cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants

The purpose of the study is to evaluate the pharmacokinetic (PK) and safety of darunavir (DRV) and cobicistat (COBI) after a single oral administration of Prezcobix (DRV/COBI fixed-dose combination tablet) in healthy Japanese adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This determination must be recorded in the participants source documents and initialed by the investigator
* A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[hCG\]) at screening and urine pregnancy test at the time of admission to the study site, hospitalization, and must not breast feed from screening onwards
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 30 days after intake of the study drug
* Nonsmoker or participant who habitually smokes no more than 10 cigarettes or equivalent of e-cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before study drug administration

Exclusion Criteria:

* Participant has a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, liver or renal insufficiency (estimated creatinine clearance below 80 milliliter per minute \[mL/min\]); thyroid disease, neurologic or psychiatric disease, infection, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, metabolic disturbances or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Participant has a history of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, that is considered cured with minimal risk of recurrence)
* Participant has a history of or current clinically significant skin reactions (such as but not limited to Stevens-Johnson Syndrome \[SJS\], Toxic Epidermal Necrolysis (TEN), and/or erythema multiforme) or any history of allergies to drugs, such as, but not limited to, sulfonamides and penicillins
* Participant has been contraindicated DRV and COBI per local prescribing information
* Participant is a woman, who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study
Anti-exercise-fatigue Effects of Rice Protein RP-80NY in Men

The aim of this study is to investigate the anti-exercise-fatigue effects of rice protein RP-80NY in men

Each subject must undergo a maximum oxygen consumption test 1 week before the intervention (day 1), eat the test food for 28 days (day 1 to day 28), following 14 days of wash-out (day 29 to day 42), and undergo second maximum oxygen consumption test (day 43) and another test food intervention (day 43 to day 70). The assays of anthropometric measurement, diet questionnaire survey, grip strength test and fecal collection were carried out before and after the intervention (the 1st ,28th ,43th and 35th day). Each subject has to join the Wingate anaerobic test (day 21 and day 63), and the endurance exercise test (day 28 and day 70) during the intervention. All of the trial period was 70 days, and the blood samples of the subject will be collected at the times of exercise beginning, 15 min after exercise, the end of exercise, 1 hour after rest, 2 hour after rest ,and 3 hour after rest. During the whole period of participating in the program, blood will be collected 14 times, the blood volume of each times is 10 mL. Gas is collected before the period and within 1 hour, 2 hour and 3 hour after exercise (5 minute at a time). After intervention, the exercise time, oxygen intake, blood biochemical value and gut microbiota will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* The subject is a male and aged 20-40.
* The subject has a usual exercise habit (exercising 2 times or more per week) and did not participate in professional sports competitions or professional sports training during the study period.
* No smoking or drinking habits.
* No food allergies and the liver function is normal.
* No cardiovascular diseases or other chronic diseases, and no serious illnesses requiring hospitalization during the study period.
* The subject can understand the test process described in the consent form and the possible potential risks and benefits, and can sign the consent form.
* The subject can accept dietary control during the trial period.

Exclusion Criteria:

* Those who have taken nutritional supplements containing branched-chain amino acids.
* Those who cannot complete the wingate anaerobic test and the endurance exercise test.
* Those who are diagnosed with kidney disease, heart disease, or cancer and are still under active treatment.
* Have used other drugs, whose pharmacological effects may affect fatigue.
* Subjects who have systemic infections and require systemic antibiotics.
Age-related Correlates of Treatment for Late-acquired Sounds

Late-acquired sounds, such as /r/ are difficult to learn and many children experience persistent errors on these sounds. The purpose of the present study is to determine whether treating these sounds earlier in the child's life may result in better outcomes.

Late-acquired sounds, such as /r/ are difficult to learn and many children experience persistent errors on these sounds. However, these sounds are often treated later in a child's life because they are not expected to be fully acquired until quite late--age 7-8 for some sounds. This practice places treatment in a time of the child's development in which they struggle to learn new sounds.The purpose of the present study is to determine whether treating these sounds earlier in the child's life may result in better outcomes, and to examine treatment efficacy and efficiency for two methods of treatment.

Eligibility Criteria:
Inclusionary Criteria:

* Normal Hearing
* Typical Receptive Language
* Speech Sound Disorder
* No motor speech impairment
* Typical non-verbal intelligence
* Produces at least one late-acquired sound with \<7% accuracy
* Monolingual English-speaking
* Typical in terms of motoric and neurological development

Exclusionary Criteria:

* Neurological disorder
* Hearing loss
* Nonverbal IQ \< 16th percentile
Prognostic Role of Inhibitor of Apoptosis Protein Overexpression on Recurrence Rate in Cervical Cancer

Overexpression of inhibitors of apoptosis proteins (IAPs) in patients treated for locally advanced cervical cancer with exclusive radio-chemotherapy may have a prognostic role on the local recurrence rate at 24 months.

