cyrilzakka/clinical-trials huggingface dataset:
Study Investigating NTLA-5001 in Subjects With Acute Myeloid Leukemia

This study will be conducted to evaluate the safety, tolerability, cellular kinetics (CK), activity, and pharmacodynamics (PD) of NTLA-5001 in participants with Acute Myeloid Leukemia (AML).

This 2-part first in human (FIH) study is comprised of two open-label arms. It is a multi-center, Phase 1/2a study evaluating the safety and activity of NTLA-5001 in subjects with persistent or recurrent Acute Myeloid Leukemia after first-line or later therapy.

Eligibility Criteria:
Inclusion Criteria (abbreviated):

* Has AML as defined by World Health Organization
* Has detectable disease following first-line therapy
* Is ≥ 18 years of age.
* Carries the human leukocyte antigen-A0201 (HLA-A\*02:01) allele.
* Has ECOG performance status of 0 to 1.
* Has adequate absolute total lymphocyte count
* Has adequate cardiac, renal, and liver organ function

Exclusion Criteria (abbreviated):

* Has received AML-directed therapy or immunomodulatory therapy within a specified window prior to study entry.
* Has received allogeneic hematopoietic cell transplant within 84 days, with ongoing GVHD, with recent DLI, or on active immunosuppression.
* Has CNS involvement by tumor.
* Has severe autoimmunity requiring immunomodulatory therapy.
* Has active disseminated intravascular coagulation (DIC), bleeding or coagulopathy.
* Has leukocytosis ≥ 20,000 blasts/μL despite hydroxyurea or has rapidly progressive disease
* Has human immunodeficiency virus (HIV) infection, or any uncontrolled infection.
* Female subjects are pregnant or breastfeeding; or are of childbearing potential and are unwilling to use protocol specified method of contraception.
* Male subjects who have female partners of childbearing potential and are unwilling to use protocol specified method of contraception.
The Prevalence of Hearing Loss Among Children With Congenital Hypothyroidism

Congenital hypothyroidism (CH) occurs in 1:4000 live births. Neurological disturbances like speech delay, motor delay and lower IQ were reported in children with CH. Evidence from animal experiments indicate that CH is associated with high frequency of deafness. Morphological changes of the external and internal cholera hairs were reported in mutagenic mice with CH. Anatomical changes of the internal ear and low hearing threshold were reported in mice bearing Dual oxidase 2 (Duox2) gene mutations, which is responsible of oxidation of iodide. Knockout of Pax8 gene in mice resulted in both agenesis of thyroid gland and deafness. Early L-thyroxin therapy prevented the development of deafness in those mice. The expression of thyroid receptor α (TRα) in the external and internal cholera hairs in mice indicates that the thyroid hormones have an important role in the development of the internal ear.

The etiology of deafness in human is both genetic and environmental. The prevalence of deafness in live births is 1:1000 and among them 60% is genetic. Connexin 26 gene mutations are the most common cause of inherited deafness and account for about 40% of the genetic cases. In two conditions in human the coexistence of hypothyroidism and deafness were reported; Pendred syndrome and thyroid hormone resistance syndrome.

The prevalence of hearing loss in human with CH was explored in only few studies and the results are contrary.

The aim of the current study is to study the prevalence of hearing loss among children with CH and to compare the clinical, biochemical and genetic characteristics between subjects with hearing loss to those without hearing loss.


Eligibility Criteria:
Inclusion Criteria:

* Patients with congenital hypothyroidism aged 2-30 years

Exclusion Criteria:

* Hearing defects in the family
* Intrauterine infections
* Perinatal hypoxia
* Long term therapy with aminoglycosides
* Acoustic trauma in the past
Lcr35 for Children With Functional Constipation

The aim of this study is to assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 administration for the treatment of functional constipation in children.

Functional constipation is a common problem which affects over 3% of children. The standard treatment does not provide sustained relief of symptoms. As a consequence, there is interest in other therapeutic options. Previously, one small (n=40) randomized controlled trial (RCT) involving 27 children showed that Lactobacillus rhamnosus casei Lcr35 compared with placebo increased treatment success defined as ≥ 3 spontaneous defecations per week with no episodes of faecal soiling, increased the defecation frequency, reduced the frequency of abdominal pain, reduced the use of glycerin enemas during the four weeks of therapy, and decreased the percentage of hard stools. However, there was no difference between groups in the use of lactulose or the number of episodes of faecal soiling. Available evidence is insufficient to draw meaningful conclusion. Further studies are needed.

