cyrilzakka/clinical-trials huggingface dataset:
First in Human Study of M6223

The main purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), immunogenicity and (if observed) the maximum tolerated dose (MTD) of M6223 as a single agent (Part 1A) for both the every 2 weeks (Q2W) regimen and the every 3 weeks (Q3W) regimen and of M6223 combined with bintrafusp alfa (Part 1B) for Q2W regimen in participants with metastatic or locally advanced solid unresectable tumors.


Eligibility Criteria:
Inclusion Criteria:

* Participants have histologically or cytologically proven locally advanced or advanced solid malignancies who are refractory to or have progressed under standard treatment and have no other treatment options known to confer clinical benefit
* Participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at Screening
* Participant has a formalin-fixed paraffin-embedded block containing tumor tissue or a minimum of 15 (preferably 25) unstained tumor slides suitable for immunohistochemistry-based staining of protein expression
* Participants with life expectancy of at least 12 weeks
* Participants with measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
* Adequate hematological, hepatic and renal function as defined in the protocol
* Other protocol defined inclusion criteria may apply

Exclusion Criteria:

* Participants with persisting toxicity related to prior therapy Grade greater than (\>) 1 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, however, alopecia, sensory neuropathy Grade less than or equal to (\<=) 2, or other non-immune-related Grade \<= 2 not constituting a safety risk
* Participants with prior organ transplantation including allogeneic stem cell transplantation
* Participants with prior toxicity related to an immune checkpoint inhibitor Grade greater than equal to (\>=) 3 NCI-CTCAE Version 5.0 unless resolved to Grade \<= 1 prior to study inclusion
* Participants with current significant cardiac conduction abnormalities, including corrected QT interval (QTcF, corrected with Fridericia formula) prolongation of \> 450 milli seconds (ms) on triplicate 12-lead ECG or impaired cardiovascular function, ventricular tachycardia, hypokalemia or a history of paroxysmal atrial fibrillation, serious cardiac arrhythmia and family history of sudden death or long QT syndrome
* A history of vascular, cardiovascular or cerebrovascular disease like, cerebral vascular accident/stroke (less than \[\<\] 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class \>= II), deep vein thrombosis (\< 3 months prior to enrollment) or pulmonary thrombosis/embolism (\< 3 months prior to enrollment)
* Other protocol defined exclusion criteria may apply
Pilot Study of Description of Cicatrisation Rates of Digital Ulcers in Systemic Scleroderma

To make an updated inventory of digital ulcer care protocols in scleroderma patients and to specify the French data on monthly healing rates and local care with patients in care centers experience, and thus to know the impact of ulcers in different dimensions To evaluate the rate of healed digital ulcers at the end of the study


Eligibility Criteria:
Inclusion Criteria:

* Patient with systemic scleroderma according to the ACR / EULAR 2012 criteria
* Patient with one or more active digital ulcers
* Patient with internet access and camera or smartphone

Exclusion Criteria:

* Minor patients
* Patient deprived of liberty or subject to a court order
* Patient subject to a legal protection measure
* Pregnant or lactating woman
* Patient unable to complete the questionnaires
Food Design for Improved Day-long Glycaemic Regulation

The study focus is on the possible improvement in glucose tolerance at a second standardized meal that can be achieved when preceded by a test meal with a low GI and a high GP.

A study in healthy subjects using spaghetti as the test breakfast and a white wheat bread as the reference. Glycaemia, insulinaemia, NEFA, TG and subjective appetite are studied up to the time of the lunch meal that is served 4h after breakfast. After lunch the blood sampling continues for 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* BMI 19-25

Exclusion Criteria:

* Smoker, Diabetes, Gluten intolerance, vegetarian
Impact of Immune Status on Secondary Infections in Patients With Acute Respiratory Failure

This is a retrospective observational study over the period 1/2019 - 02/2024 with the aim of identifying patients with a predisposition to secondary infections.

As a reference center, Charité Universitaetsmedizin Berlin has been treating patients with the most severe form of acute respiratory failure, known as acute respiratory distress syndrome (ARDS), for more than 30 years. Despite lung-protective forms of ventilation and the use of extracorporeal procedures for oxygenation and decarboxylation (ECMO), mortality is around forty percent. In addition to the primary cause of ARDS, further infectious complications often develop during the course of the disease, which delay recovery.

