cyrilzakka/clinical-trials huggingface dataset:
Comparison of Ultrasound, CT, and Classical Methods for Selecting Sizes and Placement of Left-Sided Double-Lumen Tubes

Investigators aimed to compare anatomical measurements obtained using ultrasound and computed tomography with classical methods to select the appropriate size of double-lumen tubes more quickly and easily and to determine the optimal depth of placement.

In modern thoracic anesthesia, one-lung ventilation (OLV) is essential for managing surgeries, and double-lumen tubes (DLTs) have been a key advancement. DLTs allow separate lung ventilation, facilitating lung deflation and preventing material transfer to the healthy lung. However, improper DLT placement can compromise these functions, emphasizing the importance of correct sizing and positioning.

Choosing the right DLT size depends heavily on patient-specific factors. Undersized DLTs can cause airway injuries, increased resistance, and displacement, while oversized DLTs are linked to postoperative issues like sore throat and difficult intubation. Despite this, no universal criterion exists for DLT size selection. Traditional methods rely on height and gender, but weak correlations with airway size often lead to improper choices, especially in shorter individuals.

Imaging techniques like chest X-rays, Computed Tomography (CT), and ultrasonography (USG) offer a more precise approach to airway measurements for DLT selection. USG is especially advantageous due to its accessibility, speed, and ease of use in operating rooms and emergencies. To improve the accuracy and ease of DLT size selection and placement, investigators aimed to compare anatomical measurements from USG and CT with traditional methods.

Eligibility Criteria:
Inclusion Criteria:

* Requiring lung isolation in thoracic surgery,
* American Society of Anesthesiologists (ASA) risk score of 1-2-3,
* Patients who are literate and able to provide informed consent

Exclusion Criteria:

* Patients with an ASA score of 4 or higher,
* Criteria for difficult intubation,
* Difficulty in mouth opening, small jaw deformities,
* Abnormal cricoid cartilage appearance,
* A history of laryngeal or neck surgery,
* Preoperative throat pain and hoarseness,
* Tumors and deformities in the main airway
Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)

This study will evaluate the safety and clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation.

This study will evaluate the pharmacokinetics and preliminary clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and palbociclib is a small molecule inhibitor of CDK 4 and 6.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
* Unresectable or metastatic disease.
* No available treatment with curative intent
* Adequate organ function

Exclusion Criteria:

* History of significant toxicity on prior KRAS G12C or CDK4/6 inhibitor therapies
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter the absorption of study treatment or result in an inability to swallow
* Other active cancer
* Cardiac abnormalities
Assessment of New Ostomy Devices in Subjects Having an Ileostomy

The study investigates the performance of three new adhesives with regard to leakage and the skin condition.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent and in DK: signed a letter of authority
2. Be at least 18 years of age and have full legal capacity
3. Have had their ileostomy for at least 3 months
4. Must be able to use custom cut product
5. Can use a product with max cut size 45 mm
6. Self-reported problems with leakage (3 x within 14 days)
7. Get a negative result of a pregnancy test for women of childbearing age (only DK)

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
3. Are pregnant or breastfeeding
4. Are participating in other interventional clinical investigations or have previously participated in this investigation 4.1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP264) protocol.
5. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
6. Have known hypersensitivity towards any of the products used in the investigation
Human Intestinal Microbiota in Obesity and Nutritional Transition

The objectives of this study are: 1-To qualify the relationship between the gut microbiota and the host nutritional and metabolic status during dietary transition.2-To define the impact of nutritional transition on the intestinal microbiota and identify metagenomics signatures of nutritional transition.

French overweight (BMI \> 27) and obese people (BMI \> 30 kg/m2, N=50) will be submitted to a low calorie diet (1200 Kcal) for 8 weeks. This type of intervention is know to modify the metabolic phenotype and expected to change the gut microbiota. Nutritional interventions are planned for 6 months, each subject being studied before (base line), after the intervention (8 weeks) and 2 months after the low calorie diet has stopped and a diet of weight maintenance will be provided. This protocol will be implemented in the nutrition department of the Pitié Salpétrière Hospital in Paris, within the Centre de Recherche en Nutrition Humaine d'Ile-de-France, where patients will be followed on the clinical, biological and histological levels. Evaluation will include medical history, physical, and nutritional evaluations. They will be excluded of the protocol if they had evidence of acute or chronic inflammatory disease, infectious diseases, cancer and/or known alcohol consumption (\> 20g per day), as well as other causes of liver, kidney or heart diseases. Physical evaluation will include weight, height, measures of waist/hip ratio, measure of blood pressure. At each time point, body composition will be measured by dual-energy X-ray absorptiometry performed with a total body scanner (Hologic QDR 2500 densitometer). Resting metabolic rate will be evaluated after a one-hour resting period in supine position. Oxygen consumption (VO2) and carbon dioxide production (VCO2), monitored over 30 min by using an open-circuit ventilated-canopy system (Deltatrac II monitor, Datex Instrumentarium Corp., Helsinki, Finland) calibrated with a reference gas. Blood samples will be obtained systematically for biological parameters including lipids (cholesterol, HDL-Chol, TG), insulin and glucose values and OGTT (enabling the determination of insulin sensitivity parameters, adipokines and inflammatory parameters such as leptin, adiponectin, IL-6, TNF alpha, SAA, hsCRP. Serum will be kept for all supplementary measures. The histopathological evaluation of subcutaneous adipose tissue will be performed to evaluate the adipocyte size and the degree of tissue inflammation. Stools samples will be collected for metagenomic studies.

