cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of Ziftomenib Combinations in Patients with Relapsed/Refractory Acute Myeloid Leukemia

The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.


Eligibility Criteria:
Key Inclusion Criteria:

* Has been diagnosed with relapsed/refractory AML.
* Has a documented NPM1 mutation or KMT2A rearrangement.
* Has a documented FLT3 mutation (cohort A-3 only).
* Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.
* Has adequate hepatic and renal function as defined per protocol.
* Has an ejection fraction above a protocol defined limit.
* Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
* Has agreed to use contraception as defined per protocol.

Key Exclusion Criteria:

* Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.
* Has clinically active central nervous system leukemia.
* Has an active and uncontrolled infection.
* Has a mean corrected QT interval (QTcF) \> 480ms.
* Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
* Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \<14 days or within 5 drug half-lives prior to the first dose of study intervention.
* Has had major surgery within 4 weeks prior to the first dose of study intervention.
* Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.
* Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD.
* Participant is pregnant or lactating.
Virological Response Study of the HCV Vaccine IC41

The objective is to investigate the virological (HCV-RNA) responses following biweekly immunization with IC41.

Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained prior to study entry
* Patients with chronic hepatitis C; genotype 1
* Treatment naive patients
* Male and Female, 18 to 55 years
* Presence of HLA-A2 marker
* Mentally healthy
* No clinically relevant pathological findings in any of the investigations at screening
* Treatment naive patients with chronic Hepatitis C of genotype 1

Exclusion Criteria:

* Positive results in HIV, HBsAg and HAV-Ag (IgM)
* Other causes of chronic hepatitis
* History of autoimmune diseases
* Previous vaccination with any prophylactic or therapeutic Hepatitis C vaccine (in a clinical study)
* Active or passive vaccination 4 weeks before and during the entire study period
* Decompensated liver disease
* History of severe hypersensitivity reactions and anaphylaxis
* Known allergic reactions to one of the components of the vaccine and Imiquimod cream
* Clinically significant diseases which, in the opinion of the Investigator, might lead to frequent hospitalization/medical attendance
* Malignancies
* Immunosuppressive therapy
* Pregnancy, lactation or breast-feeding
* Unwillingness to practice appropriate contraception
* Participation in another study with an investigational drug within 1 month prior to enrolment and the entire study period
* Patients, who in the opinion of the Investigator, might not be able to comply with the study protocol (e.g.: Drug addiction, alcoholism)
A Study on Paxlovid Once in the Market, to Observe Its Safety and Effectiveness in Patients Who Have a High Chance of Getting Severe COVID-19

The purpose of this study is to look at the safety and effectiveness of PAXLOVID in the real world and not in clinical studies. The study observes patients who have a high chance of getting severe COVID-19 in Korea.

This study is seeking participants who are:

* Patients with mild-to-moderate COVID-19 symptoms and at high chance of getting severe COVID-19, including hospitalization or death.
* Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.
* Patients who have signed informed consent documents after understanding all the important parts of the study.

All participants are treated according to routine medical practice and there are no scheduled visits required by this study. All participants will be studied for a follow-up period of 28 days from the last PAXLOVID treatment to understand the safety and the effectiveness of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received, are currently receiving, or are going to receive PAXLOVID according to locally approved label.
* Patients (or a legally acceptable representative) who are willing to provide written informed consent/assent prior to study enrollment.

Exclusion Criteria:

* Patients with contraindication according to locally approved label of PAXLOVID.
* Patients who are going to receive any investigational medicine during the observation period.
Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)

The purpose of this study is to evaluate the effects that electromagnetic field exposure from using a tablet and smart phone have on a leadless pacemaker (MICRA device).

With advancement in technology, people are exposed to new sources of electromagnetic field like tablets and smart phones. There are magnets in smart phones and tablets that could affect the functions of pacemakers. The main purpose of this study is to evaluate the effects of electromagnetic field exposure from using a tablet and a smart phone with participants that have a leadless pacemaker (MICRA device) implanted inside them. Participants will be asked to report any symptoms that they experience during the testing.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital
* Able to consent

Exclusion Criteria:

* Patients not enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital
* Children and vulnerable populations
Functional Results With Attune Fixed Bearing Posterior Stabilized Knee Arthroplasty (A-16)

Functional results with Attune Fixed Bearing Posterior Stabilized total knee arthroplasty evaluated with KOOS. A prospective longitudinal cohort study with repetitive measurements 6 weeks, 3, 6, 12 and 24 months postoperative.

