cyrilzakka/clinical-trials huggingface dataset:
Study of the ZN-d5 and ZN-c3 in Subjects With Acute Myeloid Leukemia (AML)

A Phase 1/2 dose escalation study of BCL-2 Inhibitor ZN-d5 and the Wee1 Inhibitor ZN-c3 in Subjects with Acute Myeloid Leukemia (AML).

This is an open-label multicenter Phase 1/2 dose escalation study, evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of the novel BCL-2 inhibitor ZN-d5 and Wee1 inhibitor ZN-c3 in subjects with AML.

Eligibility Criteria:
Inclusion Criteria:

* Adults with AML (including secondary or therapy-related), relapsed from or refractory to one or more prior lines of therapy, which may include venetoclax except in Expansion Cohort A
* ECOG performance status score ≤2.
* Projected life expectancy of at least 12 weeks.
* Estimated glomerular filtration rate ≥60 mL/min
* Women of childbearing potential must not be pregnant and must use effective birth control during the study and for 6 months after the last dose of study drugs.
* Men must agree to use a condom when having intercourse during the study and for 3 months after the last dose of study drugs.

Exclusion Criteria:

* Known active CNS involvement
* Diagnosis of acute promyelocytic leukemia.
* Peripheral blast count of \>25 × 109/L (cytoreduction permitted).
* Adequate washout from prior therapy including hematopoietic stem cell transplant and recovery from prior treatment-related toxicities to Grade 2 or lower
* Significant cardiovascular disease
* Corrected QT interval (QTc) of \>480 msec
* Active hepatitis B or hepatitis C infection
* Concurrent treatment with strong CYP3A inhibitors or strong or moderate CYP3A inducers
Use of Self-collected Vaginal Swabs as an Innovative Approach to Facilitate Testing for Repeat Chlamydia Infection

The purpose of this study is to determine if, among women who were treated for a prior chlamydial infection, home-based, self-collected vaginal swabs can increase rescreening for chlamydia in comparison with rescreening in the clinic. The study design is two randomized trials with enrollment at multiple family planning clinics and sexually transmitted disease (STD) clinics following a common protocol.

The study consists of two complementary trials, denoted as Part A and Part B. In Part A, women/girls who had a positive test for chlamydia will be enrolled when they visit the study clinics for treatment. After written informed consent is obtained, women will be randomly assigned to the Clinic Group, in which they will be advised to return to the clinic for rescreening for chlamydia, or the Home Group, in which women will be asked to collect a vaginal swab at home and mail it to the study laboratory for chlamydia testing. In part B, women who were tested and empirically treated for a chlamydial infection will be called if their tests were positive. Enrollment will be offered over the phone after verbal consent. Rescreening will be scheduled 3 months after treatment of the initial infection for women in both trials.

Eligibility Criteria:
Inclusion Criteria:

* Women/girls with a lab-confirmed genital chlamydia infection

Exclusion Criteria:

* Women who are pregnant, or are trying to conceive in the following 3 months.
* Women who are planning to move in the following 3 months or currently living outside the study areas.
* Inability to understand spoken English adequately to assure informed consent and compliance with study procedures.
* Self-reported HIV infection; other serious illnesses or disability.
* Self-reported allergy to macrolide antibiotics such as azithromycin.
* Referrals from providers or clinics other than the STD or family planning clinics, unless women are re-tested at the STD clinics and test positive for chlamydia.
Electrochemotherapy for Non-curable Gastric Cancer

This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of electrochemotherapy for non-curable gastric cancer.

