cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Conversion During Video-assisted Thoracoscopy Resection for Lung Cancer Does Not Alter Survival

Anatomical resection with systematic lymph-node dissection is currently the standard of care for the treatment of early stage non-small cell lung cancer. The use of minimally invasive approaches has increased greatly over the last two decades \[either video-assisted thoracoscopic surgery (VATS) or robotic-assisted thoracoscopic surgery (RATS)\], as they provide the patient with better outcomes than open thoracotomy. Minimally invasive VATS lobectomy for a standard case is generally a straightforward procedure for a well-trained surgical team, although concomitant preoperative pathologies or intraoperative findings/adverse events may result in technical difficulties, leading to intraoperative conversion, commonly by thoracotomy.

The investigators aimed to assess long-term outcomes in a consecutive cohort of patients treated by anatomical pulmonary resection either using VATS, VATS requiring intraoperative conversion to thoracotomy, or upfront open thoracotomy for lung-cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients treated by anatomical lobar pulmonary resection (lobectomy, bilobectomy) or anatomical sublobar pulmonary resection (segmentectomy) for non-small cell lung cancer (NSCLC), either by VATS (eventually with intraoperative conversion) or upfront thoracotomy.

Exclusion Criteria:

* patients with non-anatomical pulmonary resection (wedge resection)
* patients with a histology other than NSCLC (benign or metastatic from another primitive cancer), stage IV NSCLC disease,
* patients with multiple primary NSCLC (synchronous or metachronous)
* patients with incomplete resection (R+)
* patient for whom a VATS approach was never considered
Mother-to-child Hepatitis D Transmission

HBV can be transmitted from mother-to-child, with a risk increasing according to maternal HBV DNA during pregnancy. HDV is a defective virus using HBs Ag for its own replication. Nucleosides analogues have only a minor impact on quantitative HBs Ag level. Data about vertical HDV transmission are old, justifying a new study.

Hepatitis B Virus (HBV) can be transmitted from mother-to-child, with a risk increasing according to maternal HBV DNA viral load during the last trimester of pregnancy. Nucleosides analogues, lamivudine, telbivudine, or nucleotides analogues, tenofovir DF decrease HBV mother-to-child transmission risk, and are recommended in Guidelines (EASL 2012) for pregnant women with HBV DNA above 1,000 000 I.U/mL. HDV is a defective virus using HBs Ag for its own replication. HDV-HBV co-infection is a re-emerging infectious disease in western countries, due to immigration of people coming from endemic areas. Nucleosides analogues have only a minor impact on quantitative HBs Ag level (Boyd A et al. AIDS Research and Human Retroviruses 2013). Data about vertical HDV transmission are old (Rizzetto, et al. J Med Virol 1982), before a large use of nucleosides/nucleotides analogues in HBV infected pregnant women, justifying a new study.

Eligibility Criteria:
Inclusion Criteria:

* children born in the Maternity Department, Lariboisiere Hospital,
* from HBV-HDV co-infected women
* with a positive HDV RNA during pregnancy in the pregnant woman

Exclusion Criteria:

* negative HDV RNA during pregnancy in the pregnant woman
A Drug Interaction Study of ACH-0145228

This was a 2-part study (Part 1 and Part 2), with each part being an open-label, fixed sequence, 2-period study in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening.
2. No clinically significant history or presence of electrocardiogram abnormalities at screening and prior to first dosing in Period 1.
3. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
4. Female participants must be of non-childbearing potential and need not employ a method of contraception.

Exclusion Criteria:

1. Clinically significant laboratory abnormalities.
2. History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
3. History or presence of drug or alcohol abuse within previous 2 years, current tobacco/nicotine user, or positive for alcohol and/or drug screen at screening or Day -1 of Period 1.
4. History or presence of clinically significant seizures, head injury, or head trauma.
5. History of procedures that could alter absorption or excretion of orally administered drugs.
6. A history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
7. Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1.
8. Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, or receipt of blood products within 6 months prior to first dosing.
9. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever is longer.
10. History or presence of any risk factors for Torsades de Pointes.
Study of the T CD8 Immune Response in Horton's Disease

The research hypothesis is that T lymphocytes CD8 play a role in the physiopathology of Horton's disease.

At the inclusion visit, patients will have, as is the case in the usual strategy:

* A complete clinical examination carried out by the doctor in charge of the patient
* ESR, and CRP and fibrinogen assay
* A full blood count for leukocytes and lymphocytes
* A biopsy of the temporal artery (TAB) to screen for signs of vascularitis, suggesting Horton's disease. The clinician in charge of the patient will decide if a second biopsy is necessary. The biopsy will be sent to and analysed at Anatomy and Pathological cytology service. Immunohistochemical analyses will be done if the TAB is positive.

