cyrilzakka/clinical-trials huggingface dataset:
Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects

The purpose of this study is to collect information on the safety, tolerability and immunogenicity of an investigational smallpox vaccine at different doses and using different routes of administration in vaccinia-naive and vaccinated healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects, aged 20 - 55 years
* Signed informed consent

Exclusion Criteria:

* Prior vaccination against smallpox (study part I only)
* Abnormalities suspicious of any underlying disease, detected at routine tests prior to study inclusion.
* Any immune modifying therapy within 4 weeks prior to entry
* Participation in any other investigating drug trial
* Known allergy to a component which may be part of the vaccine
* Allergic reaction or any other severe adverse effects experienced after previous smallpox vaccination (study Part II only)
The Effect of Balanced Crystalloid Versus 5% Albumin on Endothelial Glycocalyx Degradation in Patients Undergoing Off-pump Coronary Artery Bypass Surgery

It is being revealed that the more severe the damage of the endothelial glycocalyx (EG) layer, the more likely it is that the prognosis of the patients is poor. For that reason, research is being actively conducted on methods for reducing damage and promoting recovery of the EG layer.The natural regeneration process of the EG layer is up to 7 days. Considering the fact that it is quiet slow, reducing the damage of EG layer is considered to be very important for improving the prognosis of patients undergoing surgery, but there is no clinically proven method.

One of the ways receiving attention to reduce damage of EG layer is to stabilize the layer through fluid therapy with albumin. The purpose of this study is to compare the protective effect of the EG layer according to the type of fluid (balanced crystalloid solution vs. 5% albumin) during surgery in patients undergoing off-pump coronary artery bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 20 years of age undergoing off-pump coronary artery bypass surgery

Exclusion Criteria:

* Emergency operation
* Minimally-invasive surgery (under one-lung ventilation)
* Chronic kidney disease (eGFR\<30 ml/min/1.73m2) or Dialysis
* Acute kidney injury
* Infectious disease
* Preoperative steroid use
* Malignancy
* Reported allergic reaction to albumin preparations
* Patients who participated in other clinical studies that could affect prognosis
* Patients who have difficulty in reading the informed consent and voluntarily agreeing to participate in the study
Patient Self Testing of Warfarin Therapy

To test the hypothesis that home international normalised ratio (INR) monitoring with supervised patient self-testing (PST)can provide comparable or superior time in therapeutic range (TTR) to that provided by traditional outpatient anticoagulation.

Indications for anticoagulant treatment to prevent thromboembolic disease have increased in recent years. INR must be monitored frequently to determine the safest dose and to minimize the risk for thrombotic and haemorrhagic complications. Standard warfarin therapy is associated with rates of major haemorrhage of up to 5-9% annually and recurrent venous thromboembolism of up to 8%. These event rates are dependent of the model of care used to manage warfarin therapy, with better outcomes associated with home testing of the INR which enables patients to monitor their response to warfarin more frequently. INR results must still be 'managed' by communicating the data to the healthcare provider, usually be telephone or fax.

In this study we will evaluate a novel method of PST; supervised PST with an internet based expert system, which 'manages' patients on oral anticoagulation by utilizing clinical and laboratory data provided by the patient and dose adjustment and retesting algorithms derived from clinical practice. Patients will be randomized to either 6 months of supervised PST or routine medical care by the AMS. At the end of the 6 month period, each patient will then 'cross over' to the other management regimen and the difference in TTR between the two periods will be compared.

Eligibility Criteria:
Inclusion Criteria:

* on warfarin therapy for a minimum of 2 months
* are expected to be on warfarin therapy for the duration of the 12 month study
* internet access

Exclusion Criteria:

* inability to provide informed consent
* inability to use a home INR meter
* patients who do not have a telephone
* more than 2 missed clinic appointments in the preceding 6 months
* patients on anticoagulant drugs other than warfarin (eg heparin, low molecular weight heparin)
* history of hemorrhagic complications with a therapeutic or therapeutic INR in the preceding 6 months
* inability to attend the hospital at short notice, if necessary
mHealth Intervention for Improving Eye Health at Community Level

This study is a community trial that aims to establish and evaluate an mHealth screening and promotional tool for improving eye health in Iran. Sampling frame is a region in Tehran province with around 1 million sub-urban and rural inhabitants. investigators have obtained the list of health centers and their underserved population from the health authorities. In this region, health services are delivered through rural health houses, urban health posts and overhead health centers (221 units in total). investigators choose 27 units using cluster random sampling method with a probability proportional to size strategy, then investigators randomly assign them into three arms (explained below). The interventions will be at community level with the community as the unit of randomization.