Total knee arthroplasty is a well documented and efficient treatment method for degenerative knee arthritis. Nevertheless it is reported that 15-20% of patients are not satisfied with the result. Some of the complaints are anterior knee pain, mid flexion instability and range of motion. Attune Fixed Bearing Posterior Stabilized knee have been developed to address the common complaints after knee arthroplasty surgery . The investigators like to use the Attune Fixed Bearing Posterior Stabilized knee with patella resurfacing on 65 of Our departments eligible patients to evaluate the functional results. Our primary outcome measure is change in Knee Osteoarthritis Outcome Score.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 50-80 years eligible for total knee arthroplasty at our hospital

Exclusion Criteria:

* Patients unable to cooperate
* Larger deformity that not suitable for a Posterior Stabilized total knee prostheses.
* Revision operation
* Diagnosed with inflammatory arthritis
* Previously septic arthritis in the current knee joint
* Local malignancy/general bone metastases
* Serious Medical conditions that inflict on the walking ability
* Active infections, latent infections og increased risk og infection
* Previously arthrodeses or not well functioned arthroplasties in hips, knees or ankles.
* Neurologic illness with symptoms from the current limb
Effect of Early Antiviral Therapy on Duration of Cough in Flu Patients

This study mainly focused on the effect of early antiviral treatment on the duration of cough in influenza patients.investigators conducted an early investigation of patients with positive influenza virus and asked whether patients used antiviral drugs in the early stages. According to the use of drugs, patients were divided into oral oseltamivir group, oral lotus phlegm group and other groups, and investigators will collected Inspection information and medication status,during the treatment period of patients.

Cough is a common symptom of respiratory diseases and helps to clear respiratory secretions and harmful factors, but frequent severe coughing has a serious impact on the patient's work, life and social activities. Upper respiratory tract viral infection is a common cause of coughing. Many patients have a long duration of cough after suffering from flu. Cough can last for several weeks, and most often have irritating dry cough or a small amount of white mucus sputum. This type of cough is also often referred to as "subacute cough" or "post-infection cough." The mechanisms that cause this cough have not been fully elucidated, and the effect of conventional treatment is not good, and chest imaging has no obvious abnormalities. The use of large amounts of antibiotics is ineffective or ineffective. Antihistamine H1 receptor antagonists and central antitussives are often only effective or ineffective in the short term. The effects of various bronchodilators and even hormone drugs are not clear. Due to the poor efficacy of multiple treatments, patients are repeatedly subjected to various tests, which not only increases the pain but also aggravates the economic burden.

Therefore, it is necessary to further clarify the causes and treatment measures of post-influenza cough patients.

Eligibility Criteria:
Inclusion Criteria:

For patients with flu-free flu, cough for at least one week.

1. In line with the flu etiological diagnostic criteria: According to the guidelines set by the National Health and Health Committee, the diagnosis is based on etiological screening methods or confirmed methods; ages 18 to 70 years.
2. There are no influenza complications such as acute lower respiratory tract infection, tonsillitis, sinusitis, otitis media, myocarditis, etc.
3. It is usually healthy and there are no chronic underlying diseases such as hypertension and diabetes.
4. Treating with cough as the main symptom, the cough lasts for at least one week and the chest radiograph is normal.
5. Signed informed consent.

Exclusion Criteria:

1. Suspected flu patients who have not received the flu etiology test;
2. There is a clear comorbid disease (combined with other sites of acute bacterial or viral infections);
3. There is a clear cough caused by other reasons;
4. With severe liver and kidney dysfunction;
5. Pregnant women.
Observational Study of Sub-populations From Cologuard Post-Approval Study (2014-01)

The primary endpoint is to obtain longitudinal information on four sub-populations from the Cologuard Post-Approval Study.

Subjects who consented to enroll in Exact Sciences Protocol 2014-01, that fit one of the following sub-populations, will be asked to participate in the sub-study. Population 1 includes those whose Cologuard T0 result was positive and colonoscopy result was negative. Population 2 includes those whose Cologuard T0 result was positive and subject declined to complete a colonoscopy per protocol. Population 3 includes those whose Cologuard result at T3 was positive and colonoscopy result at T3 was negative. Population 4 includes those whose Cologuard result at T3 was positive and subject declined to complete a colonoscopy per protocol. Subjects that enrolled in the Exact Sciences Protocol 2014-01, who provided written informed consent to participate in this sub-study, will asked to complete the Follow-Up Questionnaire during a phone interview.

