cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants

The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2.


Eligibility Criteria:
Inclusion Criteria:

* Must have been born in Japan of Japanese parents and maternal and paternal Japanese grandparents
* Body mass index (weight kg/m\^2) between 18 and 27 kilogram per square meter (kg/m\^2) (inclusive), and body weight greater than 50 kg but less than 100 kg
* Generally in good health on the basis of physical examinations, medical history, vital signs, laboratory tests, electrocardiograms (ECGs) and cardiac telemetry performed at Screening and/or prior to administration of the initial dose of study drug
* Must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, bleeding or thrombotic disorders (including any personal or family history of abnormal bleeding as assessed by a detailed bleeding history or blood dyscrasias), or with an underlying coagulopathy that may lead to a clinically relevant bleeding risk, autoimmune disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
* Acute illness, including an upper respiratory infection (with or without fever), within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration
* Clinically significant abnormal physical exam at Screening or Day -1
* Clinically significant abnormal vital signs at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
* Clinically significant abnormal cardiac telemetry, or ECG at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples

This is a prospective, observational evaluation study to assess the stability of the analytes tacrolimus, cyclosporine A, everolimus and sirolimus measured with Cascadion™ SM Immunosuppressants Panel. Study is pre-market evaluation for the regions where Cascadion™ SM Immunosuppressants Panel is not on the market yet and post-market evaluation where it is.

To assess the stability of tacrolimus, cyclosporine A, everolimus and sirolimus in patient whole blood samples after they are collected, processed and subjected to various storage conditions or freeze-thaw cycles that represent common sample handling conditions in the commercial clinical laboratory setting.

Study subjects will undergo one venous sample collection where 30 mL of blood is drawn.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Ability to sign informed consent form
3. At least one of the following

   1. Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A
   2. Kidney or liver transplant patient using everolimus
   3. Kidney transplant patient using sirolimus

Exclusion Criteria:

1. Inability to provide informed consent
2. Pregnancy or breastfeeding
3. Likely to believe that the sample collection procedure will pose an unusually high risk for subject's physical or mental health or their comfort
Evaluation of Patient Information in Interventional Radiology.

Interventional radiology is developing. Patient information modalities are also evolving, in particular information videos.

The aim of this work is therefore the evaluation of patient information in interventional radiology


Eligibility Criteria:
Inclusion Criteria:

* Any patient who receives a consultation before an interventional procedure.

Exclusion Criteria:

* None
A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee

The main purpose of this study is to evaluate the safety and efficacy of retatrutide once-weekly in participants who have obesity or are overweight and have osteoarthritis (OA) of the knee. The study will lasts about 77 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) ≥27 kilogram/kg/m² at screening.
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
* Have index knee pain for \>12 weeks prior to screening, and presence of index knee pain for \>15 days over the previous month.
* Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening.
* Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.

Exclusion Criteria:

* Have had steroid joint injections within 90 days of screening.
* Have had other joint injections and procedures within 6 months of screening.
* Have joint disease other than osteoarthritis.
* Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
* Have been taking weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
* Have a prior or planned surgical treatment for obesity.
* Have diabetes mellitus.
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding

This study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding

This is an open-label, randomized, Phase III, active-control, study of the efficacy and safety of IV iron vs oral iron in patients with anemia secondary to heavy uterine bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects \>/= 18 years of age
* History of Heavy uterine bleeding
* Hgb \</= 11
* Practicing acceptable birth control
* Demonstrate ability to understand and comply with protocol

Exclusion Criteria:

* Known Hypersensitivity to oral or IV iron
* Anemia other than iron deficiency anemia
* Iron storage disorders
* Initiation of treatment that may effect degree of heavy uterine bleeding
* Anticipated need for surgery
* Severe psychiatric disorder
* Active infection
* Positive Pregnancy test
* Known Hep B or C or Active Hepatitis
* Received investigational Drug within 30 days
* Alcohol or drug abuse
Immune Response Following COVID-19 in Hemodialysis Patients

Patients with chronic kidney disease (CKD), particularly those undergoing hemodialysis (HD), are at high risk of a severe form of COVID-19.

This study aims to characterize the inflammatory and antiviral response during SarsCov2 infection in adult

Inclusion criteria were (1) Adult (\>18 years old) patient on HD \> 6 months, and (2) infection by SARS-CoV-2. Diagnosis of COVID-19 was assessed by Reverse-Transcriptase-Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2 in nasopharyngeal swab or by typical COVID-19 radiological images on thoracic computerized tomography (CT scan).