The aim of this study is to investigate infectious complications (ventilator-associated pneumonia, reactivation of Herpes viridae, pathogen resistance despite formally correct therapy, fungal infections) depending on the immune status.

Eligibility Criteria:
Inclusion Criteria:

* Male and female acute respiratory distress syndrome patients who had an immune status within 48 h of admission
* Patients who received intensive care treatment for acute respiratory distress syndrome ward 8i at Charité in the period from 01/2019 to 02/2024 with a maximum follow-up period of 90 days

Exclusion Criteria:

* None
Acoustic Pharyngometry in Obstructive Sleep Apnea Syndrome Patients, With Indication of Continuous Positive Air Pressure

Acoustic Pharyngometry (AP) is a method of measurement of Transversal Sectional Areas (TSA) and Volumes of oral cavity and pharynx, based on acoustic waves. The aim of this study is to describe changes on oropharynx dimensions caused by CPAP (Continuous Positive Air Pressure) in patients with severe Obstructive Sleep Apnea Syndrome when compared with patients with Primary Snore, using AP. The exam will be made during the use of CPAP, at various pressures. The investigators also intend to determine if pressure determined by Polysomnography in OSAS patients cause some type of different change in AP graphic.

The investigators are performing AP exams in severe apneics (cases) and primary snorers (control group),first basal, and then at the same time of using CPAP with a nasal mask, at progressive pressures (from 4 to 10 cmH20 in snorers, and until 2 pressures above the polysomnography determined pressure in apneics). The wave tube of pharyngometer is connected to the patient´s mouth by a mouthpiece, and to the computer. It makes a graphic of area x distance for each measurement. Then the investigators compare the changes in area, distance and volume of oral cavity and pharynx, determined by CPAP pressures, in both groups, and compare the measurements inside each group and between the two groups. Finally, the investigators analyse the CPAP pressure that most modifies the AP graphic, observing if it has some relationship with the polysomnography determined CPAP pressure.

The investigators intend this way to show the kind of modifies determined by CPAP in oral cavity and oropharynx and, secondarily, observe some relationship of AP and polysomnography in determine the CPAP ideal pressure for severe apneic patients.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 - 65 years old
* Female and male

Exclusion Criteria:

* Cardiopathies
* Chronic nasal obstruction
* Using neurologic or psychiatric drugs
The PREDICT Study: Prospective Early Detection In a Population at High-risk for Common Malignant Tumor

This is a observational, multicenter study, monitoring the circulating tumor DNA (ctDNA) in people who is at risk of cancers，assessing the sensitivity and specificity of ctDNA detection in early screening of pan-carcinoma.

2000 patients with positive tumor protein markers or cancer screening were recruited. All patients were tested for ctDNA at enrollment and followed up at 6 months and 1 year. The study was completed at the time of cancer diagnosis or the longest follow-up time (1 year).

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged at or over 45 years old.
2. Patients who with one or more of the following situations:

   1. In AFP (\>20UG/L), CA125 (\>70U/ml), CEA (\>7ng/ml) and CA199 (\>60U/ml), more than one item was abnormal for two consecutive times within one month.
   2. Patients with viral hepatitis (Hepatitis B / C surface antigen positive with liver function damage.
   3. Patients with liver nodules detected by ultrasound and hemangioma excluded.
   4. Patients with compensated cirrhosis.
   5. CA125\>35U/ml and HE4 was abnormal (the reference value of HE4 in premenopausal and postmenopausal women was 68.96 pmol/L and 114.90 pmol/L respectively).
   6. Patients with ovarian masses found by ultrasonography (premenopausal \> 5cm, postmenopausal \> 3.5cm).
   7. Patients with pancreatic space-occupying found by ultrasonography.
   8. Patients with BI-RADS grade 4 or above by ultrasound or mammography.
   9. CA125\>35U/ml and BI-RADS above grade 3 by ultrasound or mammography.
   10. CA153\>25U/ml and BI-RADS above grade 3 by ultrasound or mammography.
   11. Family genetic history of breast cancer and ovarian cancer, and BI-RADS above grade 3 by ultrasound or mammography.
   12. Patients with a positive fecal occult blood test and haemorrhoids excluded
   13. Patients with a positive fecal occult blood test and positive CEA
   14. More than 2 items were abnormal in PGI, PGR and G-17 (criteria: PGI≤70 UG/L, PGR≤7.0, G-17≤1 pmol/L or G-17≥15 pmol/L).
3. Ability to collect specimens from each time point and provide corresponding clinical information.
4. Understand the research plan and voluntarily participate in the study, sign the informed consent form.

