cyrilzakka/clinical-trials huggingface dataset:
Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders

To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with aplastic anemia and related bone marrow failure diseases.

BACKGROUND:

Aplastic anemia has been shown to respond to ATG. An immunological basis for aplastic anemia has been suggested by previous observations although the precise mechanism of action of ATG has not been defined. This serum, produced by immunization of horses with human thymocytes, may have broad reactivity with many human cells.

DESIGN NARRATIVE:

Patients in Group I with acute severe disease were randomized to receive ATG in either ten day or twenty-eight day courses. Patients in Group II with moderate or chronic disease were randomized to receive either ATG for ten days or high doses of the androgen, nandrolone decanoate. Patients in Group III with a variety of bone marrow diseases were also treated with ATG.

The study completion date listed in this record was inferred from the last publication listed in the Citations section of this study record.

Eligibility Criteria:
Men and women with moderate or acute, severe, aplastic anemia.
Benefit Evaluation of Foot Reflexology in Oncology

Chemotherapy with platinum salts is very emetic. The aim of this study is to evaluate the benefits of foot reflexology in nausea and vomiting induced by platinum salts-based chemotherapy in patients with thoracic or digestive tumors.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a thoracic or digestive cancer with indication of management with platinum salts-based chemotherapy
* Good performance status of (ECOG 0-2)
* More than 18 years old
* Ability to complete the questionnaires (comprehension oral and written French language) and to carry out the required exercises.
* Patient affiliated to Social Security or equivalent
* Informed consent signed

Exclusion Criteria:

* Phlebitis
* Cellar syndrome
* Weight loss\> 5% in 3 months
* Uncontrolled pain
* Patients under morphine and derivatives
* Brain metastases
* Patient benefiting from foot reflexology outside the study
* Patient under guardianship or curatorship or deprived of his rights
Long-Term Follow-Up Studies at Year 6, 7, 8, 9, 10: 2 Formulations of Combined Hepatitis A/B Vaccine Compared in Subjects Aged 12-15 Years

To evaluate the persistence of anti-hepatitis A virus (anti-HAV) and anti-hepatitis B surface antigen (anti-HBs) antibodies up to 6, 7, 8, 9 and 10 years after administration of the first dose of the study vaccine.

Open, randomized, long-term antibody persistence studies. Immune persistence was compared between subjects who received one of the two formulations of GlaxoSmithKline Biologicals' combined hepatitis A and hepatitis B vaccine according to a two-dose or three-dose schedule. These long-term follow-up studies involved taking blood samples at approximately 6, 7, 8, 9 and 10 years after the primary vaccination of combined hepatitis A and B vaccine, to assess antibody persistence and a retrospective safety follow-up.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers vaccinated in study HAB-084.
* Written informed consent obtained from the subject before the blood sampling visit of each year.

Exclusion Criteria:

• none
Inositol Supplementation to Treat PCOS (INSUPP-PCOS)

To determine if Inositol, a dietary supplement, will improve ovarian and adrenal androgen excess in women with Polycystic Ovarian Syndrome(PCOS).

This trial will test prospectively the effects of inositol supplementation in a dose ranging double blind randomized controlled trial, according to CONSORT guidelines. This will be a four armed study of three doses of inositol vs. placebo over a three month period with the reduction in hyperandrogenism (based on serum testosterone levels) as the primary outcome and key secondary outcomes of the change in sex hormone binding globulin(SHBG) and the related free androgen index, fasting insulin levels and area under the curve glucose levels from an oral glucose challenge test (OGTT). The hypothesis is that women with PCOS who receive inositol supplementation will have a dose related reduction in hyperandrogenism. Further, we propose that the primary mechanism of inositol will be a significant improvement in hyperandrogenism (both ovarian and adrenal) vs. placebo, as documented by a lower free androgen index \[decreased total testosterone and increased sex hormone blinding globulin (SHBG)\], lower sebum measures and lower antral follicle counts of the ovary and anti-Mullerian hormone, all of which will correlate with the decrease in hyperandrogenism.

