cyrilzakka/clinical-trials huggingface dataset:
Study of Adecatumumab Relative to FOLFOX After R0 Resection of Colorectal Liver Metastases

The purpose of this study is to determine the effect of adecatumumab alone or following FOLFOX in patients with R0 resected liver metastases from CRC (colorectal carcinoma) and to compare the effect to FOLFOX alone.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologically confirmed complete resection (R0) of liver metastases from colorectal adenocarcinoma
* Age ≥18 years
* ECOG performance status ≤ 2
* Patient was informed, has read and understood the patient information / informed consent form and has given written informed consent

Exclusion Criteria:

* Extra-hepatic distant metastases or locally recurrent disease at time of enrolment
* Neoadjuvant chemotherapy of liver metastases prior to surgery
* Any anticancer chemotherapy within 4 weeks prior to study entry
* Start of Oxaliplatin-based chemotherapy within 9 months prior to study entry
* Any biological anticancer therapy or immunotherapy within 4 weeks prior to study entry
* Any radiotherapy or radio frequency ablation (RFA) to the liver prior to surgery
* Treatment with any investigational product within a time range of 4-5 half-lives (t½) prior to study entry
* Acute or chronic pancreatitis or history of alcohol induced pancreatitis
* Liver cirrhosis, acute hepatitis or chronic hepatic disease
* Any unresolved complications from prior surgery
* Persistent neuropathy
* History of other malignancy within 5 years prior to study start, with the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix and Ductal Carcinoma in Situ (DCIS)
* History of inflammatory bowel disease
* Active severe infection, any other concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the investigator
* Use of immune-suppressive agents such as the regular use of systemic corticosteroids
* HIV positivity
* Known hypersensitivity or intolerability to immunoglobulins in general, other recombinant human or humanized antibodies, Folinic Acid, 5-Fluorouracil, Oxaliplatin or a component of the study drug formulations, known dihydropyrimidine dehydrogenase (DPD) deficiency
* Pregnant or nursing women
* Women of childbearing potential or male patients not willing to use an effective form of contraception during treatment phase of the study and at least 6 months thereafter
* Not willing or incapable to comply with all study visits and assessments
* Placed into an institution due to juridical or regulatory ruling
Dexmedetomidine Versus Propofol in the Medical Intensive Care Unit (MICU)

This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (\> 24 hours) in critically ill patients who require mechanical ventilation.

Mechanically ventilated critically ill patients are routinely given sedative and analgesic medications to relieve pain and anxiety associated with intubation, mechanical ventilation, and critical care in general. While integral in minimizing discomfort, these medications may increase mechanical ventilation time, the duration of intensive care unit (ICU) stay, ICU complications (e.g. delirium, ventilator associated pneumonia, venous thromboembolism), the morbidity associated with critical illness, and patient mortality. This study compares two sedative medications that have been used in patients who require a mechanical ventilator. Enrolled patients will be randomly assigned to receive propofol or dexmedetomidine for sedation while they require ventilatory support. All patients will also receive the pain medication fentanyl as needed.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* mechanically ventilated through endotracheal tube
* anticipated need for ventilation \> 48 hours
* requiring sedative/analgesic medication

Exclusion Criteria:

* on mechanical ventilator \> 96 hours
* primary neurologic disease
* post cardiac arrest
* do not speak English (assessment only English language validated)
* pregnancy or lactation
* active myocardial ischemia
* second or third degree heart block
* pancreatitis
* elevated serum triglycerides (\> 400 mg/dL)
Evidence of Neuroplasticity After Performing a Cognitive Task in Idiopathic Parkinson's Disease Patients

As seen in previous studies Diffusion Tensor Imaging (DTI) MRI is able to detect very subtle changes in brain tissue even after a very short timescale of hours resulting from performing a cognitive task and learning, We wish to explore and compare those changes to patients with idiopathic PD (IPD) and see if there are changes in the learning process and can we detect them using widely available noninvasive techniques such as MRI.

Aim: to utilize high sensitivity DTI MRI methodology to explore evidence for subtle microstructural brain alterations after performing a cognitive task and to compare those changes in patients with PD to healthy controls of the same age.

PD patients and controls will undergo a full cranial MRI scan for depiction of anatomy and structural abnormalities (scan duration \~40 min). Immediately afterwards the subjects will play a car race computer game (Need for Speed) for 90 minutes. Following the game, the patients will undergo an additional DTI MRI scan (\~15 minutes).