In addition to the standard clinical examination and complementary examinations relative to the patients' pathology, the following will be done:

* Lymphocyte immunophenotyping for the quantity of T CD4 (cluster of differentiation 4) and CD8 lymphocytes, B lymphocytes and natural killer lymphocytes. This will make it possible to calculate the absolute value for different T lymphocyte populations.
* A blood sample drawn into a dry 5 mL tube (large yellow) to isolate the serum, which will be stored at -80°C for future assays for cytokines and other biomarkers of interest for Horton's disease.
* 16 blood samples drawn into 6 mL heparinized tubes (large green). These will be used immediately for cytometric and functional analyses.


Eligibility Criteria:
Inclusion Criteria:

Patients

* Patients who have provided written informed consent
* Patients covered by national health insurance
* Age \> 50 years
* Patients with Horton's disease at the diagnosis before any treatment

Horton's disease is defined by American College of Rheumatology criteria, the diagnosis is made if any 3 of the following 5 criteria are associated:

* age at the onset of the disease 50 years or above
* recent onset localised headache
* indurated temporal artery or decrease/absence of temporal pulse
* erythrocyte sedimentation rate (ESR) above 50 mm for the first hour (or CRP\>20 mg/L)
* positive TAB showing vascularitis with infiltration of mononucleated cells or granulomatous inflammation with or without giant cells.

Controls Controls will be healthy volunteers recruited from blood donors of Dijon CHU, voluntary hospital personnel (nurses, doctors, laboratory technicians and secretaries) and patients without infectious or inflammatory disease, cancer or auto-immune disease (CRP\<5mg/L) recruited in the department of the investigators at Dijon CHU. They will be matched for age and sex.

* Age \> 50 years
* Patients covered by national health insurance
* who have provided written informed consent to take part
* Absence of inflammatory syndrome (CRP\<5 mg /L)

Exclusion Criteria:

* Any patient not meeting inclusion criteria
* Patient treated with corticoids or immunosuppressants in the month preceding inclusion
* Patients treated with chemotherapy
Bioequivalency Study of Mycophenolate Mofetil 250 mg Capsules Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Mycophenolate Mofetil 250 mg Capsules under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.
A Study of the Trigeminal Cardio-Reflex in Endodontic and Other Dental Treatment

This study sought to comprehend the relationship between syncope and dental related therapy. If the relationship between dental related therapies and syncope is proved, clinical dentists will be remained to monitor changes of patient's blood pressure during root canal procedure.

This study sought to comprehend the relationship between syncope and dental related therapy. If the relationship between dental related therapies and syncope is proved, clinical dentists will be remained to monitor changes of patient's blood pressure during root canal procedure.

Previous Trigemino-Cardiac Reflex(TCR) related studies reported that stimulation of trigeminal nerve induces trigeminal nerve reflection, and then causes blood pressure rapidly decreasing. Finally, sudden blood pressure decreasing results in syncope. Clinical data has been collected and analyzed in the past four months, and the primary results showed significantly difference. This phenomenon may be probably observed in other dental treatments. Hence, the objective of this study is to remind clinical dentists to monitor patients' physical conditions when conducting root canal relevant treatments and to avoid situations such as syncope, and reduce medical disputes and benefit dentists and patient as a result. In the recent year, syncope often occurs during denture procedures. The value of this study will inform clinical dentist to notice risk of dental relative treatments. In addition, it will improve patients' safety.

Eligibility Criteria:
Inclusion Criteria:

* Patients who sign the informed consent forms
* Patients with Pulpitis
* Patients aged 20 or order

Exclusion Criteria:

* Patients aged under 20
Key Technology Research and Application Demonstration of Individual Protective Equipment for High-Level Biosafety Laboratories

Systematically evaluate the safety performance, intelligent application effect and experience of PPE developed in different scenarios.

In high-level biosafety laboratories, the National Center for Infectious Disease Medicine, medical consortiums and other national platforms, systematic assessment of the project developed individual physical protection equipment in different scenarios of the safety performance, the intelligent application of the effect and the use of experience, the assessment of the indicators covering the protection performance, safety, stability, comfort, environmental protection, intelligence, ease of operation, including but not limited to local breakage protection performance, Aerosol protection performance, airtightness, liquid penetration performance, differential pressure stability, noise value, air supply flow, ease of wear and removal, ease of movement, ease of operation, degradability, degree of intelligence, etc., and ultimately determine the technical indicators and testing methods of individual physical protective equipment, and establish evaluation technical standards. Based on the determined technical indexes and testing methods of individual physical protective equipment, we will carry out parallel comparative evaluation of similar foreign imported equipment, and form a technical research report on the evaluation of the performance of relevant protective equipment. Optimise the quantitative performance indexes of PPE for domestic shortcomings and weaknesses. Prepare standard operation norms and technical standards for individual physical protective equipment.