This is an explorative, phase I clinical trial. Aim of this study is to establish the safety of electrochemotherapy as a palliative treatment for advanced (non-curable) gastric cancer. The study involves recruitment of 8 patients with histologically verified and non-curable gastric cancer (including Siewert Type II and II). Patients will be recruited from Department of Surgery, Odense University Hospital and from Zealand University Hospital after their case has been reviewed by the multidisciplinary team (MDT). Electrochemotherapy will take place at Department of Surgery, Zealand University Hospital. After the treatment patients will be referred to Odense University Hospital for follow-up. Electrochemotherapy will be performed as an additive treatment to standard oncological care. Patients are treated once and will be followed with endoscopy, biopsies, scans, blood samples and questionnaires after 4-6 weeks and 8-12 weeks with a minimum interval of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be mentally capable of understanding the information given.
* Patients must give written informed consent.
* Histologically verified gastric cancer (adenocarcinoma, including Siewert Type II and II)
* Non-curable disease according to MDT decision
* Age ≥ 18 years.
* ASA class I-III (Classification of the American Society of Anesthesiology)
* Thrombocytes ≥ 50 billions/l, INR \>1,2. Medical correction is allowed, e.g. correction of elevated INR by means of vitamin K or administration of freshly frozen plasma.
* Performance status ECOG/WHO ≤2

Exclusion Criteria:

* Locally advanced non-metastatic EGJ/GC patients that may become resectable after pretreatment
* Inability to perform upper endoscopy with attached equipment.
* Uncorrectable coagulation disorder
* Patients with ICD or pacemaker units
* Myocardial insufficiency, defined as NYHA class \>2
* Concurrent treatment with an investigational medicinal product.
* Renal impairment, defined as GFR \<40 ml/min
* Pregnancy
* Concurrent inclusion in a medical trial where the intervention may affect safety measures used in the current protocol.
* Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments.
* Acute pulmonary infection.
* Medical history of severe pulmonary disease.
* Previous allergic reactions to bleomycin.
* Previous cumulative dose of bleomycin exceeding 250mg/m2.
Study to Evaluate PF-04965842 in Patients With Moderate to Severe Psoriasis

Study B7451005 is a Phase 2 study which will assess the efficacy and safety of PF-04965842 in patients with moderate to severe psoriasis. The study will include three PF-04965842 groups (200 mg daily, 400 mg daily and 200 mg twice daily) and a placebo group. The treatment period will be 4 weeks in duration and will be followed up by a 4 week follow up period.


Eligibility Criteria:
Inclusion Criteria:

1. Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose.
2. Have plaque type psoriasis covering at least 15% of total BSA at Day 1 (at the time of the first study dose).
3. Have a PASI score of 12 or greater at Day 1 (at the time of the first study dose).
4. Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).

Exclusion Criteria:

1. Currently have non plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis.
2. 3. Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium.
3. Have received any of the following treatment regimens specified in the timeframes outlined below:

Within 9 months of first dose of study drug:

• Ustekinumab (Stelara).

Within 12 weeks of first dose of study drug:

• Any experimental therapy for psoriasis or rheumatoid arthritis.

Within 4 8 weeks of first dose of study drug:

* Biologic therapies for psoriasis have discontinuation periods determined from approximately 5x half life of the respective biologic:
* 4 weeks: etanercept (Enbrel).
* 8 weeks: infliximab (Remicade), adalimumab (Humira).

Within 4 weeks of first dose of study drug:

* Systemic treatments other than biologics that could affect psoriasis (eg, oral or injectable corticosteroids, retinoids, methotrexate, cyclosporine, fumaric acid derivatives, sulfasalazine, hydroxycarbamide (hydroxyurea), azathioprine).
* Phototherapy and psoralen plus ultraviolet A therapy (PUVA).
* Other - intramuscular gold, immunization with any live virus vaccination (eg, FluMist), herbal medications.

Within 2 weeks of first dose of study drug:

* Topical treatments that could affect psoriasis (eg, corticosteroids, tars, keratolytics, anthralin, vitamin D analogs, and retinoids).
* Phototherapy with ultraviolet B (UVB) (narrowband or broadband).
Platelet-rich Plasma Use as Prophylactic of Low Back Pain Post-spinal Following Gynecological Surgery

Platelet-rich Plasma Use as Prophylactic of Post-operative Low Back Pain Following gynecological surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elective gynecological surgery.