Eligibility Criteria:
Inclusion Criteria:

* Women with chronic anovulation or oligomenorrhea defined as spontaneous intermenstrual periods of greater than or equal to 45 days or a total of less than or equal to 8 menses per year.
* Women with Hyperandrogenism defined as a total testosterone greater than 50 ng/dL or a free androgen index greater than 10.
* Women with Polycystic Ovaries on Ultrasound defined as either 12 or more follicles measuring 2-9 mm in diameter or increased ovarian volume greater than 10 cm.

Exclusion Criteria:

* Women with Hyperprolactinemia defined as 2 prolactin levels at least one week apart greater than 30 ng/mL.
* Women with known 21-hydroxylase deficiency or other enzyme deficiency leading to the congenital adrenal hyperplasia.
* Women with elevated FSH levels greater than 10 mIU/mL.
* Women with uncorrected thyroid disease as per ASRM guidelines for nonpregnant subjects (TSH less than 0.45 mIU/mL or greater than 4.5 MIU/mL).
* Women with a suspected adrenal or ovarian tumor secreting androgens
* Women with Cushing's syndrome
* Women on confounding medications which affect ovarian function including metformin, hormonal contraceptives or other medications for type 2 diabetes
* Women with medical conditions that are contraindications to OTC inositol or previous allergic reactions to the supplement or to the placebo maltodextrin or inulin.
Safety and Immunogenicity of Q Fever Vaccine

The purpose of this study is to evaluate the safety of Q Fever Vaccine, Phase I, Inactivated, Dried, NDBR 105 and collect data on incidence of occupational Q fever infection in vaccinated personnel.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old.
* Females of childbearing potential must agree to have a urine pregnancy test on the same day before receipt of skin test AND vaccine. (Exception: documented hysterectomy or ≥ 3 years of menopause.) The results must be negative. Females must agree to not become pregnant for 3 months after receipt of the skin test or vaccination.
* Considered at risk for exposure to C burnetii and who have submitted a Request for Investigational New Drug (IND) Vaccines for the Q Fever vaccine.
* Sign and date the approved informed consent document and Health Insurance Portability and Accountability Act (HIPAA) Authorization.
* Have on their charts:

  * Up-to-date medical history (including concomitant medications)
  * Physical examination and laboratory tests within 1 year
  * Previous chest x-ray and electrocardiogram
* Be medically cleared for participation by an investigator. Examinations or tests may be repeated at the discretion of the enrolling physician.
* Willing to return for all follow-up visits.
* Agree to report any adverse events (AEs) that may or may not be associated with administration of the test article for at least 28 days after vaccination and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study (6 months).
* Agree to defer blood, bone marrow, and organ donation for 1 year after receipt of skin test antigen and/or vaccine.

Exclusion Criteria:

* Prior history of Q fever disease or vaccination.
* Clinically significant abnormal lab results (including evidence of hepatitis C, hepatitis B carrier state) or elevated liver function tests (two times the normal range or at the discretion of the principal investigator).
* Personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication.
* Confirmed HIV infection.
* Heart valve disease: prosthetic heart valve or clinically significant heart murmur. (If a murmur is detected on examination, an echocardiogram may be obtained or subject may be referred to a cardiologist to determine clinical significance.)
* Aneurysm/vascular graft.
* Joint prosthesis.
* History of chronic fatigue syndrome (or positive by chronic fatigue syndrome (CFS) Questionnaire criteria).
* Positive pregnancy test or breast-feeding female.
* Any known allergies to components of the vaccine:

  * Formalin
  * Eggs or chicken products
* Administration of another vaccine or investigational product within 28 days of skin test and subsequent Q fever vaccination.
* Any unresolved AE resulting from a previous immunization.
* Transplant recipients, subjects with cancer, and those with chronic kidney disease.
* A medical condition that, in the judgment of the principal investigator, would impact subject safety.
Performance Study to Test the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes

Over the last years, a number of systems for continuous subcutaneous glucose monitoring have been marketed and are routinely used in patients with diabetes to obtain more detailed information about 24-hour glucose profiles.