Eligibility Criteria:
Inclusion Criteria:

* Subject falls into one of the 4 sub-populations
* Willing to provide informed consent

Exclusion Criteria:

* Death
* Investigator/sponsor decision
* Subject withdrew consent
Pharmacokinetic/Pharmacodynamic Study of MP-513 With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the effect of MP-513 on 24-h glycemic control in patients with type 2 Diabetes for 4 weeks administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are 20 - 75 years old
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 8 weeks before administration of investigational drug
* Patients whose HbA1c is ≥6.5% and \<10.0%
* Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 8 weeks before administration of investigational drug.

Exclusion Criteria:

* Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
* Patients who are accepting treatments of arrhythmias
* Patients with serious diabetic complications
* Patients who are the excessive alcohol addicts
* Patients with severe hepatic disorder or severe renal disorder.
* Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception
Decitabine, Venetoclax and Blinatumomab for Maintenance Following HSCT in Patients With Ph-Negative B-ALL

This study aims to evaluate whether maintenance therapy with decitabine, venetoclax and blinatumomab could improve the 2-year progression free survival (PFS) of patients with philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who had recently received an allogeneic stem cell transplant and in measurable residual disease-negative remission.

This is a phase Ⅱ, open-label, single-arm, multi-center study in patients with philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who had recently received an allogeneic stem cell transplant and in minimal residual disease-negative remission. In this study, patients will be treated with 4 cycles of maintence therapies for up to one year (or until intolerable toxicity, death, withdrawal, or study termination). In cycle one and three, patients will receive decitabine monotherapy, and in cycle two and four, patients will receive a combination of venetoclax and blinatumomab. This study aims to evaluate whether maintenance therapy with decitabine, venetoclax and blinatumomab could improve the 2-year progression free survival (PFS) of those patients, and explore the efficiency and safety.

Eligibility Criteria:
Inclusion Criteria:

* 1.Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia who underwent an alloHSCT as follows:

  1. patients in CR1 with high-risk features,including adverse clinical features, cytogenetic or molecular alterations according to NCCN 2023.V3.
  2. patients lack of achievement of complete remission after standard induction chemotherapy.
  3. patients with detectable minimal residual disease pre-transplantation.
  4. patients in second and higher CR pre-transplantation. 2.Negative minimal residual disease prior to enrollment (FCM-MRD \<0.01% and fusion gene negative).

  3.≥3 months post-transplantation. 4.hematopoietic reconstitution, i.e., ANC ≥0.5 x 109/L, and platelets \>20 x 109/L.

  5.Eastern Cooperative Oncology Group (ECOG) score: 0-2. 6.Total serum bilirubin ≤ 3 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 5 x ULN, aspartate aminotransferase (AST) ≤ 5 x ULN.

  7.Creatinine clearance ≥ 30 mL/min. 8.Provide informed consent.

Exclusion Criteria:

* 1.Patients with another malignant disease. 2.Patients with uncontrolled active infection. 3.Patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade III/IV cardiovascular dysfunction according to the New York Heart Association Classification.

  4.Detectable minimal residual disease post-transplantation 5.Active GVHD requiring systemic steroid therapy. 6.Patients with uncontrolled active bleeding. 7.Pregnant and lactating women; patients of childbearing potential should be willing to practice methods of contraception throughout the study period.

  8.Patients with other commodities that the investigators considered not suitable for the enrollment.
Role of Office Hysteroscope in Premenopausal Uterine Bleeding

The aim of this study is to photographically characterize the endometrium in patients presenting with abnormal uterine bleeding at age group from 20 to 45 years old.

and compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding.

Menstrual dysfunction is the cause of discomfort and disturbed healthy lifestyle. Abnormal uterine bleeding (AUB) is considered as a common problem in premenopausal women. AUB is defined as bleeding from the uterine that is abnormal in volume, regularity, and/or timing.

There are various diagnostic modalities available in the market, ranging from traditional dilation and curettage (D\&C), transvaginal sonography, hysteroscopy and saline infusion sonography. Dilation and curettage is the most widely used simple day care procedure for histological evaluation of the endometrial. It was once considered as the gold standard of investigating women with AUB.

