cyrilzakka/clinical-trials huggingface dataset:
Prostate Active Surveillance Study

The Prostate Active Surveillance Study (PASS) is a research study for men who have chosen active surveillance as a management plan for their prostate cancer. Active surveillance is defined as close monitoring of prostate cancer with the offer of treatment if there are changes in test results. This study seeks to discover markers that will identify cancers that are more aggressive from those tumors that grow slowly.

This is a multi-center, prospective active surveillance study with selective intervention in patients with previously untreated, clinically localized prostate cancer at diagnosis. Candidates are assessed based on an extended core biopsy, serum PSA (including PSA kinetics, if available), digital rectal examination (DRE), and assessment of cancer grade and extent.

Active surveillance is defined as serial PSA measurements and prostate examination with routine prostate biopsy and therapeutic intervention considered at the time one or more of the following:

* Grade or volume progression
* Clinical progression

The objectives of the study are as follows:

Primary Objective

• To discover and confirm biomarkers that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables.

Secondary Objectives

* To determine the proportion of patients on active surveillance who progress based on the above criteria.
* To determine the clinical predictors of disease progression.
* To measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate from a prostate biopsy.
* Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
* No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
* ECOG Performance Status 0 or 1.
* Patient has elected Active Surveillance as preferred management plan for prostate cancer.
* Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens.
* Patient is accessible and compliant for follow-up.
* Prostate cancer diagnosis cannot be more than 3 years prior to baseline visit date.
* No more than two prostate biopsies including the initial biopsy in which cancer was diagnosed.
* If cancer diagnosis is more than one year before enrollment, there must be two prostate biopsies including the initial biopsy in which cancer was diagnosed and a subsequent biopsy. The subsequent biopsy may occur on the same day as the baseline visit.
* Biopsies must have at least 10 cores.

Exclusion Criteria:

* Unwillingness or inability to undergo serial prostate biopsy.
* History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for \> 5 years.
Long-term Follow-up Study of Patients Receiving CAR-T Cells

This protocol is designed as a long-term follow-up study of participants who will receive CAR-T cells as part of a clinical trial at the Medical College of Wisconsin/ Froedtert Hospital. The clinical trials include the following:

Phase 1 Study of CAR-20/19-T Cells in Patients with Relapsed Refractory B Cell Malignancies (NCT03019055); Phase I Trial of BCMA-TGF-BETA CAR-T Cells in Relapsed, Refractory Myeloma (NCT05976555); CAR20.19.22 T-cells in Relapsed, Refractory B-cell Malignancies (NCT05094206); LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies (NCT05990465); CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies (NCT04186520)

The objective is to follow participants receiving CAR-T cells from years 2 to 15 post-treatment for persistence of CAR-T cells, development of secondary malignancies, or other medical complications.

Eligibility Criteria:
Inclusion Criteria:

* All participants who enrolled in a CAR-T study at Froedtert Hospital \& the Medical College of Wisconsin.

Exclusion Criteria:

* There are no exclusion criteria for this study.
Controlled Ovarian Stimulation Followed by Timed Intercourse or Intrauterine Insemination in Infertile PCOS Patients

At the present the first options to induce ovulation in polycystic ovary syndrome with anovulatory infertility are clomiphene citrate (CC) and metformin. Notwithstanding the effectiveness of CC and metformin alone or in a sequential or combined regimen, a percentage of patients ranging from 5% to 30% remain anovulatory. For these patients, the use of gonadotropins for controlled ovarian stimulation (COS) is indicated.

Moreover, to date it isn't clear if COS should be followed by timed intercourse (TI) or intrauterine insemination (IUI).

The aim of the present study will be to compare TI and IUI in infertile PCOS patients undergoing COS in terms of cost-benefit.

Infertile PCOS patients who remain anovulatory after CC or metformin treatment will be enrolled. All patients will receive gonadotropins in low-dose step-up protocol for COS, and randomized to receive three trials of TI (group A) or IUI (group B).

All patients eligible will undergo baseline assessment consisting of anthropometric, hormonal, and ultrasonographic evaluations.

In all patients the COS will be obtained using highly purified urinary FSH in a low-dose step-up protocol, and both TI and IUI will be performed after 35 hours from ovulation induction with human chorionic gonadotropin.