Eligibility Criteria:
Inclusion Criteria:

* Children below 5 years of age
* Functional constipation according to Rome III criteria i.e. 1 month of at least 2 of the following:

  * Two or fewer defecations per week
  * At least 1 episode per week of incontinence after the acquisition of toileting skills
  * History of excessive stool retention
  * History of painful or hard bowel movements
  * Presence of a large fecal mass in the rectum
  * History of large- diameter stools that may obstruct the toilet

Exclusion Criteria:

* Irritable bowel syndrome
* Mental retardation
* Endocrine disease (e.g. hypothyroidism)
* Organic cause of constipation (e.g. Hirschsprung disease)
* Spinal anomalies
* Anatomic defects of the anorectum
* History of previous gastrointestinal surgery
* Functional nonretentive fecal incontinence
* Use of drugs that influence gastrointestinal motility
A Study of LY3053102 in Healthy Participants

The main purpose of this study was to evaluate the safety and tolerability of the study drug known as LY3053102 in healthy participants. The study also investigated how much of the study drug entered the blood stream and how long it took the body to dispose of the study drug. Information about any side effects that occurred was also collected. The study was expected to last approximately 8 weeks for each participant (up to 4 weeks from screening to the administration of study drug and an additional 4 weeks of follow up).


Eligibility Criteria:
Inclusion Criteria:

* Normal blood pressure
* Female participants were not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause
* Had a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m\^2), inclusive, at screening

Exclusion Criteria:

* Had known allergies to LY3053102 or related compounds
* Had a history of significant disease that may have affected the actions of drugs or may pose a risk when taking the study medication
* Had a history of developing allergies, asthma, severe drug allergies (symptoms including, but not limited to, itching, red rashes, sores on the skin, scaling and shedding of skin), allergies or reactions to more than one drug, or have had bad reactions to skin creams containing corticosteroids
* Heavy smokers (more than 10 cigarettes a day)
Changes in Serum, Follicular Fluid SREBP1c and LRG1 Levels in PCOS Patients and Correlation With Insulin Resistance

Polycystic ovary syndrome (PCOS) is a common reproductive endocrine and metabolic disease that affects 6-20% of women of childbearing age worldwide. Due to changes in modern lifestyles such as low fiber, high fat diets, sedentary lifestyles, smoking, and alcohol consumption, the risk of developing this disease has increased. Its clinical manifestations are heterogeneous, with typical clinical manifestations being oligomenorrhea or amenorrhea, infertility, hirsutism, and polycystic ovarian changes under ultrasound. Women affected by PCOS face significant reproductive challenges, seriously affecting their quality of life and increasing their psychological burden.LRG1 has various regulatory functions, including glucose and lipid metabolism, IR, angiogenesis, organ fibrosis, and inflammation. LRG1 can activate the transcription factor SREBP1 and participate in liver lipid synthesis in obese mice. SREBP1c is the active form of SREBP1. Research has shown that SREBP1c can directly or indirectly participate in the development of IR. Therefore, the investigators speculate that LRG1 may play a certain role in the progression of PCOS through SREBP1c.Understanding the local changes or metabolic characteristics of follicular fluid in patients with PCOS can help elucidate the pathogenesis of PCOS. Therefore, in this study,the investigators aim to detect changes in serum and follicular fluid LRG1, SREBP1c, and related hormone levels, and explore their role in the pathogenesis of PCOS from a systemic and ovarian perspective, providing new ideas for the prevention and treatment of PCOS and IR.

1. The diagnostic criteria for all participants with polycystic ovary syndrome included in the study were based on the 2003 European Society for Human Reproductive and Embryonic Medicine and American Society for Reproductive Medicine (ESHRE/ASRM) diagnostic criteria in Rotterdam.
2. Collect basic data of all participants.
3. After informed consent, all participants were evaluated for insulin sensitivity(the degree of insulin resistance), using the insulin resistance index of the steady-state model. All participants were conducted after signing an informed consent form.
4. After informed consent, all participants were given fasting venous blood samples in the morning for measuring blood sugar, blood lipids, insulin, C-peptide, glycosylated hemoglobin (HbA1c), and a complete set of sex hormones.
5. After collecting follicular fluid from all participants, centrifuge at 1000xg for 20 minutes, filter and precipitate, and freeze in a refrigerator at -80 ° C for the determination of LRG1, SREBP1c, and related hormone levels in follicular fluid.
6. Use SPSS 22.0 statistical software for data analysis.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Polycystic Ovary Syndrome

Exclusion Criteria:

Congenital adrenal cortical hyperplasia Adrenocortical carcinoma Cushing syndrome.
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC

A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC


Eligibility Criteria:
Inclusion Criteria:

* Subjects who received the study treatment of SB3-G31-BC.
* Subjects who provide informed consent.

