cyrilzakka/clinical-trials huggingface dataset:
High Intensity Focused Ultrasound (HIFU) Treatment of Basal Cell Carcinoma

The overall objective of the study is to evaluate the safety and efficacy of treatment of Basal Cell Carcinoma (BCC) using a new modality based on high-intensity focused ultrasound (HIFU). BCC is the most common type of skin cancer in Europe, Australia and the US. It accounts for more than 75% of all skin cancer cases in those regions. There are currently more the 14000 BCC cases registrations in Poland every year, and occurrences on a global scale are counted in several millions per year. Given the trend of aging population those numbers will only increase with time. Finding new and more effective treatment methods are therefore highly relevant from both a clinical and socioeconomic perspective. The investigational device used in the study is a system capable of making controlled and targeted thermo-mechanical treatment of small intradermal volumes containing e.g. BCC cells, but without inflicting damage to the surrounding tissue.

The investigation involves an evaluation of the safety and efficacy profile 3 months after a single few-minute treatment. Subsequent follow-up of secondary endpoints is done every third month until the end of the study one year after the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subjects of each gender aged 18 years or older at the time of informed consent. There is no upper limit of age.
* Subjects who have received oral and written study information, accepted participation and signed the informed consent document.
* Subjects who are willing and mentally and physically capable to understand and follow the treatment and follow-up schedule including post-treatment care instructions.
* Subjects who are willing to have photographs and images taken of the treated lesions to be used anonymously or coded in evaluations and publications.
* Subjects, who have histologically and clinically verified basal cell carcinoma cancer of thickness not more 2.0 mm measured by ultrasound imaging or histopathological examination.

Exclusion Criteria:

* Subjects who are less than 18 years at the time of informed consent.
* Subject is pregnant or lactating at time of first treatment
* Subjects with extensive, invasive or advanced skin cancer when another method in use such as radiotherapy or Mohs' surgery has priority and offers the patient better opportunity of cure.
* Cancers on anatomical sites where the ultrasound probe cannot be adapted for anatomical reasons
* Any systemic disease that according to investigator's assessment may interfere with the spontaneous course of a skin cancer.
* Any condition predisposing to treatment-related adverse effects or complications from the ultrasound treatment.
* Subjects with abnormal scar formation
* Subjects with impaired wound healing
* Subjects with any other acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study
* Subjects undergoing immunosuppressive treatment
Multiple Ascending Dose Study of GLPG0974 in Healthy Subjects

The purpose of this study is to evaluate the safety and tolerability after multiple ascending oral doses of GLPG0974 given to healthy male subjects for 14 days, compared to placebo.

Furthermore, during the course of the study, the amount of GLPG0974 present in the blood and urine (pharmacokinetics) as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood and stool samples (pharmacodynamics) will be characterized compared to placebo.

Also, the effect of the compound on glucose tolerance will be explored as well as the potential of cytochrome P450 (CYP)3A4 induction by repeated dosing with GLPG0974.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking
Effects of Daytime Eszopiclone Administration in Shift Workers

The purpose of this study is to test the effects of eszopiclone on daytime sleep and overnight wakefulness in shift workers.

The current study seeks to extend the currently available treatments for SWSD by addressing the putative root cause of the problem-the inability of night-shift workers with or without SWSD- to obtain adequate daytime sleep in the face of the circadian drive for alertness that increases across the biological day. Even healthy, young subjects who are sleep-deprived overnight exhibit daytime sleep marked by frequent awakenings and low sleep efficiency, less slow-wave sleep, and altered sleep architecture, e.g. earlier predominance of REM sleep. Many night-workers routinely report 3-6 hours of habitual sleep duration for daytime sleep. Pharmacological interventions to decrease awakenings and improve total sleep time during daytime sleep could improve subsequent alertness during a night shift. Improving the wakefulness of night-shift workers over the nighttime could result in substantial benefits for the individual workers, improve workplace productivity and safety, and improve public health.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-50 (men or women)
* Current shift worker (for at least 3 months, at least 5 overnights/month and 3 consecutive)
* A willingness and ability to comply with study procedures
* If of child-bearing potential, using a medically-accepted method of birth control, including abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, implanted, or injected) in conjunction with a barrier method, or intrauterine device \[IUD\]).