In addition, blood, urine and fecal water samples will be collected and frozen for subsequent metabonomic analysis, and fecal samples for metaproteomic assessment of the microbiota.

Eligibility Criteria:
Inclusion Criteria:

1. BMI 27 to 38 kg/m2
2. age: 25 to 65 years.
3. non diabetic subjects
4. fasting glycemia \< 1,26 g/l

Exclusion Criteria:

1. SGOT ou SGPT \> 2.5x normale
2. Glycemia \> 1,26 g/l
3. any other health problem or chronic treatment
Phase I Clinical Trial of a Candidate PCV13 in Healthy People

Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world.

This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.


Eligibility Criteria:
Inclusion Criteria:

* Satisfy the age requirements of the clinical trial; willing to provide proof of identity;
* Subjects or guardians must provide informed consent forms with personal signature and date;
* Male and female of childbearing age should agree to take effective contraception measures;
* Subjects or guardians can obey the requirements of the clinical study;
* Axillary temperature below 37.3 °C.

Exclusion Criteria:

* Laboratory indicators (expect those have no clinical significance) out of normal ranges required;
* Received any pneumococcal vaccine;
* Allergic history to any drugs, vaccine or vaccine-related component;
* Infants with congenital malformations, developmental disorders, genetic defects, or severe malnutrition;
* Infants diagnosed with pathological jaundice that lasts for 2\~4 weeks and occurs repeatedly;
* Breast-feeding or pregnant women, or positive U-HCG;
* High blood pressure uncontrolled by medication;
* Known or suspected immune deficiency or immune suppression;
* Serious congenital malformation, history of organ resection or serious chronic illness;
* Received blood products or intravenous immunoglobulin (except Hepatitis B immunoglobulin);
* History of clinic-proven or serology-proven infectious disease especially caused by streptococcus pneumoniae;
* History of convulsions, epilepsy or encephalopathy or a family history of mental illness;
* A vaccination-related contraindications that other investigator believes;
* Plans to participate in or is participating in any other clinical study;
* Any other factors judged by investigator that may interfere subject's compliance with the protocol.
Calcium Carbonate on Labor Induction

The investigators aim to evaluate the safety and efficacy of administering calcium carbonate to laboring participants undergoing labor inductions. The investigators hypothesize that calcium carbonate is a low-risk preventative measure to decrease oxytocin induction time and dosage, decrease the rate of labor dystocia, decrease the rate of cesarean deliveries, and demonstrate no differences in maternal or neonatal safety outcomes.

The investigators plan to assess (1) duration of induction with oxytocin administration, (2) rate of labor dystocia/failed induction, (3) rate of cesarean section, and (4) maternal/neonatal safety. Currently, calcium carbonate is used by clinicians in patients with varying characteristics, at varying doses, and at various times in their labor process based on their professional preference and experience. The investigators will implement a standardized treatment protocol for calcium carbonate use within a defined patient population who voluntarily agree to prospectively receive the intervention and then analyze predetermined safety and efficacy outcomes in comparison to a historical cohort of patients meeting the criteria for the defined patient population who did not have any documented calcium carbonate use during labor.

Eligibility Criteria:
Inclusion Criteria:

* Adult laboring patients ( ≥ 18 years of age)
* Able to speak and read English or Spanish (for historical cohort, preferred language should be English or Spanish)
* Singleton gestation
* Greater ≥ 37 weeks gestation in vertex presentation
* Present for induction of labor inclusive of medical indication, elective indication at greater than 39 weeks gestation, trial of labor after cesarean
* Receive standard-dose oxytocin during induction

Exclusion Criteria:

* Participants will be excluded from the study if they do not meet the above inclusion criteria or they will be further excluded under the following circumstances:
* Known need for cesarean section prior to induction of labor
* Known allergy to calcium carbonate
* Known contraindication to taking calcium carbonate including renal calculus, high urine calcium levels, elevated serum calcium, low serum phosphate, achlorhydria, or suspected digoxin toxicity.
* Inability to tolerate oral intake (i.e., nausea/vomiting)
* Need to be nothing by mouth (NPO)
Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome

Guillain-barre syndrome (GBS) is an acute immune-mediated polyneuropathy. Intravenous Gamma globulin is an effective therapy.Although high doses of gamma globulin are clinically effective, the patient's recovery and clinical prognosis vary. The establishment of a cohort study on the therapeutic effect of gamma globulin in Guillain-barre Syndrome is beneficial to the diagnosis of the disease and to the understanding of the natural course of the disease and the efficacy of drug treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Meet the Brighton Guillain-Barre Syndrome diagnosis criteria in 2014;
2. Age ≥18;
3. Patients with AIDP, AMAN and AMSAN;

5. IVIG was treated within 2 weeks of onset; 6. GBS disability scale\>2; 6. Cooperate with patients who were followed up for 180 days and sign the informed consent;

Exclusion criteria:

1. Age \<18;
2. Pregnant or nursing women;
3. Patients with Chronic inflammatory demyelinating multiple peripheral neuropathy;
4. Combined with other types of immune system diseases;
5. Accept drugs that affect the function of the immune system within 5 or 3 months;
6. Concomitant neoplastic diseases.
7. The patient or guardian refused to sign the informed consent.
Anticoagulation in Chronic Hemodialysis Patients Versus Hemodialyzer Fiber Patency, Bleedings and Quality of Life

Stable chronic hemodialysis patients are included in this observational study. After a midweek dialysis (test moment 1), the hemodialyzer is dried and scanned in a micro Computed Tomography scanner to quantify the number of patent fibers. All dialysis parameters are collected as well as the anticoagulation dose. During the same session, patients are asked about their bleeding and quality of life status. Four (test moment 2) respectively eight weeks later (test moment 3), patients are asked again for their bleeding and quality of life status using validated questionnaires.

All stable chronic hemodialysis (HD) patients having daytime dialysis in the Ghent University Hospital, are included.

From the patient's record, data are collected: demographic data (i.e. age, weight, dialysis vintage), blood data related to clotting (i.e. number of platelets, hemoglobin, International Normalized Ratio (INR), C-reactive protein (CRP)). All data is pseudomized.

The study has three test moments. During the entire study, patients are dialyzed with their usual dialyzer on their usual dialysis machine and with their usual dialysis settings and anticoagulation dosis. After the first midweek test session (test moment 1), the used hemodialyzer is rinsed with the standard rinsing procedure, dried in blood and dialysate compartment with positive pressure ventilation during 12-24h, eventually stored at 5°C, and finally scanned in a micro-CT scan in order to quantify the number of patent fibers. The dialyzer is vertically mounted on a rotating disc in front of the X-ray bundle. Scans are made every 0.15° with 2401 projections during 500ms each. After image reconstruction, visualisation are obtained from cross-sections of the hemodialyzer. Open fibers are counted with an open source computer program used for biological image analysis. By comparing the number of open fibers with the total number of fibers in an unused hemodialyzer, the percentage of open fibers can be quantified.

During the same week of the first test moment, several validated questionnaires will be completed: questionnaires about intention for bleeding (i.e. the International Society of Thrombosis and Haemostasis (ISHT) Bleeding Assessment Tool and the Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly (HASBLED) score), and a questionnaire about quality of life (i.e. EuroQoL 5D (EQ5D)). Besides, a visual inspection is performed of the limbs of the patient in order to quantify bruising.

By comparing the percentage of open fibers with the administered anticoagulation dosis and the different questionnaires about bleeding, mutual relations can be drawn.

In order to check reliability, questionnaires and visual inspection are repeated after 4 weeks and 8 weeks (test moments 2 and 3).

Eligibility Criteria:
Inclusion Criteria:

* treated with chronic daytime hemodialysis

Exclusion Criteria:

* no active infection at the time of inclusion
Investigation of Early Hormonotherapy Efficacy of Prostate Cancer

The purpose of this study is to determine whether early hormonotherapy is effective in the treatment of high risk prostate cancer patients after radical prostatectomy.

The primary purpose of this study is to evaluate the hypothesis, that early administration of adjuvant hormonotherapy (triptorelin) can prolong survival data for high risk patients. Control group (randomised study) will be treated with hormonotherapy, when PSA recidive appear (on demand treatment). Secondary purposes will be to compare PSA dinamics and quality of life data in the groups.

