cyrilzakka/clinical-trials huggingface dataset:
Micro-transplantation in Elderly Patients With Acute Myeloid Leukemia

This study aims at evaluating the safety and the tolerance of the micro-transplantation in elderly patients with acute myeloid leukemia who are ineligible to conventional allogeneic transplantation.

Acute Myeloid Leukemia (AML) is an aggressive hematological malignancy with a median age at diagnosis of 65 years. Outcomes of AML in elderly population remain unsatisfactory with low rates of complete remission, poor disease-free and overall survival. Therapeutic management of older patients with AML deals with patient-related features (i.e. comorbid conditions and performance status) as well as disease-related prognostic factors (i.e. cytogenetics and molecular genetics). Even if allogeneic hematopoietic-cell transplantation provides the strongest antineoplasic effect, this treatment option remains limited for older patients owing to toxicities, the development of significant graft-versus-host disease (GVHD) and logistics of donor availability. More recently, micro-transplantation has emerged as an alternative strategy based on the infusion of mobilized HLA-mismatched related donor cells after induction chemotherapy, thus exerting a graft-versus-leukemia effect without substantial donor engraftment and GVHD. Therefore, there is much of interest in investigating the efficacy and the safety of this method for older patients with AML who are not candidates for allogeneic stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated to a social security regimen or beneficiary of the same
* Signed written informed consent form
* Patient, ≥ 60 years-old - \< 75 years-old, with established diagnosis of de novo or secondary AML with intermediate-risk or adverse-risk cytogenetic profile, or with established myelodysplasic syndromes (RAEB), in pathologically confirmed complete remission following anti-leukemic induction therapy (\<5% blasts)
* Contra-indication to conditioning regimen in conventional allogeneic transplantation

Exclusion Criteria:

* Patient with established diagnosis of acute myeloid leukemia with standard-risk cytogenetic profile
* Promyelocytic leukemia t(15;17)
* CBF-AML t(8;21) or inv(16)
* Normal karyotype with a favorable molecular profile: NPM1+ and FLT3-; NPM1+, FLT3- and double mutation CEBPα or chronic myeloid leukemia in blastic phase
* Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent
* Refusing participation
An Open Label Extension Study of the Efficacy of MORAb-003

An open label extension of the MORAb-003-002 study in order to continue the active patients in the MORAb-003-002 study on maintenance MORAb-003 infusions after the main study is closed.


Eligibility Criteria:
Inclusion Criteria:

* Provision of Informed consent.
* Subjects must have been enrolled in and have met the inclusion/exclusion criteria of the MORAb-003-002 study.
* Subjects must have achieved a normalization of CA 125 levels and/or CR or PR (or stable disease and an investigator's assessment of a clinical benefit) after MORAb-003 in combination with standard chemotherapy and have not yet met the criteria for disease progression during participation in the MORAb-003-002 study.
* Subjects must be currently receiving single-agent MORAb-003 maintenance therapy.

Exclusion Criteria:

• Subjects that discontinued the MORAb-003-002 study for any reason.
Comparison of the Effect of Testosterone Administered for Micropenis Hypospadias Surgery With Bispectral Index

The aim of this observational study is to learn the effects of hormone therapy (testosterone) applied in micropenis hypospadias surgery on the depth of anesthesia under general anesthesia. The main question it aims to answer is: The effect of testosterone therapy on the depth of general anesthesia. Based on these, to comment on the depth of anesthesia of patients who have just started using testosterone for sex change. To follow the depth of anesthesia of patients who have undergone hypospadias surgery with BIS monitoring and to record respiratory parameters under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Ages 1-16
* Patients with ASA I (Normal healthy patients except for surgery)
* Patients who will undergo surgery for hypospadias repair

Exclusion Criteria:

* Morbidly obese patients (body mass index \> 40kg/m2)
* ASA II-III-IV patients (other groups of patients with additional diseases)
* Volunteers who do not want to participate in the study
Application and Evaluation of Group Cognitive Intervention for Depressed Adolescents

Cognitive behavioral therapy (CBT) is effective and CBT with parental involvement has potential in preventing and treating adolescent depression. The purpose of this study was to compare the short- and long-term effectiveness of CBT alone and CBT plus parental education for community-based adolescents at risk for depression and suicide in Taiwan. It is hypothesized that the CBT alone and CBT with parental education group are more effective than the control group.