During the study, the clinical and reproductive outcomes, the adverse experience will be evaluated in each patient.

Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant. Continuous variables will be analyzed with the unpaired t test and general linear model for repeated measures analysis with Bonferroni test for the post-hoc analysis as required. For categorical variables, the Pearson chi-square and Fisher's exact tests will be used. Cumulative pregnancy rate, our primary end-point, will be calculated by the Kaplan-Maier method, and the differences between the two groups will be assessed with the log-rank test. Cox proportional-hazards model will be used to calculate the hazard ratio for new pregnancy in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Polycystic ovary syndrome (using NIH criteria)
* Anovulatory infertility (using WHO criteria)

Exclusion Criteria:

* Age \<18 or \>35 years
* Severe obesity (BMI \>35)
* Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
* Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
* Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, anti-obesity drugs, hormonal drugs
* Intention to start a diet or a specific program of physical activity
* Organic pelvic diseases
* Previous pelvic surgery
* Suspected peritoneal factor infertility
* Tubal or male factor infertility or sub-fertility
Influence of Clopidogrel on the Pharmacodynamics and Safety of Fradafiban in Healthy Male Subjects

To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg Lefradafiban tid


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent in accordance with good clinical practice (GCP) and local legislation
* Healthy male subjects
* Age ≥ 18 and ≤ 45 years
* Broca ≥ - 20 % and ≤ + 20 %

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of

  * Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * Any bleeding disorder including prolonged or habitual bleeding
  * Other hematologic disease
  * Cerebral bleeding (e.g. after a car accident
  * Commotio cerebri
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
* History of any familial bleeding disorder
* Thrombocytes \< 150000/µl
Parent's Knowledge, Attitude and Practices Towards Oral Health of Their Children With Primary Dentition: A Cross-sectional Study

Study aims to assess Parents Knowledge, Attitude and Practices towards Oral Health of their Children with Primary Teeth.

Dental caries is a chronic slowly progressing localized destruction of dental hard tissues by the acidic products formed as result of carbohydrates fermentation by bacteria due to disturbance in equilibrium between tooth minerals and plaque products through time. (Trindade et al., 2014) It's a worldwide disease affecting all ages both sexes with different socioeconomic levels. Dental caries commonly affects children and adversely affects their quality of life and so their weight and growth if left untreated (Gokhale and Nuvvula, 2015). The environmental factor is a very valuable factor affecting dental caries especially the mother and the family as whole, the family habits are directly influencing their children (Suma G and Anisha P, 2017). As parents are the primary decision makers for children and their first role models, their oral health knowledge, attitude and practice as well as habits influence their children (Dikshit et al., 2018).

There is lack of data about parent's oral health knowledge, attitude and practice and their implications on their children in Egypt.

Acquiring information about oral health knowledge of parents, will help identifying those children who are at risk of dental caries consequently it will be possible to offer the proper preventive and curative measures for them.

So, we need to know the effect of oral health knowledge, attitude and practice (KAP) of parents on caries prevalence of their children.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children and their parents.
* Children with primary dentition.

Exclusion Criteria:

* Parents refuse to participate.
Comparison of Postoperative Pain Score Between Perioperative Intravenous Ketamine and Placebo in Patients Undergoing Unilateral Total Knee Arthroplasty Under General Anesthesia

The goal of this clinical trial is to compare postoperative pain score between perioperative intravenous ketamine and placebo in patients undergoing unilateral total knee arthroplasty under general anesthesia. The main question\[s\] it aims to answer are:

* Can perioperative intravenous ketamine reduce postoperative pain score during rest and movement at 0, 2, 4, 8, 12, 18, 24 hours better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia?
* Can perioperative intravenous ketamine reduce morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid better than no administration of Ketamine in patients undergoing Unilateral total knee arthroplasty under general anesthesia? Participants will receive intravenous ketamine intraoperative TKA and comparison group will receive placebo that is normal saline. Researchers will compare perioperative intravenous ketamine and placebo to see postoperative pain score, morphine consumption in postoperative 24 hours, length of hospital stay, first time to receive opioid and side effect or complication from ketamine and opioid.


