cyrilzakka/clinical-trials huggingface dataset:
Measure Airway Compliance by Endobronchial Optical Coherence Tomography

Optical Coherence Tomography （OCT）is a novel, non-invasive, high resolution special optical imaging techniques. In airway, Measure airway area and airway wall thickness is the most usage of Endobronchial Optical Coherence Tomography (EB-OCT）. Recently, the new protocol of EB-OCT is used to measure airway compliance, We will establish a new methodology of EB-OCT for measuring airway compliance, which will provide a new means to study respiratory diseases.


Eligibility Criteria:
Inclusion Criteria:

1. Regardless of gender, age 18-70 years old;
2. Patients with clinical diagnosis of pulmonary nodules, COPD, asthma or restrictive pulmonary diseases;
3. Can tolerate bronchoscopy patients;
4. Sign the informed consent form.

Exclusion Criteria:

1. Suffering from any of the following respiratory diseases: bronchiectasis, etc;
2. Have malignant tumors that are not completely remission or cured;
3. The patient's systemic infection is not controlled;
4. Recent use of immunosuppressants, recent use of anticoagulants (such as warfarin or aspirin within 2 weeks of drugs that affect blood clotting function);
5. Serious other systemic diseases: myocardial infarction, unstable angina, cirrhosis, acute glomerulonephritis, etc.;
6. Those who are positive for syphilis, HIV, HBV, and HCV antibodies;
7. Patients with coagulation dysfunction diseases, such as hemophilia, giant platelet syndrome, platelet weakness, etc.;
8. Severe renal impairment, serum creatinine \> 1.5 times the upper limit of normal value;
9. Liver disease or liver function impairment: ALT, AST, total bilirubin \> 2 times the upper limit of normal value;
10. Those with a history of mental illness or suicide, a history of epilepsy or other central nervous system diseases;
11. 12-lead ECG showing severe arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or conduction abnormalities of the heart of grade II and above;
12. Those who are allergic to catheters and related materials required for experiments;
13. Subjects who have received any other clinical studies within 3 months prior to enrollment;
14. Those who have poor compliance and difficulty in completing the study;
15. Any condition that the clinician believes may increase the risk to the patient or interfere with the clinical study.
Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury

The aim of this study was to study the effect of stem cell therapy on common symptoms of spinal cord injury patients.

Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by standard rehabilitation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cases of any type of chronic Spinal cord injury
* Age above 6 months

Exclusion Criteria:

* presence of acute infections such as Human immunodeficiency virus/ Hepatitis B Virus/ Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* other acute medical conditions such as respiratory infection
* pregnancy and lactation
Vaginal Vault Suspension During Benign Hysterectomy. A Questionnaire and Register-based Study.

Female pelvic organ prolapse (POP) is characterized by lack of vaginal support which enables pelvic organs to bulge into the vaginal walls and sometimes protrude through the genital hiatus. POP is more frequent among women who had their uterus removed.

We would like to investigate whether suspension of the top of the vagina during remowal of the uterus prevents subsequent POP.

The purpose of the PhD project is therefore to describe validity, terminology, and operative performance of used suspension methods during benign hysterectomy in Denmark. Further, to investigate these suspension methods' possible association with pain, life quality, sexuality, pessary use, and POP .

In 2012 the investigators introduced codes of suspension methods to the Danish hysterectomy and hysteroscopy Database's registration chart. Consequently, validity of these codes needs to be ensured to enable their use in further research.

Thereafter, the prevalence of Danish gynecologists' use of the different suspension methods will be investigated. A questionnaire will elucidate a possible relation between the suspension methods and pain, life quality and sexuality. Through a register based study in the National Patient Register the association between suspension methods and post hysterectomy POP and possible confounding will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Alive women two years after hysterectomy
* Benign hysterectomy
* Willingness to participate (in the questionnaire)

Exclusion Criteria:

* Death
* Emigration
* Secret address
Role of New Diagnostic Tool in Device (ICD / PM) Associated Infections

Infections related to implantable pacemakers or cardioverters defibrillators are sometimes difficult to be diagnosed. Diificulties in the diagnosis include a low sensitivity of standard markers of inflammation such as C-reactive protein or white blood cell count and the diagnosis is mainly based on the clinical presentation. The observational DIRT-study evaluates if new biomarkers may be more suitable to support a diagnosis of device associated infections than the currently available ones.


