cyrilzakka/clinical-trials huggingface dataset:
Intravenous Iron Injection in Cancer Patients With Anemia

* Multifactorial pathogenesis is involved in anemia of cancer patients and defining the causes of anemia is not always simple.
* Currently, treatment options available for anemia in cancer patients include red blood cell (RBC) transfusion, erythropoietin stimulating agent (ESA), and iron supplementation, accompanying considerable pros and cons for each treatment.
* Previous studies have demonstrated benefit when treating with IV iron in combination with ESA and, more recently, evidence is emerging to suggest a role for IV iron alone.
* In this study, investigator will assess the efficacy of intravenous iron for the treatment of anemia in cancer patients.
* Improvement of anemia and the improvement of quality of life compared to conservative treatment of intravenous iron

This study is a comparative clinical trial of prospective, multicenter, randomized trials to evaluate the efficacy of intravenous iron (Ferinject®) in cancer patients with anemia.

Changes in hemoglobin in the treated and conservative treatment groups with a single intravenous Ferrinject® in patients with anemia by chemotherapy are identified.

1. Clinical Drug Ferinject Injection For patients undergoing chemotherapy, ferinject 1000mg will be injected within 24 hours or 24 hours after day 1 of the next chemotherapy cycle.

   Patients using targeted therapies can be dosed at any time after recognizing Hb 8.0-10.5g / dL and injecting 1000 mg of ferinject.
   * The administration of ferinject is a single dose, no re-administration. If chemotherapy is not performed, it can be administered at any time if the selection and exclusion criteria are met.
   * The administration period for ferinject should be administered within 24 hours or 24 hours after the day 1 of the chemotherapy cycle based on the results of phase 2 studies
2. remedies Within the period of sample collection of visits 2 to 4 after study enrollment, if the physician determines that treatment for clinically meaningful anemia is necessary, treatment for anemia other than ferinjects will be followed. Treatment for anemia will include remedies such as iron (oral or intravenous), hematopoietic accelerators, and blood transfusions, and will be determined by researchers at each institution to provide optimal treatment for patients. At the time this treatment is administered, the subject will be dropped from the clinical trial.

Eligibility Criteria:
Inclusion Criteria:

The subject should be diagnosed with solid cancer or lymphoma. Hemoglobin level of test subject should be in the range of 8.0-10.5g / dL, or he / she has experienced hemoglobin reduction of 2g / dL or more during chemotherapy.

Exclusion Criteria:

The patients have a history of iron (oral or intravenous), hematopoietic stimulating agents (ESA), and dialysis within 4 weeks of study enrollment.

There is evidence that the patient's disease is a bone marrow invasion. There is a hypersensitivity reaction to ferinject or the components of ferinject.
A Study of Lasmiditan in Healthy Japanese and Caucasian Participants

The main purpose of this study is to evaluate the safety and tolerability of lasmiditan in healthy Japanese and Caucasian participants. The study will also investigate how much lasmiditan gets into the bloodstream and how long it takes the body to get rid of lasmiditan when given to Japanese and Caucasians. The study will last up to 47 days for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy Japanese (first generation) or Caucasian males or females, as determined by medical history and physical examination
* Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion Criteria:

* Have known allergies to lasmiditan, related compounds or any components of the formulation of lasmiditan
* Have previously received the investigational product in this study, withdrawn from this study, or received lasmiditan in any other study investigating lasmiditan
* Have an abnormal supine blood pressure at screening.
* Have a history of syncope, presyncope, uncontrolled vertigo, postural dizziness, or a risk of falls, as judged to be clinically significant by the investigator, or have orthostatic decreases in supine blood pressure of \>20 millimeters of mercury (mmHg), or have orthostatic decreases in diastolic blood pressure of \>10 mmHg at screening.
* Are women who are pregnant, lactating, or have a positive pregnancy test at screening or admission to the clinical research unit (CRU)
* Have donated blood of more than 500 milliliters (mL) within 1 month prior to screening
Use of the Ozone in Periodontal Treatment

The purpose of this study is to evaluate the clinicaland laboratory (as oxidative stress and pro-inflammatory mediators) effects of the use of gaseous ozone in periodontal treatment in addition to scaling and root planning.

The study population consisted of 40 patients with CP (chronic periodontitis). It was performed with two groups; The Test Group, and the Control Group. SRP plus gaseous ozone \[1 W (100 mJ, 10 Hz)\] was applied to the Test Group. The Control Group, on the other hand, had only SRP.The clinical periodontal parameters were performed and saliva samples were taken before SRP (baseline) and 1 month after treatment. The periodontal examination involved assessing the plaque index, gingival index , probing depth, and clinical attachment level. The total antioxidant status, total oxidant status, nitric oxide, 8-hidroxi-deoksiguanosine, myeloperoxidase, glutathione, malondialdehyde and transforming growth factor-beta levels were determined in the saliva samples.