Eligibility Criteria:
Inclusion Criteria:

* preoperative PSA\>20ng/ml
* postoperative PSA \>0.2 ng/ml
* Gleason \> 7
* pT3b
* signated infomed consent

Exclusion Criteria:

* neoadjuvant hormonaltherapy before RP
* R1 RP
* N+ RP
* unstable cncomitant conditions
Special Survey for Patients With Type 1 or Type 2 Diabetes

This study is conducted in Japan. The aim of this study is to evaluate the incidence of severe hypoglycaemia under normal clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients with no treatment history of insulin aspart (NovoRapid®)
Enhancing HIV Risk Reduction Among Indian Women With Risky Husbands

This grant involved the development, implementation, and assessment of the feasibility and acceptability of an HIV prevention intervention for at-risk wives in Mumbai, RHANI Wives (Raising HIV Awareness among Non-Infected Indian Wives). The RHANI Wives intervention was adapted from the HIV Intervention Program (HIV-IP), a community-based, multi-session HIV intervention with demonstrated effectiveness among Latinas whose primary risk for HIV was from their primary male partner (Raj et al. 2001).

Specific aims of this study are as follows:

1. To adapt HIV-IP, a culture and gender-tailored HIV intervention for Latinas with demonstrated effectiveness in reducing risk for HIV, and to create RHANI Wives for use with at-risk Indian wives.
2. To determine the feasibility and acceptability of RHANI Wives with at risk wives\* in India. A two-group cluster randomized trial will involve random assignment of 12 neighborhood clusters (25 women/cluster) to receive the intervention (n=150) or a control condition (n=150). Intervention effects on the more proximal and likely safer sex mediating outcome of marital communication for this feasibility trial will be assessed via surveys at baseline and 3 month follow-up.

NOTE: Only 220 participants were able to be recruited into the study.

\*At risk wives are defined as having a husband at higher risk for transactional sex based on wife's reports of his risky alcohol use (drunk in past 30 days, 3+ drinking days in past 7 days) or partner violence perpetration


Eligibility Criteria:
Inclusion Criteria:

1. married female aged 18-40 years
2. fluency in Hindi or Marathi
3. residence with husband in the area of study for a period of 2 months or greater
4. reports that husband engaged in either heavy drinking- past 30 day drunken behavior, or frequent drinking- 3 drinking days in past 7 days, or lifetime spousal violence perpetration
5. no plans to relocate from the area in the next year.

Exclusion Criteria:

* cognitive impairment indicated at recruitment
CancerenD24 Screening as an Aid to the Clinician for the Diagnosis of Cancer

The purpose of the researchers is to test whether the CancerenD24 index, an algorithm based on the quantitative value of CD24, CD11b, clinical and laboratory characteristics, developed in the laboratory can help in the early detection of a malignant disease in a population of healthy subjects.

CD24 is a protein found naturally in the body and serves as a natural regulator of the immune system, in order to prevent its uncontrolled and disproportionate reaction. It is known that in a normal state the CD24protein is almost never expressed in healthy cells with the exception of the white blood cells of the blood cells in the adult person. In contrast, cancer and even pre-cancer cells express high levels of CD24. Sometimes this expression is associated with a more violent course of the cancer. Similarly, CD11b is another protein that is expressed on the surface of white blood cells and affects the migration of white blood cells and their penetration into the tissue. In addition, CD11b plays an important role in the tumor microenvironment and cancer progression. And it is used as a prognostic marker. The role and involvement of these proteins (CD24/CD11b) in various cellular processes, led our group of researchers to hypothesize that an algorithm based on CD24and CD11b protein expression on white blood cells can help in the early diagnosis of cancer and assist doctors in diagnosing this serious disease in its early stages.

The test is intended for routine use, as an aid to doctors to identify most types of cancer in earlier stages. CancerenD24 is not affected by fasting and the time of day when the blood sample is taken.

In this study, it is expected to recruit 2000 male and female subjects, who will be recruited over a period of 36 months. The experiment does not involve any treatment. During the visit to the medical center, an experienced staff member will explain the study to the patient, and after agreeing to his participation, the patient will sign an informed consent form, as is customary. After that, the same staff member will interview the patient in order to obtain demographic data and information about risk factors. After that, a venous blood sample will be taken from the patient as part of the routine blood tests taken as part of the work at the Medical Center. For this purpose, patients over the age of 40, without active cancer in the last 5 years, who come for a cancer screening (and sometimes other screenings) at the Integrated Cancer Prevention Center and the Medical Center will be recruited.

Eligibility Criteria:
Inclusion Criteria:

1. Completion of all medical exams and questionnaires including cancer diagnoses, demographic data and other epidemiologic information
2. Willing and able to sign an informed consent
3. Age ≥40 years

Exclusion Criteria:

1. Age \< 40 years
2. Pregnancy or breastfeeding
3. Any type of fever
4. Any cancer active at study entry or up to 5 years prior to study entry
5. Polyposis syndromes
6. Inflammatory bowel disease
7. Unwilling or unable to provide informed consent