cyrilzakka/clinical-trials huggingface dataset:
Factors Affecting Timing of Hypothyroidism Following Radioactive Iodine Therapy Patients With Graves Disease

The purpose of this retrospective study was to clarify the possible risk factors of early hypothyroidism after RAI therapy in Graves' disease.

Hyperthyroidism is a clinical syndrome caused by increased thyroid hormone in the blood, it can lead to multiple complications, including cardiac, hepatic, and hematologic system complications. More than 80% of hyperthyroidism are caused by Graves' disease (GD). 3% of women and 0.5% of men may suffer GD in their lifetime \[1\].

Radioactive iodine (RAI) therapy is an important treatment option for Graves' disease (GD), the main side effect of RAI treatment is hypothyroidism, and the factors resulting in hypothyroidism are still controversial \[2\]. Male gender, smaller thyroid weight, higher thyroid-stimulating hormone, and smaller thyroid volume are Suggested to be the main risk factors for early hypothyroidism \[2\]-\[3\].

Eligibility Criteria:
Inclusion Criteria:

1. Graves' disease patients after one year of RAI therapy .
2. Suppressed serum thyrotropin (TSH) \<0.55 µU/ml , elevated serum free triiodothyronine (FT3) \> 6.5 pmol/L , free thyroxin FT4 \>22.7 pmol/L .

Exclusion Criteria:

1. Patients with other causes of hyperthyroidism , such as toxic multinodular goiter and single toxic adenoma
2. Thyroid cancer
3. Recurrent GD
4. Previous Thyroid surgery
5. Patients can't complete the follow -up within 6 months.
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer

The primary objective of this study is to evaluate the performance of HR-TRUS in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference.

The primary objective of this study is to evaluate the performance of HR-TRUS in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference. The analysis will include the detection of all prostate cancer lesions as well as the detection of significant prostate cancer lesions. With this approach it is possible to calculate the sensitivity, specificity, negative predictive value, positive predictive value and overall accuracy of the correct detection of prostate cancer in the prostate. These results are of importance when the ExactVu ultrasound scanner is to be used later for prostate cancer diagnosis using targeted biopsies.

Eligibility Criteria:
Inclusion Criteria:

1. men \> 35 years age and \<80 years of age
2. diagnosed with prostate cancer by prostate biopsy scheduled for radical prostatectomy
3. staging by standard procedures show localized disease (\<cT4)
4. PSA \< 50ng/ml
5. Access to the rectum for trans rectal ultrasound
6. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
7. Signed written informed consent prior to any screening procedures being performed

Exclusion Criteria:

1. Patient with absence of diagnosis of prostate cancer
2. Patient with metastatic prostate cancer
3. Patient with rectal amputation
4. Patient with contraindications for MRI
5. Patient in urgency situation, adult under legal protection, or unable to give his consent.
Surgical Treatment for Patients With Obstructive Sleep Apnea by Using Da Vinci SP Surgical System

This prospective, interventional, non-randomized, single arm, clinical trial will investigate feasibility and safety of trans-oral robotic surgery using da Vinci SP Surgical System in Taiwan for the surgical treatment of OSA. All the investigators are well trained and have received proof of training after completing the training program for da Vinci SP system provided by Intuitive.

This study will be conducted in Chang Gung Memorial Hospital at Linkou.

Informed consent will be provided to patient who has an indication of surgical treatment for OSA. Study participants will sign an informed consent before any study procedure begins. Eligibilities will be assessed during screening period (2 weeks) with blood test and other routine assessments. Eligible patient will undergo surgical intervention using da Vinci SP Surgical System. Post-operation follow-up will be performed at 1 week, 1 month, 3 months, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or more.
2. OSA with AHI ≥ 15
3. Has failed, refuses, or is unable to tolerate CPAP therapy
4. Indication of resection of tongue base with/without other invasive surgical procedure for OSA (i.e. tongue base resection only or multi-level surgery with tongue base resection)
5. ASA physical status classification 1-2 and adequate organ function
6. Patients willing and able to comply with study protocol requirements and follow-up
7. Informed consent

Exclusion Criteria:

1. BMI\>35
2. Mouth opening too narrow for TORS or trismus
3. Betel nut chewing
4. Suspicious cancer diagnosis
5. Prior head-and-neck surgery (note: prior invasive therapy for OSA allowed)
6. Other medical condition or anatomical factor not suitable for TORS, including subject with congenital malformations in the larynx, throat or tongue; 1. Subject with an American Society of Anesthesiologists (ASA) score of Grade 4 or above during preoperative evaluation
7. Active infectious disease
8. Can't follow trial-required procedures
9. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions

   * Severe heart disease (NYHA functional class III-IV)
   * Severe lung disease (GOLD Group C-D)
10. Long-term use of anti-coagulant
11. Patients with coagulopathy
12. Emergency surgery
13. Subject for whom any additional surgeries are planned for OSA within the study period, after the surgery in which the da Vinci SP System was used
14. Subject is pregnant or suspected to be pregnant
The PURI-HF (Air Purifiers on Heart Failure) Trial

Indoor air pollution and fine mode particulate matter with an aerodynamic diameter smaller than 2.5 micrometers (PM2.5) is a major contributor to global morbidity and mortality, particularly due to cardiovascular disease. This project aims to demonstrate the efficacy, feasibility and effectiveness of portable air filters in improving indoor PM2.5 levels and improving functional capacity of heart failure patients with reduced ejection fraction in India. The findings from the project will add to existing knowledge of innovative and scalable strategies to improve environmental and cardiovascular health worldwide.

The overall objective of this study is to demonstrate the efficacy, feasibility, and effectiveness of portable air filters in improving indoor PM2.5 levels and improving functional capacity of heart failure patients with reduced ejection fraction in India.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age diagnosed with HF with a reduced ejection fraction of ≤ 40% within the last six months in NYHA class II-IV.

Exclusion Criteria:

* listed for a cardiac transplant
* history of CRT device implantation in last 3 months
* on oxygen therapy
* with severe pulmonary disease
* participants unable to ambulate
Venous Thromboembolism Taskforce Audit Program

To determine the effect of an interventional campaign run by a dedicated "VTE Nurse Educator" over a 6-month period and the effect on prophylaxis rates.

To determine the proportion of medically admitted patients with risk factors for VTE.

To assess and compare the use of venous thromboembolism (VTE) prophylaxis in hospitalized medical patients versus recommendations and current guidelines.

To determine the patient characteristics of those deemed to be at risk of VTE. To determine the proportion of patients receiving appropriate thromboprophylaxis for their risk.

To determine the type and duration (where possible) of prophylaxis used.


Eligibility Criteria:
Inclusion Criteria:

* Hospital admission for an acute illness with an in-patient hospital stay of 3 days or more.

Exclusion Criteria:

* Patients who have undergone any type of surgery during current admission
* Patients who are admitted to a ward or department that is excluded from this study e.g psychiatric, paediatric, maternity, intensive care unit, coronary care unit.
* Prior enrollment in this protocol during current admission
* Prior enrollment in a VTE study involving pharmaceutical or mechanical treatment within last 90 days.
* Admission for suspected or diagnosed deep vein thrombosis

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sensory Evaluation of Oral Nutrition Supplements in Patients at Risk for Mucositis Undergoing Cancer Treatment

This pilot clinical trial studies sensory evaluation of oral nutrition supplements in patients at risk for mucositis undergoing cancer treatment. Sensory evaluation may help to obtain input about new oral nutritional supplements that may increase nutrient intake and maintain or improve nutritional status, functional capacity, and quality of life in cancer patients.

PRIMARY OBJECTIVES:

I. To identify two products (one from the creamy shake category and one from the tea category) with the highest total average score that will be selected to move onto further testing.

OUTLINE:

Patients receive 10 different nutrition supplements orally (PO) and complete questionnaires based on each sample in a single session over 60-90 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing cancer treatment (chemotherapy, radiotherapy, and/or immunotherapy)
* At risk for mucositis OR with stage I mucositis or esophagitis (i.e. radiotherapy to the head, neck, esophagus or lung OR treatment with fluorouracil (5-FU) or other chemotherapeutic agents that are known to cause mucositis or esophagitis) or at risk for xerostomia
* Within the first 3 weeks of initiation of a new type of therapy
* Able to read and write in English
* Able to provide written informed consent

Exclusion Criteria:

* Food allergy to any component of the supplement
* Inability to taste or smell due to medication or health condition
Assessment of the Possible Association Between Left Ventricular Diastolic Dysfunction and Carotid Atherosclerosis and Brain White Matter Damage