Cognitive behavioral therapy (CBT) is well known for its active, directive, time-limited, and structured approach. Despite an increasing prevalence of adolescent depression in Taiwan, few studies have been conducted to evaluate the immediate and long-term effectiveness of CBT for community-based adolescents at risk for depression and suicide. Also, little is known about the effectiveness of the involvement of parents in CBT groups. The Adolescent Coping with Depression Course (CWDA) (19) is an effective CBT-oriented group intervention for adolescent depression. However, it has not been tested in specific cultural groups. The primary purpose of this study was therefore to compare the immediate and long-term effectiveness of CBT alone, CBT with parental education, and control groups for community-based adolescents at risk for depression and suicide.A quasi-experimental research design was used in this study. Community-based high school students at risk for depression and suicide were recruited and assigned to one of two experimental groups or a control group. Students in the experimental groups received CBT plus parental education (group A, n = 9) or CBT alone (group B, n = 10). The control group was designed as a waiting list group (group C, n = 12). Both experimental groups received a follow-up session 1 year after the intervention. Several outcome variables (depressive symptoms, suicidal ideation, cognitive triad, learned resourcefulness \[LR\], and salivary cortisol level) were used to determine the effectiveness of treatment.

Eligibility Criteria:
Inclusion Criteria:

* willing to participate group assignment and grant consents

Exclusion Criteria:

* unwilling to participate potential group activity and grant consents
* severe physical or psychiatric disorders
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR).

Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.


Eligibility Criteria:
Inclusion Criteria:

1. The candidate/candidate's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
2. Weight is ≥ 20 kg (44 lbs).
3. RVOT/PV with moderate or greater PR by TTE.
4. RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm, and minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff.

Exclusion Criteria:

1. Active infection requiring current antibiotic therapy (if temporary illness, patient may be a candidate 2 weeks after discontinuation of antibiotics).
2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days.
3. Leukopenia (WBC \< 2000 cells/μL), anemia (Hgb \< 7 g/dL), thrombocytopenia (platelets \< 50,000 cells/μL) or any known blood clotting disorder.
4. Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV.
5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
6. Interventional/surgical procedures within 30 days prior to the Alterra or valve implant procedure
7. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure
8. History of or current intravenous drug use
9. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
10. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
11. Known hypersensitivity to nitinol, cobalt-chromium, nickel or contrast media that cannot be adequately pre-medicated
12. Currently participating in an investigational drug or another device study \[Note: Trials requiring extended follow up for products that were investigational, but have since become commercially available, are not considered investigational devices.\]
13. Positive urine or serum pregnancy test in female patients of child-bearing potential
14. Renal insufficiency (creatinine \> 3.0 mg/dL) and/or renal replacement therapy
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)

The primary objective of this study is to compare the duration of subject reported comfortable contact lens daily wear time in subjects with a history and current complaint of CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to rewetting drops


Eligibility Criteria:
Inclusion Criteria:

* Have a history of and current complaint of CLDE.
* Use properly fitted daily-wear soft contact lenses.
* Able to wear contact lenses for at least 8 hours a day.
* If female, are non-pregnant or non-lactating.

Exclusion Criteria:

* Have changed brand of contact lens or care solutions within one month prior to Visit 1.
* Use extended (overnight) wear contact lenses.
* Have a clinically significant ophthalmic abnormality.
* Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening.
* Have any active ongoing ocular infection or ocular disease.
* Have a serious medical condition which could confound study assessments.
Trial Comparing Routine Intraoperative Transesophageal Echocardiography During Radical Cystectomy to Standard of Care

This is a prospective randomized controlled trial looking at the utility of intraoperative transesophageal echocardiography (TEE) on clinical outcomes after radical cystectomy. Patients in the control group will have standard of care, patients in the TEE group will have standard of care and TEE monitoring throughout. Intraoperative and postoperative variables, such time to extubation, postoperative cardiac and pulmonary complications, intraoperative fluid and vasopressor use will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients have elective radical cystectomy at The University of Chicago Hospital.

Exclusion Criteria:

* Patient refusal, emergent surgery, preoperative mechanical ventilation, preoperative hemodynamic instability (intravenous vasopressor support), and/or esophageal/gastric pathology contraindicating insertion of the transesophageal echocardiography probe.
Botulinum Toxin in the Treatment of Idiopathic Detrusor Overactivity

Overactive Bladder (OAB) is a chronic condition caused by instability of the detrusor or bladder muscle, which gives rise to symptoms of urinary urgency and often urinary incontinence. Idiopathic Detrusor Overactivity (IDO) is a subset of OAB where the cause for the bladder muscle instability is unknown.

