cyrilzakka/clinical-trials huggingface dataset:
Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children

This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad population of children. Half of participants will receive the high dose, while the other half will receive the low dose.


Eligibility Criteria:
Inclusion Criteria:

* Before starting treatment, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.
* According to the height statistical data of Chinese children's physique development in nine cities in 2005, height is lower than the third percentile of growth curve of normal children with the same age and gender.
* Height velocity (HV) ≤5.0 cm/yr.
* GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma \<10.0ng/ml.
* Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (CA).
* Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
* Receive no prior GH treatment within 6 months.
* Sign informed consent.

Exclusion Criteria:

* People with abnormal liver or kidney function (ALT\> 2 times the upper limit of normal value, Cr\> the upper limit of normal value).
* Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg).
* People with known highly allergic constitution or allergy to the drug of the study.
* People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency.
* Potential tumor patients (family history).
* Diabetic.
* Abnormal growth and development, such as Turner syndrome, constitutional delay of growth and puberty, Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome.
* Subjects took part in other clinical trial study within 3 months.
* Other conditions which in the opinion of the investigator preclude enrollment into the study.
Process and Outcome Evaluation of Different Psychotherapies

In this study, adult patients and therapists at the Outpatient Clinic for Psychotherapy of the Paris Lodron University Salzburg will complete questionnaires throughout the course of psychotherapy in order to evaluate the course and outcome of psychotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients: indication for psychotherapy, adult patients capable of giving consent, with sufficient knowledge of German to complete the questionnaires, signed treatment contract and declaration of consent
* Psychotherapists: officially registered psychotherapists and psychotherapists in training under supervision (in Austria), signed work contract and declaration of consent
Skeletal Muscle and Adipose Tissue Responses After Acute Exercise: Comparing Effects of Three Different Intensities

The study will assess the exercise-induced changes in chromatin accessibility and gene expression in a cell type-specific manner in skeletal muscle from healthy adults in response to exercise at three different intensities - 1) low-intensity continuous exercise, 2) moderate-intensity continuous exercise, and 3) high-intensity interval exercise.


Eligibility Criteria:
Inclusion Criteria:

* Age:18-40
* Body Mass Index: 20-30 kg/m2
* Must engage in regularly planned aerobic-type exercise at moderate-vigorous intensity, 3 times per week for at least 30-60 minutes/session
* Women must have regularly occurring menses and must be premenopausal
* Subject willingness to opt-in for the Michigan Genomics Initiative (MGI) Repository

Exclusion Criteria:

* Evidence/history of cardiovascular or metabolic disease.
* Taking anti-coagulate medications or medications known to affect metabolism or inflammation
* Weight instability ≥ ±3kg in the last 6 months
* Tobacco or e-cigarette users
* Women must not be pregnant or actively lactating
Restylane-L for Correction of Infraorbital Hollows

This is a prospective, randomized, evaluator-blinded, no-treatment controlled, parallel group, multi-center US study to evaluate the safety and effectiveness of Restylane-L® for correction of Infraorbital Hollows.


Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe infraorbital hollows with no more than one grade difference between the left and right side at baseline as assessed by the blinded evaluator.
* Males or non-pregnant, non-breastfeeding females, over the age of 21.
* Intent to undergo correction of both orbital hollows.

Exclusion Criteria:

* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
* Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
* Previous deep and/or superficial facial dermal therapies.
* Active or a history of recurrent or chronic infraorbital edema or rosacea or uncontrolled severe seasonal allergies.
EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)

The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease. After completion of the interventional part of the study (primary study completion) a subset of participants will be followed up in a post-trial observational (non-interventional) manner for cardio-renal outcomes (estimated study completion date).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years or at "full age" as required by local regulation
* Evidence of chronic kidney disease at risk of kidney disease progression defined by at least 3 months before and at the time of Screening Visit

  * CKD-EPI eGFR ≥20 to \<45 mL/min/1.73m² or
  * CKD-EPI eGFR ≥45 to \<90 mL/min/1.73m² with urinary albumin:creatinine ratio ≥200 mg/g (or protein:creatinine ratio ≥300 mg/g);
* Clinically appropriate doses of single agent RAS-inhibition with either ACEi or ARB unless such treatment is either not tolerated or not indicated
* A local Investigator judges that the participant neither requires empagliflozin (or any other SGLT-2 or SGLT-1/2 inhibitor), nor that such treatment is inappropriate;