Eligibility Criteria:
Inclusion Criteria:

* Patients with IPD based on a clinical diagnosis of PD according to the United Kingdom Parkinson's Disease Society Brain Bank criteria (however patients with a positive family history and symmetrical onset may be included)
* Healthy subjects should have no known neurological disease matched for age and sex with the study group

Exclusion Criteria:

* History of cranial surgery, radiation therapy, tumor, stroke or significant head trauma
* History of psychiatric disease (major depression, bipolar affective disorder, schizophrenia)
* Patients with severe tremor or dyskinesias that may interfere with performance of the MRI scan
* Patients with Montreal Cognitive Assessment (MoCA) score of 22 or under
* Contraindications for MRI (metal objects: implants/shrapnel/bullet; any electrically, magnetically or mechanically activated implants: cardiac pacemakers/defibrillator, biostimulators, neurostimulators, cochlear implants, hearing aids, insulin pump; claustrophobia)
* Subjects who are familiar and have played on multiple occasions the computer game "need for speed"
Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges

The purpose of this study is to examine whether an exergaming, aerobic physical education (PE) curriculum is acceptable and elicits improvements in behavioral self-regulation and classroom functioning among children with behavioral health challenges attending a therapeutic day school. After following an approved consent/assent process, children attending the school were randomized by classroom to take part in either 7 weeks of the experimental PE curriculum, or 7 weeks of the standard PE curriculum; after a 10 week washout period, children then crossed over into the other arm.


Eligibility Criteria:
Inclusion Criteria:

* Attending the Manville School at the time of study initiation

Exclusion Criteria:

* Medical exemption from physical education classes
* Parental opt out from physical education classes
Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension

Compare the effect of milrinone versus sildenafil in treatment of neonates with persistent pulmonary hypertension.

40 neonates with PPHN, met inclusion criteria, randomly assigned to 2 groups, each includes 20, first group received intravenous milrinone and second group received nasogastric sildenafil. both groups receive other supportive care.

Eligibility Criteria:
Inclusion Criteria:

* gestational age \>34 weeks
* postnatal age \<10 days

Exclusion Criteria:

* neonates with congenital heart disease
* neonates with congenital diaphragmatic hernia
Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea

The purpose of this study is to determine whether combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.


Eligibility Criteria:
Inclusion Criteria:

* primary dysmenorrhea

Exclusion Criteria:

* severe hepatopathy
* pregnant woman
Impact of Selenium on Methotrexate Induced Spermatotoxicity; A Comparative Study

The aim of this study is to assess the potential protective role of selenium on semen parameters and its effect on seminal glutathione peroxidase level in patients on MTX therapy

The aim of this study is to assess the potential protective role of selenium on semen parameters and its effect on seminal glutathione peroxidase level in patients on MTX therapy. informed consent was obtained from each patient after explanation of the purpose of the study. All patients were subjected to history taking and general and local examination. Baseline semen analysis and seminal glutathione peroxidase (GPX) were done for all patients and then they were divided into four groups each has 10 patients.

The no Se or MTX group was not eligible for neither Se nor MTX intake. The Se group started Se intake in a daily dose of 200 µg according to the United States National Academy of Sciences for 3 months.

Patients of both MTX groups (MTX group \& MTX and Se group) were chosen from psoriatic patients already planned to start MTX treatment with subcutaneous dose of 0.3-0.4 mg/kg/week.

The MTX and Se group started Se intake in a daily dose of 200 µg according to the United States National Academy of Sciences for 3 months.

After 3 months, semen analysis and seminal GPX level were repeated.

Eligibility Criteria:
Inclusion Criteria:

* adult males from 18-60 years old for the 2 methotrexate (MTX) study groups, the males included were chosen from patients already planned to start MTX treatment for psoriasis

Exclusion Criteria:

* History of drug intake that can affect semen parameters i.e., cytotoxic drugs, anti-androgens, sulfasalazine, gonadal hormones, nitrofurans or salicylic acid within previous three months.
* History of smoking within the last three months.
* Chronic disorders such as diabetes mellitus, hypertension, obesity, chronic liver or renal disease.
* Organic diseases that can affect fertility i.e., varicocele, testicular tumor or undescended testis.
* Genitourinary diseases.
Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA)

This is a two-part randomized, double-blind, placebo-controlled study.

This is a two-part randomized, double-blind, placebo-controlled study. The study comprises a SAD (Part 1) assessment which will include a food effect assessment that contributes data to inform a subsequent MAD (Part 2) dose-ranging study. Safety measurements will be collected throughout the study for all subjects. Blood samples will be collected to determine the PK parameters of SRP-3D (DA).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female. Females must not be pregnant or breastfeeding.
2. Is between 18 and 55 years of age (inclusive).
3. Able to speak and understand English or Spanish.
4. Agrees to comply with testing procedures.
5. Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
6. The subject meets good health criteria.
7. Females of non-childbearing potential or agree to use birth control.
8. Male subjects must be surgically sterile or agree to the use birth control.
9. Agree to the confinement period and return for the outpatient visits.
10. Has vital signs at screening within appropriate ranges.

