cyrilzakka/clinical-trials huggingface dataset:
Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism

Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector

This study will evaluate, if testosterone enanthate administered subcutaneously once each week by an auto-injector to men with low testosterone, can raise their levels into the normal range.

The study will investigate the ability to adjust testosterone enanthate dose levels using single point blood concentrations.

Safety and tolerability of testosterone administration will be evaluated along with the patient's ability to use the auto-injector and follow the instructions for auto-injector use.

Eligibility Criteria:
Inclusion Criteria:

* Adult males aged ≥ 18 year of age with a documented diagnosis of hypogonadism
* Total testosterone levels \< 300 ng/dL at two qualification visits
* Patients in good general health

Exclusion Criteria:

* Allergy to sesame or testosterone products
* BMI ≥ 40 kg/m2
* Hematocrit ≥ 52%
* History or current evidence of breast or prostate cancer
* Elevated PSA (Prostate-Specific Antigen) for age.
* Abnormal DRE (digital rectal examination)
* Obstructive uropathy of prostatic origin
* Poorly controlled diabetes
* Congestive heart failure
* Within 6 months of screening, MI (myocardial ischemia), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, ceratoid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease.
* History or current treatment of thromboembolic disease.
* Use of ACTH (adrenocorticotropic hormone) or oral/depot corticosteroids within 6 weeks of screening.
* History of severe, untreated sleep apnea
* Subjects with any clinically significant medical condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study
* Positive serology for HIV, hepatitis B or hepatitis C
* Current evidence of drug or alcohol abuse.
* Skin conditions in injection site that could confound injection site assessments.
* Administration of other investigational compounds within one month of screening or 5 half-lives of the investigational compound, whichever is longer).
* Use of estrogen, GnRH (gonadotropin-releasing hormone) or growth hormone within 12 months of screening.
* Use of other androgens (DHEA(Dehydroepiandrosterone), anabolic steroids, other sex hormones) or other substances/supplements know to affect the PK (pharmacokinetics) of testosterone enanthate
* Considered or scheduled surgical or dental procedures associated with blood loss ≥500 mL during study.
* Donation of plasma or blood within 56 days of screening or history of donation of \> 50 mL of blood or plasma within 3 months of screening.
* Donation of plasma or blood during study
REKOVELLE PEN for S.C. Injection General Drug Use Survey (Controlled Ovarian Stimulation in Assisted Reproductive Technologies)

This survey targets controlled ovarian stimulation with this drug for the development of multiple oocytes in women undergoing assisted reproduction (ART) such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).


Eligibility Criteria:
Inclusion Criteria:

* Participants who received the REKOVELLE in controlled ovarian stimulation in assisted reproductive technologies and have consented to participate in the survey.

Exclusion Criteria:

* No exclusion criteria because data are collected under conditions of use in daily practice.
The Reliability and Validity of the Turkish Version of the Occupational Sitting and Physical Activity Questionnaire

The aim of our study is to investigate the validity and reliability of the Occupational Sitting And Physical Activity Questionnaire (OSPAQ) scale in Turkish by making a cultural adaptation in office workers, which was developed to evaluate work-related sitting, standing, walking and doing heavy work. 100 office workers will be included in the study. Physical activity level of office workers will be evaluated with Turkish OSPAQ and International Physical Activity Questionnaire.

It is reported that those who do desk work in working life act less as a result of their professional requirements. Considering the benefits of physical activity, it is recommended that the risks of desk workers, especially those in the risk group who produce work by consuming less energy, should be reduced and encouraged to participate in physical activity at a level and manner suitable for a healthier life. For this reason, it is important to determine the level of physical activity according to different variables in individuals working at desk jobs.The aim of our study is to evaluate the validity and reliability of the "Occupational Sitting And Physical Activity Questionnaire (OSPAQ)" scale in Turkish, which was developed to evaluate the situation of sitting, standing, walking and doing heavy work. All forms will be sent through the media. 100 office workers will be included in the study. Physical activity level of office workers will be evaluated by Turkish OSPAQ and International Physical Activity Questionnaire. For the reliability study, after 7 days, the physical activity of office workers will be re-evaluated with Turkish OSPAQ. Factor analysis methods will be used to examine the factor structure of the scale, correlation analysis (Pearson and Spearman coefficients) in validity analysis and test-retest reliability. Cronbach alpha analysis will be used in the reliability analysis.