Left ventricular diastolic dysfunction is caused by impaired relaxation and increased left ventricular stiffness with a consequent increase in filling pressures. Currently, it is possible to classify it in 3 grades: grade 1 with normal filling pressures, grade 2 and grade 3 with high pressures. Diastolic dysfunction is closely associated with several risk factors such as hypertension, diabetes, and obesity, as well as the risk of heart failure, cardiovascular events, and death. In the field of cerebrovascular diseases, however, diastolic dysfunction is still being researched. Thus, this study aims to: 1) evaluate the white matter hyperintensities volume in association with the increase of diastolic dysfunction and filling pressures 2) evaluate the possible association with carotid atherosclerosis in case of brain damage caused by dysfunction diastolic 3) understand the mechanism of damage caused by left ventricular diastolic dysfunction on the cerebrovascular system. In order to do this, this study proposes to evaluate in a cohort of patients, between 35 and 65 years, the possible association of diastolic dysfunction with lesions on the cerebrovascular system in a future view of new marker of brain damage and new modifiable risk factor.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 35 and ≤ 65 years
* written informed consent

Exclusion Criteria:

* previous stroke or TIA
* arrhythmia or severe cardiac disease
* renal disease
* psychiatric disease
* neurological or neurodegenerative disease
* dementia
* previous carotid artery stenting or carotid surgery
* inability to be subjected MRI analysis
Progestagen Type in Postmenopausal Hormone Therapy and Blood Gene Expression Profile

The purpose of this study is to compare combined postmenopausal hormone therapy natural progesterone to the one containing synthetic progestagen (i.e. chlormadinone acetate) at the blood transcriptome level.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women defined as:

  * 45 years\< age \< 65 years
  * Amenorrhoeic for ≥ 1 year
  * Amenorrhoeic for \< 1 year either without any withdrawal vaginal bleeding for 3 consecutive months in spite of a cyclic progestagen treatment and/or blood estradiol levels ≤ 20 pg/mL and blood FSH levels ≥ 40 UI/mL
  * Women with bilateral ovariectomy
* Women suffering of at least 1 postmenopausal symptoms listed:

  * Hot flashes,
  * Memory and Concentration Problems,
  * Mood Swings,
  * Insomnia,
  * Urinary Incontinence,
  * Night sweating,
  * Join pains,
  * Asthenia.
* No use of hormone therapy (HT)
* Previous HT user:

  * HT use \< 3 months - stop for 6 months
  * HT use \<= 1 year - stop for \> 12 months
* If previous use of soya derivatives in dietary supplements: washout period = 3 months
* Signed informed consent, after having received both oral- and written- information regarding the study goals, its risks and benefits and its constraints, including the 12 month follow-up. A delay should be respected between information and the signature of the written consent.

Exclusion Criteria:

* Past HT users who have used treatment for more than 1 year
* Hysterectomized women
* Women without health insurance (only in French centre)
* History of cardio-vascular accident either arterial or venous
* Untreated high blood pressure
* Liver disease
* Diabetes
* History of cancer except basal-cell skin cancer and colon cancer
* Severe history of familial breast cancer defined as at least 2 women first degree- relatives with breast cancer diagnosis before 50 years
* History of severe mastalgia
* History of breast biopsy showing hyperplasia (with or without atypia)
* Undiagnosed vaginal bleeding
* Diagnosed endometrial hyperplasia
* Auto-immune disease (e.g. lupus)
* Women with kidney transplant
To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis

This study is designated to evaluate the safety and efficacy of Sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects able and willing to give written informed consent and is available for entire study.
2. Male or female ≥ 18 years old
3. Willing and able to comply with the study protocol visits, assessments and accessible for follow up
4. Known Diagnosed Rheumatoid arthritis
5. Subjects of child bearing potential should be non-lactating and must be practicing an acceptable method of birth control as judged by the Investigator

Exclusion Criteria:

1. Subjects who are pregnant or intend to become pregnant during the study
2. Subject with positive hepatitis panel and / or anti-hepatitis B core antibodies, and / or hepatitis C virus antibody \[anti-HCV\]), and / or a positive Human immunodeficiency virus (HIV) antibody.
3. Known sensitivity to any component of the study drug or previous hypersensitivity reaction or other clinically significant reaction to IV medications, biologic therapy or IV radiocontrast agents.
4. Active infection requiring systemic treatment
5. Planned surgery during the study period or had undergone major surgery within the 60 Days prior to the Screening visit.
An Image-guided SBRT for Adrenal Gland Metastasis in Oligometastatic Patients

The study is designed to to assess the efficacy of ablative SBRT delivered with VMAT technique in oligometastatic patients affected by adrenal gland metastases.

This is a phase II, single arm, trial for testing efficacy of ablative high hypofractionated dose delivered with VMAT technique in oligometastatic patients with adrenal gland metastases. The potential advantages of this approach include the possibility to lead an increased local control in irradiated adrenal gland metastases. Other purpose of this study is to assess acute and late toxicity in terms of maintenance of endocrine mechanisms of hormonal production.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18years.
* WHO performance status ≤ 1 (ECOG - KPS).
* Histologically-proven of primary cancer disease
* Metastases at adrenal gland radiologically proven
* Written informed consent

Exclusion Criteria:

* Prior radiation to the interested adrenal gland.
* Patients allergic to contrast used in CT scans or who cannot be premedicated for the use of contrast.
Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C

This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).