Exclusion Criteria:

* Spinal Pathology
Weight Loss and Maintenance for Rural, African American Communities of Faith (The WORD)

The WORD (Wholeness, Oneness, Righteousness, Deliverance) is a faith-based weight loss study in rural, African American adults of faith. The study will see whether a weight loss + maintenance intervention will cause participants to maintain their weight better than a weight loss only intervention.


Eligibility Criteria:
Inclusion Criteria:

* African American
* Aged 18 and older
* Have a BMI ) \> 25 kg/m²
* Associated with a participating church through membership or participation in a church activity
* Free of medical problems that might contraindicated participation in a behavioral weight reduction program containing an exercise component
* Individuals taking sulfonylureas who have a letter from their doctor supporting their participation in the study will be considered eligible

Exclusion Criteria

* Not had a heart attack or stroke in the past 6 months
* Not currently on medication that might affect weight loss or require medical monitoring (i.e. insulin)
* Not pregnant, not pregnant in the previous six months, or lactating
* Not enrolled in another weight reduction program
* Agree to complete the program assigned to them
* Never had weight loss surgery
* Not have lost more than 10% body weight in the previous 6 months
* Not have a clinically significant medical condition likely to impact weight or any condition that makes it unlikely the participant would be available to follow the protocol for 18 months
CGB-400 for the Reduction of Facial Redness

Open-label multicenter study using CGB-400 Gel (cosmetic) to reduce facial redness

This is a Open-label multicenter study to evaluate the ability of CGB-400 Gel to reduce facial redness typically associated with rosacea. Approximately 25 subjects will be enrolled.

Subjects will receive study treatment for 4 weeks and attend a total of 4 study visits (BL, W1, W2, W4).

Eligibility Criteria:
Inclusion Criteria:

1. Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing potential must have a negative UPT at Baseline and practice a reliable method of contraception throughout the study.
2. Facial redness associated with rosacea.
3. Facial redness (IGA-R) score of 2 or 3 (i.e., mild or moderate).
4. Absence of any skin conditions that could interfere with the visual erythema assessments.
5. Willing to forego any other topical or non-topical treatment on the study areas during treatment (other than sun protection or the study specified face wash and moisturizer).
6. Willing to use the provided skincare regimen (e.g., face wash and moisturizer) over the duration of the study.
7. Sign the IRB-approved ICF (which includes HIPAA) prior to any study-related procedures being performed.

Exclusion Criteria:

1. Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Products (i.e., essential oils, fragrance, choline, phosphatidylcholine, etc.).
2. Any transient flushing syndrome.
3. History of basal cell carcinoma within 6 months of Visit 1.
4. History or presence of a skin condition/disease that is located in the treatment area(s) and might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, psoriasis, significant actinic damage, vitiligo, open wounds, infection, etc.).
5. Diagnosis of severe rosacea, ocular rosacea, rhinophymatous rosacea, or acne fulminans at Baseline.
6. Blepharitis/meibomianitis requiring systemic treatment by an ophthalmologist.
7. Uncontrolled systemic disease.
8. Foreseen unprotected and intense/excessive UV exposure during the course of the study.
9. Use of any of the following concomitant medications/procedures:

   * Cosmetic and/or OTC products for redness reduction and/or skin clearing
   * Topical medications for rosacea
   * Systemic antibiotics or corticosteroids
   * Topical antibiotics, corticosteroids, or antiparasitic agents
   * Intense/excessive ultraviolet (UV) radiation
   * Phototherapy, energy-based therapy, facials, chemical peels, microdermabrasion
10. Exposure to any other investigational drug/device within 30 days prior to study entry.
Premature Infants in Need of Transfusion (PINT)

Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular leukomalacia/ventriculomegaly).

Primary Objective: To determine whether either a liberal or more restrictive threshold of hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold.