Exclusion Criteria:

* Current diagnosis of DSM-IV Axis I disorder (other than insomnia)
* Regular treatment (\>1time/wk) with CNS-active medication within 1 month of first inpatient visit
* Uncontrolled medical illness that would interfere with participation in the study
* BMI\>32 or \< 19.8 kg/m2
* Current symptoms or diagnosis of any moderate to severe sleep disorder other than SWSD
* Periodic Leg Movement of Sleep Index (PLMSi)\>20/hr of sleep or Respiratory Desaturation Index (RDI)\>15 on polysomnography (PSG)
* Current alcohol or drug dependence/abuse
* Menopausal or peri-menopausal symptoms that disrupt sleep
* Pregnant, lactating, or planning to become pregnant
* Current smoking of more than 10 cigarettes per day
* Current use of over the counter sleep aids such as Benadryl or melatonin
A Phase II Study of Stereotactic Body Radiation Therapy in Patients With T1N0M0 Non-small Cell Lung Cancer (JCOG0403)

To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer

To evaluate the efficacy and safety of SBRT for T1N0M0 non-small cell lung cancer，the following questions should be answered. Can SRT be an alternative standard treatment modality for inoperable patients? Can SRT can be a comparable standard treatment modality with lobectomy for operable patients? 12 Gy is the daily dose at the isocenter，and 48 Gy in total by 4 fractions will be irradiated by stereotactic irradiation over 4 to 8 days.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or transbronchoscopic cytologically confirmed non-small cell lung cancer
2. Stage IA with images within 28 days
3. No other intrathoracic lesions
4. Dose constraints of the organs at risk seem to be limited within range
5. Operable (Standard or Limited surgery) or Inoperable
6. Age\>=20
7. No previous thoracic radiation
8. No previous chemotherapy
9. ECOG PS=0-2
10. Respiratory function (\<=14 days) PaO2\>=60 torr FEV1.0\>=700 ml
11. Written informed consent

Exclusion Criteria:

1. No apparent radiation pneumonitis and fibrosis
2. No active tuberculosis without oral drugs
3. No double cancer
4. No pregnancy
5. No psychiatric disorder
6. No steroid administration
A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS

A Phase I Pharmacologic Study of CYC140, a polo-like kinase 1 inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes

This is a First in Human, open-label, single arm, dose escalation study in patients with advanced leukemias or myelodysplastic syndromes. Patients will receive CYC140 as a 1 hr infusion once a week for 2 weeks followed by 1 week of rest on an outpatient basis. One treatment cycle is 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsed or refractory advanced leukemias or MDS
* ECOG 0-2
* Adequate renal function
* Adequate liver function
* ≥ 2 weeks from prior chemotherapy, radiation therapy or major surgery
* ≥ 4 weeks from other investigational anticancer therapy
* Agree to practice effective contraception

Exclusion Criteria:

* Known CNS involvement by leukemia
* Currently receiving radiotherapy, biological therapy, or any other investigational agents
* Uncontrolled intercurrent illness
* Pregnant or lactating
* Known to be HIV-positive
* Known active hepatitis B and/ or hepatitis C infection
The Safety and Effectiveness of Ribavirin in the Early Stages of HIV-Infection

The objective of this clinical trial is to determine whether long-term oral dosage of ribavirin delays development of symptomatic HIV disease in HIV antibody positive subjects who are completely asymptomatic (CDC classification group II), who have only the lymphadenopathy syndrome (CDC classification group III), or who have clinical symptoms but not severe HIV disease as defined by CDC classification, and whether the dosage regimen is safe and tolerable in these subjects.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Acyclovir.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* CDC classification group IV A (ARC).
* CDC classification group IV C-1 (AIDS) and IV C-2 (including Thrush or Herpes zoster during the past 2 years). Positive plasma p24 antigen.
* Unstable medical condition, including serious cardiovascular, renal, hepatic, neurologic, infectious, or oncologic condition even if unrelated to HIV infection.
* Splenectomy.

Concurrent Medication:

Excluded:

* Isoprinosine.

Patients with the following are excluded:

* Failure to give informed consent.
* CDC classification group IV A (ARC).
* CDC classification group IV C-1 (AIDS) and IV C-2 (including Thrush or Herpes zoster during the past 2 years).

Positive plasma p24 antigen.

* Unstable medical condition, including serious cardiovascular, renal, hepatic, neurologic, infectious, or oncologic condition even if unrelated to HIV infection.
* Splenectomy.