Exclusion Criteria:

1. History or presence of clinically significant diseases.
2. Abnormal diet 4 weeks preceding the first dose of study medication.
3. Received any investigational product in a clinical study.
4. Previously been administered IMP in this study.
5. Taking any prescribed or OTC drug.
6. Taking moderate or strong inhibitors/inducers of cytochrome P450.
7. History of hypersensitivity to acetaminophen or similar chemical entities.
8. Presence or history of allergy or blood or plasma donation.
9. Blood or plasma donation
10. Smokers and those who have smoked within the last 12 months.
11. Current users of e-cigarettes and nicotine replacement products.
12. Consumption of prohibited beverages or foods.
13. Prior history of substance abuse or treatment.
14. Regular alcohol consumption.
15. Positive alcohol urine test at screening or admission.
16. Is a female with a positive pregnancy test result.
17. Positive urine screen for drugs of abuse.
18. Positive test for hepititus B or C, or HIV.
19. Active infection, periodontal disease,. certain dental appliances.
20. Glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
21. Significant serious skin disease.
22. Cohort 3 only: history of cholecystectomy or gall stones.
23. Have poor venous access that limits phlebotomy
24. Evidence of current SARS-CoV-2 infection
25. Clinically significant abnormal clinical chemistry, hematology or urinalysis.
26. Immediate family members of a study site or Sponsor employee.
27. Failure to satisfy the Investigator of fitness to participate.
Hinged Versus Conventional 8 Plate for Correction of Genu Valgum or Varum

To assess the therapeutic effect of hinged 8-figure plate by comparing with the traditional 8-figure plate through a randomized controlled clinical trial by assessing the differences between preoperative and postoperative data.

The hypothesis is that the hinged 8 plate provides low complications that this treatment is as good as the traditional one.

Angular deformities of the lower limb is major clinical problems encountered in pediatric orthopedics. Deformities can be either valgus or varus and most commonly affect the knee joint, which may result in patella dislocation, gait instability and serious impact on the appearance and function of the lower limbs. Biomechanical studies and gait analysis found that genu varus increased medial articular surface pressure of the knee, while genu valgus increased lateral articular surface pressure, and both of them are the risk factors for osteoarthritis. Surgical treatment techniques include osteotomy and hemiepipysidesis. Osteotomy surgery is the gold standard for severe angular deformity or epiphyseal closed patients, but it was associated with lots of complications, including osteofascial compartment syndrome, neurovascular injury, deep soft tissue infection, nonunion and requiring a long recovery time. While, for patients whose epiphyseal is not closed, the traditional 8 plate hemiepipysidesis has fewer complications. However, it showed some problems in clinical applications, such as steel plate or screw broken. The investigators designed a new hinged 8 plate, which has two arms and a built-in hinge. Based on the previous studies, investigators designed the rotation of the two arms ranged from 155° to 170° to better fit the contour of the physis in all stages of angular correction. That automatic change can also disperse repeated stress on the surface of periosteum and perichondrium during walking. The plate had been tested on animal models that the use of the hinged plate and screw system may be a more reliable technique with minimal complications for correction of angular deformities of the lower limb.

Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic genu valgus or varum
2. Without any treatment
3. lower limb mechanical axis over the tibial plateau in the range of 1/2;
4. Epiphyseal not yet closed, with more than 12 months of growth potential

Exclusion Criteria:

1. Physiological genu valgus or varum
2. Epiphyseal have closed or no growth potential
3. Pathological limb deformity(Blount disease, inflammation,trauma)
4. Other causes of lower limb angular deformity.
5. With surgical contraindications
A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation

The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.

The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.

Eligibility Criteria:
Inclusion Criteria:

1. The subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent.
2. Male or female subjects who are between the ages of 2 years (24 months) and 70 years old when consent is signed.
3. Infestation with head lice as demonstrated by the presence of live lice prior to first treatment.
4. Willing and able to attend all study visits as scheduled.
5. Females of childbearing potential must have a negative urine pregnancy test at screening and before receiving a second treatment, if necessary.