Key Exclusion Criteria:

* Currently receiving SGLT-2 or SGLT-1/2 inhibitor
* Diabetes mellitus type 2 and prior atherosclerotic cardiovascular diseasee with an eGFR \>60 mL/min/1.73m2 at Screening
* Receiving combined ACEi and ARBf treatment
* Maintenance dialysis, functioning kidney transplant, or scheduled living donor transplant
* Polycystic kidney disease
* Previous or scheduled bariatric surgery
* Ketoacidosis in the past 5 years
* Symptomatic hypotensiond, or systolic blood pressure \<90 or \>180 mmHg at Screening
* ALT or AST \>3x ULN at Screening
* Hypersensitivity to empagliflozin or other SGLT-2 inhibitor
* Any intravenous immunosuppression therapy in last 3 months; or anyone currently on \>45 mg prednisolone (or equivalent)
* Use of an investigational medicinal product in the 30 days prior to Screening visit
* Known to be poorly compliant with clinic visits or prescribed medication
* Medical history that might limit the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease; history of cancer or evidence of spread within last 4 years, other than non-melanoma skin cancer; or recent history of alcohol or substance misuse)
* Current pregnancy, lactation or women of childbearing potential (WOCBP), unless using highly-effective contraception
* Type 1 diabetes mellitus
Supplementation of Alpha-linolenic Acid (ALA)-Rich Oil in Humans

The objective of this study is to investigate the accumulation of n-3 LC-PUFA (EPA, DPA and DHA) in human lipids by oral supplementation of ALA-rich linseed oil. In addition, the accumulation of n-3 LC-PUFA is compared between subpopulations of different age, gender and physiological conditions (overweight, increased serum total cholesterol).

N-3 PUFA are important for human health and nutrition. Unfortunately, the land-based n-3 ALA is a limited precursor for the formation of n-3 LC-PUFA. The conversion of ALA depends on the rate-limiting ∆6-desaturation.

The first objective of this study is to investigate differences of the accumulation of n-3 LC-PUFA (EPA, DPA and DHA) in human lipids during supplementation of ALA-rich linseed oil dependent on age, gender and physiological conditions (overweight, increased serum total cholesterol). One study group will receive fish oil with mainly EPA as positive control.

The second objective is to compare the n-3 LC-PUFA enrichment during the linseed oil supplementation (study LSEP H50-KK) with the n-3 LC-PUFA enrichment during the further Echium oil supplementation (study LSEP H42-KK). The second study will be the control for the first study.

Therefore, it is planned to recruit the same subjects for the linseed oil supplementation.

Eighty volunteers will be recruited and allocated into four study groups depending on age and BMI. Three groups (each n=20) will receive daily ca. 15 g linseed oil (mean age: 25 and 55 years; mean BMI \< 25; and mean age 55 and BMI \> 25). One group (n=20) will receive n-3PUFA free olive oil (mean age 25 and 55, BMI \< 25). The double-blind, randomized, parallel-designed study will start with a two-weeks run-in period, followed by an eight-weeks supplementation period. After the run-in period, one week and eight weeks of oil supplementation blood will be drawn and 24-h urine will be sampled.

Altogether, the fatty acid distribution after Echium oil and linseed oil supplementation from similar subjects can be statistically analysed.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* cholesterol lowering drugs
* chronic diseases
* pregnancy, lactation
* intake of nutritional supplements
Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function

THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.

To evaluate the effects of artemether/ lumefantrine on the auditory function.


Eligibility Criteria:
Inclusion Criteria

* 12 years of age or older
* P. falciparum parasitemia between 50 and 100,000 parasites/μl
* History of fever or presence of fever (temperature ≥ 37.5°C)

Exclusion Criteria

* Signs/symptoms of severe/complicated malaria
* Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months
* History of any drug-related hearing impairment.
* Abnormal hearing function at study entry
* Exposure to sustained loud noises, by self-report, within the past 24 hours. -- Present ear problems

(Other protocol-defined inclusion/exclusion criteria may apply.)
Designing Animated Movie for Preoperative Period

Background: Using visual materials is effective in education to decrease children's pre-operative fear and post-operative pain. Children, especially those aged between 6 and 12 years, are interested in technology. This study aims to investigate the effects of watching an educational animated movie in the pre-operative period on fear and postoperative pain in children who are having surgery.

