cyrilzakka/clinical-trials huggingface dataset:
Selenium Treatment in Autoimmune Thyroiditis (AIT)

Selenium suppresses autoimmune destruction of thyrocytes and decreases titers of serum TPOAb in AIT patients. Older 4 clinical trials approved the efficacy of the daily dose of 200micg. It's believed that Se saturates the deficient stores of GPX so GPX saves the thyrocytes against to oxidative stresses. Although less than 70 micg/d is sufficient to maximize GPX activity, none of the authors tested the doses less than 200 micg/d. Our hypothesis was that If 100 micg/d can not suppress the TPOAb titers,it means autoimmune destruction can not be blocked by saturation of deficient stores of GPX solely and the mechanism of action requires more than repletion of deficient stores. It's important not only to estimate the optimal dose but to understand the mechanism of action. High dose therapy may also suppress TPOAb levels in Se-non-deficient AIT patients, if it is so, Se therapy may becomes the solely treatment modality which can suppress the autoimmunity in more than 400 million AIT patients. Because there've been no way to suppress autoimmune war and replacement of LT4 had been the only treatment modality for palliation. An other independent part of the study is to test the effect of Se in adolescent AIT patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range.

Exclusion Criteria:

* Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption.
Clinical Study on Prevention and Treatment of Pyrotinib Associated Diarrhea With Traditional Chinese Medicine

Pyrotinib is an important drug for the treatment of breast cancer, but the incidence of diarrhea is very high. At present, there is no particularly effective drug for diarrhea induced by pyrotinib. Trying to intervene with traditional Chinese medicine may bring better results to patients.

Pyrotinib is an important drug for the treatment of breast cancer, but the incidence of diarrhea is very high. At present, there is no particularly effective drug for diarrhea induced by pyrotinib. Trying to intervene with traditional Chinese medicine may bring better results to patients.

Eligibility Criteria:
Inclusion Criteria:

* 1. Meet the following two conditions:

  1. Planned administration of pyrotinib ≥ 21 days;
  2. Grade 1-3 diarrhea after taking pyrotinib, and it is planned to continue taking pyrotinib;

     2. Age ≥ 18 years old;

     3. ECOG PS 0-2；

     4. Life expectancy ≥ 6 months;

     5. Voluntarily join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up

     Exclusion Criteria:

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  1. Those who may be allergic to pyrotinib or excipients;
  2. It has many factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, etc;
  3. Patients with biliary obstruction;
  4. Participate in other diarrhea related clinical trials;
  5. Female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptives during the whole test period;
  6. according to the researchers' judgment, there are serious diseases that endanger the safety of patients, or affect the patients to complete the study (including, but not limited to, severe hypertension and severe diabetes, which can not be controlled by drugs).
  7. Any other circumstances in which the investigator believes that the patient is not suitable to participate in this study.
Safety and Efficacy Study of JTT-130 in Obese Type 2 Diabetic Patients

The purpose of this study is to evaluate the effect of JTT-130 on diabetes as well as the safety and tolerability of JTT-130 in obese Type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Have type 2 diabetes;
2. Body mass index (BMI) of \> 27.0 kg/m2 and ≤ 45.0 kg/m2;
3. Are either drug naïve with respect to hypoglycemic agents OR are currently being treated with metformin alone or in combination with a sulfonylurea. Metformin and sulfonylurea dosing must be stable.

Exclusion Criteria:

1. Females who are pregnant or breast-feeding
2. Known medical history or presence of type 1 diabetes, pancreatitis, unstable or rapidly progressing retinopathy, nephropathy or neuropathy;
3. Acute coronary syndrome or uncontrolled hypertension;
4. Does not meet medication restriction criteria, as described in the protocol.
Collaboration Between Department of Old Age Psychiatry and Nursing Homes

Dementia is a serious health problem showing an increasing prevalence rate with increasing age. In Norway, about 80% of nursing home patients have dementia. The mean age of nursing home residents in Norway is around 84 years. Disruptive and agitated behaviour affect 30-50% of all individuals with dementia at some point in the course of the illness. In addition, they have a combination of physical and psychological diseases which necessitates a close collaboration between different specialities in medicine and Old Age psychiatry. In collaboration with the communalities, our Old Age psychiatry services want to provide a new approach to this challenge and validate it on patient and personnel level.


Eligibility Criteria:
Inclusion Criteria:

* All patients at nursing home units

Exclusion Criteria:

* Patients that are in a final state and patients that have not been at the nursing home unit more than two weeks
The Effect of Straining Techniques on Women and Newborn

Purpose: To examine the effects of straining techniques on the duration of labor, perineal trauma status and newborn apgar score.

Method: This study is a randomized controlled trial. The straining techniques were explained to the pregnant women who gave written consent to participate in the study and were randomly assigned to groups in the latent phase (natural, spontaneous, Valsalva), and the techniques were applied in the second phase of labor.