Cervical cancer remains one of the most common cancers in women in terms of both incidence and mortality. Human Papilloma Virus carriage is a necessary condition for the development of these cancers but is not the only factor responsible for malignant transformation. Numerous molecular alterations come into play in the development of these tumours, involving the activation of oncogenes or the inactivation of tumour suppressor genes. Treatment of locally-advanced cancer is based on radiotherapy or a combination of radiotherapy and chemotherapy. Responses to anti-neoplastic treatments remain very heterogeneous from one woman to another. Predicting the response to these treatments would make it possible to envisage early therapeutic alternatives for patients identified as not very sensitive to standard treatments. IAPs (inhibitors of apoptosis proteins), which include XIAP, cIAP1 and cIAP2, are proteins involved in many cancers and capable of downregulating tumour cell apoptosis. It seems justified to investigate the role of these IAPs in resisting apoptosis-inducing anti-neoplastic treatments such as chemotherapy or radiotherapy. The aim of our study is to assess the prognostic role of overexpression of IAPs in locally advanced cervical cancer treated exclusively with radio-chemotherapy. This research seems all the more important as IAP-inhibiting molecules are currently being studied in other types of cancer (ear, nose and throat cancers) and appear to have a very encouraging radiosensitising effect. The hypothesis is that overexpression of IAPs in patients treated for locally advanced cervical cancer with exclusive radio-chemotherapy has a prognostic role on the local recurrence rate at 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with the exclusive radio-chemotherapy combination for locally advanced cervical carcinoma (stage Ib-IVb according to FIGO classification).
* Patients aged ≥ 18 years.
* Patients with a minimum of 2 years post-treatment follow-up.
* Patients for whom the initial biopsy specimen (before treatment) is available.
* Patients who have not indicated that they do not wish to participate in the study.
* Patients affiliated to or benefiting from a health insurance scheme.

Exclusion Criteria:

* Patients under court protection, guardianship or curatorship.
Skin Lipid Profiles in Term and Preterm Infants

This study is designed to compare the skin lipid and protein composition between term and premature infants and determine how the skin composition changes over the first four weeks of life. The investigators hope to elucidate the unique characteristics of premature skin by measuring the lipid and protein content in skin, how it changes during the first month of life, and how it varies with formula feeding versus breast feeding. Additionally, the investigators will study the relationships among diet, skin composition and plasma lipids in premature infants over the first four weeks of life.

Infants in the UCDMC Neonatal Intensive Care Unit with no congenital or acquired diseases of the skin or cardiovascular system will be enrolled after informed consent has been obtained from their parents. This is an observational study with no intervention. Procedures: At enrollment, 2 weeks and 4 weeks of age, skin lipids will be collected using three methods. First two small pieces of blotting paper (2 cm x 2 cm) will be placed on the infant's skin, one on the left side of the abdomen just above the umbilicus and one on the left inner thigh. The blotting paper will be left in place for 15 seconds and then removed. Second, two adhesive discs will be placed on the skin, one just below the umbilicus and one on the right inner thigh. The discs will be left in place for 30 seconds and then removed. Third, two areas of skin, one on the right side of the abdomen just above the umbilicus and the other on the inner right thigh, will be gently swabbed with sterile cotton swabs (one for each location). The intent is to remove a thin layer of oil/lipid from the skin upon removal of the paper or the adhesive disc or with swabbing without disrupting the skin surface (similar to taking a fingerprint). Blood specimens will be obtained three times, each time 1 ml : once at enrollment, at 2 weeks and the last one at 4 weeks of age, to generate a plasma lipoprotein profile and size distribution (HDL, LDL, VLDL, total cholesterol). For infants that are fed expressed human milk, we will also obtain a sample of mother's milk for analysis of lipid profile (about 2 ml).

Eligibility Criteria:
Inclusion Criteria:

* infants who are likely to be inpatients in the NICU for at least 4 weeks

Exclusion Criteria:

* congenital or acquired skin disease,
* cyanotic congenital heart disease,
* neonates that are not viable and
* those with lethal anomalies such as anencephaly, trisomy 13, trisomy 18, renal agenesis
Wean Obese Study : Determination of the Optimal Spontaneous Breathing Trial for Obese Patient

The decision to extubate a patient after acute respiratory failure is based on clinical observation and measurement of pulmonary mechanics. Current extubation criteria(tidal volume, respiratory frequency...) lack of specificity. The best way to evaluate and predict patients breathing abilities after extubation is to challenge him to a spontaneous breathing trial (SBT) with endotracheal tube in place immediately before extubation to predict the patient's ability to breathe spontaneously after extubation. The intention is to approximate, while the patient is still intubated, the work of breathing that will be required of the patient after extubation. Different approaches of ventilatory settings are currently used for the preextubation SBT, whether pressure support ventilation (PSV), continuous positive airway pressure (CPAP), or spontaneous ventilation through an endotracheal tube (T piece), all supported by literature with different benefits. To the investigators knowledge, few studies define which mode of ventilation most closely approximates the work of breathing during spontaneous respiration after extubation, and none have studied a specific population of obese patient in respiratory weaning. The main objective of the investigators study is to determine, between five different SBT, which one is the best to approximate the work of breathing of obese patient after extubation.