Prior Medication:

Excluded within 4 weeks of start of screening tests:

* Zidovudine.
* Other drug with scientifically accepted anti-HIV properties.
* Scientifically accepted immunostimulant treatment.
* Immunosuppressant.
* Myelosuppressant or other known toxic drugs.

HIV infection group II (CDC), asymptomatic HIV infection.

* HIV antibody positive by Western blot with antibodies to p24 band and GP160 band and/or GP41. Two positive tests during screening will be required. CDC HIV infection group II, asymptomatic HIV infection, as defined in Appendix A, or CDC HIV infection group III, persistent generalized lymphadenopathy (PGL, formerly LAS).
* OKT4+ lymphocyte count greater than 300 cells/mm3 and less than 600 cells/mm3. The counts will be determined on three separate evaluations separated by at least 7 days between evaluations. These three counts will be averaged and for inclusion in the study the mean of the OKT4+ lymphocyte count must be greater than 200 cells/mm3 and less than 600 cells/mm3. Conclusion of screening tests:
* Within 42 days of starting them. Patients must be entered into the study within 14 days of screening completion. Ability to participate as outpatient:
* Ambulatory, competent to sign informed consent, and able to cooperate with the treatment plan and evaluation schedule. Informed consent:
* Must be signed before randomization to treatment. Physical activity evaluation with Karnofsky score greater than or equal to 90.
Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty (TKA)

The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of the tibial tubercle. 2) Understand if patients with a combined axial rotation couple at the tibiofemoral joint and quantitative intercompartmental balance, achieved with the use of VERASENSE, exhibit less post-operative knee pain and improved clinical outcomes. Radiographic outcomes will also be assessed to measure post-operative alignment and to evaluate the prevalence and location of radiolucency and/or osteolysis.

Hypothesis: TKA with VERASENSE results in a more reliable and precise option for establishing implant-to-implant congruency and joint balance leading to less knee pain, faster return to normal activities and higher patient satisfaction compared to TKA without VERASENSE.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet the indications for use for Triathlon® Total Knee System using VERASENSE™
* Subject must be diagnosed with one or more of the following conditions
* osteoarthritis
* rheumatoid or other inflammatory arthritis
* post-traumatic arthritis
* Subject is likely to be available for all study visits
* Subject is able and willing to sign the informed consent and follow study procedures

Exclusion Criteria:

* Prior Total Knee Arthroplasty
* Avascular Necrosis
* Any knee surgery other than meniscectomy (can be arthroscopic or open)
* Ligament insufficiencies, prior surgeries such as anterior cruciate ligament (ACL) or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
* Ipsilateral foot/ankle and hip arthritis
* Range of motion less than 90°, flexion contracture greater than 20°
* Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Any subjects meeting any contraindication criteria as identified in the locally approved labeling for the device should be excluded from this study.
A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes

The purpose of this clinical research study is to determine whether dapagliflozin can improve (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal impairment.This study will be conducted at approximately 100 centres from countries across North America and European regions. It is planned to randomize a total of 302 patients.


Eligibility Criteria:
Inclusion Criteria:

* Female or male aged ≥18 years and \<75 years.
* History of T2DM for more than 12 months.
* Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11%
* Stable anti-diabetic treatment regimen
* Renal impairment: CKD 3A

Exclusion Criteria:

* Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period.
* History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
* Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or Diastolic Blood Pressure (DBP) ≥110 mmHg
* Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to signing the consent at visit 1:

Myocardial infarction, Cardiac surgery or revascularization(CABG/PTCA), Unstable angina, Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously undiagnosed arrhythmia.

* History of any biopsy or imaging verifying intercurrent kidney disease (such as glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy or diabetic nephropathy with nephrosclerosis.
* Significant hepatic disease, including, but not limited to, chronic active hepatitis and/or severe hepatic insufficiency.
* Ongoing treatment with any SGLT2-inhibitor, GLP-1 analogue, or rapid/short acting insulins at screening.
* Participation in another clinical study with an Investigational Product (IP) during the last 30 days prior to signing the consent at visit 1.
A Comparative Study of the Performance of a New Type Non-contact Patient Monitor

To verify the accuracy and reliability of the ultra wideband (UWB) non-contact breath rate and heart rate monitor, ICU bedside monitor is used as the gold standard.

In this study, 50 volunteer patients are tested on the UWB non-contact breath rate and heart rate monitor. The testing time length for each patient is set to two hours. Subject is not to be restrained and nurse is allowed to take care the subject while testing. The breath rate and heart rate data will be analyzed for their accuracy against the MP60 (Philips) bedside monitor.