Severe forms of COVID-19 were defined as requiring oxygen therapy, admission in intensive care unit (ICU) or death

Primary end point :

\* Characterization the cytokine's profile at the early (day 7) and inflammatory (day 14) phase of COViD-19 in HD patient

Secondary End points :

* Analyse the kinetic of the antiviral response (type I and III interferon ) between the early (day 7) and inflammatory (day 14) phase of COViD-19.
* Analyse the kinetic of proinflammatory cytokine response between the early (day 7) and inflammatory (day 14) phase of COViD-19.
* Define an antiviral signature associated with severe form of COVID-19
* Define an anti inflammatory signature associated with severe form of COVID-19

Cytokine's profile is define by the measure of 28 cytokines by Luminex technology

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years old) patient on HD \> 6 months, and
* Infection by SARS-CoV-2. Diagnosis of COVID-19 was assessed by Reverse-Transcriptase-Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2 in nasopharyngeal swab or by typical COVID-19 radiological images on thoracic computerized tomography (CT scan). The date of diagnosis was defined as the day when RT-PCR or CT-scan confirmed the diagnosis.

Exclusion Criteria:

* Inability to give consent
68Ga-NOTA-RM26 PET/CT in Glioma Patients

The aim of this study was to investigate the value of 68Ga-NOTA-RM26, an antagonist targeting gastrin-releasing peptide receptor (GRPR) PET tracer, in the diagnosis of high WHO grade glioma and prediction the grade of glioma using positron-emission tomography/computed tomography (PET/CT).

The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label brain PET/ CT study was designed to assess its clinical diagnostic value in patients with glioma.

Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed untreated glioma patients
* signed written consent.

Exclusion Criteria:

* pregnancy
* breastfeeding
* known allergy against Pentixafor
* any medical condition that in the opinion of the investigator,may
* significantly interfere with study compliance
The Effect of Spermatic Vein Embolization on Prostatic Hypertrophy

In varicocele the venous pressure in the prostatic bed is increased .This may result in raised hydrostatic pressure which in turn may stimulate prostatic hypertrophy.

Restoring normal venous drainage is expected to lower hydrostatic pressure followed by inhibition of prostatic growth and possibly leading regression in prostatic dimensions.

35 male patients, aged 45 years or older, with documented benign prostatic hypertrophy (BPH)and varicocele as visualized by ultrasound and/or termography examination will be enrolled.

Each patient will undergo a full urologic examination to exclude possible malignancy as well as a thorough medical examination to establish eligibility for treatment.

In all selected patients the varicocele will be obliterated by means of embolization of the spermatic veins.

The patients will be followed every three months by abdominal ultrasound as well as by serial PSA for a period of 6-12 months.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age \> 45 \< 80 years
* BPH
* Bilateral varicocele.

Exclusion Criteria:

* Coagulation disturbance
* CHF
* Malignancy
* Renal failure.
Ponto Implantation Using a Minimally Invasive Surgical Technique

This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study.

The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique.

This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Sweden, Denmark and the Netherlands). In total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study.

The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique. The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor three months after implantation/surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patient indicated for surgical intervention with a bone anchored hearing system
* Signed informed consent
* Adequate bone quality to allow for a Ponto implant insertion, as judged by the investigator, and an expected bone thickness above 5 mm, where no complications during surgery are expected
* Skin thickness of 12 mm or less at the implant site

Exclusion Criteria:

* Patient undergoing re-implantation
* Patient who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales
* Known condition or previous treatment that could jeopardize skin condition and wound healing over time as judged by the investigator (e.g. uncontrolled diabetes, previous radiotherapy in the area of interest)
* Known medical condition that contraindicate surgery as judged by the investigator
* Known and/or planned pregnancy at time of surgery
* Any other known condition that the investigator determines could interfere with compliance or investigation assessments
* Simultaneous participation in another clinical investigation with pharmaceutical and/or medical device which might cause interference with investigation participation
Sarcopenia and Cirrhosis

The study investigates the effect of aminoacid infusion on proteinturnover in muscle from cirrhosis subjects, compared to healthy controls.

The hypothesis is that aminoacid infusion can attenuate the increase in proteindegradation that follows cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects
* Diagnosis of cirrhosis, Child-Pugh A, B, C.

Exclusion Criteria:

* Acute illness within 3 weeks
* Ascites collections within 10 days
* Heart-, kidney, pulmonary disease. Cancer. Type 1 diabetes.
* Active alkoholdrinking
Oral Health and Wilson's Disease: SOMAWI

Patients with Wilson disease have poorer dental and periodontal health and a have lower oral quality of life than control patients. Patients with a neurological form would also more frequently present limitations in the function of the masticatory apparatus. Systemic treatments for Wilson disease are associated with lesions of the oral mucosa. Analysis of copper level in saliva could testify to the effectiveness of copper depletion in treated patients The main objective is to compare the state of dental health between: patients with Wilson disease in the hepatic form and patients with the neurological form, and a population of controls.

The comparaison between the three groups is based on evaluation criteria wich is CAOD index of caries severity (developed by Klein and Palmer in 1940) counting the number of permanent teeth with caries (evolving to include non-cavitary caries) (C), absent due to caries (A) and filled (O) in an individual. The maximum score is 28 (third molars are not taken into account). The index is obtained from clinical examination and panoramic dental imaging.