Methods: The study was a prospective randomized controlled trial. This study was conducted between 6- to 12-year-old children in the Pediatric Surgery Clinic of Ege University Medical Faculty Hospital. The current study includes data from 132 children who were chosen doing block randomization. The "Child and Family Identification Data Form", "Children's Fear Scale" and "Wong-Baker FACES Pain Rating Scale" was used in data collection. The patients were divided randomly into three groups as the "Educational Animated Movie Group" (EAMG), "Documentary Movie Group" (DMG) and "Control Group" (CG). The Educational Animated Movie and Documentary Movie were screened using Virtual Reality (VR). Data were collected by the researcher in the pre-operative period. The pre-operative fear of the child was evaluated by the child and the parent, and the post-operative pain of the child was evaluated by the child, parent, and nurse using scales about fear and pain.


Eligibility Criteria:
Inclusion Criteria:

* First surgery
* Daily surgery and uncomplicated surgery
* Agree to participate in the study
* Speaking Turkish

Exclusion Criteria:

* Refusal to participate in the study
* A genetic/congenital disease
* A chronic disease
* Second or more surgery
* Not speaking Turkish
A Comparison of Cognitive Training Approaches in Psychotic Disorders

Cognitive remediation (CR) is the best treatment to improve neurocognitive abilities for individuals with psychosis, however, there is no gold standard method of cognitive remediation available. Cognitive training refers to the training component of CR in which people practice computerized exercises that train specific cognitive abilities. There is no agreed upon approach within the field as to the type of training that is most effective with some studies, training higher level cognitive abilities, some training perceptual abilities, and others training general cognitive skills. This study will directly compare two competing methods of cognitive training on measures of neurophysiology, neurocognition, functional competence, and real-world functional performance.


Eligibility Criteria:
Inclusion Criteria:

* psychotic disorder
* No previous cognitive remediation in past 6 months

Exclusion Criteria:

* Brain injury
* Substance abuse
* Neurocognitive disorder
* Developmental Disability
A Comparison of 2-octyl Cyanoacrylate Skin Adhesive and Polyester Mesh for Wound Closure in Total Knee Arthroplasty, A Randomized Controlled Study

The goal of this randomized controlled study is to investigate the Efficacy of Using skin adhesive (Dermabond) and skin adhesive with polyester mesh (Dermabond Prineo )for Wound Closure in Total Knee Arthroplasty, The main question it aim to answer

1 Are skin adhesive alone and with Polyester mesh in Total knee arthroplasty different in Patient satisfaction evaluated by POSAS score

Nowadays, there are many methods of wound closure in Total Knee arthroplasty, such as nylon, skin staple, and sterile strip, which differ in advantages and disadvantages of each technique. However, these methods have the same disadvantages: wound discharge, which may lead to infection, wound separation, and the need for wound dressing. It is also a burden for patients and caregivers. In travelling to change the wound in a hospital, There are many costs in terms of wound dressing equipment, travel costs and time off from work for caregivers to take patients to get wound dressing.

Skin adhesive is an innovation for wound closure in total knee arthroplasty. It reduces the problem of wound separation, with no need for wound dressing.

Skin adhesive mesh has been studied in many studies, showing that it can be used well. Strong It is no different from traditional wound closure; the scar is more beautiful. Patients are more satisfied. But the disadvantage is the high price.

Skin adhesive without polyester mesh has the advantage of being cheaper three times than polyester mesh but less intense than with mesh. This makes it unpopular.

No studies have been found comparing wound dressings with mesh and no mesh After knee replacement surgery.

Therefore, this study is to compare skin adhesive and skin adhesive plus polyester mesh in closure wound total knee arthroplasty.

Are there differences in patient satisfaction Are wound complications such as wound oozing, wound separation, superficial wound skin infection, and contact dermatitis different?

Eligibility Criteria:
Inclusion Criteria:

* OA knee need for Total knee arthroplasty
* Age 50-80 years old

Exclusion Criteria:

* Previous surgery of knee
* History of Keloid, Scar, Psoriasis at the knee
* History of contact dermatitis with skin adhesive
* Cognitive impairment
Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution

This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.