Patients : 20 obese patients (defined by BMI over 30 kg/m2) ongoing for spontaneous breathing trial and clinically ready for immediate extubation will be enrolled after obtaining their consents. Material : An oeso-gastric double balloon catheter will be inserted in order to record oesophageal and gastric pressure and to calculate Work of Breathing and Pressure Time Product. Pulmonary Volumes will be recorded by a pneumotachograph. Functional Residual Capacity will be recorded thanks to the azote double dilution technique used by the Engström respiratory care station.Study Protocol : When physicians in charge of the patient decided that the patient is ready to be weaned and to have a SBT before extubation, the patient will be included in the study. Before extubation, patients will be placed under 5 different spontaneous breathing trials conditions in the same order : 7 cm H2O continuous positive airway pressure, T piece,7 cmH2O of pressure support, 0 cmH20 of pressure support and 7 cm H2O pressure support ventilation with 7 cmH20 of end expiratory pressure. Each trial will be performed fo 20 min. Between 2 spontaneous breathing trials, and before extubation, patient will receive a 10 minutes period of recovery to their respiratory baseline, defined by the respiratory settings before the spontaneous breathing trials.The last step, after extubation, will consist in recording the data after 15 minutes, when patient's breathing pattern appears calm.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30 kg/m2
* Weaning procedure achieved, ongoing for extubation

Exclusion Criteria:

* Contra indication for nasogastric catheter placement
Nicotinamide in Non-Alcoholic Fatty Liver Disease Patients

The purpose of the study is to evaluate the efficacy and safety of Niacinamide supplementation on clinical outcome of fatty liver patients having type II DM through measurement of the following before and after Niacinamide administration: Liver enzymes, Lipid profie, HOMA-IR, Oxidative stress markers and endothelial dysfunction marker. Fibroscan with CAP will be done at baseline and at the end of the trial. Also, Evaluation of quality of life of patients before and after Niacinamide administration using Chronic Liver Disease questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* 1. Male or female outpatients age 18 to 70 years old. 2. The diagnosis of NAFLD will be established according to the appearance of fatty liver on US or elevated liver enzymes (\>1.5 times normal level).

Exclusion Criteria:

* 1. History of alcohol abuse (as defined by an average daily consumption of alcohol \> 30 g/day in men and \> 20 g/day in women).

  2. Cirrhotic patients.
* Fibroscan result \> 12Kpa or as
* predicted from FIB 4 score \> 3.25

FIB-4 = age (yr) \* AST (IU/L)/platelet count (109/L) \* ALT1/2 (IU/L) 3. Hyper / hypoparathyroidism. 4. Cancer. 5. Viral hepatitis. 6. Biliary disease. 7. Autoimmune hepatitis 8. Other causes of liver disease (hemochromatosis, Wilson's disease). 9. Participants who took antibiotics, probiotic supplements and/or hepatotoxic medicines (NSAIDs, Amiodarone and methotrexate) within 6 months before the start of the study and during the study.

10. Ascetic patients and congestive heart failure patients will be excluded due to unreliability of Fibroscan results in them.

11. Pregnancy and lactation.
Genome Studies of Hepatocellular Carcinoma Developed in Hepatitis C Patients With Sustained Virological Response

In this international collaboration study, the research group will analyze somatic mutations of hepatocellular carcinoma (HCC) developed after sustained virological response (SVR) in patients treated with hepatitis C (HCV) therapy

Method Paired liver tissue samples will be collected from the tumour sections and also from the adjacent non-tumour tissues, for comparison in each individual. The tissues have been collected as part of routine clinical work/other studies, by liver biopsies or at liver resection/liver transplantation. Data regarding the patient characteristic will be collected. Whole genome sequencing analyses are planned to be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sustained virological response (SVR) after interferon (IFN)-containing or IFN-free treatment, and developed hepatocellular carcinoma (HCC)
* Available liver biopsies from hepatocellular carcinoma and non-HCC tissue

Exclusion Criteria:

* Co-infection with chronic hepatitis B (HBsAg positive) or HIV infection.
* Liver transplantation prior to treatment-start, leading to SVR.
* Patients with diagnosed HCC prior to treatment-start, leading to SVR.
Genomic Assessment of Patients With Severe Radiation Reactions

Determine an underlying etiology behind unexpectedly severe reactions to radiation by blood draw.