Eligibility Criteria:
Inclusion Criteria:

* Being in the age range of 20-45 Being resident in Turkey Working at a desk job for at least one year Using a computer for at least 4-5 hours a day at work Volunteering to participate in the study

Exclusion Criteria:

* Exercising regularly for the last 2 months Having a cardiac, neurological or rheumatic chronic disease Being pregnant
Sun Protection Factor Assay (343/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
The RELIEF™ Ureteral Stent Randomized Controlled Trial

Assessment of the backwards flow of urine from the bladder into the ureter (retrograde urine reflux) after placement of the RELIEF® Ureteral Stent using imaging of the bladder after filling it with contrast and assigning a urinary reflux grade. Randomized controlled trial for evaluation of the stent placement and the adequacy of short term drainage (defined as the presence of the stent in the ureter and the lack of surgical or standard of care double J stent to treat symptoms associated with the stent itself on the stented side during the first 48 hours).


Eligibility Criteria:
Inclusion Criteria:

* Has capacity to consent
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Persons, 18 years of age or older
* Male or female subjects with confirmed ureteral and/or renal stones or strictures documented via abdomen X-ray KUB (kidney ureter bladder) or CT (computed tomography)

Exclusion Criteria:

* Distal ureteral obstruction where suture portion of stent may be placed
* Urinary reflux (assessed by pre-stent cystogram)
* Pregnancy or lactation
* Patients requiring bilateral surgical stone management procedure
* Infected stones
* Patients where 24cm or 26cm stent lengths are not suitable
* Ureteral structure in distal third of ureter
* Intraoperative exclusion: based on urologist's discretion, if trauma has been induced to the distal ureter due to ureteroscopy maneuvers, exclude these patients
Palliative Radiochemotherapy Against Palliative Surgery in Stage IV Rectal Cancer With Unresectable Metastases

Short course palliative radiotherapy (5x5Gy)to the pelvis in patients with symptomatic rectal tumours and with unresectable metastases may prevent palliative surgery with a good palliative outcome.The consolidating chemotherapy of XELOX may increase the efficacy of irradiation.

Patients with symptomatic rectal cancer and unresectable metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy after one week. Investigators arbitrarily assumed that palliative radiotherapy to the pelvis can replace the immediate surgery if at least 30% of patients would avoid delayed surgery until the end of their lives, or for at least 18 months in the case of long-term survival.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary carcinoma of the rectum (Lower border of tumour ≤ 10 cm from anal verge)
* Occurrence of subjective clinical symptoms of the primary tumor
* Non-resectable synchronous distant metastases. The decision of non-resectable metastases will be made at multidisciplinary clinical meetings.

Exclusion Criteria:

* Obstruction of the gastrointestinal tract
* Previously constructed stoma
* prior radiotherapy of the pelvis
Hemodynamic Changes During Normal Pregnancy

Prospective, observational study of the changes in hemodynamic variables such as blood pressure, cardiac output, systemic vascular resistance, and of changes in respiratory variables such as vital capacity, and functional residual volume.A cohort study of 100 healthy pregnant women tested with non-invasive methods during pregnancy and 6 months after delivery.

Healthy pregnant women with the willingness to consent in physiologic tests at 3 different time points during, and one time point after pregnancy. Spirometric tests will be performed with V-MAX, non-invasive measuring of hemodynamics will be measured by Finometer.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who at first admission are healthy

Exclusion Criteria:

* Co-existing diseases who represents decreased physical or psychological function
Fear Among Dentists During COVID-19 Pandemic

This study aimed to evaluate the anxiety and fear of infection between dentists working during the present corona virus disease 2019 (COVID-19) pandemic and to explore dentist's knowledge about various practice modifications and guidelines to fight the novel corona virus

The spread of corona virus (COVID-19) has posed significant challenges for dentistry and medicine, and dental and medical schools, in all affected countries.

The speed of reaction and type of response to this disease around the world have been very variable according to differing healthcare systems, economies and political ideologies

Eligibility Criteria:
Inclusion Criteria:

* Dentist having bachelor of dentistry or equivalent degree

Exclusion Criteria:

* paramedical staff and dental students
Real-time Artificial Intelligence System for Detecting Multiple Ocular Fundus Lesions by Ultra-widefield Fundus Imaging

This prospective multicenter study will evaluate the efficacy of a real-time artificial intelligence system for detecting multiple ocular fundus lesions by ultra-widefield fundus imaging in real-world settings.

The ocular fundus can show signs of both ocular diseases (e.g., lattice degeneration, retinal detachment and glaucoma) and systemic diseases (e.g., hypertension, diabetes and leukemia). The routine fundus examination is conducive for early detection of these diseases. However, manual conducting fundus examination needs an experienced retina ophthalmologist, and is time-consuming and labor-intensive, which is difficult for its routine implementation on large scale.