Arm 1- Training of the Primary Health Care (PHC) workers + PHC workers will be empowered with the mHealth tool to monitor, screen and promote community members Arm 2- PHC system will be strengthened with health promotion and screening programmes (same content as the mHealth tool) and PHC workers will deliver eye health messages and screening tests by the conventional facilities.

Arm 3: Control group: only observation and registering of routine care


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were living in one of the non-institutionalized urban or rural residential areas in one of the survey area, being resident in the same address for at least 6 months during the year before the enrolment, age 50 and over and Iranian nationality.
Curcumin (Diferuloylmethane Derivative) With or Without Bioperine in Patients With Multiple Myeloma

Primary Objectives:

1. To evaluate clinical tolerance and response to curcumin alone and in combination with Bioperine in patients with multiple myeloma.
2. To compare the pharmacokinetics and pharmacodynamics of curcumin and curcumin + Bioperine and evaluate the effect of Bioperine on the bioavailability of curcumin.
3. To evaluate the biologic effects of curcumin alone and in combination with Bioperine on the expression of NF-kB and related genes in the Multiple Myeloma (MM) cells.

Curcumin, a yellow substance extracted from the plant Curcuma longa, is commonly used as a food additive. It is a natural anti-inflammatory compound and has shown anti-tumor activity in the laboratory. Bioperine is a pepper extract that increases the absorption of nutrient supplements.

In this study, 6 patients at a time will be randomly assigned (as in the toss of a coin) to one of two groups of 3 patients each. One group (Arm A) will receive curcumin alone. The other group (Arm B) will receive curcumin in combination with Bioperine. There is an equal chance of being in either group. While on study you may receive standard supportive care as appropriate.

Both of the study agents will be taken by mouth two times a day. Each group will have five dose levels of curcumin, starting with the lowest dose. After 6 patients have been enrolled in the first level (3 in each arm), the next group will be treated at a new dose level. You will always receive the same dose during your treatment, which will continue for at least 12 weeks unless there is evidence that the disease has gotten worse or intolerable side effects occur. You may receive treatment up to one year depending on your response to treatment.

You may be treated as outpatient and may receive your treatment at home. You will be asked to return to M. D. Anderson every 4 weeks for evaluation and physical exam.

This is an investigational study. A total of up to 30 evaluable patients will take part in the study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple myeloma who have been previously untreated, are asymptomatic and without serious or imminent complications; or have relapsed or failed treatment with conventional therapy.
* Adequate hematologic, renal, and hepatic functions.
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.

Exclusion Criteria:

* Previously untreated patients with high tumor mass; symptomatic or impending fractures.
* Patients with significant cardiac disease.
* Patients with comorbid condition which renders patients at high risk of treatment complications.
* History of significant neurological or psychiatric disorders.
PRP Prevents Recurrence of Intrauterine Adhesions

Effect of platelet-rich plasma (PRP) on uterine scar fibrosis, endometrial receptivity and pregnancy outcome in patients with severe intrauterine adhesions

1. Inclusion criteria: patients with intrauterine adhesions (AFS score \>9 points); age 21 to 40 years old, with fertility requirements.
2. Study design:prospective, randomized controlled cohort study, patients with intrauterine adhesions were randomized into two groups, the control group and the intervention group (intraoperative and postoperative 1 week postoperative PRP). The surgical procedures and postoperative medication regimens were the same.
3. Compare the biochemical pregnancy rate, clinical pregnancy rate, abortion rate and live birth rate after hysteroscopic resection in PRP group and control group, and explore the effect of PRP on pregnancy outcome after intrauterine adhesion.

Eligibility Criteria:
Inclusion Criteria:Patients with intrauterine adhesions (AFS score \>9 points); age 21 to 40 years old, with fertility requirements -

Exclusion Criteria:Endometrial tuberculosis, endometrial polyps, uterine submucosal fibroids, endometrial hyperplasia, endometrial malignant lesions, premature ovarian failure, chromosomal abnormalities

-
Student Stress Levels and Management Through Meditation

The professional program in Physical Therapy is rigorous and demanding on students, resulting in high levels of fatigue, stress, and sleep disturbance that can impact student performance and wellbeing. This project seeks to investigate ways to reduce student stress, monitor their quality of sleep and possibly enhance their learning through the practice of meditation.

Utilizing a randomized controlled study design, a cohort of doctoral students in their first year of physical therapist education will undergo an 8 week intervention of a mantra-based Meditation (twice daily 20 minutes) with pre and post measures of blood pressure, sleep hygiene via the Pittsburgh Sleep Quality Index (PSQI) and stress surveys, including Perceived Stress Scale (PSS) and Visual Analogue Scale for stress (VAS), as well as daily logs of sleep to assess sleep quality.

As many as 32 students (total number in cohort) per year may participate with 1/2 serving as controls and 1/2 undergoing the meditation practice for 8 weeks.

Baseline measurement details:

QUESTIONNAIRES: Each participant will be given a 1-item Visual Analogue Scale for stress (VAS), a 10 item Perceived Stress Scale (PSS), and a 9 item Pittsburgh Sleep Quality Index (PSQI) questionnaire. The VAS simply asks subjects to score how much stress they are feeling at that one moment in time on a 0-100 scale. The PSQI scores and assesses sleep quality and disturbances over a 1-month time interval and will be administered at the 4 week mark 1/2 way into the study as well as at pre and post intervention data collection events.

BLOOD PRESSURE: Blood pressure will be measured individually in a separate room to ensure confidentiality. The BP measurements will be administered using an Omron professional automatic blood pressure monitor (model number HEM 907X) to ensure comfort/safety and the accuracy of the reading. Also for accuracy of blood pressure measurements subjects will be asked to refrain from caffeine (coffee, tea or chocolate), cigarettes/nicotine, or exercise that morning until after measurements are taken and avoid alcohol the evening prior. One identified researcher will take all blood pressure reading and will be blinded to which subjects are part of the research or the control groups.

Eligibility Criteria:
Inclusion Criteria:

* Graduate student in the first year of the Doctorate of Physical Therapy (DPT) program at California State University, Northridge (CSUN)

Exclusion Criteria:

* Taking blood pressure or sleep medication; or already currently practicing a daily meditation.
Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes

Standardized longitudinal data collection of diabetes management relevant factors in women with T1D (insulin requirements, glucose variability, nutritional information, and menstrual cycle information) to identify categories of cycle trajectories.


Eligibility Criteria:
Inclusion Criteria:

* Living with Type 1 Diabetes
* Perimenopausal people with menstrual cycle
* Using a hybrid closed-loop system
* Signed digital informed consent

Exclusion Criteria:

* Using hormonal therapy or contraception
Expanded Access Use of INCB054329 to Treat a Single Patient With Metastatic Renal Cell Carcinoma

Expanded access use of INCB054329 to treat a single patient with metastatic renal cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Cardiac Resynchronization Therapy in Congenital Heart Defects

The objective of this multicentre prospective therapeutic study is to evaluate the effects of CRT on the right and left ventricular function of patients with CHD in the medium and long term. Patients who reject the randomization or cannot be paced with right ventricular pacing alone will be enrolled in group C with continuous biventricular pacing, which is the main group in this study. Optional: Immediately after implantation the patients are divided into group A and B (randomized, single blind (for the patient), cross-over design).

The treatment and the completing follow-up examination will take approximately 18 months and includes seven visits - one previous to the CRT and six at certain times afterward. At selected time intervals echocardiographic 3D and Tissue Doppler Imaging to evaluate the global and regional ventricular function are performed. Subjective quality of life assessment (questionnaire) will also be performed at the defined follow-up intervals, and if applicable (optional) also objective assessment of the physical performance (VO2 max).

55 patients also including children and adults with CHD are planned to be included in the study. The main target is to provide evidence of the effectiveness of CRT with biventricular stimulation in terms of improved ventricular function (ejection fraction and QRS interval).


Eligibility Criteria:
Inclusion Criteria:

* Patients with congenital heart defects
* Heart failure of the Morphologically right or left system ventricle with an absolute ejection fraction of \< 40% in the failed ventricle
* NYHA classes II-IV
* Optimal drug therapy for heart failure according to the ESC guidelines
* QRS interval ≥ 120 ms (demonstrated in at least two relevant ECG derivations, depending on existing bundle branch block symptoms)
* Patients with chronic stimulation of the subpulmonary ventricle by a 1- or 2-ventricle pacemaker, which also meets the above-mentioned criteria
* Patients with morphologically right ventricle in system position and significant insufficiency of the systemic atrioventricular valve, if they also meet the criteria listed above

Exclusion Criteria:

* PTCA, cardiomyoplasty or myocardial infarction / unstable angina pectoris or cerebral insult within the 6 weeks preceding the planned cardiac resynchronisation therapy
* Patients with pulmonary hypertension / Eisenmenger's syndrome
* Life expectancy \< 1 year due to a non-cardiac disease
* Anticipated poor compliance by the patient
* Pregnancy and breastfeeding
* Known or persistent abuse of prescription medicines, recreational drugs or alcohol
French One Day Survey in 2011 - Knowing Our Population of Labile Blood Products Recipients

Describe the epidemiologic profile and clinical context of transfusion recipients in France. Describe the clinical context of transfusion.