Purpose: The present study was planned to determine the effects of straining techniques on the duration of labor, perineal trauma status, and newborn Apgar score.

Method: The study, which had a randomized-controlled experimental design, was conducted in Sivas Numune Hospital Birth Unit. The sampling size was calculated using power analysis. In the literature, spontaneous straining is used by pregnant women in the range of 25-81%, and Valsalva -type straining has a rate of 32-75%. To represent the population of the study, sample volume was determined at =0.05 significance level, 1- =0.95 Confidence Interval, =0.20 error risk, and 1- =0.80 power, and the total number of individuals was determined as 354. The data of the study were collected with the "Pre-Evaluation Form", "Personal Information Form", "Labor Evaluation Form", and "Apgar Score" created by the researchers in line with the literature data. The straining techniques were explained to the pregnant women who gave written consent to participate in the study and were randomly assigned to groups in the latent phase (natural, spontaneous, Valsalva), and the techniques were applied in the second phase of labor. ANOVA, Kruskal Wallis H-test, Chi-square test, Exact test, Tamhane T2 test, and Dunn Test were used to evaluate the data obtained in the study. Statistical significance was evaluated at a 0.05 significance level and the SPSS version 23.0 was used.

Eligibility Criteria:
Inclusion Criteria:

* 38-42. being at the gestational week,
* Having a singleton pregnancy
* Fetus in vertex position
* Being in the latent phase in the first stage of labor
* Planning and having a normal vaginal birth,
* Not having a diagnosed chronic physical disease,
* Not having a diagnosed psychiatric disease,
* No risk of risky pregnancy or fetal anomaly,
* Being literate,
* No communication problem
* Giving birth in the lithotomy position
* Volunteering to participate in the study

Exclusion Criteria:

* 38-42. not in the week of pregnancy,
* Having multiple pregnancy
* Fetus out of vertex position
* Being in the latent phase in the first stage of birth,
* Having a cesarean section while planning a normal vaginal delivery,
* Having a diagnosed chronic physical illness,
* Having a diagnosed psychiatric illness,
* Having a risky pregnancy or fetal anomaly risk,
* illiteracy,
* Having a communication problem
* Giving birth in different positions
* Not willing to participate in the study
Analgesic Efficacy of Paravertebral Morphine

The investigator will test the analgesic efficacy of paravertebral morphine as an adjuvant to local anesthetics for acute postoperative pain following breast surgery and renal surgery


Eligibility Criteria:
Inclusion criteria

* Adult patients subjected to mastectomy or renal surgery

Exclusion criteria

* Patients complaining of coagulopathies
* Patients with vertebral anomalies
Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients

The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo at some point in the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have fibromyalgia.

Exclusion Criteria:

* Patients with other painful conditions cannot participate.
Observation of Patients With Primary Pulmonary Hypertension Receiving Prescribed Ventavis Inhalation Therapy Regarding Safety and Efficacy for up to 4 Years

This is an observational study to monitor the continued effectiveness of Ventavis (inhaled iloprost) in the long-term. The study observes the effects and the safety of Ventavis inhalation therapy over at least 2 years and up to 4 years. A total of 54 patients from around 30 study sites in Europe will be included in the study. This observational study will collect information in patients receiving a medication that is already available on prescription in the participating countries. Ventavis is used to treat moderate cases of primary pulmonary hypertension.


Eligibility Criteria:
Inclusion Criteria:

* The treating physician has chosen Ventavis as a suitable long-term treatment for the patient
* Patient with primary pulmonary hypertension (i.e. Idiopathic Pulmonary Arterial Hypertension or Familial Pulmonary Arterial Hypertension) and classified as NYHA functional class III (NYHA = New York Heart Association)
* No prior treatment with Ventavis or other active treatments for primary pulmonary hypertension within 6 weeks of date of study inclusion (unless otherwise advised by Bayer Schering Pharma)

Exclusion Criteria:

* Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis Summary of Product Characteristics and patient package insert)
Nutritional Therapy in Patients at Risk for Malnutrition and Sarcopenia in Pulmonary Rehabilitation

Malnutrition and sarcopenia (muscle wasting) are common in health care settings and represent a health and economic burden due to associated increased mortality and prolonged hospital stays. Nutritional therapy co-management is recommended for both diagnoses.

This study investigates the efficacy of individualized nutrition therapy (iNT) in pulmonary rehabilitation. Patients at significant risk for malnutrition already receive iNT within clinical routine during rehabilitation. The investigators will investigate if patients with only mild to moderate risk of malnutrition and possible sarcopenia also benefit from iNT.

The participating patients are randomly assigned to two groups after giving written consent.