This study will develop an artificial intelligence system integrating with ultra-widefield fundus imaging to automatically screen for multiple ocular fundus lesions in real time and evaluate its performance in different real-world settings. The efficacy of the system will compare to the final diagnoses of each participant made by experienced ophthalmologists.

Eligibility Criteria:
Inclusion Criteria:

All the participants who agree to take ultra-widefield fundus images.

Exclusion Criteria:

1. Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths.
2. Patients who do not agree to sign informed consent.
Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease

The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have ESRD and have been receiving maintenance hemodialysis for at least 12 weeks prior to the Screening Visit
* Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit

Exclusion Criteria:

* Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to admission
* Uncontrolled hypertension at the Screening Visit or Day -1
A Follow-up of the Influencing Factors of Dyskinesia in Patients With Parkinson's Disease

Parkinson' patients who have not had dyskinesia would be observed for 2 years in a multicenter prospective study with the purposes to clarify the predicting factors of dyskinesia.

Parkinson' patients with daily levodopa dosage above 200mg and no dyskinesia would be recruited into the study. They would be observed for two years for analyzed the predicting factors of dyskinesia. At the baseline, demographic information, Clinical information, blood sample, picture of tongure coating would be collected at the baseline. All participants were evaluated every three months for two years. The severity of motor symptoms were evaluated every 6 months.

Eligibility Criteria:
Inclusion Criteria:

- 1) Patients have been clinically diagnosed with Parkinson disease at the recruitment.

2) Patients have received Levodopa treatment with the daily dosage above 200mg.

Exclusion Criteria:

* 1) be suspicious of atypical Parkinson or other Parkinson syndrome. 2) have experienced dyskinesia. 3) incorporation to the investigation
Brief Interventions With Text Messaging to Reduce Adolescent Alcohol and Marijuana Use

This study tests the feasibility of an intervention to prevent risky alcohol or marijuana use that adds a 4-week course of tailored text messaging to a brief motivational intervention for 13-18-year-old adolescents.


Eligibility Criteria:
Inclusion Criteria:

* 13 to 18 years old
* Able to provide consent or assent and parental permission
* have a functioning cell phone without pay-as-you-go text messaging

Exclusion Criteria:

* currently enrolled in any substance abuse program;
* have medical/psychiatric condition that precludes participation
Video Emergency Calls of Bystanders

Emergency center dispatchers often face the challenge that emergency calls typically provide only verbal information. However, many first responders use smartphones, which could enable the option for video calls during emergencies. Leveraging this technology could offer control center staff additional insights, potentially transforming the way they manage emergency situations. Despite this, the impact of video emergency calls on call duration and user experience remains largely unexplored.

In this project, 20 control center employees will undergo a one-hour training session on a video emergency call system. After the training, each dispatcher will handle four simulated emergency calls-two via audio and two via video. To facilitate this, 80 first responders will be recruited from public spaces, such as shopping centers. These responders will face simulated emergencies, including epileptic seizures, shortness of breath, forehead lacerations, or injuries to the upper extremities with minor bleeding. Professional medical actors will simulate the emergencies, and the responders will be tasked with making either an audio or video emergency call.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years
* User of a smartphone
* German Language

Exclusion Criteria:

* EMS personnel
Amplifying Graft-Versus-Tumor Effect by Donor Regulatory T-Cell Depletion Before Donor Lymphocytes Infusion

The investigators have previously shown that depletion of CD4+CD25+FoxP3+ regulatory T cells (Treg) enhances the alloreactivity of T lymphocytes, as attested by an accelerated GVHD after allogeneic hematopoietic stem cell transplantation (HSCT) in mice. The investigators thus propose a clinical trial to test whether Treg-depleted donor lymphocytes infusion (dDLI) could induce an improved graft-versus-tumor (GVT) effect in patients refractory to standard DLI (stdDLI) for treatment of relapse after HSCT.

We have previously shown that depletion of CD4+CD25+FoxP3+ regulatory T cells (Treg) enhances the alloreactivity of T lymphocytes, as attested by an accelerated GVHD after allogeneic hematopoietic stem cell transplantation (HSCT) in mice. We thus propose a clinical trial to test whether Treg-depleted donor lymphocytes infusion (dDLI) could induce an improved graft-versus-tumor (GVT) effect in patients refractory to standard DLI (stdDLI) for treatment of relapse after HSCT.

