cyrilzakka/clinical-trials huggingface dataset:
Idiopathic Anemia of Aging (IAA)

The purpose of this trial is to examine whether Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse idiopathic anemia.

As individuals become older, the frequency of anemia increases. While the cause of anemia in many cases can be determined and corrected, in a number of individuals there is no correctable cause found and the patient must live with their anemia. This is known as idiopathic anemia, and can have serious consequences for the individual. Numerous studies have demonstrated that anemia is associated with loss of energy and stamina, causing individuals to decrease their activities, which adversely affects both their sense of well-being as well as their physical strength. Losses in these areas are associated with the clinical manifestations of frailty.

The current pilot study will examine whether or not administration of Epoetin Alfa, a hormone stimulating production of red blood cells, can reverse this type of anemia. We will examine the consequences of reversing the anemia in terms of physical strength and function, cardiovascular function and sense of well-being and mental function.

In this study, individuals with anemia will be treated for six months with Epoetin Alfa following the correction of their anemia and measurements done to evaluate physical strength, performance, cardiac, mental and kidney function. At the end of treatment, individuals will be followed for an additional six months to determine whether the anemia recurs and physical function decreases.

Participation in this study is voluntary. All testing and medication received are free to the participant.

Eligibility Criteria:
Inclusion Criteria:

* 70 years of age or older
* Diagnosed with anemia
* Hemoglobin level less than or equal to 11
* Able to perform most activities of daily living without restriction

Exclusion Criteria:

* History of serious heart, liver or kidney disease
* Cancer treated within the last year except for skin cancer (excluding melanoma)
* Problems with your immune system
* Received Epoetin Alfa within the last year
Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease

The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease. Subjects had to be in remission (CDAI\<=150) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease Activity Index (CDAI) score of ≥ 220 ≤450)

Exclusion Criteria:

* Active or draining fistula present at screening
* Lactating and/or pregnant female subjects
* A history of any health condition that could potentially interfere with the disease and/or the treatment
* A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product
* Any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study
* History of drug or alcohol abuse in the prior year
* Receipt of any experimental therapy within or outside a clinical trial in the 3 months prior to Visit 0
Efficacy of TAK-085 in Participants With Hypertriglyceridemia

The purpose of this study was to determine the efficacy and safety of TAK-085, once daily (QD) or twice daily (BID), compared to ethyl eicosapentaenoate (EPA-E), three times daily (TID) in participants with hypertriglyceridemia undergoing lifestyle modification.

TAK-085 is an oral capsule medicine licensed to Takeda Pharmaceutical Company Ltd. TAK-085 contains omega-3 fatty acid ethyl (mainly, ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoic acid (DHA-E)).

This is a phase 3, double-blind, randomized study to evaluate the efficacy and safety of TAK-085 compared to EPA-E in participants with hypertriglyceridemia who are undergoing lifestyle modification.

The study period is a total of 20 weeks, comprised of an 8- week screening period and 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Participants with values of fasting triglyceride level at Visit 2 (Week -4) and Visit 3 (Week -2) are 150 mg/dL or higher and less than 750 mg/dL, and the difference between these 2 values is within 30% of the higher one.
2. Participants with differences between 2 values of fasting Low density lipoprotein - cholesterol level measured at Visit 2 (Week -4) and Visit 3 (Week -2) are within 25% of the higher one.

Exclusion Criteria:

1. Participants who have coronary artery diseases (eg, confirmed myocardial infarction and angina pectoris) within 6 months prior to Visit 1 (Week -8) or participants with a history of revascularization.
2. Participants who received aortic aneurysmectomy or is complicated with aortic aneurysm within 6 months prior to Visit 1 (Week -8).
3. Participants who have a history or complication of a clinically significant hemorrhagic disease (eg, hemophilia, capillary fragility illness, digestive tract ulcer, urinary tract hemorrhage, hemoptysis, vitreous haemorrhage and so forth) within 6 months prior to Visit 1 (Week -8).
4. Participants who have been diagnosed with pancreatitis.
5. Participants who have been diagnosed with lipoprotein lipase (LPL) deficiency, apolipoprotein C-II deficiency or type III familial hyperlipidemia.
6. Participants with complication of Cushing's syndrome, uremia, systemic lupus erythematosus (SLE) or serum dysproteinemia.
Acute Effect of Blood Flow Restricted High-Intensity Resistive Training