Eligibility Criteria:
Inclusion Criteria:

* device associated infections

Exclusion Criteria:

* malignancy
* cytostatic or immunomodulating therapy
G-PLUS (GALLANT, GALLEX and ARMOR - Post Treatment Follow-up Study)

This is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24 months, in patients with type 2 diabetes after participation in the phaseII/III studies GALLANT, GALLEX and ARMOR. In addition, selected patients, including those with pre-defined laboratory or clinical findings, will have a 12-week post-treatment follow-up visit, including laboratory evaluation and adverse event recording.


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who either completed at least 6 months in a previous treatment study GALLANT, GALLEX or ARMOR or met a pre-defined laboratory or clinical finding during participation in any of the said studies.

Exclusion Criteria:

* Received open-label treatment with tesaglitazar (since this is a post-treatment study)
Hypertensive and Normal Pregnancy--Calcium Metabolism and Renin-Angiotensin - SCOR in Hypertension

To study calcium metabolism and the renin-angiotensin system in hypertensive and normal pregnancy.

BACKGROUND:

Beginning in Fiscal Year 1975, the multidisciplinary SCOR examined causes, consequences, and treatments of human hypertension. A central theme was the renal basis for human hypertension. The subproject on calcium metabolism and the renin-angiotensin system in hypertensive and normal pregnancy began in December, 1990.

DESIGN NARRATIVE:

A longitudinal study was performed on normal pregnant women and women with chronic hypertension who had a high incidence of superimposed preeclampsia. In a previous study, the investigators had demonstrated that preeclampsia was associated with reduced urinary excretion of calcium and with lower plasma renin activity (PRA) compared with normal pregnancy. The goal of the investigators was to identify the metabolic and cellular basis for these alterations in calcium homeostasis and in the renin angiotensin system. They tested two hypotheses. The first hypothesis was that diminished placental and/or renal production of 1,25-dihydroxyvitamin D, leading to lower serum calcium, higher parathyroid hormone, and increased renal tubular reabsorption of calcium, was the metabolic basis for hypocalciuria in preeclampsia. The second hypothesis was that lower PRA in preeclampsia was due to systemic and renal vasoconstriction with hypertension and diminished natriuresis.

Serial measurements of 1,25-dihydroxyvitamin D, parathyroid hormone, serum ionized calcium, PRA, estradiol and progesterone, and urinary calcium and electrolytes were obtained, particularly at the onset of preeclampsia. Acute renal hemodynamic studies were also performed in women with preeclampsia and in gestational age matched normals. The studies investigated the relationships among glomerular filtration rate, renal blood flow, parathyroid hormone, vitamin D, atrial natriuretic factor, renin, estradiol and progesterone, and sodium and calcium excretion during infusion of inulin and PAH with either saline or calcium chloride.

Intracellular free calcium concentration in platelets and lymphocytes of pregnant women participating in longitudinal and acute renal hemodynamic studies were also measured. Basal and stimulated (with angiotensin II, ionomycin and thrombin), intracellular free calcium concentrations were compared in normal and hypertensive pregnant women and correlated with calcium regulatory hormones, plasma renin activity and hypertension.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
The Development of an Intergenerational Movement Program for Grandchildren and Their Grandparents Using Co-creation

The aim of this study is to develop, evaluate and implement an intergenerational physical activity program for grandchildren and their grandparents using co-creation focusing on the promotion of (co-)physical activity as a primary outcome and cognitive functioning, psychosocial well-being, the family relationship, expectations regarding aging and motor competence in grandparents and grandchildren as secondary outcomes.

In recent years, increased attention has been devoted to intergenerational physical activity (PA) programs because they may have several benefits for children and older adults (e.g., learning skills from each other, reduction of ageism). An intergenerational PA program focusing on grandchildren and -parents in a 'standard' family setting and the combination of PA and cognitive functions is innovative and may hold potential to promote PA and improve cognitive functions in both grandchildren and their grandparents. The aim of this study is to describe the protocol of the GRANDPACT (GRANDparents and GRANDchildren improve their Physical Activity and Cognitive functions using co-creaTion) project, focusing on the development of an intergenerational PA program for grandchildren and -parents using the theoretical framework "Behaviour Change Wheel" in combination with a co-creation approach. One co-creation trajectory will be organized to develop the program, followed by an efficacy trial to refine and evaluate the program with measurements pre (at baseline), post (after 24 weeks) and follow-up (after 36 weeks) to measure the outcomes of (co-)PA, cognitive functions, psychosocial well-being, the quality of the family relationship, expectations regarding aging and motor competence in grandchildren and -parents. The outcomes will be measured using accelerometery for PA, Cambridge Neuropsychological Test Automated Battery (CANTAB) testing for cognitive functions and questionnaires for psychosocial well-being, quality of the family relationship and expectations regarding aging. Motor competence will be tested with different field tests in grandparents and grandchildren. Co-development with end-users and stakeholders during the co-creation trajectory is expected to result in an effective, attractive and feasible program. Co-PA is expected to improve PA, cognitive functions, psychosocial well-being, quality of the family relationship, motor competence and motivation to be physically active in grandchildren and -parents. Both will also have better expectations regarding aging.