Follow-up at a corrected age of 18 months represents a conventional age at which to first assess neurodevelopmental outcomes, and to predict long-term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* birth weight \<1000g
* postnatal age \<48 hours
* no transfusion beyond first 6 hours of life
* estimated gestational age of 30 completed weeks or less

Exclusion Criteria:

* infant considered non-viable by attending physician
* infant has cyanotic congenital heart disease
* infant's parents known to be opposed to blood transfusion
* either parent has hemoglobinopathies or congenital anemias
* infant has hemolytic disease
* infant has severe acute hemorrhage, severe shock, severe sepsis with coagulopathy or requires peri-operative transfusion
* prior treatment with or intention to treat with erythropoietin
Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation

The purpose of this study is to determine if repetitive transcranial magnetic stimulation (TMS) will alleviate symptoms of major depressive disorder (MDD) in pregnant women.

TMS uses electromagnetic impulses to encourage neurons in the brain to communicate more effectively with one another. Effective neuron communication is thought to lead to the lessening of depressive symptoms. In this study subjects require daily TMS treatment for approximately four weeks.

We hypothesize that there will be a decline in the Hamilton Rating Scale for Depression (HDRS-17) scores from the beginning to end of treatment. We expect that this decrease will be significantly greater in subjects receiving active transcranial magnetic stimulation (TMS) compared to those receiving placebo TMS. Treatment response will be defined as greater than 50% reduction in HDRS-17 score.

We also hypothesize that levels of Brain Derived Neurotrophic Factor (BDNF), a protein thought to regulate mood and cognitive functioning, will increase in subjects who respond to TMS treatment. We expect BDNF levels to increase by greater than or equal to 20% in those who respond to TMS. As previously stated, TMS response will be defined as a significant decrease (50% or greater) in the HDRS-17 from baseline to end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are capable of giving written informed consent and complying with all study procedures;
* Female age 18-39 years old at date of enrollment;
* Pregnant, weeks 14-34;
* Current Depressive Symptoms;
* No change in antidepressant medication at least two weeks prior to study entry if using an antidepressant.

Exclusion Criteria:

* Any alcohol or drug abuse/dependence over the 6 months prior to study entry;
* History of a seizure disorder in subject or first degree relative;
* Anti-psychotic, lithium, or anti-convulsant medications within 2 weeks of study enrollment;
* History of known brain lesions, or severe head trauma;
* Subjects with any metallic object implanted in the skull;
* Subjects with significant cardiac disease;
* Neurological or psychiatric disorders;
* Serious medical illnesses that may compromise patient safety or study conduct;
* Currently taking a drug with known potential for fetal toxicity;
* Previous pregnancy with an adverse fetal outcome;
* Current obstetrical complications
* Actively suicidal;
* History of depression unresponsive to treatment with electroconvulsive therapy (ECT).
Measurement of Handgrip Strength and Pinch of Children and Adolescents Using an Electronic Dynamometer

This study has quantified the hand strength in movements of handgrip and pinch with electronic dynamometer.

The hand is considered the most improved tool and differentiated of the human, with great importance in the accomplishment of numerous actions due to an essential function: The handgrip strength. The handgrip and pinch movements are very important for an accomplishment of daily activities. For an evaluation of the movements, the dynamometry has been used in many fields of health and frequently in the area of rehabilitation. However, if the type of dynamometer used is not suitable for children, a measurement of the handgrip may be compromised. Therefore, the present study verified the effectiveness of an electronic dynamometer to evaluate the handgrip strength and pinch in children and adolescents.

Eligibility Criteria:
Inclusion Criteria:

* neurological disorder Absence
* Informed Consent signed by the responsible
* with preserved cognitive.
* consent form signed by the volunteer

Exclusion Criteria:

* change Absence of skeletal muscle in the upper limbs
A Study to Assess CSF1R-related Leukoencephalopathy After Stem Cell Transplantation

The purpose of this study is to measure the effect of Hematopoietic Stem Cell Transplantation (HSCT) on symptoms of CSF1R-related Leukoencephalopathy.

The purpose of this study is to measure the effect of Hematopoietic Stem Cell Transplantation (HSCT) on symptoms of CSF1R-related Leukoencephalopathy.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age.
* Genetic confirmation of a mutation in the CSF1R gene.
* Diagnosis of CSF1R-related leukoencephalopathy.
* Anticipated to undergo haematopoietic stem cell transplantation (HSCT).