Recommended by many professional organizations such as the American College of Sports Medicine (ACSM) and the National Strength and Conditioning Association (NSCA), resistance exercise training improves muscle strength, body composition, performance, functionality and quality of life in healthy young adults. Blood flow restriction (BFR), also known as Kaatsu training, is proposed as a new method to improve muscle strength and muscle hypertrophy in a short time. Although there are studies in the literature in which BFR is applied with low-intensity resistance training, no studies have been found examining the effects of BFR applied with high-intensity resistance training on the neuromuscular adaptations of the quadriceps femoris muscle. Determining whether high-intensity resistance training with BFR is more effective on the quadriceps femoris muscle compared to high-intensity resistance training applied without BFR may provide faster and more effective responses by arranging resistance training protocols in terms of neuromuscular gains. Between 07.03.2022 and 07.06.2022, in the Biruni University Physiotherapy and Rehabilitation Department Application Laboratory, in which 24 healthy young adults between the ages of 18-25 (from 12 BFR, 12 BFR) will be included, exercise training to be applied with and without BFR was determined. Its effects will be compared with electromyographic measurement, single leg squat test, and measurement of late-onset muscle pain (Visual Analog Scale). IBM SPSS 21.0 statistical program will be used for statistical analysis. Whether the variables are suitable for normal distribution will be analyzed with the Shapiro-Wilk test. If the variables show normal distribution, the variation within the group will be analyzed with the paired samples t test, and if it does not show normal distribution, the Wilcoxon Signed rank test will be analyzed. Comparison of groups will be made with independent samples t-test in independent groups if the variables show normal distribution, and with Mann Whitney-U test if they do not show normal distribution. Categorical data distributions will be evaluated with the Chi-square test.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-25
* Healthy
* Be volunteer to participate the study

Exclusion Criteria:

* Pregnancy
* Breastfeeding status
* Cardiovascular disease
* Musculoskeletal problems
* Orthopedic problems related to the lower extremities
* Peripheral or central neurological disorders
Ovarian Function of Nasopharyngeal Carcinoma Women Survivors

This is an observational cohort study aimed to explore the fertility concerns, fertility preservation strategies, fertility status (pregnancy and Ovarian Failure) and birth outcome among young woman Nasopharyngeal carcinoma patients.

The purpose of this study was to explore the effects of radiotherapy and chemotherapy on ovarian function and pregnancy outcome after treatment in female survivors of non-metastatic nasopharyngeal carcinoma, so as to clarify the relationship between ovarian dysfunction after treatment and pregnancy outcome, as well as clarify the relationship between pregnancy after treatment and tumour progression.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III ,with no distant metastasis
2. Age between 18-45, female
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal (ULN),serum total bilirubin (TBIL) ≤2.0 times the upper limit of normal (ULN) .
5. Adequate renal function: creatinine clearance rate≥60 ml/min or Creatinine ≤1.5× upper limit of normal value.
6. No history of infertility.
7. No history of hysterectomy or bilateral ovariectomy.
8. Patient have signed on the informed consent, and well understood the objective and procedure of this study

Exclusion Criteria:

1. Histologically or cytologically confirmed with keratinizing squamous cell carcinoma of the nasopharynx.
2. Women in the period of pregnancy, lactation, or reproductive without effective contraceptive measures.
3. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
4. Patients with severe dysfunction of heart, liver, lung, kidney or marrow.
5. Patients with severe, uncontrolled disease or infections.
6. Refuse or fail to sign the informed consent .
7. Patients with personality or mental disorders, incapacity or limited capacity for civil conduct.
Efficacy of the Combination Bismuth + Neomycin + Procaine in the Treatment of Recurrent Aphthous Ulceration

To evaluate the efficacy of the product Bismu-Jet ® (bismuth tartrate and sodium, neomycin sulfate and procaine hydrochloride) produced by EMS S / A compared to placebo in reducing the signs and symptoms resulting from UAR in patients of both sexes, with age over 12 years.

The period of practical study will be conducted at the Center for Orofacial Rehabilitation Aesthetics, located in Campinas-SP, where there are several beds and a large number of people served by dentists attending post-graduate, under the supervision of Dr. Claudio Azenha. Thus, patients are instructed to find the center if they experience the first signs of UARs.

Will be included only where the top of the table has not extrapolated 48 hours. These patients will be referred to the visit of screening and early treatment (day 0 - Visit 01). At a screening visit will be informed all the relevant aspects of research, enabling the patient judge the feasibility of their participation in the study. After signing the Informed Consent, patients will be randomized and will receive one of the treatments. This consultation will be a clinical examination where the examiner will tell the lesions and measure the size of each. Besides the clinical examination there is a subjective test, in which the patient must consider the intensity of pain you're feeling at that moment, using the visual analogue scale (VAS). The drug will be administered by the investigator, the patient showing the correct way of administration. After 15 minutes, the pain will be measured again, using the VAS.