Exclusion Criteria:

1. Subject and/or legal guardian has not signed informed consent.
2. Subject was treated for pediculosis within 2 weeks prior to the screening evaluation.
3. Subject with an infestation of body lice or pubic lice.
4. Subject is suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment, which in the opinion of the investigator and visiting physician could influence the results of the study.
5. Subject with other diagnoses which, in the opinion of the investigator, would interfere with efficacy or safety assessments or would preclude study participation.
6. Subject with very short (shaved) hair.
7. Subject who will not be available for follow up visits.
8. Subject has been treated with a systemic antibiotic within the previous two weeks before screening.
9. Subject has been previously enrolled in any clinical study within the past 30 days; subject may not participate in another study while participating in this study.
10. Subject with history of allergy/sensitivity to active ingredient or related products; or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.
11. Pregnant and/or nursing females.
Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes

This study will test the effects of resistant starch type 4 on blood sugar and hunger in adults with Type 2 diabetes.

To measure the blood glucose response, after an overnight fast, blood samples will be collected before eating and 15, 30, 45, 60, 90, and 120 minutes after eating each bar. The incremental area under the curve was used to calculate glycemic index. The investigators will also measure the second meal effect by measuring the metabolic response (glucose, insulin, and gut hormones) after a standardized lunch two hours following the first assessment.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetics

Exclusion Criteria:

* Diagnosed with other metabolic disorders
* Allergies to wheat
* Non-smokers
Ultrasound Study by Texturization as a Predictor of Pregnancy in Oocyte Donation Programs

This study is focused on analysing the application of ultrasound scanning techniques as new biomarkers in reproductive medicine. Those biomarkers are based on the analysis of ultrasound texture in different areas of uterine tissue, using 2D/3D ultrasound scanning. Investigators will use the algorithm Text® to analyse the ultrasound texture of the endometrium and myometrium. The aim of the project is to study if it is possible to obtain measurable, objective and reproducible data in healthy volunteers which can be used to predict pregnancy and determine the best moment to perform embryo transfer in assisted reproductive technology (ART) cycles


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18 and 30 kg/m2
* Not taking the contraceptive pill in a previous cycle
* Non-pregnant: beta human chorionic gonadotropin (HCG) test with negative result at the beginning of the study)
* No previous history of inflammatory diseases, circulatory diseases, abdomen or pelvic diseases
* Physical gynecological exploration without pathological findings
* Gynecological ultrasound study of the uterus with a normal result

Exclusion Criteria:

* Ultrasound studies with technical defects in image acquisition
* Simultaneous participation in other studies
* Previous participation in other study which can affect the results of the present study
Sleepiz One+ Versus Capnography and Electrocardiography

EtCO2, or exhaled carbon dioxide, is a non-invasive and commonly used measure for respiratory rate and function. It can be easily monitored using a device called a capnograph, which consists of a sensor that is placed near the patient's mouth or nose and a monitor that displays the concentration of carbon dioxide in the respiratory gases in real-time.

EtCO2 capnography is generally considered a reliable and accurate method for monitoring respiration and is often used as a gold standard for comparing the performance of other methods for measuring respiration.

Therefore, the primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ and EtCO2 Capnography for measuring respiration rate, in healthy adults and patients suffering from chronic conditions (e.g. hypertension, COPD, asthma, diabetes), at rest in a clinical setting. Additionally, the performance of heart rate estimation will be evaluated against ECG.


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Age \>=18years
* Informed Consent as documented by signature
* One (or more) chronic medical condition/s (e.g., diabetes, asthma, cardiovascular or respiratory diseases, etc.)

Healthy volunteers

* Age \>=18years
* Informed Consent as documented by signature
* No diagnosed chronic medical condition

Exclusion Criteria:

Patients

* Previous enrolment into the current study,
* Cardiac pacemaker or another implanted electrical device
* Women who are pregnant or breastfeeding
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant

Healthy volunteers:

* Previous enrolment into the current study,
* Cardiac pacemaker or another implanted electrical device
* Women who are pregnant or breastfeeding
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant
* Presence of diagnosed chronic medical condition
Clozapine Hematological Monitoring Regulatory Compliance Assessment in Psychiatry

Clozapine is a drug that requires regular and diligent hematological monitoring throughout its use. This follow-up is, in France, framed by a compulsory paper format of the blood count follow-up notebook for each patient. Due to the multiplicity of the different modes of transmission of the different documents necessary for compliance with the regulations for the prescription, dispensing and administration of clozapine, we decided to carry out a current inventory in the department of Loire with respect for the latter. The main objective of this study is to assess the rate of non-compliance in circuits of prescription, dispensing and administration of clozapine by sending a questionnaire on habits of prescriptions, dispensing and administration of health professionals (psychiatrists, pharmacists), and by sending a questionnaire to the patients treated by clozapine.


Eligibility Criteria:
Inclusion Criteria:

* Population 1: all patients stabilized of Medical-Psychological Center (CMP) of St-Etienne treated with clozapine
* Population 2 : all psychiatrists of the Loire department
* Population 2 : all pharmacists of the Loire department

Exclusion Criteria:

NA