Exclusion Criteria:

* Concurrent diagnoses that may confound neuropsychological testing; e.g., major hearing/visual impairment.
* Concurrent diagnoses that may confound ambulatory measurements; e.g., amputee.
* Inability to undergo magnetic resonance imaging (MRI); e.g., MR-incompatible implant.
Assessment of Pouch Emptying With MRI After Roux-en-Y Gastric Bypass

A cross-sectional observational study in which pouch emptying rate is measured with MRI in good (TWL\>35%) and bad responders (TWL\<25%) two years after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB).


Eligibility Criteria:
Inclusion Criteria:

* Women aged between 20 and 55 years
* Patients must be able to adhere to the study visit schedule and protocol requirements
* Patients must be able to give informed consent (IC) prior to any study procedures
* Patients who had a follow-up period up until two years after LRYGB and have successful or unsuccessful weight loss.
* Willing to be informed about incidental findings of pathology and approving of reporting this to their general physician

Exclusion Criteria:

* Diabetes Mellitus
* Menopausal
* Gastrointestinal problems, gastric or intestinal diseases
* Drug or alcohol addiction
* Inability to stop smoking during the overnight fasting period
* Pregnant or lactating
* Having an intolerance or allergy for one of the components of the test product
* Inability to stop medications that affect gastrointestinal emptying like antisecretory drugs, narcotics and prokinetic agents
* Inability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids)
* Having a contra-indication to MRI scanning (including, but not limited to):

  * Pacemakers and defibrillators
  * Intraorbital or intraocular metallic fragments
  * Ferromagnetic implants
Upper Extremity Stability and Balance in Youth Basketball Players

Ball games require extensive skill, including physical, technical, mental and tactical abilities. Among them, the physical abilities of the players show obvious effects on the players' own skills and the tactics of the team. It involves skillful moves that include shooting, defending, and dribbling. It requires repeated maximum effort, such as a.

Endurance is defined as the strength of the physical and physiological characteristics of a basketball player to cope with fatigue. Flexibility is the ability of the athlete to use the range of motion he uses while demonstrating the movements, in every possible direction in the joint range.

Eligibility Criteria:
Inclusion Criteria:

* Being a basketball player
* Regular attendance at training sessions

Exclusion Criteria:

* Known neurological disorder
* Serious orthopedic disorders that prevent exercise
* cognitive impairment
Treatment of Dysphagia by Using a Synchronized Electrical Stimulation Device

The purpose of this study is to determine the synchronized electrical stimulation device effective in the treatment of dysphagia.

* Design: Prospective study
* Inclusion criteria of the patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study(N=10)
* Inclusion criteria of the control group: who does not have any dysphagia symptoms, and does not have any underlying disease(N=10)
* Setting: Hospital rehabilitation department
* Intervention: Participants are applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"

Eligibility Criteria:
Inclusion Criteria:

* who have dysphagia symptoms and verified deglutition disorder by video fluoro swallowing study

Exclusion Criteria:

* who reject the checkup their deglutition function by high resolution manometry
* who reject apply "Synchronized Electrical Stimulator"
Distributed Registry

The purpose of this study is to test if a patient can be directly connected to a quality assurance (QA) database, traditionally known as a registry. Patient-reported outcomes (PRO) data will be entered into the database directly from a patient's mobile phone from their index procedure for 12 months. The investigators hope this study to be a "proof of concept" for such a distributed registry and evaluate 1) consistency of data acquisition, 2) engagement of patients, 3) overall value of patient-reported outcomes to enhance long term follow up.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with cardiovascular disease who are scheduled or have undergone either a) open or endovascular vascular procedure, or b) open or percutaneous cardiac procedure.
2. Patients with smartphones (iOS or Android) with unlimited data plans.
3. Patients who agree to remote surveillance

Exclusion Criteria:

1. Patients unwilling to download a research study app.
2. Data plans which are not unlimited.