Eligibility Criteria:
Inclusion Criteria for children:

* Aged between 6 and 10 years old
* Having at least 1 grandparent
* Speaking Dutch
* No serious physical, cognitive or psychiatric health problems

Inclusion Criteria for grandparents:

* Having at least 1 grandchild (aged between 6 and 10 years old)
* Speaking Dutch
* No serious physical, cognitive or psychiatric health problems

Exclusion Criteria grandparents:

- Having medical health problems (epilepsy) that can cause a risk when participating in the intervention
Epinephrine Nebulization Prior to Nasotracheal Intubation

This randomised, prospective study performed in Ain shams university hospitals over 126 Patients ASA I and ASA II, trauma patients who suffered isolated mandibular fractures and necessitated nasal intubation during general anesthesia. The patients were randomly assigned to one of two equal groups: nasal Lidocaine drops followed by Oxymetazoline nasal drops group (OL) or Epinephrine mixed with Lidocaine as nebulization session (EL) group.

One group received epinephrine mixed with lidocaine as nebulization session (EL group) and the other group received nasal lidocaine drops followed by Oxymetazoline nasal drops group (OL). Before the preparation of the airway, we examined the nasal cavity by using a light source to select the target nostril; if we could not determine, we chose the right nostril. No premedication was administered.

Group (EL) (63 patients) received a session of nebulization in the pre-induction area, consisting of 1 ml epinephrine (1:1000 Martindale Pharma, an Ethypharm Group Company, ampoule 1 mg added to 9 ml of normal saline, then 1 ml of that put in nebulization cup + 2 ml lidocaine 2%), nebulized prior to the induction of anesthesia.

Group OL (63 patients): These patients received five drops of lidocaine hydrochloride (Xylocaine 2%, 20 mg/ml; AstraZeneca, London, UK) using a prefilled dropper, followed by six drops of hydrochloride Oxymetazoline (Otrivin adult nasal drops 0.1%, 10 ml of 1 mg/ml; Novartis Consumer Health, UK Ltd, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK) in each nostril in the

Eligibility Criteria:
Inclusion Criteria:

* Cases with American Society of Anesthesiologists (ASA) classes I and II.
* Patients scheduled for elective oral isolated mandibular fracture fixation requiring nasotracheal intubation.

Exclusion Criteria:

* Nasal abnormality history (such as polyp , surgery or nasal trauma).
* Frequent epistaxis history.
* Patients suffering valvular heart disease, hypertension, ischemic heart disease or arrhythmias.
* Patients using drugs (anticoagulation therapy, non-steroidal anti-inflammatory drugs, and oral decongestants).
* Patients receiving medications known to alter the parameters under investigation including β-blockers, calcium channel blockers, or vasodilators.
* Patients known to have hypersensitivity to medications used in this study.
Iodine I 131 in Treating Patients With Thyroid Cancer

RATIONALE: Radioactive iodine kills thyroid cancer cells by giving off radiation.

PURPOSE: This clinical trial is studying the side effects, best dose, and how well iodine I 131 works in treating patients with thyroid cancer.

OBJECTIVES:

* Determine the relationship between estimated absorbed dose of iodine I 131 and tumor response or normal organ toxicity for different dosimetric measures, using data derived from clinical radionuclide therapy studies in patients with thyroid cancer.

OUTLINE: Patients receive oral dosimetric iodine I 131 (\^131I) on day 2 and then undergo nuclear medicine imaging at 0.5-4 hours, 24, 48, and 72 hours after dosimetric \^131I. Single-photon emission computed tomography (SPECT)/CT scans are performed at 0.5-4 hours and 24 or 48 hours over the head and neck region, including the salivary glands. Subsequent SPECT/CT scans are performed over the candidate tumor sites. Patients undergo \^131I therapy on day 11.

Saliva is collected on days 1 and 2, weeks 2 and 4, and months 3 and 6 to measure saliva flow rate. Blood is collected at baseline and periodically during study to measure FLT3 ligand levels.

PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of thyroid cancer
* Measurable disease by CT scan or nuclear medicine imaging
* Eligible, by standard of care criteria, for iodine I 131 therapy

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective non-barrier method contraception (e.g., combined or progesterone-only oral contraceptive pill, intrauterine device, depot progesterone, or stable relationship with a partner who has had a vasectomy)
* No other malignancy within the past 5 years except squamous cell or basal cell carcinoma of the skin
* No nonthyroidal conditions known to affect iodine I 131 uptake (e.g., New York Heart Association class III or IV congestive heart failure or renal failure)
* No alcoholism or drug abuse within the past 2 years
* No severe emotional, behavioral, or psychiatric problems that would preclude study compliance (e.g., severe claustrophobia)

PRIOR CONCURRENT THERAPY:

* No intravenous water-soluble radiographic contrast within the past 4 weeks
* No iodinated contrast agent within the past 3 months
* No concurrent drugs that may affect thyroid or renal function (e.g., renal drugs, lithium, amiodarone, other iodine-containing medication, or corticosteroids)
* No other concurrent investigational drugs
rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP

The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining with Rituximab for the treatment of adults with refractory immune thrombocytopenia (ITP), compared to conventional Rituximab therapy.

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 240 refractory ITP adult patients from 14 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300 Units/kg for 14 consecutive days,following with a flexible dosage depending on platelet count until the 29th day), combining with rituximab (given intravenously at a dose of 100 mg weekly for 4 weeks, i.e. Day 1, 8, 15, 22; the others are selected to receive low-dose of rituximab treatment (given intravenously at a dose of 100 mg weekly, i.e. Day 1, 8, 15, 22). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of the combination therapy compared to conventional rituximab therapy for the treatment of adults with refractory ITP.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years.
3. To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
4. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
5. Willing and able to sign written informed consent

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received high-dose steroids or \[2\] intravenous immunoglobulin transfusion(IVIG)in the 3 weeks prior to the start of the study.
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than ITP. 4.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)

5.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.

6.Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.

7.Patients who are deemed unsuitable for the study by the investigator.
Respiratory Strength Training in Heart Transplant Recipients

This research study is investigating whether completing breathing exercises before surgery helps heart transplant patients recover after surgery. Previous studies have shown that breathing exercises can improve breathing, cough, and swallow function in patients with other diseases/conditions. The current study will investigate the impact of a preoperative respiratory muscle strength training program on breathing and cough function, swallow function, patient-reported eating and swallowing fatigue, and health outcomes in individuals undergoing heart transplantation.

Participants will:

* undergo tests of breathing, cough, and swallow function
* complete questionnaires about the treatment, their swallow function
* complete breathing exercises daily

This study will involve three in-person research evaluations to our lab or in the hospital that will last 45 minutes- 1 hour and will consist of a screening, breathing and cough testing, swallow function testing, and completion of questionnaires. Following the initial research evaluation, individuals will complete daily exercises of active or sham respiratory muscle strength training for several weeks with one telehealth or in-person session per week. The exercises will take 10-15 minutes to complete, and individuals will fill out training logs daily. Prior to transplantation and after completion of the breathing exercises, individuals will undergo a second research evaluation. Then, following surgery, individuals will undergo a third research evaluation and outcomes will be tracked via the electronic health records system.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (18-90 years old)
2. Not pregnant
3. Undergoing evaluation or actively waitlisted for heart transplantation at VUMC with a waitlist status of 1-6
4. Have a computer, tablet or electronic device with a stable internet connection for telehealth sessions (outpatient)
5. Be willing to undergo testing procedures and complete the exercise training program.

Exclusion Criteria:

1. Individual \<18 years old, \>90 years old
2. Pregnant
3. No access to a computer, tablet or electronic device with a stable internet connection for telehealth sessions
4. Unwilling or unable to undergo testing procedures and complete the exercise training program.
Regional Anesthesia for Head and Neck Reconstruction

By utilizing regional anesthesia blocks at the surgery tissue donor sites, it can potentially reduce post-operative pain while also reducing the use of opioids. It can aim to measure the reduction in opioid use, reduction in pain scores, patient satisfaction, and because there is not a current protocol established for regional anesthesia use for free flap reconstruction, and we aim to standardize the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing microvascular fibula free flap reconstruction of the head and neck
* Subjects undergoing primary reconstruction for both benign and malignant etiology

Exclusion Criteria:

* Pregnant women
* Subjects with true allergies to the study drugs, reporting anaphylaxis in the past
* Subjects undergoing reconstruction with more than 1 free flap
* Subjects undergoing secondary reconstructions
* Subjects undergoing surgery for osteonecrosis
* History of enrollment in a pain management program
* Any subject currently enrolled in pain management, or currently taking long acting opioids such as methadone or oxycontin