Exclusion Criteria:

1. Patients with previous or present cancer.
2. Patients with serious diseases, especially those with a survival period of less than 3 years.
3. Patients with factors that affect the diagnosis of the disease (such as MRI related cardiac pacemakers, ferromagnetic implants, etc.).
4. Patients with a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
5. Women who are pregnant or preparing for pregnancy.
6. Patients who voluntarily withdraw for any reason.
7. Patients who cannot complete the research plan
Effect of Salt Restriction on Renin Activation

The present prospective, randomized, crossover study is designed to investigate the effect of salt consumption on blood pressure in hypertensive subjects.

Secondary objectives of the study are to evaluate the effect of salt consumption on blood pressure among the subjects who are hypertensive and obese and normal according to body mass index and to evaluate the effect of salt consumption on renin activity in hypertensive subjects.

The present study is carried out with the subjects who are chosen among the nursing home residents in İzmir. The subjects were randomized to 2 groups and while one of these groups had low salt diet (50mmol), the other group had normal salt diet (250mmol) for 3 weeks. Subjects had normal salt diet in their daily routine life for the following 2 weeks. According to crossover nature of the study, the group that had normal salt diet at the first 3 weeks of study had low salt diet at the last 3 weeks of the study. The other group that had low salt diet had the normal salt diet at the last 3 week of the study.

At the beginning of the study, information such as demographic, family story, medical story, diet habits, concomitant medication and physical measurements (height, weight and waist circumference) were received from the subjects.

24 hour blood pressure of the subjects is measured for four times, before the beginning of diet specific to their groups, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet. The subjects were asked for collecting 24-h urine in the same days of blood pressure measurement. Sodium, potassium, urea, creatinin and microalbumin measurements were measured in the collected urine. Blood samples were collected for three times, at the end of the 3-week diet, before the beginning of the second diet and at the end of their second diet. Plasma renin activity and aldosterone levels were measured in the blood samples collected. Aldosterone level was measured in the 24-hour urine in mentioned days.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are 50 years and older
* Subjects whose systolic blood pressure is ≥ 140 mmHg
* Subjects whose diastolic blood pressure is ≥ 90 mmHg
* Subjects who is normal weighted defined as body mass index \< 25 or who is obese defined as body mass index \> 30
* Subjects who have intellectual capacity to adapt diets and 24 hour urine collection
* Informed about the study and consented to include the study

Exclusion Criteria:

* Known heart failure
* Known renal failure
* Known chronic liver disease
* Antihypertensive drug use
* nonsteroidal anti inflammatory (NSAI) drug use
Walking Speeds in Patients With Chronic Obstructive Pulmonary Disease

A growing body of evidence suggests that in individuals with chronic lung disease their walk speed is related to their daily function and quality of life. It is possible to assess their usual (routine) and fast walking speeds by getting them to walk in a flat hallway.

In individuals with chronic lung disease, we anticipate that their usual walk speed will be helpful in exercise prescription and use in multidimensional scoring systems. However, it is important to first determine the measurement properties of these two walk speeds.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and spirometric diagnosis of COPD
* Able to provide written informed consent

Exclusion Criteria:

* Unstable cardiovascular disease
* Acute respiratory exacerbation within 4 weeks
* Neurologic or orthopedic limitation to walking
* Inability to comprehend instructions in English
Volumetric Pouch Study After Laparoscopic Sleeve Gastrectomy

This study aimed to evaluate Laparoscopic Sleeve Gastrectomy in the treatment of morbidly obese patients pre and post-operatively after 3 months, 6 months, and 1-year follow-up and assess the volumetric changes of the gastric reservoir 1 year after LSG using multi-slice computer tomography.