Eligibility Criteria:
Inclusion Criteria:

* Staff at outbreak sites, infectious disease wards, BSL-3 and 4 laboratories

Exclusion Criteria:

* NA
Outcomes of Proactive Management of Children With Myelomeningocele

Spina bifida birth prevalence in Africa is 0.13%. Myelomeningocele (MMC) represents the most frequent and most severe cause of NB in children. Treatment of neuropathic bladder secondary to spina bifida is an ongoing challenge. Damage of the renal parenchyma in children with NB is preventable given adequate evaluation, follow-up and proactive management. Proactive management was defined as use of clean intermittent catheterization (CIC), and/or anticholinergics at presentation, or based on initial high-risk urodynamic findings by 1 year of age. The proactive approach to treat SB (CIC and pharmacotherapy) has contributed to decreasing chronic kidney disease (CKD). Myelomeningocele is considered a complex congenital disease. Hence, a multidisciplinary team is the best choice for management of spina bifida, involving neurosurgeons, orthopedic surgeons, urologists, physical medicine and rehabilitation specialists and pediatricians. Currently, children with spina bifida in Egypt must visit multiple different locations to access the complex care they need. Here, we review our experience with patients with spina bifida who will be followed with this team with an emphasis on patients' upper urinary tract protection and decreasing urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* all patients with myelomeningocele attending Assiut university urology hospital.

Exclusion Criteria:

* Associated other urological congenital anomalies (e.g., PUV or bladder exstrophy)
Location of Injection of Local Anesthetics in the Adductor Canal Block

The adductor canal block (ACB) is the standard of care for analgesia after Anterior Cruciate Ligament (ACL) repair. ACB is performed by injecting local anesthetic (freezing) in the subsartorial canal in the thigh which is about 7-10cm long. Preliminary evidence suggests that different injection sites within the canal may produce different degrees of analgesia and quadriceps motor block. This trial seeks to determine the effects of various ACB injection sites on postoperative analgesia and motor power following ACL repair.

Adductor canal block (ACB) is replacing femoral nerve block (FNB) as the peripheral nerve block of choice for knee surgery. The ACB aims to inject local anesthetics (LA) within the neurovascular sheath in the subsartorial adductor canal around the femoral nerve. The point where the sartorius muscle crosses over the femoral artery is generally the accepted site for performing ACB. Clinically, injecting LA in the adductor canal blocks the sensory innervation of the knee and thus offers pain relief that is similar to FNB while conserving motor power around the knee. While these benefits are desirable, the exact location for performing ACB that ensures these benefits, remains debatable. The subsartorial adductor canal itself is 7-10cm long and the anatomical location of the sensory and motor nerves that innervate the knee and its surrounding muscles in this canal may vary. This randomized controlled trial is designed to identify and refine the ACB technique by clinically determining the effects of various ACB injection locations on postoperative analgesia and quadriceps motor power following ACL repair.

Eligibility Criteria:
Inclusion Criteria:

* Patients booked for anterior cruciate ligament surgery under general anesthesia
* English speaking
* BMI \<38 kg/m2

Exclusion Criteria:

* Refusal or inability to provide informed consent
* Allergy to local anesthetics
* Contraindication to regional anesthesia including coagulopathy or bleeding - diathesis
* Infection
* Nerve Injury at the site of the nerve block
* Malignancy at the site of the nerve block
* History of drug and/or alcohol dependence
* History of long term opioid intake or chronic pain disorder
* History of pre-existing neuropathy in the operative leg
* History of significant psychiatric conditions that may affect patient assessment
* Inability to understand the informed consent and demands of the study
* Allergy to any of the components of multi-modal analgesic regimen
* Revision ACL repair
177Lu-P17-087/177Lu-P17-088 in Patients With Metastatic Castration-resistant Prostate Cancer

This is a pilot study to assess the safety and measure image-based absorbed dose of 177Lu-P17-087/177Lu-P17-088 in patients with metastatic castration-resistant prostate cancer (mCRPC) who will undergo radioliagnd therapy using 177Lu-P17-087/177Lu-P17-088. All patients underwent whole-body 68Ga-PSMA PET/CT for selection and accepted intravenous injection with single dose 1.1 GBq (30 mCi) of 177Lu-P17-087/177Lu-P17-088 within one week, then monitored at 1.5 hours, 4 hours, 24 hours, 48 hours, 72 hours, 120 hours and 168 hours after 177Lu-P17-087/177Lu-P17-088 administration with serial whole body planar and SPECT/CT imaging.