OAB is usually treated by conservative measures or with oral medications eg. anticholinergics. Injection of onabotulinum toxin A (onaBoNT-A) into the bladder wall is licenced in the treatment of refractory IDO where oral medications fail. The injected toxin paralyses the bladder by blocking the ability of certain (motor) nerves to communicate with the bladder muscle. As these nerves are mainly concentrated in what is known as the "body" of the bladder this is traditionally where the injections are given.

In addition to its action on motor nerves, onaBoNT-A also affects sensory nerve pathways. Recent studies show that IDO is caused by both motor and sensory nerve dysfunction, therefore injecting the "trigone", a part of the bladder where sensory nerves are particularly dense, may be of clinical benefit. Three studies comparing trigone versus trigone-sparing injection of botulinum toxin in the treatment of IDO have been carried out. One of these indicated a significant benefit in targeting the trigone and the other two did not show any difference.

Our study aims to examine if injection of onaBoNT-A into the trigone alone will provide symptom and functional improvement in patients with IDO by comparing peritrigonal injection of onaBoNT-A with the traditional method of injection which spares the trigone.


Eligibility Criteria:
Inclusion Criteria:

* Fulfil ICS criteria for OAB
* Urodynamically proven detrusor instability
* Symptoms lasting \>6/12
* Patients must discontinue anticholinergic medication \>14 days prior to randomisation and withhold the use of anticholinergics for the duration of the study.
* Patients with mixed incontinence are eligible if their urge symptoms are predominant. These will be instruced to record only episodes of urge urinary incontinence.
* Providing informed consent to participate in the study
* At least 18 years of age

Exclusion Criteria:

* Previous BoNT-A injection within 9 months of randomisation
* History of any neurological condition e.g. MS, Parkinsons, CVA
* Contraindication to BoNT e.g. Myaesthenia gravis
* Urinary tract infection in previous 6/12
* Antimicrobial therapy in previous 6/12
* Previous or current diagnosis of prostate or bladder cancer
* History of treatment with cyclophosphamide
* Radiation cystitis
* Urethral dilatation, cystometrogram, bladder cystoscopy under anaesthetic or a bladder biopsy in previous 3/12
* Augmentation cystoplasty, cystectomy or neurectomy
* Urethral stricture of \<12ch
* Pregnancy
* Sexually active women of childbearing potential who are unwilling to use contraceptive measures for the duration of the trial.
STEPS: An Efficacy Trial of a Chronic Pain Self-Management Program for Older Adults

The goal of this study is to determine whether community health workers (CHWs)-i.e., lay health workers with close ties to the communities they serve - can effectively teach cognitive-behavioral pain management strategies to older adults in a disadvantaged urban setting. Specific aims are: to test, in a sample of 414 primarily African American older adults, whether the STEPS pain self-management intervention, delivered over 7 weeks through telephone sessions with a CHW and mobile health tools, improves pain outcomes at 2 and 12 months compared to a usual care control group. We will also assess the mechanisms by which the intervention may bring about positive changes in pain outcomes. We will use mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and factors affecting implementation.


Eligibility Criteria:
Inclusion Criteria:

* Community-living
* Have a cell or landline phone
* Self-reported chronic musculoskeletal pain (pain in muscles or joints for \>= 3 months); \>=4 (0-10 scale) average pain level over last week; \>=1 day/previous 30 when pain made it difficult to do usual activities.
* Able to converse comfortably in English

Exclusion Criteria:

* Serious acute illness or hospitalization in last month
* Planned major surgery in next three months that would interfere with program participation (e.g., knee or hip replacement);
* Severe cognitive impairment or other severe physical or psychiatric disorder judged by study team to pose significant barrier to participation
Efficacy and Safety of Lactoferrin in Heart Failure Patients

This study will be conducted to determine the efficacy and safety of lactoferrin versus oral iron versus lactoferrin plus oral iron as an add on therapy in reduced ejection fraction heart failure patients with iron deficiency.