Eligibility Criteria:
Inclusion criteria:

1. Patients with chronic HCV genotype 1 infection with previous PI treatment failure
2. Three months minimum time from the last dose of previous PI treatment to the first dose of study medication

Exclusion criteria:

1. Use of other investigational drugs at the time of enrollment
2. History of hypersensitivity to PEG or RBV
3. Any null non-responders to prior PEG/RBV treatment

Other protocol-defined inclusion/exclusion criteria may apply.
Prevalence of Stress Urinary Incontinence in Obese Versus Non-obese Nulligravid Women

Urinary incontinence (UI) is more common than any other chronic disease. Stress urinary incontinence (SUI), among the various forms of urinary incontinence, is the most prevalent (50%) type of this condition. Female urinary continence is maintained through an integrated function of pelvic floor muscles (PFMs), fascial structures, nerves, supporting ligaments, and the vagina. In women with SUI, the postural activity of the PFMs is delayed, and the balance ability is decreased. Many women, by learning the correct timing of a pelvic floor contraction during a cough, are able to eliminate consequent SUI. Timing is an important function of motor coordination and could be affected by proprioception.

We aim to assess stress urinary incontinence in obese and non-obese Nulligravid females.


Eligibility Criteria:
Inclusion Criteria:

* Women aged between18 and 45 years.
* Non obese females with BMI \<25kg/m2.
* Obese females with BMI ≥30kg/m2.
* Nulligravid females.

Exclusion Criteria:

* Multiparous Females
* Patients with active urinary tract infection.
* Patients with respiratory or neurological diseases.
* Patients with communication problems, cognitive disorders \& mental disturbance.
* Current treatment with drugs (benzodiazepines, diuretics)
* Patients who underwent any previous abdominal or pelvic surgery.
COVID-19 Search in Conjunctival Cells

The patients enrolled in this study will be all patients entering triage with suspicion of SARS-CoV2. Planned activities are required by the nasopharyngeal swab in parallel with the analysis of the conjunctival swab to identify new potential alternative and equally effective diagnostic pathways.

Simultaneously systemic data (as Pulmonary images, hematological parameters etc.) will be collected to observe a possible correlation between conjunctival swab positivity and systemic impairment.

In recent months, considerable interest has turned to Coronavirus infection in terms of early diagnosis and targeted therapy. Thanks to the experimentation of new therapeutic strategies, it becomes more and more evident how some subgroups of patients can benefit from a specific treatment, while others would have no benefit.

Alongside these innovative clinical research techniques, early diagnosis that would lead to identifying those at risk of a new disease and new infection is becoming increasingly important.

COVID-19 occurred in China in December 2019 but probably already had an expression in the previous months. The number of victims reached its peak in January 2020 with prevalent involvement of patients already at risk or with previous physical debilitations. But even apparently healthy and young individuals can be affected by infections with a lethal outcome. Since January 2020 new cases have been registered all over the world and prevalently in Italy. The main way of infection identified is the respiratory tract, but infection through conjunctival may not be excluded.

The main outcome of this research is to investigate the positivity of the COVID-19 virus in the conjunctival mucosa to establish a new diagnostic target.

All patients will receive both the conjunctival swab and nasopharyngeal swab. The conjunctival swab will be performed in each eye and both swabs will be inserted into the same virus test tube. The swab samples will be sent in the same day to the microbiology laboratory for examination by Real Time-PCR.

The secondary outcome will be to evaluate the possible positivity of the conjunctival swab with the degree of systemic impairment. This objective has the purpose of personalized medicine.

Eligibility Criteria:
Inclusion Criteria:

* All patients accepted to triage with positivity or suspected positivity to COVID-19 will be enrolled in the study and both conjunctival and nasopharyngeal swab will be performed.

Exclusion Criteria:

* To date, there are no exclusion criteria
Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1

The purpose of this study is to assess potential interactions between intravenous (i.v.) cocaine and atomoxetine (Strattera) administered orally in four escalating doses.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years of age who are not seeking treatment at the time of the study
* Must be able to provide written informed consent
* Must be within 20 percent of ideal body weight and weigh at least 45 kg
* Must meet DSM0IV diagnostic criteria for cocaine abuse or dependence
* Must currently be using cocaine as confirmed by a positive BE
* If female and of child bearing potential, must agree to the use of birth control

Exclusion Criteria:

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