Eligibility Criteria:
Inclusion Criteria:

* Participant is within the approved age range as per labeling recommendations. Participants aged 1 to 3 years who are in the FibroScan subset will not undergo FibroScan assessments until they reach 4 years of age.
* Participant is either on existing Epidiolex therapy for treatment of a seizure disorder or is to be started on Epidiolex for treatment of an Food and Drug Administration (FDA)-approved indication.
* Participant is willing to refrain from strenuous exercise 48 to 72 hours prior to all study visits with the exception of unscheduled visits.
* Any non-pharmacological therapies (e.g., ketogenic diet) must also be stable up to 4 weeks prior to Screening Visit and expected to be stable throughout the duration of the study.

Exclusion Criteria:

* Participant is currently using or within 3 months of screening has used recreational or medicinal cannabis, or synthetic cannabinoid-based medications, not including Epidiolex if currently prescribed.
* Participant is not planning to abstain from using recreational cannabinoids or medicinal cannabis, or synthetic cannabinoid-based medications during the study.
* Female participant is pregnant (positive pregnancy test), lactating or planning pregnancy during the course of the study and for 3 months thereafter.
* Participant has any other significant disease or disorder which, in the opinion of the investigator, may either put the participant, other participants, or site staff at risk because of participation in the study, may influence the result of the study, or may affect the participant's ability to take part in the study
* Participant has diseases or disorders which are associated with liver fibrosis with a FibroScan score of ≥ 6.5 Kilopascals (where FibroScan results are available).
* Positive serology panel (including hepatitis B surface antigen and hepatitis C virus antibody) and/or positive human immunodeficiency virus antibody/p24 antigen screens at screening.
* Following a physical examination, if the participant has any abnormalities that, in the opinion of the investigator, would prevent the participant from safe participation in the study.
* Participant has significantly impaired hepatic function at Screening Visit alanine aminotransferase or aminotransferase \> 3 x upper limit of normal (ULN), and total bilirubin \> 2 x ULN or international normalized ratio \> 1.5.
* Participant is planning to have epilepsy surgery or other major surgery within five years.
* Participant has or plans to have any medical device implanted that is contraindicated for use with FibroScan (only applicable for FibroScan subset), with the investigator consulting with the Sponsor as needed.
* Participation in any clinical trial involving an investigational medicinal product within 3 months prior to the Screening Visit or at any point during this study.
Twice Weekly TP-HDFL for Recurrent or Metastatic Esophageal Cancer

The primary objective of this study is to find out the response rate of twice weekly paclitaxel and cisplatin and weekly HDFL in recurrent or metastatic esophageal carcinoma patients who need palliative Chemotherapy.

The primary objective of this study is to find out the response rate of twice weekly paclitaxel and cisplatin and weekly HDFL in recurrent or metastatic esophageal carcinoma patients who need palliative Chemotherapy. The secondary objectives include overall survival, progression-free survival, and toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven esophageal squamous cell or adenocarcinoma Recurrence or metastasis Measurable disease (\> 1 X 1 cm) by CXR, CT scan or MRI,Age \> 18, KPS \> 60% , Cre \< 1.5mg/dl, AST/ALT \< 3.5 X N, Bil \< 2.0mg/dl WBC \> 4,000/mm3, ANC \> 2,000/ mm3, Plt \> 100,000/mm3

Exclusion Criteria:

* Prior chemo (except as radiosensitizers)Recurrent, treated esophageal lesion only (except \> 2 months)
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies

The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil).


Eligibility Criteria:
Key Inclusion Criteria:

* Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma with life expectancy ≥3 months as assessed by the Investigator
* Eastern cooperative oncology group (ECOG) Performance Score of 0-1
* At least one measurable target lesion per RECIST v1.1.
* Adequate organ and marrow function
* Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing

Key Exclusion Criteria:

* Participants with underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational products hazardous
* Only for Cohort A: Known Human Epidermal Growth Factor Receptor 2 (HER-2) positive tumor
* Known untreated, symptomatic, or actively progressing central nervous system (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
* Discontinued use of prior immune checkpoint therapy due to immune related adverse events; received prior treatment with an anti-TIGIT monoclonal antibody.
* History of trauma or major surgery within 28 days prior to enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.