Eligibility Criteria:
Inclusion Criteria:

1. A patient undergo unilateral total knee arthroplasty under General anesthesia at Chomthong Hospital Chiang Mai During 2024 to December 2025
2. Age is more than 18 years old
3. ASA (American society of anesthesiologist) status are I,I,III
4. A patient can cooperate in research

Exclusion Criteria:

* Patients allergic to local anesthetic agent
* Patient who has contraindication to use ketamine
* Patients has coagulopathy.
* Injection site is infected.
* Patients with chronic pain received painkillers for more than 3 months.
* The patient has a history of opioid use.
* The patient has a history of alcohol dependence.
* Patients allergic to fentanyl or morphine.
* Patient who has unstable cardiovascular disease
* Patient who has increase intracranial pressure and high ocular pressure
* Pregnancy
* The patient who has communication problems cannot describe the level of pain
* The patient refused to participate in the study.
NLG802 Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors

This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed solid tumor cancer (including glioblastoma)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematologic and organ function

Exclusion Criteria:

* Active or history of medically significant autoimmune disease
* Cytotoxic therapy or investigational agent use within 28 days
* Human immunodeficiency virus (HIV), active hepatitis B or C
* Untreated brain metastases
* Known QT interval prolongation
* Use of concomitant medications with high risk of causing Torsades des Pointes.
* Use of immune suppressive agents within 30 days
* More than one active malignancy at the time of enrollment
Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males

This study will evaluate the safety, blood levels, and effects of TRV130A on pain perception and sedation in healthy adult males.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male 19 - 50 years of age
* Body weight \>/= 50 kg
* Capable of giving written informed consent

Exclusion Criteria:

* Clinically significant disease or conditions that may place the subject at unacceptable risk as a participant in the study, or that may interfere with the safety, tolerability or pharmacodynamic evaluations in the study
* Laboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C virus antibody; elevations of aspartate aminotransferase or alanine aminotransferase; positive drug or alcohol test; positive urine test for cotinine
* Major surgery within 4 weeks of screening
Right Ventricular Septal Versus Apical Pacing: Echocardiographic Study

This study aims to compare the effect right ventricular apical versus septal pacing on left ventricular function by deformation imaging using 2D speckle tracking echocardiography.

Permanent cardiac pacing is the most efficient treatment for various conduction disorders, including high-degree atrioventricular block and symptomatic sick sinus syndrome. High-burden right ventricular (RV) pacing is often tolerated for decades without overt left ventricular (LV) failure in most patients. It has been shown, however, that prolonged RV pacing reduces LV function and ultimately causes heart failure. Left ventricular ejection fraction (LVEF) may decrease in specific individuals with pacemaker implants following pacing, which is called Pacing-induced cardiomyopathy (PICM). However, pacing-induced LV dysfunction (PIVD) at milder severity levels has also been documented.RV apical pacing, the classic site for pacemaker lead implantation, results in ventricular dys-synchrony and deterioration of left ventricular (LV) function and ejection fraction, like left bundle branch block. Recently, alternative sites are arising, such as right ventricular outflow tract (RVOT) and the septum. Studies show that deformation imaging by speckle tracking echocardiography following pacemaker implantation can predict the patients at higher risk for PCIM and PIVD at long-term follow-up. Deformation imaging, or strain imaging, provides unique Information on regional and global ventricular function. Global longitudinal strain is Known to be more precise than ejection Fraction. It is now used in patients with heart failure, ischemic heart disease, and Receiving chemotherapy to detect early Changes in cardiac function before changes in ejection fraction. Speckle tracking Echocardiography for strain measurement Depends on tracking of speckles throughout the Cardiac cycle in apical 4,3, and 2 chamber Views. The software allows the elaboration of myocardial deformation in 3 spatial directions: Longitudinal, radial, and circumferential. Predicting PICM and PIVD 6 months after pacemaker implantation is possible by measuring global longitudinal strain (GLS) baseline one and six months after implantation.

Eligibility Criteria:
Inclusion Criteria:

1. Any patients older than 18 years with conduction disturbances necessitating pacemaker implantation and
2. who had preserved LVEF (≥50%) were presented to Assuit University Heart Center.