Eligibility Criteria:
Inclusion Criteria:

* BMI of \> 40 kg/m 2 or \> 35 kg/m2 with comorbidities e.g. hypertension and type 2 DM.
* All patients failed in supervised conservative management for obesity for at least 2 years.

Exclusion Criteria:

* BMI \> 60
* previous bariatric surgery
* symptomatic reflux oesophagitis disease, gastric pathology (tumor, active peptic ulcer)
* Significant psychological disorder, active alcohol or substance abuse
* severe eating disorders (bulimia)
* severe systemic disease making anesthesia or surgery prohibitively risky (American Society of Anesthesiologists (ASA) class IV
Comparative Study Between Fat Injection And Platelet Rich Plasma In Post Burn Facial Scar

Best method in management of facial burn scar

The stages of wound healing:proceed in an organized way and follow four processes: hemostasis, inflammation, proliferation and maturation. Although the stages of wound healing are linear, wounds can progress backward or forward depending on internal and external patient conditions. The four stages of wound healing are:Hemostasis Phase Hemostasis is the process of the wound being closed by clotting. Hemostasis starts when blood leaks out of the body. Inflammatory Phase Inflammation is the second stage of wound healing and begins right after the injury when the injured blood vessels leak transudate (made of water, salt, and protein) causing localized swelling. Proliferative Phase The proliferative phase of wound healing is when the wound is rebuilt with new tissue made up of collagen and extracellular matrix. Maturation Phase Also called the remodeling stage of wound healing, the maturation phase is when collagen is remodeled from type III to type I and the wound fully closes.

Fat Injection In Facial burn scar:The effects of the lipofilling can be seen starting from 3 weeks after the procedure, in terms of better scar color, pliability, thickness, relief, itching, pain, scar vascularization and pigmentation. Indeed, autologous fat grafting makes the skin softer, more flexible and extensible; besides, the color seems similar to the surrounding unharmed skin.

Platelet Rich Plasma In Facial burn scar: Impaired wound-healing and a long treatment course in severe burns as well as secondary complications originating from uncovered wounds motivate research to accelerate the wound-healing process and speed up re-epithelialization in burn patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients With Post Burn Facial Scar
2. Age: 15 _60 Yrs Old
3. Mature Burn Scar (After 3 Months)

Exclusion Criteria:

1. Patients Less Than 15 Yrs Old
2. Patients More Than 60 Yrs Old
3. Patients With Comorbidies (Hypertension-Diabetes-Thromboembolic Diseases-Immunocomprimized Patients)
4. Patients With Burn Scar In Any Site Of Body Other Than Face
ALFApump System Post Marketing Surveillance Registry

This is a post market surveillance registry to monitor the safety and performance of the ALFApump system.


Eligibility Criteria:
Inclusion Criteria:

* Refractory or recurrent ascites and liver cirrhosis or malignancy
* written informed consent

Exclusion Criteria:

* \< 18 years
* pregnant
* not able to use the Smart charger
Optimal Intubating Technique Using Videolaryngoscopy in Patients With Semi-rigid Neck Collar

In the case of tracheal intubation using a video laryngoscope, both techniques, one is 'conventional technique' in which intubation is performed by placing the blade tip on the vallecula and the other is 'sliding technique' performed by sliding the blade under the epiglottis, are commonly conducted by anesthesiologists. Investigators would like to compare if the sliding technique can improve the condition of tracheal intubation in patients wearing semi-rigid neck collars in cervical spine surgery.

