cyrilzakka/clinical-trials huggingface dataset:
A Study of AK119 (Anti-CD73 Antibody), a Treatment for COVID-19, in Healthy Subjects

This is a first-in-human (FIH), Phase 1, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, PK and immunogenicity of AK119, a humanized monoclonal antibody targeting the CD73. The study will consist of 4 cohorts of healthy subjects. Eight subjects will be enrolled per cohort, randomized in a 3:1 ratio to receive a single dose of either the active drug AK119 (N=6) or matching placebo (N=2). Approximately 32 subjects (24 receiving active drug and 8 receiving placebo) will participate in this study.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet ALL the following inclusion criteria (as applicable) to be eligible for participation in this study:

* Adults between 18 and 55 years of age, inclusive, at screening.
* Must have a calculated body mass index (BMI, weight \[kg\]/height \[m2\]) within 18.0 to 30.0 kg/m2 (inclusive) at screening, and a total body weight ≥50 kg for men or ≥45 kg for women at screening and Day -1 before randomization.
* Must, in the opinion of the Investigator, be in good general health based upon medical history, physical examination (including vital signs), and 12-lead ECG; and clinical laboratory tests (up to 1 repeat permitted) must fall within the clinical laboratory"s reference normal ranges.

Exclusion Criteria:

Subjects who meet ANY of the following exclusion criteria will not be enrolled in this study

* Have a history of latent or active granulomatous infection, including histoplasmosis, candidiasis, or coccidioidomycosis prior to screening, or a history of any other infectious disease within 4 weeks prior to screening that, in the opinion of the Investigator, affects the subject"s ability to participate in the study.
* Have a history of multiple drug allergies or a known allergy or hypersensitivity to any biologic therapy at screening that is important in the opinion of the Investigator.
* Have a known allergy or reaction to any component of the AK119 formulation.
* Have any known malignancy or have a history of malignancy within the previous 5 years.
* Have a 12-lead ECG demonstrating QTcF interval \> 450 msec for male subjects and \>470 msec for female subjects at screening and Day -1 from average of 3 ECGs obtained after 5 minutes of supine rest.
* Blood pressure (BP) \>150 mmHg (systolic) or \> 95 mmHg (diastolic) at screening and Day -1, following at least 5 minutes of supine rest.
* Have had a live vaccination within 12 weeks prior to the study dosing or intend to have a live vaccination during the course of the study or have participated in a vaccine clinical study within 12 weeks prior to the study dosing.
Web Based Orthopaedic Sports Medicine Registry

The purpose of this study is to establish an international, web based clinical registry to collect baseline characteristics of patients undergoing orthopaedic, sports medicine, arthroscopy, and related surgery, and the subsequent outcomes and cost-effectiveness associated with the surgical procedures and nonoperative treatments.


Eligibility Criteria:
Inclusion Criteria:

* All patients electing to schedule routine and medically indicated orthopedic, sports medicine, arthroscopy and related surgery or nonoperative treatment

Exclusion Criteria:

* Non English or Spanish speaking
* vulnerable populations, excluding minors
Participation in Procurement of Tissue, Serum, Plasma, Cell Bank, DNA and RNA Samples, and Urine for Biological Studies Related to Prostate Cancer and Prostate Cancer Treatment Follow Up

This research study is being done to collect regular and routine follow-up information related to the outcome of treatment for prostate cancer.

This study is also being done to relate treatment outcome to measurement of substances in the blood such as prostate-specific antigen (PSA) and other markers. Also environmental and genetic factors that might be responsible for prostate cancer are being investigated.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent explained and signed prior to any study related procedures.
2. Age ≥18 years
3. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better, or Karnofsky performance of 60% or better.
4. Histologically confirmed adenocarcinoma of the prostate within 10 years of study entry.
5. Willingness to return to Mayo Clinic Rochester for follow-up or participate in mail-in PSA processing.
6. Must be disease-free from a previous diagnosis of cancer for a period of time = 5 years excluding cutaneous malignancies of squamous cell or basal cell carcinoma.

Exclusion Criteria:

1. Life expectancy \< 5 years.
2. Inability to return to Mayo Rochester for follow-up appointments, sera, and urine collection per protocol.
3. Previous or a concurrent diagnosis of cancers other than basal cell or invasive squamous cell carcinoma of skin within the past 5 years.
Diagnosis of Cardiac Amyloidosis With 99mTc-PYP; Comparison Between Planar Imaging, SPECT/CT and Cardiac-dedicated CZT Camera

1. Patients will undergo clinical and laboratory assessment, as well as imaging tests, at the discretion of the attending cardiologist and will be referred at their discretion to perform cardiac mapping using 99mTc-PYP.
2. On the day of the examination, the examiner will be admitted to the Office of Nuclear Medicine and will be admitted to administrative. Before conducting the test, the subject will undergo a brief interview by a physician, receive an explanation of the study and, if agreed, sign an agreement to perform a further examination on the CZT camera.
3. The patient will, as is customary, be installed on Vanflon 22 G periphery, through which a 15 millikiric (mCi) of


Eligibility Criteria:
Inclusion Criteria:

A. Patients undergoing "cardiac amyloidosis clinic" at Tel Aviv Medical Center and there is a clinical suspicion of having cardiac amyloidosis.