Exclusion Criteria:

* Subjects unwilling to follow the study requirements are not eligible for the study.
A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)

This study is to prove that the handling (also referred to as pharmacokinetics) of the following drugs PF-06439535, Avastin® (bevacizumab) that is licensed for use in the United States (bevacizumab-US) and Avastin® (bevacizumab) obtained from Europe (bevacizumab-EU) is similar in healthy male volunteers after receiving a single intravenous dose of either drugs.

During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06439535, bevacizumab-US and bevacizumab-EU. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects 21-55 years old
* Subjects who have previously been exposed to a biologic agent (other than a VEGF \[Vascular Endothelial Growth Factor Receptor\] inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50kg (110lbs)

Exclusion Criteria:

* Evidence or history of a clinically significant disease or clinical finding at Screening
* Previous treatment with an anti-VEGF antibody, or any other antibody or protein targeting the VEGF receptor.
Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Primary objective:

* End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD.

Secondary objectives:

* MSHQ-EjD improvement by visit
* Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit
* Onset of action of XATRAL 10mg OD
* Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.


Eligibility Criteria:
Inclusion criteria:

* Patients suffering from moderate to severe LUTS suggestive of BPH
* I-PSS total score ≥ 8
* Patients sexually active

Exclusion criteria:

* Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening condition
* Previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. Planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period
* Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer
* Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-blockers within 30 days prior to inclusion
* Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
* History of postural hypotension or syncope
* Known hypersensitivity to alfuzosin

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions

The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg ER Tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense

The ultimate goal of this study is to show that fexinidazole offers an alternative over the existing treatments of Human African trypanosomiasis due to Trypanosoma brucei rhodesiense (r-HAT): melarsoprol in patients with stage 2 r-HAT and suramin in patients with stage 1 r-HAT. The main questions it aims to answer are:

* Is the short-term fatality rate and failure rate associated with fexinidazole lower than those of melarsoprol in patients with stage 2 r-HAT?
* Is the long-term failure rate associated with fexinidazole lower than that of melarsoprol in patients with stage 2 r-HAT?
* Can fexinidazole in patients with stage 1 r-HAT replace the treatment with suramin?
* Is fexinidazole treatment safe in patient with r-HAT, regardless of stage?

Participants will receive fexinidazole oral treatment for 10 days. Regular blood draws and lumbar punctures will be performed over 12 months to confirm the cure of the disease. Other assessments will include the recording of adverse events, signs and symptoms of the disease, laboratory tests, vital signs, electrocardiograms.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form (plus assent for children)
* ≥ 6 years old
* ≥ 20 kg body weight
* Ability to ingest at least one complete meal per day (or at least one Plumpy'Nut® sachet)
* Karnofsky index ≥ 40
* Parasitological confirmation of T. b. rhodesiense infection
* Having a permanent address or being traceable by others and willing and able to comply with follow-up visit schedule
* Agreement to be hospitalised for a minimum of 13 days and to receive the study treatment

Exclusion Criteria:

* Active clinically relevant medical conditions other than HAT that may jeopardize subject safety or at the investigator discretion may interfere with participation in the study.
* Compromised general health or severely deteriorated general condition, such as severe malnutrition, cardiovascular shock, respiratory distress, or terminal illness
* Patients with severe hepatic impairment (e.g.: clinical signs of cirrhosis or jaundice)
* Known hypersensitivity to fexinidazole, to any nitroimidazole drugs (e.g. metronidazole, tinidazole), or to any of the excipients
* Patients previously enrolled in the study or having already received fexinidazole
Post Marketing Surveillance Study of Cuprimine

Cuprimine (penicillamine) was made available in the Philippines by the Sponsor under a Compassionate Special Permit issued by the Bureau of Food and Drugs. Physicians were able to request the drug for their patients from the Sponsor. A Clinical Study Report form was completed for each purchase of Cuprimine.


Eligibility Criteria:
Inclusion Criteria:

- None

Exclusion Criteria:

- None
Observational Safety and Effectiveness Study of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine

This observational study will evaluate the safety and effectiveness following administration of adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine through both an ad hoc active monitoring system and a passive surveillance of hospitalization in a large cohort.


Eligibility Criteria:
Inclusion Criteria:

* Subjects resident in Emilia-Romagna and either registered with the AUSL of Reggio Emilia, Bologna, Modena and Parma or working in the province of Reggio Emilia, Bologna, Modena and Parma included in the target groups described in the Study Protocol vaccination with H1N1sw vaccine Focetria is recommended - according to the national pandemic plan adopted at the local level - will be eligible for enrolment.