For patients who need to limit the movement of the cervical spine, the tracheal intubation becomes difficult because the head must be positioned in the neutral position. Most of all, with a semi-rigid neck collar that maintains the neutral position of the head and neck, movement is limited and the mouth is not well-opened make the environment of tracheal intubation worse, which result in hypoxia or throat complications related to general anesthesia. Fortunately, it is possible that the development of video laryngoscope assists tracheal intubation easier for patients who have the limited movement of the cervical spine. However, the preferred intubation style and instrument selection for each operator are varied; the established method is required. In the case of tracheal intubation using a video laryngoscope, both techniques, one is 'conventional technique' in which intubation is performed by placing the blade tip on the vallecula and the other is 'sliding technique' performed by sliding the blade under the epiglottis, are commonly conducted by anesthesiologists. Investigators would like to compare if the sliding technique can improve the condition of tracheal intubation in patients wearing semi-rigid neck collars in cervical spine surgery.

Eligibility Criteria:
Inclusion Criteria:

- Adult patients (over 19 years of age) with ASA class I-III undergoing cervical spine surgery at our institution in the department of spine neurosurgery

Exclusion Criteria:

* When rapid sequence induction is required
* When awake intubation is required
* If a subject is on the medication for asthma
* If as subject cannot read or understand the consent form of study
Efficiency of Physical Activity on the Physical Condition of Elderly Women

The purpose of this study was to identify the effects and the efficiency of an adapted physical activity program as regards the physical condition of older Brazilian women.

Although physical activity programs for the elderly have proved to be able to curb harmful changes due to ageing, not all programs show the same effectiveness, even though they are generally regarded as being effective. The existence of a wide variety of programs calls for debate about their outcomes.

Specific research tools and designs can assist in identifying not only program effectiveness but also program efficiency and use in terms of a better physical performance of subjects on carrying out exercises with less effort, influenced by multiple factors, one of them being adherence to the program. These analyses allow the influence of efficiency and the factors that determine it or are associated with it to be tested, and can provide classifications and subgroups to which interventions should be adapted if they are to offer the best service to them in the short and medium term.

Eligibility Criteria:
Inclusion Criteria:

* 60 or more years
* participants of an Adult Revitalization Program in São Carlos (São Paulo State - Brazil)

Exclusion Criteria:

* physical characteristics and previous health problems that might hinder their participation in the program activities.
* adherence to the program sessions lower than 75%.
Effectiveness Of A Program That Includes Counseling And Patient Support On Adherence To Treatment With Lipitor

Despite extensive reports of the benefits of statins in reducing serious cardiovascular events such as stroke and heart disease in patients with elevated LDL-cholesterol, patients do not take their medicines regularly as prescribed. Reasons include forgetfulness, lack of understanding of the seriousness of the disease, and fear of side effects. An intervention strategy comprising 3-5 minutes of counseling, emotional support and cost-sharing may be motivational and improve adherence to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male and female aged \>21 years
* Have received a new or re-fil prescription for atorvastatin at first study visit to Prairie Heart Institute
* Signed informed consent

Exclusion Criteria:

* Unwilling to give written informed consent
* Failed statin treatment in the past
* Switched from another statin to atorvastatin because of co-pay program
* Participated in an earlier Market Research study on Impact of cholesterol management behaviors post in-clinic adherence intervention
Oscillation Mechanics of the Respiratory System in Never-smoking Patients With Silicosis

Silicosis is a chronic and incurable occupational disease that can progress independent of the end of exposure. Recent works suggest that the Forced Oscillation Technique (FOT) may help to improve our understanding of the changes in lung mechanics, as well as in the detection of these changes.

Objectives: Analyze the effects of airway obstruction in silicosis on the respiratory impedance and evaluated the diagnostic use of the FOT in these patients. For this, the investigators used spirometry to classify airway obstruction, which resulted in four categories: control, patients with normal exam, mild obstruction, and moderate-to-severe obstruction. Resistive data were interpreted using the zero-intercept resistance (R0), the resistance at 4 Hz (Rrs4) and the mean resistance (Rm). The investigators also analyzed the mean reactance (Xm) and the dynamic compliance (Crs,dyn). The total mechanical load was evaluated using the absolute value of the respiratory impedance (Z4Hz). The diagnostic potential was evaluated by investigating the area under the receiver operating characteristic curve (AUC).


Eligibility Criteria:
Inclusion Criteria:

* • Volunteers with silicosis for Patients Group;

  * Volunteers without any respiratory disease for the control group.

Exclusion Criteria:

* Smokers