In the hospital, numerous factors influencing glycemic control and possibly leading to glucose excursions out of the desired range exist, e.g. interventions for which the patient has to remain fasting or medications such as corticosteroids or vasopressors. A reliable continuous glucose signal could help to observe levels of glycaemia not only at defined time-points but continuously, making it possible for physicians and nursing staff to better adjust antihyperglycemic therapy and to react before the patient is exposed to severe hypo- or hyperglycaemia.

In the hospital setting, vascular access is granted in the majority of patients and could as well be used as an alternative site for continuous glucose monitoring.

The aim of the present study is to assess accuracy of the glucose data obtained by means of an intravascular microdialysis-based CGM system against venous blood glucose reference measurements.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained after being advised of the nature of the study
* Male or female aged 18 - 75 years (both inclusive)
* Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months
* Body mass index 20.0 - 29.5 kg/m² (both inclusive)
* HbA1c \< 86.0mmol/mol

Exclusion Criteria:

* Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods.
* Skin pathology or condition prohibiting needle insertion as judged by the investigator.
* History of bleeding disorder.
* History of heparin-induced thrombocytopenia (HIT)
* Current participation in another clinical study.
* Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator.
* Lipodystrophy
* Current treatment with systemic (oral or i.v.) corticosteroids or any anticoagulation medication.
* Blood donation or blood loss of more than 500 mL within 12 weeks prior to the study day.
* Known hypersensitivity to Fondaparinux sodium (Arixtra®).
* Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen.

Study day exclusion criteria:

* Non-fasting (i.e. consumption of food or beverages, other than water, later than 22:00 hours the evening before the visit) except if slight intake of rapidly absorbable carbohydrates has been necessary in order to prevent hypoglycaemia.
* Positive result of alcohol breath test.
Renal Tracer Elimination in Thyroid Cancer Patients Treated With 131-Iodine

Correlation analysis between estimated renal function and biological half life of 131-I during radioiodine treatment of patients with differentiated thyroid cancer.

131-I during radioiodine treatment of patients with differentiated thyroid cancer is mainly renally excreted. It is advised in the clinical guidelines that serum creatinine should be determined before applying 131-I and if necessary the administered dose should be reduced. Nevertheless no guideline gives advice in what extent the dose should be decreased. The adjustment is at the discretion of the attending physician.

Aim of this prospective study is to correlate the biological half life of 131-I with the renal function to give objective recommendations concerning the reduction of the applied dose in patients with limited renal function.

Eligibility Criteria:
Inclusion Criteria:

* patients with differentiated thyroid carcinoma
* stationary for treatment or diagnostic with radioiodine
* state after thyroidectomy
* written consent of the patient
* minimum age 18 years

Exclusion Criteria:

* no written consent of the patient
* patients with large residual thyroid tissue (iodine uptake \> 10%)
* children under 18 years of age
* inclusion in concurrent interventional studies
* patients without TSH-stimulation by rhTSH
Characteristics of Gut Microbiota in Patients With Colon Cancer of Different Traditional Chinese Medicine Syndromes

Guided by the idea of combining disease differentiation with syndrome differentiation in traditional Chinese medicine, this study used the form of questionnaire to summarize the changes of TCM syndromes, TCM constitution types in colorectal cancer patients before and after surgery. The Next-generation sequencing technology was used to explore the changes and differences of intestinal microorganisms before and after surgery. The correlation between changes of TCM syndromes, TCM constitution types, intestinal microbial evolution and tumor biological characteristics in colorectal cancer patients before and after surgery was analyzed. To explore the rationality of TCM in the prevention and treatment of colorectal cancer recurrence and metastasis in order to guide the individualized treatment and dietary regulation of TCM.