After three days, patients should return for the 02 tour, which will be clinically evaluated and will be assessed for intensity of pain, in addition to the reporting of adverse events. The same procedures will be repeated in the return of seven days (Visit 03). This visit some patients may receive high clinic.

The study will be finalized after 14 days of treatment (Visit 04), when patients must return to the office to the final evaluations, as will high or be exempted from the clinical study.

Patients who do not have improvement in time, receive replacement therapy funded by the sponsor and provided by waxen, according to the needs of each individual case, judged by expert researchers.

Eligibility Criteria:
Inclusion Criteria:

* Consistency with the purposes of the study and all topics of FICT;
* Age above 12 years;
* Both sexes;
* Diagnosis of type UAR minor

Exclusion Criteria:

* Use of nutritional supplements such as iron, folic acid and vitamins of the B complex;
* immunocompromised;
* systemic diseases (endocrine-metabolic);
* rheumatic diseases;
* Pregnancy and lactation;
* Use of topical or systemic corticosteroids;
* UAR type major;
* UAR type Herpetiformis;
* UAR over 48 hours of development;
* Background allergic to any components of the formula.
Assessment of GERD Knowledge Level Among Patients With it in Korea

* 1. Research topic: How much do patients with GERD know about their own disease in Korea? (multicenter survey)
* 2. Questionnaires for multicenter survey:

  1. Questionnaire 1 - include items for basic characteristics of participant patients
  2. Questionnaire 2 - modification of GERD knowledge test which was used in BMC Health Services Research 2008;8:236 (Prof. Jorgen Urnes)
* 3. Subjects: patients with GERD in secondary or tertiary hospital
* 4. Participant institutes: GERD club members, The Korean Society of Neurogastroenterology and Motility

Validation process to produce Korean version of GERD knowledge test

1. Forward Translation of GERD knowledge test of prof. Jorgen Urnes: through certified translation company
2. Expert's review of the forward translated knowledge test : among members of GERD club,
3. Pilot survey among nurses and some patients
4. Korean Version, provisional
5. Backward translation: through certified translation company
6. Consultation with Prof. Jorgen Urnes about backward translated knowledge test
7. Korean Version, final
8. Print and distribution
9. Study start

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as GERD by doctors

Exclusion Criteria:

* Patients without GERD
Comparison of Foley Balloon With or Without Traction for the Cervical Ripening

We will compare the use of foley bulb catheters placed in the cervix for ripening of the cervix for labor induction,.

One arm will have the foley balloon placed alone in the cervix. And one arm will have the foley balloon placed in the cervix and then attached to a weight (1000 cc Iv Bag of fluid). Our hypothesis is that the weighted balloon will be more effective than the non-weighted balloon in the ripening of the cervix for induction of labor

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy scheduled for induction of labor

Exclusion Criteria:

* Preterm pregnancy that require induction for fetal indications
A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments.

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of our research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus Type 2 or Type 1
* Age between 18-80 years
* Chronic foot ulcer more than 6 weeks
* No sufficient response to best standard care delivered for six weeks.
* PAD up to Fontaine stage III or IV period
* CLI with the ankle brachial index (index ankle-brachial, ABI) \<0.7 and (or) the percutaneous oxygen partial pressure (oxygen tension transcutaneous, TcPO2) \<30mmHg

Exclusion Criteria:

* HbA1c \>12%
* Hemoglobin \<10 mg/dl
* Creatinine clearance rate \<30ml/min
* Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, HIV, B19 infection, herpes virus infection) and sepsis
* Have accepted the treatment of stem cells or growth factors
* Have a history of malignant disease
* Pregnancy
* Mental illness history
* Abnormal coagulation function
* Allergic reaction
* Severe cardiac insufficiency (III-IV NYHA)
* Using vasoactive substances
Combination Chemotherapy With Sildenafil Plus Carboplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer

A comparison of combination chemotherapy of sildenafil plus carboplatin and weekly taxol with carboplatin and weekly taxol in patients with previously untreated advanced non-small cell lung cancer. The study hypothesis is that sildenafil may improve the distribution and efficacy of cytotoxic anticancer agents.

Sildenafil is one of selective phosphodiesterase type 5 inhibitors. It is used to block the degradative action of phosphodiesterase type 5 on cyclic GMP in the smooth muscle cells lining the blood vessels, which leads to smooth muscle relaxation in blood vessels and increases blood flow. Because phosphodiesterase type 5 is also present in the arterial wall smooth muscle within the lungs, phosphodiesterase type 5 inhibitors is also used for the treatment of pulmonary hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically confirmed stage IIIB or IV non-small cell lung cancer
* Good performance status (ECOG 0-1)
* No previous treatment
* Adequate bone marrow, liver and renal functions
* Must be able to swallow tablets
* Provided written informed consent

Exclusion Criteria:

* Severe complications or a concomitant malignancy
* Contraindicated sildenafil, carboplatin or taxol
* Inappropriate patients for entry to this study, judged by the physicians
A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults

The objective of this study is to assess the bioavailability of risankizumab liquid vial manufactured with the new process (CMC3) relative to the current process (CMC2).


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal at the time of screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
* Body weight less than 100.00 kg at Screening and upon initial confinement.

Exclusion Criteria:

* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* Previous exposure to any anti-interleukin (IL)-12/23 or anti-IL-23 treatment for at least one year prior to Screening.
Single Photon Emission Computed Tomography/Computed Tomography With Pentavalent 99mTc Dimercaptosuccinic Acid in Patients With Brain Glioma; Correlation With IDH Mutation

The aim of this study is to evaluate the correlation between degree of 99mTc-DMSA (V) uptake at SPECT/CT and IDH mutation in patients with brain glioma.

Every year, nearly100,000 people worldwide are diagnosed as having brain gliomas. Although it comprises \<1% of all newly diagnosed cancers, brain glioma is associated with substantial mortality and morbidity. Gliomas are intrinsic brain tumors that originate from neuroglial progenitor cells. Conventional therapies, including surgery, chemotherapy, and radiotherapy, have achieved limited improvements in the prognosis of glioma patients.

Radiation therapy to the brain may lead to postradiation injury which typically occurs within the first 3 to 12 months after radiotherapy but it was reported up to several years and even decades later. The clinical picture of radiation necrosis (RN) is variable and may include seizures, headache, personality changes, and neurologic deficits. These symptoms mimic tumor recurrence and differentiation between the two entities clinically or even by conventional radiological modalities is difficult but is necessary because the two conditions have different treatment modalities and prognosis.

SPECT has the advantages of being widely available and not expensive. Multiple SPECT tracers have been explored. Of them Thallium-201 and 99 mTc-MIBI are, possibly, the most extensively discussed. The main disadvantage of 201Tl is the lower spatial resolution, relatively large radiation dose, and the reported high false positive results. Normal uptake of MIBI in the choroid plexus may be confounding for assessing tumors around the ventricles.

Pentavalent 99mTc dimercaptosuccinic acid (99mTc (V) DMSA), is a nonspecific tumor targeting SPECT radiotracer, that has been used for imaging of various tumors including lung and breast carcinoma. However, to date, scarce reports discussed the utility of DMSA-V in patients with glioma.

Isocitrate dehydrogenase (IDH) enzymes, of which there are three isoforms, are essential enzymes that participate in several major metabolic processes, such as the Krebs cycle, glutamine metabolism, lipogenesis and redox regulation.

Major advances in cancer genetics over the past decade have revealed that the genes encoding IDHs are frequently mutated in a variety of human malignancies, including gliomas, acute myeloid leukaemia, cholangiocarcinoma, chondrosarcoma and thyroid carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a pathologically proven glioma. • patients conscious to provide informed consent

Exclusion Criteria:

* Pregnant women.
* severely ill patients and those with disturbed conscious level,
* patients who were judged that they cannot lie down comfortably without movement for at least 20 min
Treatment of Opioid Dependent Patients With Suboxone: Acceptability & Safety Data From Real Life Scenario (Study P05603)

The aim of this post marketing surveillance study is to investigate the retention rate after 12 months of drug dependence treatment with SUBOXONE® (buprenorphine plus naloxone) of opioid dependent patients under real life conditions.

Nonprobability sampling was done by invitation to volunteer with the intention to document 4 to 5 patients per physician where a substitution therapy with Suboxone is planned and indicated.

Eligibility Criteria:
Inclusion Criteria:

* Both adult and adolescent patients over 15 years of age who have consented to addiction treatment for opioid dependence within the scope of medical, social and psychotherapeutic measures can be included. Therapeutic indications and contraindications for SUBOXONE® must be observed when selecting patients.

Exclusion Criteria:

* In accordance with the product information, it is to be taken into consideration that patients are not suffering simultaneously from acute alcoholism, delirium tremens, or severe respiratory and severe liver insufficiency.