B. Patients who performed will be referred for mapping using 99mTc-PYP and sign a consent form to take another photograph, under the cardiac-dedicated CZT camera

Exclusion Criteria:

1.None
Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome

This is a prospective randomized, double-blind placebo-controlled trial of 6 months' duration evaluating the effect of fenofibrate (200 mg/day) in females with polycystic ovary syndrome and mild hypertriglyceridemia. The investigators primary objective will be to determine whether fenofibrate will reduce hepatic adiposity as measured using MRI, and our secondary outcomes will be to delineate the impact of fenofibrate on biochemical or clinical parameters for insulin resistance, cardiovascular disease, and reproductive status.


Eligibility Criteria:
Inclusion Criteria:

* premenopausal women ≥ 18 years
* diagnosis of PCOS based on the recent 2006 Androgen Excess Society criteria (modified from Rotterdam 2003)
* waist circumference \>88 cm
* fasting TG 2.0 - 5.0 mmol/L
* stable on any type of oral contraceptive for a minimum of 3-months

Exclusion Criteria:

* known contraindications for MRI
* pregnancy, lactation, desire to become pregnant
* participation in another clinical trial
* fasting TF level ≥ 5.0 mmol/L
* AST or ALT \> 2.5 times upper limit of normal (ULN)
* creatinine kinase (CK) \> 6x ULN
* creatinine \> 115 μmol/L
* fasting glucose ≥ 7.0 mmol/L and/or 2h glucose post oral glucose tolerance test (OGTT) ≥ 11.1 mmol/L or personal history of DM2
* personal history of renal disease, liver disease (except NAFLD), or heart disease
* body mass index (BMI) \< 18 or \> 40 kg/m²
* increased alcohol use (\>9 standard drinks per week \[standard drink = 12oz beer, 5oz wine, or 1.5oz spirits\]) or drug use
* use of other hormonal contraception, growth hormone, glucocorticoids, anti-diabetic/anti-dyslipidemia medications, or anabolic steroids.
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1558 in Healthy Adult Volunteers

This study aims to compare the pharmacokinetics and safety following administration of DWJ1558 and co-administration of DWC202310 and DWC202311 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* over 19 year old

Exclusion Criteria:

* Pancreatitis
* Diabetic ketoacidosis
Clinical Outcomes Following Treatment With SYSTANE® BALANCE

The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to attend all study visits;
* Must sign an informed consent form;
* Best-corrected visual acuity (BCVA) of 55 letters or better in each eye as assessed using an early treatment diabetic retinopathy study (ETDRS) chart;
* Willing to take study products as directed for entire study;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential who are pregnant, plan to become pregnant during the study, breast feeding, or not using adequate birth control methods;
* Contact lens use within 30 days prior to Screening Visit, or unwilling to avoid contact lens use during the course of the study;
* Use of medication excluded by the protocol;
* Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
* Ocular surgeries or procedures excluded by the protocol;
* Other protocol-specified exclusion criteria may apply.
En-mass Retraction by KILBON Versus CAT Appliances

en-mass retraction by lingual retractor versus clear alighner therapy

Comparative Effectiveness Of Lingual Retractor Versus Clear Aligner Appliances In Adult Patients With Maxillary Dentoalveolar Protrusion Treated By Upper First Premolars Extraction And Enmass Retraction Of Maxillary Anterior Teeth Segment Using Palatal Orthodontic Miniscrews :A Randomized Clinical Trial

Eligibility Criteria:
Inclusion Criteria:

* adult patients with maxillary dentoalveolar protrusion with mild crowding

Exclusion Criteria:

* - adult patients with maxillary dentoalveolar protrusion with moderate to severe crowding
Do Oral Contraceptives Protect Against ACL Injuries in Female Athletes

The purpose of this research study is to examine the impact of one type of commonly used birth control pill on blood levels of relaxin and measure changes in knee movement to determine whether there are changes in joint instability (indicating the knee is less stable) that may predispose female athletes to injury. Women not on hormonal birth control will also be enrolled to analyze differences between athletes on and not on birth control and to evaluate typical relaxin levels and knee laxity when birth control pills are not used.


Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years of age or older
* Currently playing basketball, soccer, or volleyball at Loyola Marymount or Pepperdine
* If not currently on COC, regular menstrual cycle occurring every 21-35 days

Exclusion Criteria:

* Previous ACL injury
* Underlying neuromuscular disease
* Medical contraindication to COC use
* History of pregnancy
* Desire to conceive in the next year
Evaluation of Different Anesthesia for Uterine Curettage

Anesthesia during uterine curettage is a problem. Paracervical block is used in general for such an operation, though, the anesthetic efficacy is incomplete. Propofol is the short-lasting intravenous anesthetic administrated popularly. Sevoflurane is a new inhalational anesthetic well-known for it's "easy come, easy go" property. The investigators hypothesized that propofol, sevoflurane and paracervical block had different anesthetic efficacy during uterine curettage. Which one is the optimal selection for such operation needed to be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* ASA status I-II
* Performing abortion operation (medical- or surgical)
* Requiring painless abortion

Exclusion Criteria:

* \< 19 yrs, and \>=45 yrs
* History of central active drugs administration
* Drug abuse
* Hypertension
* Diabetes
* Any other chronic diseases
* Allergy to the study drugs
* Habit of over-volume alcohol drinking
* Records of history of centrally active drug use and psychiatry
* Any organic disorder
Pulse Diagnosis and Anemia: Exploring Integrated Traditional Chinese and Western Medicine Approaches

This observational study evaluates the efficacy and safety of integrated Traditional Chinese Medicine (TCM) and Western medicine in managing moderate to severe anemia. The study examines hemoglobin (Hb) level improvements and correlations with TCM pulse diagnosis parameters at six diagnostic positions (Right and Left Chung, Guan, and Chi). Conducted at Taichung Tzu Chi Hospital, it aims to explore TCM's role as a complementary approach to anemia care while maintaining a focus on patient safety and integrated diagnostic techniques.

The study included 28 patients with moderate to severe anemia (Hb \< 10 g/dL) treated between February 26, 2021, and December 31, 2022. Participants were divided into two groups: those receiving TCM-based interventions (herbal formulations tailored to address systemic imbalances) and those following standard Western medicine protocols. Data collection involved monthly monitoring of Hb levels and pulse diagnosis parameters using the Huang-T1 Sphygmograph, which provided detailed insights into frequency-domain and waveform-derived characteristics.

Primary outcomes included Hb level improvements and safety assessments, while secondary outcomes focused on the correlations between pulse parameters and hematological changes. Results indicated consistent Hb improvements in the TCM group, with notable trends observed in pulse diagnosis correlations. These findings highlight TCM's potential as a diagnostic and therapeutic adjunct in anemia care, emphasizing its role in bridging traditional and modern medical practices.

The study adheres to ethical guidelines, with approval from the Taichung Tzu Chi Hospital Research Ethics Committee (Approval Number: REC109-61). All participants provided written informed consent prior to study inclusion. Future directions include larger-scale studies and randomized controlled trials to further validate findings and expand their clinical applicability.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of moderate to severe anemia (Hb \< 10 g/dL).
* Age between 18 and 90 years.
* Willingness to provide informed consent and comply with study procedures.
* Ability to attend monthly follow-up visits and provide clinical data for analysis.

Exclusion Criteria:

* Presence of psychiatric disorders affecting compliance.
* Significant organ diseases, such as chronic obstructive pulmonary disease, advanced liver disease, or heart failure.
* Pregnancy or lactation.
* Concurrent participation in other clinical trials or use of investigational drugs within the past 30 days.
* Non-compliance with follow-up schedules or study protocols.
Suboccipital Inhibition in Tension Headache

The researchers will carry out a randomized experimental study. Participants in the experimental group will receive a treatment based on suboccipital inhibition technique in addition to conventional treatment. Participants in the control group will only receive the conventional treatment. The existence of significant differences in both groups will be analyzed.

Conventional therapy will consist of microwaves, interference currents, and manual therapy.

Eligibility Criteria:
Inclusion Criteria:

* pathology tension headache associated with cervicalgia

Exclusion Criteria:

* pathology of nervous system
To Assess the Efficacy of the Investigational Products Compared to Placebo in Participants With IPF

A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants at least 40 years of age
* IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guidelines
* FVC ≥45% predicted
* DLCO, corrected for hemoglobin, ≥25% predicted (inclusive)
* Unlikely to undergo lung transplantation during this trial in the opinion of the investigator
* If a participant is taking nintedanib or pirfenidone, they must be on a stable regimen for at least 8 weeks prior to randomization

Exclusion Criteria:

* Airway obstruction (i.e. prebronchodilator FEV1/ FVC \< 0.7) or evidence of a bronchodilator response at screening
* Emphysema \>20% on screening HRCT
* Fibrosis \<10% on screening HRCT
* Clinical diagnosis of any connective tissue disease
* Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization

Additional protocol-defined inclusion / exclusion criteria may apply.
Factors Influencing Patient Satisfaction in an Egyptian Sample After Orthodontic Treatment of Different Malocclusions

Previously, patient satisfaction with orthodontic treatment has been reported at a broad range of 34% to 95% but these values mostly represent satisfaction for tooth alignment or simple satisfaction with treatment results. In keeping with the increased focus on patient satisfaction, many other factors were put into consideration in our study which contributes to the level of total satisfaction as host factors, concerns regarding the treatment, treatment motivation and discomfort during or after treatment. There are also a lack of studies conducted for orthodontic treatment satisfaction using previously validated questionnaires as well as correlation between patient's treatment satisfaction and ABO grading hasn't been sufficiently discussed in the literature, this study aims to address that gap. It would be also beneficial to investigate the frequency of different malocclusions presented in a sample of postorthodontic patients as it will give an insight about the distribution of the different malocclusion treated within the clinic and the degree of success in treating such malocclusions.

Research Procedure in brief:

The following will be done for each participant:

Collection of patients telephone numbers:

Through the orthodontic department patient's database ensuring complete confidentiality. Telephoning the patients for follow ups after orthodontic treatment and asking them to fill in a questionnaire during their visit for explaining our aim for the study.

Personal data chart:

Including name, age, date of birth, mobile number and address. Examination of pretreatment records of the patients included in the sample to detect the type of malocclusion presented initially.

Orthodontic treatment satisfaction questionnaire:

The questionnaire is reviewed by faculty experts to determine whether the items in the questionnaire truly represent the items to be measured.

The translated questionnaire's face validation is led by the expert faculty members who are specialists in both English and Arabic guaranteeing clarity, intelligibility and comprehensiveness of items. This is significant in light of the fact that while performing any questionnaire in another setting, not all of the items may be compatible to Egyptian culture and lifestyles. In addition, a portion of items may not be applicable to specific age groups.

ABO Grading System Study models will be selected from the orthodontic department database. The post-treatment models will be assessed using the MGS of the American Board of Orthodontics.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with different malocclusions who received and completed their fixed orthodontic treatment.
* Age: 16 years old or above.
* Patients who have completed their orthodontic treatment between November 2020 and November 2021.

Exclusion Criteria:

* Patients who refuse to participate in the study.
* Patients below 16 years old.
* Illiterate patients.
* Patients who finished their treatment before November 2020 and after November 2021
MIT Intensive Treatment Study

This study is examining the use of intensive melodic intonation therapy and video feedback as a means of aiding individuals with nonfluent aphasia and co-occurring motor speech impairments. Individuals with nonfluent aphasia have difficulty with language, particularly with word retrieval.


Eligibility Criteria:
Inclusion Criteria:

* Fluent English speakers
* Sustained a left-hemisphere stroke
* Presents with language and motor speech impairments

Exclusion Criteria:

* • History of learning disability prior to accident (per patient report)

  * Uncorrected auditory or visual impairments
  * Not meeting the criteria of stroke
  * Failure to provide evidence of stroke diagnosis (medical record history)
  * History of psychiatric disorder
Treatment of Chronic Anemia With Epoetin Alfa in Elderly

The purpose of this study is to determine if chronic anemia can be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue,quality of life or mobility among elderly.

Chronic Anemia is common among elderly. Given their somewhat non-specific nature, the clinical symptoms of anemia are often difficult to attribute directly to the anemia itself. However, it is known that anemic older adults are at an increased risk of mortality, disability, higher risk of falls, poorer quality of life, worsening cognitive function, increase hospitalization risk, and increased healthcare utilization than their non-anemic counterparts.

Yet so far, there have been no treatment studies to demonstrate the benefits of correction of chronic anemia.

Epoetin Alfa (Procrit) is a manufactured form of a naturally occurring hormone that is given as an injection by a medical professional to stimulate the bone marrow's production of red blood cells.

This study is to explore, can chronic anemia be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue, quality of life or mobility among elderly.

Overall this is a 32 week treatment study.

In this study, participants with chronic anemia will receive either Epoetin alfa or placebo (saline injection) under the skin for 16 weeks. After 16 weeks the participants who were receiving epoetin will be switched to placebo and those who were receiving placebo earlier will go on now to receive epoetin alfa for 16 weeks.

At the end of 32 weeks we will compare, if epoetin alfa corrected the anemia, how individuals felt in respect to their fatigue levels, quality of life and did mobility improve during the study.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older Diagnosed with chronic anemia Hemoglobin level less than or equal to 11.5 g/dl Community dwelling Able to make monthly clinic visits

Exclusion Criteria:

* Currently on Epoetin alfa or similar preparations Having nutritional anemia Having active cancer or received recent treatment for cancer On treatment for Kidney disease Diagnosis of dementia Inability to ambulate