to the treatment target, while reducing the dose to surrounding normal tissues.

PRIMARY OBJECTIVES:

I. To determine the accuracy of dose delivery and patient comfort with treatment time.

II. To evaluate normal tissue dose volume statistics and compare to standard planning.

OUTLINE:

Patients undergo 4pi radiation simulation and planning followed by 5 to 10 daily fractions of 4pi palliative radiotherapy. If an acceptable plan cannot be achieved using 4pi planning, then the patient will be treated with standard radiation therapy planning for palliative re-irradiation.

After completion of study treatment, patients are followed up at 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary glioblastoma multiforme (GBM)
* Patient must have previously undergone standard chemoradiation- 59.4 Gy (1.8 Gy/fraction) or 60 Gy (2.0 Gy/fraction) with concurrent and adjuvant Temodar (temozolomide)
* Patient must be diagnosed with recurrent GBM either with biopsy or radiographically
* Karnofsky Performance Status (KPS) \>= 70
* Ability to understand and willingness to sign a written informed consent
* If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment

  * For the purpose of this study, all women are considered to be of childbearing potential unless they are post-menopausal at least 1 year since last menses), biologically sterile, or surgically sterile (i.e. hysterectomy, bilateral oophorectomy or tubal ligation)

Exclusion Criteria:

* Patients with active infection
* Patients with KPS \< 70 and/or unable to tolerate potentially longer treatment times
* Refusal to sign informed consent
* Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study treatment
* Note: Concurrent and/or adjuvant chemotherapy does not make a patient ineligible; participation in a concurrent treatment protocol does not make a patient ineligible
Pharmacokinetics of Dipyridamole Administered as Aggrenox® (Dipyridamole Extended Release Plus Aspirin) Capsule Versus Dipyridamole Immediate Release Plus Aspirin Following Alteration of Stomach pH

Comparison of pharmacokinetics of dipyridamole administered as Aggrenox versus dipyridamole administered as the immediate release formulation plus aspirin, under conditions of reduced stomach acidity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age 40 - 65 years, inclusive, at time of Visit 1
* Stomach pH \> 4.0 on three consecutive measurements separated by at least five minutes, measured at Visits 3B and 5B prior to dosing with Aggrenox or dipyridamole-aspirin (DP-ASA)

Exclusion Criteria:

* Any findings of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and considered by the investigator to be of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders considered by the investigator to be of clinical relevance
* History of gastro-intestinal ulcer, perforation or bleeding
* Surgery of the gastro-intestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy), neurological disorders, or psychiatric disorders
* Chronic or relevant acute infections. Screening tests will be performed for HIV, hepatitis B, and hepatitis C
* History of hypersensitivity to Aggrenox or any of the components or excipients
* Intake of drugs with a long dominant half-life (\>24 hours) 1 month or less prior to Visit 1
* Use of any drugs which might influence the results of the trial ten days or less prior to Visit 1
* Participation in another trial with an investigational drug 1 month or less prior to Visit 1
* Known alcohol abuse
* Known drug abuse (a drug screening test will be performed at Visits 1, 3, and 5)
* Blood donation 1 month or less prior to Visit 1
* Excessive physical activities five days or less prior to Visit 1
* History of hemorrhagic diathesis
* History of bronchial asthma
* Any laboratory value outside the reference range, considered by the investigator to be of clinical relevance

For female subjects:

* Nursing
* Pregnancy
* Positive pregnancy test
* No adequate contraception (adequate contraception includes sterilization, intrauterine device, or oral contraceptives)
* Inability to maintain adequate contraception during the whole study period
Retrospective Analysis of the Incidence of Complications From Transvaginal Oocyte Retrieval (TVOR).

The investigators retrospectively analysed the complication rate of ultrasound guided transvaginal oocyte retrieval (TVOR) from all the procedures performed between 1996 and October 2016 in a tertiary level university based fertility clinic.

Ultrasound guided transvaginal oocyte retrieval (TVOR) is nowadays gold standard techniques to collect oocyte after ovulation induction in Assisted Reproductive techniques (ART). It is a very safe technique with infectious complications of any kind occurring in just 1% (Bennett et al.) of all procedures, vaginal bleeding in 0 to 1.3% of the procedures (Ludwig et al., Bodri et al., Aragona et al.) and vascular, gastrointestinal and genitourinary (Grynberg et al. and Catanzarite and al.), injuries being extremely rare (Bennett et al.). Case reports account also for rarer complications such as ovarian abscess formation (Kelada \& Ghan and Sharp et al.) pseudoanerysm formation (Bozdag et al. and Jayakrishnan et al.), uroretroperitoneum (Fiori et al.).

The rational of thestudy is to provide the percentages of complication from TVOR of the Fertility Center of Humanitas Research Hospital, also considering the development in time of technologies and techniques in Assisted Reproduction. Another rational is inquire whether there is any risk factor for such complications in order to try to prevent them in future procedures. The investigators performed a retrospective observational study including all the transvaginal oocyte retrieval procedures performed between 1996 and October 2016.