The study has been designed in a randomized parallelly-controlled and double-blinded design as a full-mouth clinical trial. The duration of the study was 1 month.

The study was performed with two groups; The Test Group, and the Control Group. SRP plus gaseous ozone \[1 W (100 mJ, 10 Hz), (n=20)\] was applied to the Test Group.

The Control Group, on the other hand, had SRP plus placebo (n=20). The patients were distributed in random order to the 2 groups (each group had 20 patients). One patient in the Ozone Group and 2 patients in the Control Group left the study.

The following clinical periodontal parameters were performed immediately before SRP (baseline), and 1 month after treatment for each test and control groups. Plaque index, GI, PD and CAL were recorded. All clinical parameter measurements were used a manual periodontal probe (PCP- 12, Hu-Friedy, Chicago, IL, USA).

The total antioxidant status, total oxidant status, nitric oxide, 8-hidroxi-deoksiguanosine, myeloperoxidase, glutathione, malondialdehyde and transforming growth factor-beta levels were determined in the saliva samples.

Eligibility Criteria:
Inclusion Criteria:

1. patients having had generalize CP which were agreed upon by consensus at the World Workshop in Periodontics in 1999 \[24\];
2. three or more teeth having at least two quadrants with probing depth between 4 and 6 mm and radiographic signs of bone loss;
3. aged 30 years and above;
4. a minimum of 20 teeth.

Exclusion Criteria:

1. received periodontal therapy within the last 12 months;
2. systemic diseases which could affect periodontal treatment outcomes;
3. having taken systemic antibiotics within the last 6 months;
4. pregnancy or breast-feeding for female patients.
Saline Sonohystrography and Office Hysteroscopy in Evaluation of Cases of Abnormal Uterine Bleeding

comparing the efficacy of the 3D saline infusion sonohysterography to the diagnostic office hysteroscopy in the diagnosis of the cause of abnormal uterine bleeding in females during their reproductive age


Eligibility Criteria:
Inclusion Criteria:

* female aged between 20 and 45 years
* with no medical disorders
* approving to participate in the study

Exclusion Criteria:

* vaginal or cervical lesions
* history or suspicion of PID
* IUD users
* bleeding disorders
* on anticoagulant therapy
* irregular use of oral contraceptive pills
Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women

This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.


Eligibility Criteria:
Inclusion criteria:

* History of PONV (postoperative nausea and vomiting) and/or motion sickness.
* Have not smoked for the last 6 months.
* Having certain abdominal, breast, thyroid or shoulder surgery.

Exclusion criteria:

* Pregnant or breastfeeding.
* Have certain pre-existing medical conditions or take certain medications.
The Efficacy of Papaverine to Prevent Radial Artery Spasm During Transradial Cerebral Angiography

Rationale:Papaverine is effective on radial artery spasm during transradial cerebral angiography.

Purpose: This multicenter, randomized, placebo-controlled, double blind, phase 2b trial aims to investigate the effect and safety of papaverine in treating radial artery spasm during transradial cerebral angiography.

Radial artery spasm (RAS) is a common complication during transradial cerebral angiography. RAS can lead to severe pain and remains the most frequent cause of transradial angiography failure. There is currently no consensus on the prevention strategy for RAS.

Papaverine has anti vasospasm, sedative and analgesic effects. However, there is no evidence for the efficacy of papaverine in preventing RAS.

This multicenter, randomized, double blind, placebo-controlled trial aims to investigate the effect and safety of papaverine in treating radial artery spasm during transradial cerebral angiography.

Eligibility Criteria:
Inclusion Criteria:

1. All patients scheduled for cerebral angiography will be eligible for screening.
2. Participant is willing and is able to give informed consent for participating in the trial.
3. Male or Female, aged 18 years or above.

Exclusion Criteria:

1. Any patient with negative modified Allen test
2. Altered liver function
3. atrioventricular heart block III degree
4. Suspected or confirmed cerebral hemorrhage patients
5. Hemodynamic Instability : systolic pressure \< 100 mmHg, heart rate \> 100 bpm, tachycardia uncontrollable.
6. Patients with cerebral edema and increased intracranial pressure within 24 hours to 2 weeks after stroke
7. Coronary artery bypass grafting(CABG) operation history and whose right radial artery is missing as a "bridge vessel"
8. Severe skin musculoskeletal malformation of forearm or failure to complete radial artery puncture and sheath placement for other reasons
9. Hypersensitivity or contraindication to papaverine
10. Hypersensitivity or contraindication to nitroglycerine
11. Glaucomatous patients
12. Parkinson's disease patients
13. Women who are suspected or known to be pregnant or breastfeeding
Non-steroidal Anti-inflammatory in Cardiac Surgery

Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for cardiac surgery (aortic valve replacement, coronary artery bypass graft, mitral valve repair or replacement, intracardiac tumor, aortic root repair)
* under cardiopulmonary bypass
* Affiliation to the French national healthcare system
* Written consent obtained

Exclusion Criteria:

* age\<18
* weight\<50 kg
* chronic use of NSAID
* mini-invasive surgery
* NSAID contraindication
* NSAID allergy
* Nefopam contraindication
* Paracetamol contraindication
* Tramadol contraindication
* Urgent surgery
* Endocarditis
* Immunosuppressive drug
* HIV infection with CD4\<200 mm3
* Organ transplantation
* Stage 4 or 5 chronic kidney disease
* Gastro duodenal ulcer
* Pregnancy
* Depression
* Auto immune disease
Effects of Exercise Intervention on Insulin Levels in Breast Cancer Survivors

The purpose of this study is to determine whether an exercise program comprised of strength and endurance training will lower fasting insulin levels in a group of breast cancer survivors. Insulin may be involved in the risk of breast cancer recurrence.

* All women taking part in this study will take part in an exercise program. Group A will start exercising immediately and Group B wil have a delay period of 16 weeks before starting to exercise so investigators can look at the changes in insulin levels that occur in a women who is not exercising.
* The exercise program will be made up of two parts: strength (or weight) training and cardiovascular exercise. The strength exercise will take place at a gym close to Dana-Farber Cancer Institute. Patients will work one on one with a personal trainer twice a week for 50 minutes. During each of these sessions, participants will have a brief warm up period and then will perform a series of Nautilus machine-based exercises under the guidance of the personal trainer. The goal of each session will be to increase strength by increasing weight lifted and repetitions.
* Participants will also do cardiovascular exercises on their own at home. Each participant will receive a pedometer and heart rate monitor. Women will be advised to exercise for at least 30 minutes three times per week on their own and will keep a journal recording how long and how intensively they exercised. Participants will receive weekly phone calls from the project manager to review the cardiovascular exercise.
* Women will undergo a series of measurements before and after the 16 week exercise intervention. They will be asked to fast for 12 hours prior to each of these measurement sessions. Measurements will include blood testing for insulin and glucose levels. Women will also be weighed, height will be measured, body composition will be computed using a noninvasive bioelectric impedance monitor, and hip/waist measurements will be taken. Group A participants will undergo testing at the time of enrolling in the study and after 16 weeks of exercise. Group B participants will undergo these tests after enrollment, after the 16 week waiting period and at the end of the exercise program.
* Participants will also complete two surveys by mail, 3 months and 9 months after completing the exercise portion of the protocol.

Eligibility Criteria:
Inclusion Criteria:

* History of pathologically confirmed stage I-IIIa invasive breast cancer
* Adjuvant chemotherapy and/or radiation must be completed at least 3 months prior to enrollment
* Body mass index \> 25 and/or a body composition analysis of \>30

Exclusion Criteria:

* Patients taking herceptin
* Evidence of residual or distant disease
* Use of any medication expected to affect insulin levels
* Baseline exercise of more than 20 minutes two times per week
* Active malignancy
* Diabetes mellitus
* Heart disease or uncontrolled hypertension
* Presence of any condition that might be expected to impact a participant's ability to perform physical activity
A Study to Evaluate the Long-Term Safety of Idecabtagene Vicleucel Treatment in Adults With Newly Diagnosed Multiple Myeloma in Korea

The purpose of this study is to monitor the long-term safety of participants who received idecabtagene vicleucel treatment as part of the KarMMa-9 (CA089-1043) Phase 3 clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants ≥19 years of age
* Korean participants with newly diagnosed multiple myeloma who had a suboptimal response after autologous stem cell transplantation (ASCT) and who were treated with idecabtagene vicleucel (assigned to Arm A) in the KarMMa-9 trial (CA089-1043)
* Participants must understand and voluntarily sign and informed consent form (ICF) for the Korea long-term follow-up surveillance study prior to any surveillance-related procedures being conducted

Exclusion Criteria:

* Participants who participate in KarMMa-9 trial (CA089-1043) but disagree with long-term follow-up surveillance in Korea
* Participants who are not possible to treat with Ide-cel within 9 days post-completion of lymphodepleting chemotherapy (LDC), if delays occur. However, depending on the participants recovery status, whether idecabtagene vicleucel is administered or not, should be discussed with a medical monitor
TRC105 Combined With Standard-dose Bevacizumab for Two Patients With Metastatic And Refractory Choriocarcinoma

The purpose of this study is to determine whether TRC105 in combination with Bevacizumab is effective in the treatment of two patients with metastatic and refractory choriocarcinoma.

Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in patients with a wide variety of solid tumor types. TRC105 is a monoclonal antibody to CD105, an angiogenic target highly expressed on the tumor vessels and the tumor cells in choriocarcinoma. Together, these antibodies may be efficacious in metastatic and refractory choriocarcinoma, a tumor type that is highly vascular and expresses endoglin. The purpose of this study is to determine whether TRC105 in combination with Bevacizumab is effective in the treatment of two patients with metastatic and refractory choriocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Willingness and ability to consent for self to participate in study
2. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
3. Measurable disease by RECIST 1.1 and elevated serum β-hCG
4. Histologically proven choriocarcinoma that has progressed despite all described lines of chemotherapy for this condition

Exclusion Criteria:

1. Prior treatment with TRC105
2. Serious dose-limiting toxicity related to prior bevacizumab
3. Current treatment on another therapeutic clinical trial
4. Uncontrolled chronic hypertension defined as systolic \> 140 or diastolic \> 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is \< 140/90 mm Hg)
5. Symptomatic pericardial or pleural effusions
6. Uncontrolled peritoneal effusions requiring paracentesis more frequently than every 2 weeks
7. Active bleeding or pathologic condition that carries a high risk of bleeding (i.e. hereditary hemorrhagic telangiectasia)
8. Thrombolytic or anticoagulant use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy
9. Cardiac dysrhythmias of NCI CTCAE grade ≥ 2 within the last 28 days
10. Known active viral or nonviral hepatitis
11. Open wounds or unhealed fractures within 28 days of starting study treatment
12. History of peptic ulcer disease or erosive gastritis within the past 6 months, unless treated for the condition and complete resolution has been documented by esophagogastroduodenoscopy (EGD) within 28 days of starting study treatment
13. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness
14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for this study
A Study of SR58611A in the Prevention of Depression Relapse in Patients With Major Depressive Disorder

The purpose of the study is to assess whether treatment with SR58611A can prevent relapse of depressive symptoms in patients with major depressive disorder. Relapse will be assessed using the MADRS scale.Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week open-label treatment period with SR58611A are randomized to continue SR58611A or switch to placebo under double blind conditions for up to 52 weeks of additional treatment. The secondary objective is to evaluate the safety of SR58611A in patients with MDD.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Major Depressive Disorder, Recurrent according to DSM-IV-TR criteria Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) and assessed with the Mini International Neuropsychiatric Interview (MINI)
* Total score on the Montgomery and Asberg Depression Rating Scale (MADRS) \> 28
* At W12 (V7), patients will be randomized into the double-blind treatment phase if they have MADRS total score \< 12

Exclusion Criteria:

* Patients with a significant risk of suicide.
* Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset.
* Patients with a current depressive episode secondary to a general medical disorder.
* Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder.
* Patients with severe or unstable concomitant medical conditions
* Patients with clinically significant abnormal laboratory value at screening
* The investigator will evaluate whether there are other reasons why a patient may not participate
Impact of an Evidence-based Electronic Decision Support System on Diabetes Care

The purpose of this study is to assess the feasibility of the use of an evidence-based decision support system (EBMeDS) in daily Belgian family medicine and to study the effectiveness of EBMeDS use on improving diabetes care.

The purpose of this study is to assess the feasibility of the use of an evidence-based decision support system (EBMeDS) in daily Belgian family medicine and to study the effectiveness of EBMeDS use on improving diabetes care.

Specific research questions are:

* Does family physicians use the EBMeDS system in daily practice?
* Does the use of the EBMeDS system by family physicians leads to an improvement in diabetes control compared to the control group?

Eligibility Criteria:
Inclusion Criteria:

* Patients are 18 years or older.
* Patients have their electronic medical records registered by one of the included family physicians. Medical records are not centralized in Belgium. Patients are free to choose any physician, and can even see several physicians at the same time. To encourage a patient to have their medical records held by a single physician, 'Global Medical Records' werr introduced a decade ago. In return for a registration fee, patients can choose a main general practitioner who keeps their central medical records. This registration is a requirement for patient inclusion in the trial. Patients with 'Global Medical Records' are reimbursed a larger proportion of the consultation fees by the health insurance fund.
* Patients have an established diagnosis of diabetes at the baseline time point of the study (identified as having (1) an ICPC (International Classification of Primary Care) code of diabetes or (2) a prescription for a diabetes-specific or (3) the necessary labo results to confirm diabetes)

Exclusion Criteria:

* Pregnancy
* Cognitive impairment