dDLI is administered after failure of 1 or several previous stdDLI of at least 107 CD3+ cells/kg, defined after a minimal follow-up of 2 months after the last injection. The absence of previous clinical manifestations of GVHD is required to be included. To prepare dDLI, CD25+ Treg are depleted from donor leukaphereses using anti-CD25 magnetic microbeads and a CliniMACS device (MYLTENYI). In order to evidence the potential effect of dDLI, the dDLI cell dose is adjusted to be below or equal to the maximal cell dose previously received in stdDLI. No comparison is planned in the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Hematological malignancy except chronic myeloid leukaemia.
* Previous allogeneic hematopoietic stem cell transplantation.
* Relapse diagnosed at the molecular, cytogenetic, or cytological level.
* Failure of a previous stdILD or inclusion in first intention if progressive disease.
* Age \> 18 years and \< 70 years at the time of inclusion.
* Performance status considered on the score ECOG \< 2.
* Life expectation 1-month-old superior.
* Signed written informed consent.
* Negative HCG in the 7 days preceding the inclusion for women in age of procreation.
* Membership of the French national insurance.

Exclusion Criteria:

* Chronic myeloid leukemia
* Grade \>II acute GVHD or chronic extensive GVHD at the time of inclusion.
* Patient receiving an immunosuppressive treatment for GVHD treatment at the time of inclusion.
* Dysfunction of liver (ALAT/ASAT \> 5 N, or bilirubin \> 50 µM), or of the renal function (creatinine clearance \< 30 ml / min).
Dexamethasone With TAP Block Increasing the Duration of the Peripheral Nerve Block in Caesarian Section

Nowadays Cesarean sections became the most popular surgery worldwide with the consumption of the hospital resources and the continuous need to decrease the costs, work load and medical stuff engagement. One of the most common problem is the need to control pain post operatively, this issue increase the work load over the pain management team and increase lead to patient in satisfaction.

This study will test the usage of dexamethasone with different doses (4 and 8 mg) either locally or intravenously (I.V.) with the local anesthetics in TAP (transversus abdominis plane) block to prolong the duration of the block and decrease the need of post-operative analgesics.

Nowadays Cesarean sections became the most popular surgery worldwide with the consumption of the hospital resources and the continuous need to decrease the costs, work load and medical stuff engagement. One of the most common problem is the need to control pain post operatively, this issue increase the work load over the pain management team and increase lead to patient in satisfaction.(1,2,3) The presence of the adjuvant which can be added to the conventional anesthetic medications can prolong the duration of action and decrease the need for frequent post-operative analgesics.(4,5) The idea of adding a catheter or placing an epidural catheter still have a quite limitation regarding the patients compliance, delayed ambulation and high costs, these limitations redirect the anesthetist again to the use of adjuvant with a single shot block to prolong the duration of it and decrease the need of subsequent analgesics.(6) Dexamethasone proved to be an effective adjuvant in prolongation of the nerve blocks with the question regarding the proper route and dose (7,8,9,10).

This study will test the usage of dexamethasone with different doses (4 and 8 mg) either locally or intravenously (I.V.) with the local anesthetics in TAP (transversus abdominis plane) block to prolong the duration of the block and decrease the need of post-operative analgesics.

Eligibility Criteria:
Inclusion Criteria:

* Any patient ASA (american society of anesthesia) I or II,
* aged between 18 and 45 scheduled for elective cesarean section.

Exclusion Criteria:

* patient refusal,
* age below 18 or above 45 years,
* coagulopathy with INR (international normalized ratio) more than 1.5 or platelets below 100000,
* uncontrolled diabetes, uncontrolled hypertensive, addict patient,
* psychological instability, and
* allergy to the used drugs,
* failure of spinal,
* conversion to general of anesthesia,
* failure of application of TAP block.
FLOR3 Gene Polymorphism in Predicting Outcomes of Tyrosine Kinase Inhibitor（TKI）Stopping in Chronic Myeloid Leukemia

For patients with chronic myeloid leukemia in chronic phase (CML-CP) who have achieved a stable deep molecular response (DMR) using BCR-ABL1 tyrosine kinase inhibitors (TKIs), treatment-free remission (TFR) following TKI cessation is an emerging goal. However, about half of the patients relapsed after TKI discontinuation. There is no definite examinations to predict the outcome of TKI discontinuation. Investigators aim to study the relationship between FLOR3 SNP rs139130389 and the outcome of TKI discontinuation.

Investigators aim to detect FOLR3 SNP rs139130389, and establish its correlation with patients' treatment response, remission time, TKI resistance and the outcome of TKI stopping.

Eligibility Criteria:
Inclusion Criteria:

1. The patient signs the informed consent form
2. Age over 18, male or female
3. The patient was diagnosed as chronic phase of CML.
4. ECoG score 0-2
5. Receive TKI treatment for at least 4 years and continuously obtain MR4 or mr4.5 for at least 3 years.
6. The subjects fully understand and comply with the requirements of the research scheme and are willing to complete the research as planned.

Exclusion Criteria:

NA