Office hysteroscopy is a very useful technique for diagnosis and treatment of uterine pathology in an office-based environment. It is directly related to the technological explosion, which during the last years has further evolved and given us the opportunity to perform hysteroscopy without providing general anesthesia or sedation to the patients, due to the narrow width of the latest generation hysteroscopes. Hysteroscopic inspection of uterine cavity is a simple and well accepted method. The direct real time visualization, real-color, hydrated, well-illuminated, and augmented vision of the uterine cavity make this diagnostic tool very accurate to detect minute focal endometrial pathology and small lesions and helping us to take well guided direct biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Perimenopausal women complaining of abnormal uterine bleeding.

Exclusion Criteria:

* Active pelvic infections
* Medical disorders
* Bleeding tendency
* Hormonal treatment
* Pregnancy
* Contraceptive treatment
Transgender, Silicone and Blood Smear

This cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection.

The principal objective is to estimate the prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smears among Male to Female Transgender population with a history of cosmetic silicon injections.

The secondary objectives are to describe the transgender population, to describe the quantity of silicone in vacuoles of circulating monocytes, and the association between dermatological complications (inflammatory and not inflammatory) and several clinical and biological characteristics (HIV status, level of immunosuppression, inflammatory syndrome, quantity of silicone which was injected , silicone quantity in blood smears).

Injectable liquid silicone is a permanent filling product which is no more used in France because of a high risk of complications. Cosmetic silicone injection is a common feminization approach for transgender populations.

This cross-sectional monocentric study will describe transgender men transitioning into women and who had cosmetic silicone injection.

The principal objective is to estimate the prevalence of Transgender with circulating monocytes containing silicone vacuoles in blood smears among Male to Female Transgender population with a history of cosmetic silicon injections.

The secondary objectives are to describe the transgender population, to describe the quantity of silicone in vacuoles of circulating monocytes, and the association between dermatological complications (inflammatory and not inflammatory) and several clinical and biological characteristics (HIV status, level of immunosuppression, inflammatory syndrome, quantity of silicone which was injected , silicone quantity in blood smears).

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Not in opposition to data collection
* Transgender men transitioning into women patients with cosmetic silicone injection
* Consultation in Bichat hospital

Exclusion Criteria:

* Unable to communicate
* Guardianship, curatorship
The Effects of 12-week Custom-made Orthotic Intervention on the Structure and Function of the Foot of Healthy Young Adults During Gait Termination

The purpose of this study is to explore the long-term effects that orthotics imposes on the structure and function of the foot. The objectives of the study are to determine if the use of custom-made foot orthotics (CFO) cause: (a) changes to the structure of the plantar intrinsic muscles, (b) changes in the rate of muscle activity and timing in the plantar intrinsic muscles and (c) creates any changes in balance control during gait termination. The aim of the study is to enhance the appropriate dispensing of orthotics, and whether additional measures, such as rehabilitation exercises are necessary to increase their overall effectiveness in the clinical setting.

Between 20-30 healthy young adults of both males and females will be recruited. A screening questionnaire will be administered to ensure that participants are appropriate for the study.

Once the participant has met the criteria of the study, the participants will be randomly allocated into one of two groups: (a) the control group or (b) the intervention group. Individuals that are selected to be in the intervention group, will be fitted with custom-made orthotics by an experienced pedorthist. The pedorthist will cast the foot posture using a foam impression to custom the design of the foot orthotic. The participant will have a week to acclimatize to the new environment, and if any discomfort arises the pedorthist will make any necessary corrections and the participant will have another week to acclimatize to the orthotic. The control group will not receive an intervention and ask to go about their daily life activities. All participants will undergo the same testing procedures at 6 and 12 weeks after baseline testing.

At baseline, 6 weeks and 12 weeks post-baseline, the researcher will take a diagnostic ultrasound image of the foot muscles prior to the gait trials. The researcher will also place 12 infrared markers and surface electrodes on the participant. All trials will be performed barefoot. The participants will then undergo a gait termination protocol. Participants will walk down an 8m walk-way with three force plates are embedded into the ground. Participants will be asked to walk to the end of the platform until instructed to stop. For 20% of the gait trials, the participants are walking forward until they hear an audio buzzer sound that will signal them to terminate their gait suddenly in the next two steps. All trials will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* a score of (+5) on the Foot Posture Index (FPI)
* navicular height \< 3.6cm
* able to walk

Exclusion Criteria:

* have worn CFOs in the past year,
* current lower limb injury, leg or foot pain
* neurological or musculoskeletal disorders affecting the function of the foot
* previous history of lower limb surgery
* protein intake above the recommended daily allowance (RDA)
* medications that effect balance.