Eligibility Criteria:
Inclusion Criteria:

1. Preoperative abdominal CT, colonoscopy and pathological examination were diagnosed as colorectal malignant tumor patients;
2. Having surgical indications;
3. Patients who were not treated with antibiotics or microbiological agents one week before surgery;
4. Patients who had not received radiotherapy and chemotherapy before surgery;
5. Patients or their legal representatives informed and agreed to participate in this clinical trial and signed a written informed consent;

Exclusion Criteria:

1. Have other cancer history;
2. Patients who have received invasive treatment within the past three months;
3. Inflammatory bowel disease such as ulcerative colitis or crohn's disease;
4. Combined with intestinal obstruction or intestinal perforation for emergency surgery;
5. Psychiatric history, can not join and standardize the completion of clinical investigators;
6. Pregnant or nursing women;
7. Patients treated with antibiotics or microbiological agents one week before surgery;
8. People have incomplete data;
Effects of Combined Sevoflurane and Nitrous Oxide Inhalation - 14

The purpose of this study is to determine the effects of combined sevoflurane and nitrous oxide inhalation on mood, psychomotor performance, and the pain response in humans.


Eligibility Criteria:
Please contact site for information.
Effect of Thoracic Mobilization in Females With Coccydynia

Coccydynia is common and prevalent among the females and several types of exercises and electrotherapy are advised. Pain can reduced significantly with both short wave diathermy and muscles stretches. There is limited evidence on indirect method like thoracic mobilization techniques to improve coccydynia. This study will determine the effects of thoracic mobilization techniques on coccydynia.

Coccydynia, refers to pain in the coccyx region. it can be caused by various factor including trauma or injury (such as falls or child birth ), repetitive strain, prolong sitting on hard surface, or even idiopathic reasons. Treatment options for Coccydynia may include conservative measures, such as pain medication, using cushion or donut-shaped pillows to relieve pressure, applying heat or cold packs, and avoiding activities that's exacerbate the pain. Physical therapy including exercises such as stretching, Muscle Energy Technique (MET) can also be beneficial in some cases. Thoracic manual therapy, which involves hands-on techniques applied to the thoracic spine, can indeed be beneficial for improving spine mobility. While it may not directly target the coccyx itself, improving overall spinal mobility can have indirect effects on coccyx pain and dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed females coccydynia patients.

Exclusion Criteria:

* Pregnancy
* 6 Months past Surgery, fracture or dislocation of coccyx.
* Malignancy or cyst in the pelvic area.
Breast cancEr, FITness and ExeRcise for Heart Health: The BE-FITTER Study

The chemotherapy medications used for breast cancer treatment are important for achieving a cure, but a potential side effect is that they can cause a decline in functional capacity (reduced exercise tolerance and impaired physical function) and increase the risk of cardiovascular disease. The risks of decreased functional capacity and cardiovascular disease are highest in breast cancer survivors as they grow older. The factors causing the decline in functional capacity are not well understood, however they may be related to a reduction in cardiac function (e.g. decreased pumping ability of the heart) or skeletal muscle function (reduced muscle blood flow and oxygenation). Exercise training is used for other populations at risk for cardiovascular disease (such as cardiac rehabilitation), but is not routinely offered to breast cancer survivors. Therefore this research study wants to test whether exercise training can improve heart and muscle health, and increase functional capacity in up to 60 older breast cancer survivors aged \>60 years old who previously received chemotherapy drugs that can affect the heart.

The purpose of this study is to compare two rehabilitation approaches: a 12-week structured exercise training program or a 12-week stretching-yoga program. The investigators want to compare whether these programs can improve functional capacity, and heart and skeletal muscle function. To do this, some of the participants in this study will be randomly enrolled in the structured exercise training program and others will be randomly enrolled in the stretching-yoga program.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 years
* Previously diagnosed with early-stage (I-III) BC
* Completed (≥1 year post) primary cardiotoxic treatment (anthracycline-based chemotherapy or trastuzumab-based biological therapy).

Exclusion Criteria:

* Have a history of coronary artery disease, heart failure, persistent and permanent arrhythmia (e.g. currently in atrial fibrillation), stroke, or chronic obstructive pulmonary disease
* Develop signs or symptoms of myocardial ischemia (≥1mm horizontal or down-sloping ST segment depression on electrocardiogram) during the cardiopulmonary (VO2peak) test
* Have any research MRI contraindications (e.g. any type of pacemaker), or any orthopedic limitation preventing exercise testing
* Currently performing structured exercise training (defined as ≥30 mins/day of moderate-to-vigorous aerobic and/or resistance exercise training on ≥4 days/week)
* Are unwilling to be randomized to either ExT or STRETCH
The COVID-19 Pandemic Process Increase Latex Glove Use and Latex Allergy Complaints in Hospital Nurses? Survey Study

Background: Global guidelines recommend the use of personal protective equipment due to the high risk of contagiousness of COVID-19 disease. The increase in COVİD-19 patients in the last two years has increased the rate of use of latex gloves in nurses. It is not known how the increase in the use of latex gloves affects the complaints of latex allergy in nurses.

Aim: The aim of this study is to determine the rates of latex glove use and allergic complaints related to the use of latex gloves during the COVID-19 pandemic in hospital nurses.

Background: Global guidelines recommend the use of personal protective equipment due to the high risk of contagiousness of COVID-19 disease. The increase in COVİD-19 patients in the last two years has increased the rate of use of latex gloves in nurses. It is not known how the increase in the use of latex gloves affects the complaints of latex allergy in nurses.

Aim: The aim of this study is to determine the rates of latex glove use and allergic complaints related to the use of latex gloves during the COVID-19 pandemic in hospital nurses.

Materials and Methods: Ethical and legal permissions were obtained before starting the research. Research; It was conducted in a descriptive and cross-sectional manner at Hatay Training and Research Hospital between May 15 and June 15, 2021. The sample of the study consisted of 448 nurses who volunteered to participate in the study. The data of the study were collected with data collection forms created by the researchers as a result of literature reviews. The data of the research were collected by the online questionnaire method. Analysis of the data was analyzed with appropriate statistical methods in SPSS 21.0 program. p\<0.05 value was accepted for statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Working as a nurse in Hatay Training and Research Hospital, Working in Hatay training and research hospital for the last month according to the date of the research
* Nurses who volunteered to participate in the study were included in the study.

Exclusion Criteria:

* Nurses who want to leave the study at any stage of the study after being included in the study
Non-contrast Enhanced Cardiac Magnetic Resonance Normal Values and Imaging Protocols

One of the main problems in cardiac magnetic resonance (MR) investigations is the strong dependence of the achieved image quality on optimal settings of sequence parameters and anatomical and physiological situations and it is well known that the diagnostic impact of cardiac MR investigations crucially depends on the adaption of imaging protocols to patients' state and ability to cooperate.

The aim of the present study is the evaluation and optimization of various 1.5 Tesla and 3 Tesla cardiac MR investigation protocols without application of contrast agent as well as the acquisition of normal values for new cardiac MR images techniques:

* normal myocardial morphology: T1-, T2- and T2\*-weighted imaging and acquisition of normal values of magnetic relaxation times (sequence- and protocol dependent),
* normal cardiac function: systolic and diastolic function (sequence- and protocol dependent),
* cardiac anatomy and coronary artery imaging: feasibility to evaluate length, diameter and blood flow (sequence- and protocol dependent),
* normal blood flow topologies in the heart and the surrounding great vessels: 2D- and 3D blood flow imaging and evaluation techniques (sequence- and protocol dependent).


Eligibility Criteria:
Inclusion Criteria:

* No history of cardiac or pulmonary diseases
* ability to give informed consent

Exclusion Criteria:

* General MR exclusion criteria eg. patients with metal devices or other magnetic material in or on the subjects body which will be hazardous for MR investigation (e.g. heart pace-maker, brain aneurysm clip, nerve stimulators, electrodes, penile implants, coloured contact lenses, patch to deliver medications through the skin, any metal implants as rods, joints, plates, pins, screws, nails or clips, embolization coil, or any metal fragments or shrapnel in the body),
* pregnancy,
* claustrophobia.