Eligibility Criteria:
Inclusion Criteria:

* Weigh at least 110 pounds
* Healthy

Exclusion Criteria:

- Pregnant
Liver Transplantation for Hilar Cholangiocarcinoma in Association With Neoadjuvant Radio- and Chemo-therapy

Single-arm pilot clinical trial. Patients with non operable CC associated with PSC will be subjected to liver transplantation after a neoadjuvant multimodal therapy protocol.

Cholangiocarcinoma (CC) accounts for 3% of all gastrointestinal cancers; it is more frequent in patients with primary sclerosing cholangitis (PSC), who carry an 8%-12% risk of developing this type of neoplasm. Only a minority of patients are suitable for resection partly because of the anatomic position of the tumor (which often arises from the bile duct bifurcation) and partly because of the frequently coexisting liver disease. In fact, CC is currently considered a major contraindication to liver transplantation (OLT) at the majority of centers, given a 5-year survival rate of 0%-35%.

New strategies have been developed for the treatment of this kind of cancer arising in PSC. The Nebraska University group showed a 1 and 3 years survival of 55 and 45 % combining a neoadjuvant intra bile duct barchytherapy and 5-FU based chemotherapy with liver transplantation. University of Pittsburg proposed also a neoadjuvant protocol prior to liver transplantation based on systemic chemotherapy and external radiotherapy reporting a 53% 5 years survival. More convincing results come from the Mayo Clinic. An accurate selection of patients and a proper neoadjuvant multimodal therapy (chemotherapy, external radiotherapy and intraluminal bile duct brachytherapy) lead to a 80% 5 years survival after liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Male or female
* Diagnosis of Cholangiocarcinoma using:
* PTBD biopsy or Brushing cytology
* Ca 19-9\>100mg/ml and/or liver mass at CT or MRI with malignant stenosis apperance at Cholangiography,
* Non resectable tumour araising above the cystic duct
* Absence of intra and extra hepatic metastasis
* ECOG score(Eastern Cooperative Oncology Group) 0
* ASA score (American Society of Anesthesiologists) ≤ 3
* Ability to understand and willingness to sign the written informed consent form (ICF)

Exclusion Criteria:

* Intrahepatic Cholangiocarcinoma
* Non controlled infection
* Previous radio or chemotherapy
* Previsous bile duct resection or attempt to resection
* Intra and/or extrahepatic metastasis
* Preivious malignant neoplasm (within 5 years)
* Execution of trans peritoneal biopsy
* Tumour diameter more than 3 cm
A Contemporary Review of Surgical Approaches in Pelvic Exenterative Surgery

Minimally-invasive surgery (MIS) techniques have revolutionised the approach to rectal cancer surgery. With increasing experience, surgeons have began to utilise these platforms increasingly in the context of pelvic exenteration (PE). This observational retrospective review plans to assess the volume of PE being performed on a global basis and to assess the comparative outcomes associated with each technique in order to assess the optimal approach to radical pelvic surgery.

Pelvic exenteration (extended pelvic multi-visceral resection) is a radical procedure that offers potential long-term cure in appropriately selected cases of locally advanced and recurrent pelvic cancers. It was first described by Alexander Brunschwig in 1948 as a viable palliative option for advanced gynaecological cancer. However, over the last 70 years, changes in surgical oncology practices have seen its role extended to include other advanced non-gynaecological cancers (locally advanced colorectal, urological, and sarcomatous neoplasms).

Although these procedures pose a significant challenge for the operating surgeon, improved surgical techniques, technology, and reconstructive options have facilitated more radical resections. Despite improved surgical options, patients still have considerable post-operative morbidity and negative impact to quality of life. However, non-surgical management options result in poor prognosis with only 3% survival at five-years. Pelvic exenteration in appropriately-selected patients offers the only hope of long-term survival.

Over the last few decades with improved perioperative management and better surgical techniques, more aggressive visceral, soft tissue and bony resections are performed. The development of minimally invasive surgery (MIS) platforms has also evolved substantially, especially regarding pelvic surgery. There are some recent sporadic (low-volume) reports highlighting the potential role for MIS exenterative surgery, however many reports have been heterogeneous and single-centre. The aim of this retrospective review is to compare the volume, disease characteristics and surgical outcomes between open, laparoscopic and robotic pelvic exenterations, and to assess the initial experience of MIS platforms in multiple specialist centres worldwide.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven locally advanced or recurrent RECTAL cancer
* Aged over 18 years
* Undergoing a multi-visceral extended pelvic resection
* Procedure took place within the specified timeframe (July 2016 - July 2021)

Exclusion Criteria:

* Extra-pelvic/ non-resectable metastatic or peritoneal disease
* Palliative pelvic exenteration
* Insufficient patient follow-up data