The intervention group receives individual counseling by nutrition therapists twice a week in addition to the usual rehabilitation program. The iNT determines the energy and protein needs of the patients and creates targeted individual measures to achieve them. Measures may include, for example, adjustments to the meal plan or nutritional supplementation. The measures are continuously adapted to the patients' needs.

The control group also receives soup fortified with a standard amount of protein and fat and, if needed, an energy- and protein-rich dessert option as part of the rehabilitation routine care for patients at risk for malnutrition. However, patients from the control group do not receive additional counseling or adjustment by the iNT.

Patients' energy and protein intake will be recorded on three subsequent days at start of rehabilitation and at three subsequent days before discharge. Average duration of rehabilitation is expected to be three weeks. As primary outcome, change in energy intake will be compared between groups. Additionally, change in protein intake and other follow-up parameters of nutritional status and sarcopenia will be examined.

Eligibility Criteria:
Inclusion Criteria:

* admission to rehab due to chronic obstructive pulmonary disease or after a pneumonia
* light to moderate risk of malnutrition (Nutritional Risk Score-2002: 3-4 Points)
* risk of sarcopenia (sarc-f \>=4)
* signed informed consent

Exclusion Criteria:

* medically described nutritional support
* reasons (cognitive, language) that prevent a informed consent
* enteral or parenteral nutrition
* after bariatric surgery
Assessment of a Novel Tracheostomy Tie

Tracheotomy is a common procedure for multiple medical indications.Tracheostomy tubes must be securely fixed to prevent movement or decannulation and tracheostomy ties must be exchanged as needed. However, the process of ties exchange is always risky and complicated. A novel tracheostomy tie has been designed to ensure the safety during exchanging and conveniences of cleaning. This study is to determine if the new device is better than the old one.

Tracheotomy is a common procedure for multiple medical indications. Nursing staff must understand the immediate postoperative and long-term management of tracheostomy patients. To provide safe and competent care, tracheostomy tubes must be taken care of carefully, including cleaning or changing the inner cannula, caring for the stoma, suctioning at least 3 times a day, and replacing tracheostomy ties according to facility-specific policy as needed. However, to avoid inadvertent dislodgement of the tracheostomy tube, the process of ties exchange is always risky and complicated, which request one person to hold the tube in place while a second person performs the tie exchange.

The investigators designed a novel tracheostomy tie to ensure the safety during exchanging and conveniences of cleaning, the primary feature of which is double belts and easy to operate. This randomized controlled trial is to determine if the new device is better than the traditional one.

Sixty tracheotomy patients without an existing neck injury will be recruited . Patients in experimental group wear a novel tracheostomy tie. The traditional one was used in control group. Difficulty level of exchanging or cleaning the tracheostomy ties, degree of comfort, skin breakdown and the actually frequency of exchanging will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥ 18 years old and ≤ 60 years old;
2. Patients with a tracheostomy;
3. With intact neck skin;
4. Willingly signs the Informed Consent;
5. Is qualified to participate in the opinion of the Investigator;
6. Without disorders of consciousness.

Exclusion Criteria:

1. With an existing neck injury or infection or clinically significant skin diseases on the application site which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, active cancer;
2. With damaged skin or conditions on the application site which includes sunburn, scars, moles or other disfiguration of the test site;
3. Has a known or stated allergy to adhesive bandages, or any of the product types being tested;
4. Uses of topical drugs on the application site;
5. Uses lotions, creams or oils on the application site;
6. Can not communicate with nurses or doctors for any reasons
ADME Study of [14C] Yiqibuvir in Healthy Male Subjects

This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of \[14C\] Yiqibuvir.


Eligibility Criteria:
Inclusion Criteria:

* signing of informed consent
* Weight: Body mass index (BMI) is 19.0\~28.0 kg/m2
* Subjects are able to communicate well with the investigators and be able to complete the trial according to the process

Exclusion Criteria:

* Those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations
* Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive
* Positive results from urine drug screen test
* Donate blood or lose blood 400 mL or more within 3 month prior to dosing
* Subjects who have used any medication, biological product, Chinese patent medicine, herbal medicine, nutritional supplements or health care products within 14 days prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication
* History of needles or blood fainting, or have difficulty in blood collection or cannot tolerate venipuncture for blood collection
Biomarkers for Diagnosis of Lung Nodules

A need exists for non-invasive testing to aid in clinical decision-making for Computerized Tomography (CT) scan detected lung nodules of indeterminate etiology. The investigators hypothesize that biomarkers detectable in blood, sputum or urine may be useful for guiding clinical decisions in the setting of CT detected lung nodules to determine which nodules are malignant and which are benign. The investigators also hypothesize that these biomarkers will decrease in concentration to the normal range after successful surgical treatment of malignant lung nodules.