Prostate cancer is the most frequent malignant tumor in men worldwide. Prostate-specific membrane antigen (PSMA), is a surface molecule specifically expressed by prostate tumors which was shown to be a valid target for radiotherapy. 177Lu-PSMA-617, a urea-based compound, provide an effective target for the treatment of metastatic castration-resistant prostate cancer. However, a major problem in the therapeutic use of 177Lu-PSMA-617 has been its short half-life and fast rate of clearance. The investigators designed and synthesized a new radiopharmaceutical based on PSMA-11, P16-093. 68Ga-P16-093 showed higher tumor uptake and clear blood clearance than 68Ga-PSMA-617. Then, the investigators shynthesis a new therapeutic radiopharmaceutical based on P16-093, P17-087; and the investigators added a selected albumin binder into P17-088 to synthesis another new radiopharmaceutical, P17-088. This study was designed to investigate the safety, dosimetry and preliminary effects of 177Lu-P17-087/177Lu-P17-088 in patients with metastatic castration-resistant prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* All the patients had progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy;
* Distant metastases with high PSMA expression were confirmed on 68Ga-PSMA PET/CT within one week before the injection of 177Lu-P17-087/177Lu-P17-088.

Exclusion Criteria:

* Patients were excluded if they had \[18F\]FDG positive tumors without corresponding PSMA uptake. Patients were also not eligible if they accepted other radionuclide therapies within 6 months or had clinically significant impaired bone marrow, liver, or kidney function with a hemoglobin level of less than 9.0 g/dL, a white blood cell count of less than 2.5×109/L, a platelet count of less than 100×109/L and a serum creatinine \> 100 μmol/L.
The Happy Older Latinos Are Active (HOLA) Health Promotion Study in HIV-Infected Latino Men

The purpose of this study is to examine the feasibility of an intervention to prevent chronic diseases like diabetes, high blood pressure, and obesity in midlife and older Latino adults living with HIV. The investigators expect that the participant will be in this study for seven months. Participants will be interviewed and asked to take part in walking groups.


Eligibility Criteria:
Inclusion Criteria:

* are Latino (self-identified);
* are age 50+ years;
* are male;
* are HIV infected but are virologically suppressed (viral load \<200 copies/mL);
* volunteer informed consent;
* have medical clearance by a physician;
* expect to stay in Miami for the next 6 months; and
* have documented risk of cardiometabolic disease.

Exclusion Criteria:

* diabetes diagnosis;
* at baseline meet criteria for current major depressive disorder or generalized anxiety disorder;
* meet criteria for current alcohol or other substance abuse disorders;
* have a lifetime history of bipolar disorder or other psychotic disorder;
* have a diagnosis of any neurodegenerative disorder or dementia (Parkinson's disease, Alzheimer's, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a Mini Mental Status Exam score \<24;
* have contraindications to physical activity outlined in the American College of Sports Medicine standards;
* have high suicide risk i.e., intent or plan to attempt suicide in the near future (a response of "yes" to questions 3, 4, and/or 5 on the Paykel Questionnaire);
* are unable to complete 10 m walk test;
* currently residing in a nursing or group home;
* have a terminal physical illness expected to result in the death within one year;
* have an acute or severe medical illness that precludes them from safely participating in a health promotion intervention.
A Study to Evaluate the Pharmacokinetics and Safety Between Single Administration of "BR6002" and Coadministration of "BR6002A" and "BR6002B" Under Fasting Conditions in Healthy Adult Volunteers

The purpose of this clinical trial is to evaluate the pharmacokinetics and safety between single administration of "BR6002" and coadministration of "BR6002A" and "BR6002B" under fasting conditions in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Those who weigh 55 kg or more for men and 50 kg or more for women and have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
* Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception (In the case of a female subject, hormone drugs is excluded) accepted in clinical trial from the date of the first administration of the investigational products to 7 days after the last administration and disagrees to provide their sperm or ovum.

  \*Methods of contraception accepted in clinical trial: Combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used.
* Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.

Exclusion Criteria:

* Those who have clinically significant diseases or past history of the gastrointestinal system, cardiovascular system, endocrine system, respiratory system, hemato-oncologic disease, infectious disease, kidney

  \& genitourinary system, neuropsychiatric system, musculoskeletal system, immune system, ENT system, skin system, ophthalmic system.
* Those who have a medical history of gastrointestinal surgery (Except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs.
* Those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 1 month prior to the first day of administration or have taken ETC, OTC, herbal medicine and health functional foods concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as Interaction of investigational products, half-life of concomitant drugs)
* Those who have participated in other clinical trials or bioequivalence tests and administered their investigational products within 6 months prior to the first administration date.
* In the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.