Exclusion Criteria:

1. Patients with impaired systolic function (LVEF \<50%).
2. Ischemic heart disease.
3. Significant valvular heart disease (moderate to severe).
4. Pregnancy.
5. Poor echogenic window.
6. Patient refusal.
Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis

To provide TEZ/IVA combination therapy to CF patients who are 12 years of age and older who completed Vertex TEZ/IVA combination therapy clinical studies (NCT02565914 or NCT03150719). To provide TEZ/IVA combination therapy to CF patients in critical need who are 12 years of age and older, homozygous for F508del.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 12 years of age and older with confirmed diagnosis of CF.

  1. - completed Vertex clinical studies NCT02565914 or NCT03150719, or
  2. - are homozygous for F508del and have (1) discontinued Orkambi within 12 weeks from start of treatment because of the onset of respiratory AEs considered to be treatment related or (2) cannot initiate Orkambi because of chronic treatment with an essential sensitive CYP3A substrate or a CYP3A substrate with a narrow therapeutic index AND who meet at least 1 of the following criteria:

     * the highest percent predicted forced expiratory volume in 1 second (ppFEV1) is \<40 in the 6 months before the date of completion of the request form, or
     * documentation of being active on a lung transplant waiting list or documentation of being evaluated for lung transplantation, but deemed unsuitable because of contraindications, or
     * rapid and persistent loss of lung function, defined as at least a 20% relative decrease in ppFEV1 in the last 6 months and sustained for at least 1 month despite appropriate treatment.

Exclusion Criteria:

* History of any comorbidity that, in the opinion of the treating physician, might pose undue risk in administering TEZ/IVA combination therapy to the patient (e.g., history of advanced liver disease).
* Ongoing or prior participation in an investigational drug study (with the exception of Vertex clinical studies evaluating TEZ/IVA) within 5 terminal half-lives of the previous investigational study drug or 30 days, whichever is longer, of first administration of TEZ/IVA.
* Subjects who are pregnant.
* Patients eligible for participation in ongoing clinical studies evaluating TEZ/IVA or other CFTR modulator therapies.

Other protocol defined Inclusion/Exclusion criteria may apply.
Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women

The purpose of this study is to find out if the two different formulations of exemestane (Aromasin), oral and injectable, are equivalent in terms of pharmacodynamics and pharmacokinetics, i.e., if ultimately both formulations have the same efficacy in postmenopausal women with metastatic breast cancer who have failed previous antiestrogens therapy and are equally safe.


Eligibility Criteria:
Inclusion Criteria:

* other diagnosed with breast cancer
* estrogen receptor positivity
* Postmenopausal status
* advanced disease
* progression to previous tamoxifen therapy

Exclusion Criteria:

* more than 1 chemotherapy and / or more than 1 hormonotherapy for advanced disease
* previous hormonotherapy other than Tamoxifen
Acceptability, Tolerance, Satiety and Prebiotic Effect of a New Infant Cereal

This study evaluates a new infant cereals on acceptability, tolerance, satiety and prebiotic effect in infants.

This is a controlled, randomized, prospective, crossover, triple-blind study to evaluate of a new infant cereal with a portion of whole grain flour on sensorial acceptability, gastrointestinal tolerance, satiety and prebiotic effect in healthy infants fron 5 to 8 months of age at the beginning of complementary feeding.

Eligibility Criteria:
Inclusion Criteria:

* Healthy term infant
* Birth weight 2500-4200 g
* Tolerance to cow's milk
* Tolerance to lactose
* No Breastfeeding at least 4 months of age
* No use antibiotic at least 2 weeks before recruitments

Exclusion Criteria:

* Intolerance to gluten (celiac disease)
* Congenital abnormalities
* Acute diseases
* Chronic situation that affect to food intake or metabolism
* Breastfeeding infant
* Any food allergy
* Participation in other study
Lumbar Assistive Exoskeletons in Caregiving

A randomized control trial will be conducted, for evaluating the effectiveness of the implementation of a lower back assistive exoskeleton on the caregivers working in nursing homes.


Eligibility Criteria:
Inclusion Criteria:

* nursing home caregivers

Exclusion Criteria:

* pregnancy
* presence of condition that prevents from the use of a lumbar exoskeleton