Describe the characteristics of the transfusion prescriptions, the use of blood products and the main indications for transfusion.

Describe transfusion practice according the type of hospital stay.


Eligibility Criteria:
Inclusion Criteria:

• Transfusion with at least one blood product on the day of the study.

Exclusion Criteria:

* None
A Phase II Clinical Study of SHR-1826 for Injection in Patients With NSCLC

This study is an open-label, multicenter Phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in patients with NSCLC.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
2. ECOG performance score of 0-1.
3. Life expectancy ≥ 3 months.
4. Have at least one measurable tumor lesion per RECIST v1.1.
5. Subjects with histologically confirmed locally advanced or metastatic NSCLC.
6. Good level of organ function.
7. Provide archived or fresh tumor tissue for vendor test.

Exclusion Criteria:

1. Subjects with active central nervous system metastases or meningeal metastases;
2. History of serious cardiovascular and cerebrovascular diseases;
3. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
4. Severe infection within 4 weeks prior to the first dose;
5. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
6. Subjects with uncontrolled tumor-related pain;
7. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
8. Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
9. Unresolved toxicities from previous anti-tumor therapy to ≤ Grade 1 (based on NCI CTCAE v5.0);
10. History of immunodeficiency, including a positive HIV test;
11. Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.
Vaginal Administration of Metformin in PCOS Patients.

Polycystic ovary syndrome is a common cause of irregular periods, poor ovulation and delay in achieving pregnancy. Certain drugs may help improve ovarian activity in such women as metformin. Oral administration of metformin is accompanied by undesirable side effects. The vagina proved to be a good alternative to the oral route for other drugs. Using metformin through the vagina and avoidance of such side effects, while maintaining its effectiveness, would help women to better tolerate this drug.

PCOS is the most common of all female endocrinopathies affecting 7-10% of women. A variety of drugs have been used to help improve follicular dynamics in PCOS patients. Metformin, an insulin sensitizer long known for its antidiabetic properties, has been used in PCOS patients. One of the major factors affecting compliance are the gastrointestinal side effects associated with oral administration of metformin. Knowing that the vagina is a good absorptive surface for many drugs, it is postulated that vaginal administration of metformin could be a good alternative to the oral route, if it proves effective. Both pharmacokinetic and clinical evidences of efficacy are traced for the vaginal route of administration.

Eligibility Criteria:
Inclusion Criteria:

* women with PCOS according to the Rotterdam criteria
* age 20-35 years
* not to have received any induction of ovulation in the preceding 3 months before enrollment

Exclusion Criteria:

* contraindications to metformin
* prior surgical management of PCOS
Methylprednisolone Before Fludeoxyglucose-Labeled Positron Emission Tomography in Patients With Lung Cancer

The purpose of this study is to determine whether giving an anti-inflammatory medication (corticosteroid) prior to a positron emission tomography scan (PET) scan may reduce or eliminate false findings related to inflammation

PRIMARY OBJECTIVES:

I. To assess whether premedication with a corticosteroid may reduce false positive findings on fluorodeoxyglucose (fludeoxyglucose F 18 \[FDG\[) PET/computed tomography (CT) scans in lung cancer patients, by reducing radiotracer uptake in thoracic lymph nodes related to inflammation.

OUTLINE:

Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone intravenously (IV) and then undergo a second FDG PET/CT scan.

After completion of study treatment, patients are followed up for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing initial staging of biopsy proven lung cancer (all cancer stages included)
* Undergone clinical FDG PET/CT scan within 14 days of enrollment

Exclusion Criteria:

* Prisoners
* Diabetic patients (on insulin, on oral hypoglycemic, or fasting glucose \> 180 mg/dl)
* Serious infection within 14 days of enrollment
* Known hypersensitivity to methylprednisolone
* Viral skin lesions
* Immunocompromised ANC(absolute neutrophil count \< 1000/microliter)
* Pregnant/nursing
* History of tuberculosis or systemic fungal disease
* History of steroid psychosis
* Current peptic ulcer disease or diverticulitis
* Corticosteroid use within 14 days of enrollment (including inhaled steroids)