Eligibility Criteria:
Inclusion Criteria:

* conscious adult,
* \> 18 years old

Exclusion Criteria:

* non-conscious,
* pregnant women,
* epilepsy patients,
* patients with heart pacemaker or ACIDS,
* patients on respirator
Hearing Problems in Children of Rheumatic Diseased Mothers

Evaluation of the hearing functions of children born to rheumatic diseased mothers who received gestational antimalarial drugs versus those didn't receive gestational antimalarials drugs compared with normal healthy children.

Rheumatic diseases are autoimmune illnesses characterized by tissue damage, caused by abnormal immunologic reaction against own cells, tissues or organs.Many of these rheumatic diseases preferentially occur in women during the childbearing age.

The transplacental passage of maternal antibody may result in a variety of adverse fetal effects including thrombocytopenia, neutropenia, hemolysis and thyroid disease. Both fetal hypo and hyper thyroidism may occur and maternal hypothyroidism particularly during the 1st trimester is associated with impaired fetal neurological development and delayed mental and motor development.

Hydroxychloroquine (CQ), the hydroxyl derivative of chloroquine, is an antimalarial agent which is widely used, either alone or in combination with other agents, in the treatment of SLE, rheumatoid arthritis (RA) and various other autoimmune diseases.

Hydroxychloroquine is safe during pregnancy, as it is not associated with an increased rate of congenital malformations. However, isolated cases of ocular (retinal pigment deposits) and auditory abnormalities were reported.

An increase in high-frequency hearing threshold is the earliest change in the auditory function for most drug induced hearing losses, including the irreversible damage caused by antimalarials.

The investigators therefore will use audiological methods for detection of hearing impairment in children delivered for mothers receiving antimalarials during pregnancy with rheumatic diseases.

Eligibility Criteria:
Inclusion Criteria:

* children males \& females
* Age 4 to 16 years.
* whose mothers have rheumatic diseases during pregnancy with gestational intake of antimalarial drugs as a treatment.

Exclusion Criteria:

* Prematurity, history of prenatal, natal or post natal medical problems.
* Family history +ve.
* Consanguinity +ve.
* Gestational intake of other ototoxic drugs.
* Use of antimalarial due to diseases other than rheumatic diseases.
* Administration of antimalarial before pregnancy.
* Children who have middle ear disorders.
Autonomic Dysfunction in Patients with Migraine: Cardiovascular and Neurophysiology Assessment

Autonomic dysfunction in patients with migraine: cardiovascular and neurophysiology assessment.

assessment if Autonomic dysfunction in patients with migraine by using cardiovascular assessment by HOTLER MONITORING and table tilt test and neurophysiology assessment by sympathetic skin response

Eligibility Criteria:
Inclusion Criteria:

* 1.fulfilling ICHD-3 criteria for migraine 2. migraine for at least 3 months.

Exclusion Criteria:

brain imaging showing structural brain lesions. .medications that could impact autonomic function such as tricyclic antidepressants, anticholinergics, or opioids.

* Patients with concomitant medical illness causing autonomic dysfunction such as: diabetes, cardiovascular, demyelinating or degenerative neurological disorders.
* Contraindications for performing the tilt test
* Pregnant patients.
The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-ONFH)

The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating osteonecrosis of femoral head patients.

This is a randomized,double-blind, paralleled study. Patients will be divided into two groups of experiment and control. All of them will receive core decompression of the femoral head, while experimental group patient will transplant hUC-MSC in addition. Follow-up visit will occur on 1 month, 3 months, and 6 months after operation, and Harris Hip score was applied to evaluate the symptoms change.

Eligibility Criteria:
Inclusion Criteria:

* Ficat classification is I, IIa, or IIb period
* no obvious improvement or ingravescence by conservative treatment
* patients or their statutory receive human umbilical cord mesenchymal stem cell of their own will, and signed informed consent form

Exclusion Criteria:

* Ficat classification is third or fourth period
* acute, chronic infection patients
* combined with heart, lung, kidney disease, and cannot tolerate operation
* ankylosing spondylitis patient
* acetabular dysplasia patient
* with tumor
* clinical data deficient
* HIV positive
* pregnancy or breast feeding women
* under other therapy that possibly influence MSC security or efficacy