Eligibility Criteria:
Inclusion Criteria:

* Express consent to participate in the study
* Member of or beneficiary of a social security scheme
* For cases: Affected by Wilson's disease
* For controls: Benefiting from a first routine dental consultation with dental panoramic imaging, outside of an emergency context or treatment follow-up/maintenance

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding women
* Severe psychiatric disorders with behavioral disorders
* For cases:

  * hepatic or neurological decompensation
  * liver transplant patient
* For witnesses:

  * Patient with hepatic or neurological disease
  * Patient taking dietary supplements enriched with copper or zinc or zinc supplementation
  * Patient wearing removable prostheses with zinc-enriched prosthetic adhesives (Fixodent ProPlus®)
A Study to Evaluate Molnupiravir Tablet Formulation Compared to the Molnupiravir Capsule Formulation in Healthy Adult Participants (MK-4482-011)

The goal of the study is to learn what happens to different forms of molnupiravir (MOV) medications in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare the amount of MOV in the healthy person's body over time when different forms of medications are given.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

- Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
* History of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food.
* Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV).
* History of a major surgery.
Clinical Anatomy of Superficial Veins of Lower Limbs

The study is focused on clinical anatomy of superficial veins of lower limbs. We are mapping their anatomy via ultrasonography. We are focusing on saphenopopliteal junction and communicants between small saphenous vein and great saphenous vein.

Research project is focused on superficial veins of lower extremities, especially their clinical anatomy. Superficial veins are located within the compartimentum saphenum. The function of superficial veins is drainage of intradermal and epifascial spaces. Superficial veins and their function are fundamental in development of chronic venous disorder. These veins are physiologically connected with deep venous system via perforators but also between each other via communicanting veins. Communicanting veins between small saphenous vein and great saphenous vein have not been described yet, particularly because of their variations. Clinically important is also the saphenopopliteal junction in the fossa poplitea. This region features many variations, which were described in many studies. Also, the nomenclature of saphenopopliteal juction is not standardised in comparison to the saphenofemoral junction. Moreover, many articles are pointing out that there were not specified all potential drainage ways of the cranial extension of small saphenous vein (extesio cranialis). Articles are uniform neither in its prevalence nor in its terminology.

The knowledge of connections between the superficial and deep venous systems as well as knowledge of communicanting veins between superficial veins is important for diagnosis and proper treatment of chronic venous disorder. Variabilities of these veins can play fundamental role in choosing the proper graft for aorto-coronary bypass grafting. The ununiformed nomenclature of superficial veins, their communicating veins and junctions can cause misleading preoperative diagnosis and overlooking of these structures in clinical practise.

Eligibility Criteria:
Inclusion Criteria:

* women and men
* age 18-80

Exclusion Criteria:

* wounds on lower limbs
Photobiomodulation, Cryotherapy Combined With Compression, and Massage for Recovery

Skeletal muscle fatigue is an inevitable phenomenon in the training and competition routine for many crossfit athletes, which can impair their physical performance and predispose them to musculoskeletal injuries. Thus, strategies and/or therapies that minimize fatigue and accelerate muscle recovery are extremely relevant for everyone involved with sport. The aim of the present study is to investigate and compare the effects of photobiomodulation, cryotherapy combined with compression, and massage as isolated therapies for muscle recovery after a protocol of induced muscle damage and fatigue in Crossfit athletes. This is a randomized, double-blind, crossover, sham-controlled clinical trial. Will be recruited 60 male participants, adults, aged between 18 and 40 years, Crossfit practitioners. They will be randomly allocated into 3 groups of 20 participants per therapy, each crossed between effective and sham every 15 days. The primary outcome will be muscle performance in functional test (free squat) and knee extensor torque in maximal voluntary isometric contraction (MVIC). Secondary outcomes will be evaluated by the levels of muscle damage via creatine phosphokinase (CPK) and inflammatory process via blood C-reactive protein (CRP); and delayed onset muscle pain via numerical verbal scale (0-10). All outcomes will be evaluated at baseline, 24h and 48h after induction of muscle damage and fatigue. Data will be analyzed and compared intra and inter groups with a significance level of 5%.

This is a randomized, double-blind, crossover, controlled clinical trial of sham therapy.

Eligibility Criteria:
Inclusion Criteria:

* Male participants;
* Adults; aged between 18 and 40 years;
* Body mass index (BMI) between 18 and 30 kg/m2;
* Crossfit practitioners of the scale, amateur, RX and elite categories;
* Training at least 5 days a week.

Exclusion Criteria:

* Orthopedic injuries in the lower limbs (2 months) or during the development of the study will be excluded;
* Participants with less than 5 training sessions per week;
* Participants making regular use of pharmacological agents and/or ergogenic supplements;
* Participants who regularly use alcohol and/or tobacco;
* Participants with skin lesions (open wounds) on the lower limbs.