The Biomarkers for Diagnosis of Lung Nodules Study is a prospective study of a cohort of 500 individuals with lung nodules of indeterminate etiology that are identified by CT scans. Either biopsy or repeat CT scans must be clinically indicated to determine the etiology of the nodule. Patients will be asked to allow investigators access to CT scan images and spirometry data, and provide blood, sputum, urine, and exhaled breath samples over the course of the study. Patients will also be asked to allow investigators to access pathology records if a biopsy or surgical excision of the nodule is clinically indicated.

Eligibility Criteria:
Inclusion Criteria:

1. Adult 18-85 years of age
2. Patients referred to pulmonologists, oncologists, or thoracic surgeons for the evaluation of peripheral lung nodules found on CT scan.
3. Repeat CT scans, biopsy or surgical excision are clinically indicated to determine the etiology of the nodule.
4. One or more lung nodules must be between 8 mm and 30 mm in the greatest diameter.
5. Patients must be fully informed of the investigational nature of the procedure and sign an informed consent.

   -

Exclusion Criteria:

1. Lung nodules or masses greater than 30 mm in the greatest dimension.
2. Lung nodules that have solid calcification.
3. Lung nodules or masses with CT evidence of partial or complete obstruction of a lobar bronchus, main stem bronchus or the trachea.
4. No prior cancer with the exception of non-melanoma skin cancer.
5. Life expectancy of \< 6 months
6. Any individual who does not give oral and written consent for participation -
Access II - Trial of Warfarin to Prevent Malfunction of Haemodialysis Catheters

This study examines whether low intensity, dose adjusted warfarin prolongs the time to mechanical failure of hemodialysis catheters without resulting in an unacceptable rate of bleeding.

Patients with end-stage renal disease receiving or about to initiate hemodialysis are randomized to receive either adjusted dose warfarin to achieve an INR of 1.5-1.9 or adjusted dose placebo within 72 hours of hemodialysis catheter placement. The primary outcome is mechanical failure of the catheter, as outlined below.

Eligibility Criteria:
Inclusion Criteria:

* Newly placed double-lumen hemodialysis catheter

Exclusion Criteria:

* Major bleed within last 3 months
* Platelet count less than 50 x 10 9/L or current coagulopathy (most recent INR \> 1.5, not due to warfarin)
* Active peptic ulcer disease
* Anticipated need for invasive intervention within next 2 weeks
* Taking warfarin for an indication other than access prophylaxis
* Allergic to, or intolerant of, warfarin
* Pregnant
* Woman of child-bearing age who has not agreed to use an adequate method of birth control for the duration of the study
* Catheter likely needed for 2 weeks or less
* Patient previously took part in the study
* Patient has known aortic aneurysm of 6cm or greater
* Patients nephrologist has refused consent
* Patient has refused consent
TEST: Registry for Endoscopic Head and Neck Surgery

The goal of this data review research study is to create a registry database using information (data) collected from patients who have had Endoscopic Head and Neck Surgery (eHNS). Researchers want to use the registry database to learn more about short-term and long-term outcomes for patients who have eHNS.

1.1 Primary Objective: To develop a registry database of patients who have had eHNS.

1.2 Secondary Objective: To evaluate short-term oncologic parameters and functional outcomes, operative for patients undergoing eHNS performed at M.D. Anderson Cancer Center (MDACC).

1.3 Tertiary Objective: To collect data on long-term oncologic outcomes including local and distant failure and survival following eHNS.

Information from medical records will be collected and entered into the registry database at M. D. Anderson Cancer Center for future research related to cancer.

The information collected from medical records will include, but is not limited to, medical history, sex, age, race, gender, type and stage of disease, type of treatment(s) you have received, radiology reports, surgical and pathological reports, the results of any test(s), treatment(s) and/or surgery performed.

This is a registry study evaluating endoscopic head and neck surgery. The data from the surgical resection will be descriptive. Comparisons will be made to non-robotic, open historical controls and patients treated with radiation therapy, based on literature reports.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with head and neck cancer who are candidates for definitive surgical resection of the primary tumor and who, in the opinion of the treating MDACC physician, are candidates for eHNS will be included
2. Medically fit for an endoscopic surgical resection by consensus of MDACC surgical oncology and anesthesia faculty (common best practice criteria).
3. Date of records anticipated to be reviewed would be from March 1, 2011 to June 30, 2013
4. Approximately 200 patients are expected to fit the criteria above in order to be eligible for prospective data collection and review.

Exclusion Criteria:

None.
Brachial Plexus Block in Children and Adolescents

This study involves a retrospective evaluation of brachial plexus anaesthesia in children and adolescents (patients under the age of 18) undergoing surgical procedures of the upper extremity following trauma. The investigators plan to recruit patients from our hospital patient database meeting our inclusion criteria. Observational period was defined between 1st of January 2002 and 31st of October 2018. Necessity to convert to general anaesthesia was defined as primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Brachial plexus anaesthesia for surgical intervention of upper extremity injuries

Exclusion Criteria:

* age above 18