Exclusion Criteria:

* Subjects already vaccinated with another pandemic vaccine or with known contraindications to Focetria, will be excluded from this study.
* Patients institutionalized in Hospital, Nursing Homes, Rehabilitation Centers, as well as home-cared patients, will also be excluded.
Rhodiola Crenulata as an Adjunctive Therapy in COPD

We hypothesize that add-on Rhodiola L extract capsule to the regimen of patients with moderate-to-severe COPD (1) may provide a potential of systemic effects of anti-inflammation and anti-oxidation for these patients, and these effects (2) may reflect in the improvement of patients' physiological measurements, quality of life and exercise tolerance.

This is a single center, randomized, double-blind, placebo controlled clinical trial.

Eligibility criteria:

1. moderate-to-severe COPD patients
2. aged 40-80 years,
3. abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,
4. no acute exacerbation of COPD,
5. clinically being stable for one month and longer,
6. not undergoing exercise training program.

Primary endpoint:

six-minute walk distance in meters at week 12.

Eligibility Criteria:
Inclusion Criteria:

1. moderate-to-severe COPD patients
2. aged 40-80 years,
3. abstaining from cigarette smoking or maintaining a stable dose of cigarette consumption,
4. no acute exacerbation of COPD,
5. clinically being stable for one month and longer,
6. not undergoing exercise training program.

Exclusion Criteria:

1. uncontrolled diabetes mellitus by plasma fasting sugar \>200 mg/dl,
2. uremia or CKD stage 5,
3. chronic heart failureby NYFC III,
4. cerebrovascular disease,
5. uncontrolled anemia by Hb \< 10 mg/dl,
6. active malignant diseases,
7. other hospitalized acute illness,
8. systemic prednisolone \> 10 mg per day.
Effect of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation

The aim of the present clinical study is to evaluate the efficacy and safety of the DA-5515 (Circulan Soft Cap.) in patients with chronic fatigue symptoms due to impaired blood circulation.

This study is conducting to assess the efficacy and safety of the DA-5515 (Circulan Soft Cap.), which has been known to have a fatigue recovery effect due to impaired blood circulation.

Eligibility Criteria:
Inclusion Criteria:

* Rutherford's category 0/0 or Ⅰ/1
* ABI \<1.0
* CIS greater than 76
* HADS less than or equal to 10
* Subjects who have fatigue symptoms more than 1 month

Exclusion Criteria:

* Subjects who have diseases that can cause fatigue
* Subjects who are taking medication that can cause fatigue
Feasibility of an Interval Exercise and Nutrition Intervention to Reduce Cardiovascular Disease Risk Factors

Purpose : Test the feasibility (acceptability, adherence) of a home-based interval exercise training (IET) and nutrition program, as well as its preliminary effects on resting heart rate, blood pressure, fasting glucose, HDL, cholesterol, weight and percent body fat, among primary care patients who have at least one risk factor for cardiovascular disease (CVD).

Participants : 30 patients who receive care from the University of North Carolina (UNC) Family Medicine Center (FMC) and meet the inclusion criteria defined below (i.e. general FMC patients, not diagnosed with severe illness), will be enrolled to test the feasibility of the home-based interval exercise and nutrition program.

Procedures (methods): A home-based IET and nutrition program will be piloted in 2 phases. In Phase I, 15 patients will be enrolled into the program, which will take approximately 3 months. At baseline, data will be collected on age, height, weight, resting heart rate, blood pressure, fasting glucose, hemoglobin A1c, fasting lipids, cholesterol, insulin, percent body fat, cardiovascular fitness, and use a series of questionnaires to evaluate mood, sleep, hunger, and quality of life. At closeout, the investigators will measure patients' adherence to each component of the intervention. In Phase II, an additional 15 new patients will be enrolled in either the identical protocol, or a slightly modified intervention (if necessary based upon our results from Phase I). All patients will have the same variables measured at baseline during their study visit at 3, 6 and 12 months after enrollment into the study.


Eligibility Criteria:
Inclusion Criteria:

Patients are:

1. \> 18-85 years;
2. receive primary care in the FMC (\> 1 visit during the previous year); and
3. have ≥1 risk factor or developing risk factors for CVD (blood pressure \>130/85 mmHG, BMI \>25 kg/m2(or \~20 lbs overweight), Fasting glucose \>110 mg/dl, OR 4) HDL \<30) (all identified via medical record)

Exclusion Criteria:

1. those for whom exercise and/or diet are contraindicated (e.g., scheduled for arthroplasty) or who are at risk of death in the next year (e.g., Class IV heart failure, end-stage renal disease).
2. those taking medication for diabetes, blood pressure, and lipids for more than 2 years.
3. pregnant or planning on becoming pregnant within the next year.
4. Allergic to any ingredient in the nutritional meal replacement.