The data have been collected from the Humanitas Fertility Center' Department database (ART.it). Because of the retrospective nature of this study, a specific informed consent was not necessary.

Eligibility Criteria:
Inclusion Criteria:

* patients that underwent ultrasound guided transvaginal oocyte retrieval during the study period

Exclusion Criteria:

* none
A Study to Compare the Menstrual Bleeding Profile Among Jaydess® and Copper Intrauterine Device (IUD) Users. COLIBRI STUDY (Copper and Levonorgestrel IUD Barcelona Research Initiative).

The intrauterine device (IUD) is a long-term birth control method that has demonstrated high contraceptive efficacy and effectiveness due to its high compliance, adherence and persistence of use. The IUD has a global prevalence rate around 14% in women of reproductive age.

Side effects are the main reason for IUD use discontinuation. The most common reasons for copper IUD discontinuation are increased menstrual bleeding, irregular bleeding and dysmenorrhea, whereas in the case of 52mg Levonorgestrel IUD are irregular bleeding and amenorrhea.

In 2014, a new hormonal IUD containing13,5mg of Levonorgestrel was marketed in Spain. There are many studies comparing the two Levonorgestrel IUDs. However, there is any study comparing the IUD 13,5mg Levonorgestrel with classic copper IUDs.

The hypothesis of this trial is that Levonorgestrel (13,5mg) IUD users have a menstrual bleeding pattern with fewer days than Copper 380 mm2 IUD users.

This is a Phase IV, national single-center, randomized 1: 1, single-blind, comparative, parallel controled trial.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subject.
* Parous or nulliparous women aged between 18 and 45 years who ask for an IUD as a contraceptive method.
* History of regular cyclic menstrual periods ranged from 21 to 35 days with non-excessive menstrual blood loss.

Exclusion Criteria:

* Absolute contraindications to IUD use, according to the World Health Organization Medical Eligibility Criteria.
* Contraindications to use 13,5 LNG-IUD.
* Anemia.
* Use of short or long-acting preparations containing sex hormones within the 12 weeks before the IUD insertion.
* Known bleeding irregularities.
* Pregnancy or breast-feeding.
Non-endoscopic Tracking of Disease Activity in Eosinophilic Esophagitis

To prospectively determine the natural history of inflammation resolution following initiation of diet treatment and to optimize the diet treatment of patients with EoE through the use of a non-endoscopic tracking device, the esophageal string test (EST).

This is an adult and pediatric prospective, longitudinal study in which we will measure symptoms, QOL and inflammation at baseline and again at 2, 4 and 6 weeks after starting stand of care (SOC) four food elimination diet (FFED) (Aim 1). Newly or previously diagnosed patients with EoE with active disease who will be undergoing SOC FFED will be offered entry into the study by the PI's or their local co-investigators at each of their institutions. EoE patients who are in remission on SOC FFED from Aim 1 will be recruited to participate in this food reintroduction trial in Aim 2. Eligible subjects will undergo SOC sequential food reintroductions and during the food introduction, ESTs will be performed at 2 and 4 week intervals during a clinic visit. If inflammation is detected by the EST, this food will be eliminated from the diet for six weeks and a repeat EST will be administered at this time to assess inflammation. If inflammation has resolved based on EST results, food reintroduction will resume. If no inflammation is detected by the EST at the 4 week interval, a new food will be added. EST will be performed after each food reintroduction as outlined above. Based on known allergenic properties of these foods, the order of food reintroduction will be soy, eggs, wheat and milk.

Eligibility Criteria:
Inclusion Criteria:

* Participant must be able to understand and provide informed consent
* Males and Females ≥7 years of age to 65 years of age
* Have diagnosis of EoE
* Have histologically confirmed active disease ≥15 eosinophils/hpf
* Symptomatic (have experienced symptoms within the last one months prior to enrollment).
* Female subjects of childbearing potential must have a negative pregnancy test upon study entry
* Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study

Exclusion Criteria:

* Inability or unwillingness of a participant to give written informed consent or comply with study protocol
* Secondary causes of eosinophilia
* Pregnancy
* Immunodeficiency states
* Have participated in any investigative drug study within 6 weeks prior to study entry
* Unable to complete study procedures including endoscopy
* Luminal stricture identified \<13mm which would prevent passage of the EST and prevent assessment of mucosal inflammation
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
Glutamate Modulation of tDCS Over Premotor Cortex Combined With Peripheral Nerve Stimulation Promoted Observation-execution-related Cortical Excitability and Motor Learning

This study aimed to investigate whether concurrent tDCS over the PMC and PNS during action observation enhance observation-execution-related motor cortex excitability and improve motor performance, and to explore the underlying mechanism


Eligibility Criteria:
Inclusion Criteria:

* normal or corrected-to-normal vision
* right-handed

Exclusion Criteria:

* pregnancy
* a history of epilepsy
* implanted medical devices
* history or presence of neurological, psychiatric or musculoskeletal disorders, other medical conditions, and left-handedness