•Patients will be randomly distributed into the three groups

* All patients will be subjected to baseline data assessment
* Follow up after 12 weeks


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-65 years old.
2. Chronic heart failure (\> 6 months duration) with reduced ejection fraction defined as LVEF ≤ 40%.
3. NYHA-class II or III or IV with stable symptoms for at least the past 3 months.
4. Stabilized on beta blockers, renin-angiotensin system inhibitor (ACEI/ARB) or angiotensin receptor-neprilysin inhibitors (ARNIs), mineralocorticoid receptor antagonists (MRAs) and sodium-glucose co-transporter 2 Inhibitors (SGLT2i) and diuretics as needed.
5. No dose changes of heart failure drugs during the last 2 weeks (exception: diuretics)
6. No introduction of a new heart failure drug class during the last 4 weeks.
7. Iron deficiency: serum ferritin level of 15 to 100 ng/mL or a serum ferritin level of 101 to 299 ng/mL with transferrin saturation of less than 20%.

Exclusion Criteria:

* 1. Arrythmia including atrial fibrillation (AF) with poorly controlled ventricular rate at rest (\> 100 beats/min).

  2. Recent cardiac related hospitalizations in the past 3 months. 3. Known active infection. 4. Associated chronic medical disorder (chronic kidney disease (creatinine clearance \< 60 ml/min), liver disease (ALT or AST \> 3× upper limit of normal), peptic ulcer or chronic blood loss).

  5. Associated bleeding disorder. 6. Previous iron supplement in past 3 months. 7. Anemia requiring blood transfusion (haemoglobin (Hb) \< 7 g/dL). 8. Folic acid or vitamin B12 deficiency. 9. Hypersensitivity to lactoferrin or iron. 10. Haemoglobinopathies (G6PD, thalassemia's, sickle cell disease). 11. Pregnancy and lactation.
Tolerability of Enecadin (INN) in Acute Ischemic Stroke Trial - TEST

The main objective of this study is to investigate the tolerability of enecadin in patients with acute ischemic stroke. Furthermore, the pharmacokinetics of enecadin in both male and female patients with acute ischemic stroke will be assessed. Efficacy trends will be evaluated up to day 30 post stroke.

In the acute stage of ischemic stroke, an ischemic core characterized by a marked decrease in blood flow is present, leading to irreversible neuronal damage at an early stage. Around the boundary of the ischemic core, there is a region called ischemic penumbra in which functional recovery is possible after recirculation of blood flow within several hours after the onset, even though the blood flow is markedly decreased. Prevention of nerve cell death in the ischemic penumbra by neuroprotective therapy should greatly improve outcome and prognosis of acute ischemic stroke.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute ischemic stroke (scoring 3-20 on the National Institutes of Health Stroke Scale \[NIHSS\]) with level of consciousness score: 0 or 1 (conscious patients) are eligible to be treated within 9 hours of onset of stroke symptoms.
* For female patients: post-menopausal or surgically sterile (post-menopausal: age ≥55 years and last menses ≥3 years ago).

Exclusion Criteria:

* Participation in any investigational study in the previous 30 days.
* Patients unable to understand trial related information.
* History or evidence of severe heart diseases further specified in the protocol.
* History or evidence of additional diseases or results of baseline visit as specified in the protocol.
* Use of concomitant and prior medications as defined in the protocol.
Vaginal Changes and Sexual Function in Patients With Cervical Cancer

RATIONALE: Vaginal changes that may effect sexual function occur in patients undergoing treatment for cervical cancer.

PURPOSE: Clinical trial to determine the type of vaginal changes such as vaginal dryness that occur in patients receiving treatment for cervical cancer and the effect these changes have on sexual function.

OBJECTIVES:

* Obtain estimates of changes in vaginal length, perceived vaginal elasticity, perceived vaginal lubrication, and sexual activity, response, and satisfaction among patients with stage IB2 cervical cancer.
* Compare these differences between the patients in the two treatment groups in GOG-0201.
* Determine the relationships between vaginal dilation activities and vaginal length changes in these patients.
* Determine the association between smoking and vaginal length and between smoking and vaginal dryness in these patients after therapy for cervical cancer.
* Assess the extent of subject interest in and preferred methods of sexual counseling related to problems resulting from treatment in these patients.

OUTLINE: Vaginal length is measured using Vaginal Sound, a modified plastic vaginal dilator. The data about vaginal elasticity and lubrication and sexual activity, response, and satisfaction are obtained from patient self-report, as well as vaginal dilation activities. Measurement and assessments are taken before treatment and then at 3, 6, 12, and 24 months.

Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: Approximately 150 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Entered and treated on GOG-0201 or eligible for and treated on either arm of GOG-0201

  * May have refused entry on GOG-0201 as long as treatment is prescribed according to one or the other arm

PATIENT CHARACTERISTICS:

Age

* Under 70

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified