cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Effects of Single Versus Triple Injections of Platelet-Rich Plasma in Patients With Knee Osteoarthritis

80 patients diagnosed with knee osteoarthritis were randomized into two groups: patients in Group 1 received a single intraarticular injection of PRP whereas those in group 2 were administered three intraarticular injections of PRP within an interval of 2 weeks between each application. Patients were evaluated before the treatment and at the 6 month after the treatment with a Visual Analog Scale (VAS) and The Western Ontario and MacMaster Universities (WOMAC) Osteoarthritis Index.


Eligibility Criteria:
Inclusion Criteria:

* ages of 35 and 80
* Kellgren-Lawrence grade of 2, 3, or 4

Exclusion Criteria:

* rheumatic diseases, coagulopathies, severe cardiovascular diseases, local infections, malignancies, immunodeficiency, schizophrenia, mental retardation, anticoagulant therapy, a hemoglobin concentration of 11 g/dL and platelets of 150,000/L, a history of severe trauma, or a history of hyaluronic acid or corticosteroid injection within the previous 6 months
A Study of INS365 Ophthalmic Solution in Patients With Moderate to Severe Dry Eye Disease

To evaluate the efficacy and safety of INS365 Ophthalmic Solution when applied topically in patients with moderate to severe dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Best corrected visual acuity of at least +0.7 ETDRS
* Six month history of dry eye disease
* Mild severity in two out of five symptoms
* Unanesthetized Schirmer score of less than or equal to 7mm
* Corneal fluorescein staining greater than or equal to 4 out of 15 or lissamine green conjunctival staining of greater than or equal to 5 out of 18

Exclusion Criteria:

* Nasal stimulated Schirmer score of less than 3mm
* Have ongoing ocular infection
* Have congenitally absent meibomian or lacrimal glands
* Have had punctal occlusion within a specified time prior to study
* Wear contact lens and refuse to remove them
* Have other excluded eye conditions.
Efficacy of Gingival Grafts During the Implantation Process on the Peri-implant Mucosa

This study aims to compare the changes in the peri-implant mucosa during the application of two soft tissue grafting methods, which are free gingival graft (FGG) and connective tissue graft (CTG) taken from the palatine in terms of the width of the keratinized mucosa and the thickness of the peri-implant soft tissues.

The presence of adequate width of the keratinized gingiva may be necessary in some special cases such as the presence of fixed prostheses on the teeth with sublingual margins or peri implants. There is an association between insufficiency of the keratinized tissues peri implants with greater plaque accumulation, signs of inflammation, soft tissue recession, and loss of attachment. The sample will consist of 33 dental implant sites and divide randomly into three groups: Group I (Experiential, n=11): FGG; Group II: (Experiential, n=11): CTG; and Group III: (Control, n=11): No procedure will be done to improve the quality of the peri-implant tissues. The width of the keratinized gingiva will be measured preoperative with a UNC-15 and the thickness of the peri-implant soft tissues will be measured clinically by direct transgingival propping method. These measurements will be repeated after 1 and 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. patients who have lost posterior teeth (premolars or molars).
2. A decrease in the amount of keratinized gingiva (less than 2 mm from the alveolar process to the mucogingival junction).
3. good oral health (plaque index ≤1).

Exclusion Criteria:

1. heavy smokers (more than 10 cigarettes per day)
2. uncontrolled diabetes or other systemic diseases.
Fatty Liver Response of Cardio-metabolic Risk Factors to Laser Acupuncture Versus Cupping

Every-two-week applied cupping (with scarification) session within one month on back of upper thorax is not compared previously regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) in fatty liver patients. This trial will compare the two procedure effects on cardio-metabolic risk factors in fatty liver.

In fatty liver patients,every-two-week applied cupping (with scarification) session within one month on back of upper thorax for 30 patients will be compared regarding its effect on cardio-metabolic risk factors to the daily application of laser on acupoints (for month, except Fridays) of other 30 patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed Fatty liver patients by ultrasonography
* Class I obese patients

Exclusion Criteria:

* Cardiovascular and respiratory disorders/diseases.
* Autoimmune disorders/diseases.
* Pregnancy
* Other liver disorders/diseases.
Clinical Trials for the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer

This study evaluates the efficacy and safety of DWJ1319 in the prevention of gallstone formation after gastrectomy in patient with gastric cancer. Two-thirds of the participants will receive DWJ1319, while the other will receive a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 19 years of age
* Patient who undergoes gastrectomy (total, distal or proximal gastrectomy)
* D1+ or D2 lymph node dissection
* Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
* Written informed consent

Exclusion Criteria:

* Patients with cholangitis, cholecystitis, non-functional gall bladder, or biliary obstruction
* Presence of gallstones on ultrasonography and/or CT
* History of previous cholecystectomy
* Patients undergoing pylorus-preserving gastrectomy
* Pregnant or lactating women and fertile women who is not using proper contraceptive method
* Patients with history of drug or alcohol abuse within 5 years ago
DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC

The main objective is to evaluate the value of dynamic contrast-enhanced Magnetic Resonance Imaging (DCE-MRI) in prediction of response of patients with hepatocellular carcinoma (HCC) to treatment with Sorafenib assessed by mRECIST.

One of the secondary objectives was to evaluate the correlation between DCE-MRI perfusion parameters at baseline and:

* Overall Survival (OS)
* Progression-Free Survival (PFS)
* Time to Progression (TTP)

Three DCE-MRI examinations were done during the study:

* at the enrolment and initiation of the sorafenib treatment
* one week after initiation of the sorafenib treatment
* two weeks after initiation of the sorafenib treatment

DCE-MRI perfusion parameters were assessed by a centralized radiologist at baseline (corresponding to the day of enrolment and initiation of Sorafenib treatment), week 1 and week 2.

According to mRECIST criteria, HCC lesions were evaluated on computed tomography images by two on-site radiologists at the time of enrolment and 8 weeks later (2 months). OS, PFS and TTP were calculated from survival and tumor progression data recorded one year after initiation of the sorafenib treatment.

Eligibility Criteria:
1. Male and female adult patients (age ≥ 20 years old)
2. Patients diagnosed with unresectable HCC \[Child Pugh class A and major vascular invasion, extrahapatic metastasis, or progression after transarterial chemoembolization more than 2 times\]
3. Presence of mRECIST target lesion within liver \[lesion which can be classified as a RECIST measurable lesion (can be measured ≥ 1 cm in at least one dimension), lesion suitable for repeated measure, lesion showing intraluminal arterial enhancement on contrast-enhanced CT or MRI\]
4. Patients planned to be treated with sorafenib
5. Patient with liver CT performed or planned to be performed within 4 weeks before initiation of sorafenib treatment
6. Patient with a life expectancy of 12 weeks or more
7. No previous treatment with sorafenib
8. Female patients who are surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea) or who have a documented negative urine hCG test at screening
Pilot Study of Warm Acupuncture in Treatment of Cold-sensitive Fibromyalgia Syndrome

Non-pharmaceutical therapies, such as acupuncture, hydrotherapy, and meditative exercises (such as Qigong (including Tai Chi and Ba-Duan-Jin), have been shown to reduce pain and improve physical function. The management recommendations of fibromyalgia issued by the European Union, Canada, Germany and Israel have all affirmed the "first-line" role of Non-pharmaceutical therapy. Because of its good efficacy and safety, acupuncture therapy has been recommended in the management guidelines and has broad application prospects. Warm acupuncture is a therapy combining acupuncture and moxibustion, which is widely used in the treatment of various painful diseases in China, especially for cold-sensitive patients . This study aims to observe the safety and effectiveness of warm acupuncture in the treatment of cold-sensitive fibromyalgia patients, in order to provide a more alternative non-drug therapy for this particular type of patients with fibromyalgia .


Eligibility Criteria:
Inclusion Criteria:

1. Meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia;
2. Be over 18 years of age;
3. The type and dose of drugs used for fibromyalgia should be stable for at least 2 weeks;
4. The VAS score of item 10 (sensitivity to cold) in FIQR scale ≧4 points;
5. Sign informed consent.

Exclusion Criteria:

1. Patients suffering from systemic or local acute infectious diseases;
2. Patients with severe visceral diseases or physical weakness who cannot tolerate acupuncture treatment;
3. Pregnant women.
Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)

The primary objective of the study is to assess the efficacy of intravitreal (IVT) aflibercept compared to sham treatment in the improvement of moderately severe to severe nonproliferative diabetic retinopathy (NPDR).

The secondary objectives of the study are:

* To characterize the safety of IVT aflibercept in patients with moderately severe to severe NPDR
* To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and reduce the incidence of DME
* To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR


Eligibility Criteria:
Key Inclusion Criteria:

1. Men or women ≥18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe nonproliferative diabetic retinopathy (NPDR) \[(diabetic retinopathy severity scale (DRSS) levels 47 or 53)\], confirmed by the central reading center, in whom panretinal photocoagulation (PRP) can be safely deferred for at least 6 months per the investigator
2. Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)

Key Exclusion Criteria:

1. Presence of diabetic macular edema (DME) threatening the center of the macula in the study eye
2. Evidence of retinal neovascularization on clinical examination or Fluorescein Angiography (FA)
3. Any prior focal or grid laser photocoagulation or any prior PRP in the study eye
4. Any prior systemic anti-vascular endothelial growth factor (VEGF) treatment or intravitreal (IVT) anti-VEGF treatment in the study eye
5. Any prior intraocular steroid injection in the study eye
6. Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye

Note: Other inclusion/ exclusion criteria apply
Prediction of Spontaneous Onset of Labor at Term

The study intends to develop a predictive model of spontaneous onset of labor between 39 and 41 weeks of pregnancy in women carrying singletons and without indication of delivery before this date. The main hypothesis is that a combination of clinical, ultrasonographic, biochemical and/or biophysical variables will allow to differentiate women who will spontaneously trigger their labors from those who will require an induction by the term of their pregnancies. A tool of this kind should aid in the individualization of the management of the final weeks of pregnancy and, at the light of recent evidence, provide support to the decision-making processes.


Eligibility Criteria:
Inclusion Criteria:

* Alive fetus
* Singletons
* Cephalic presentation
* Intact membranes
* Gestational age ≥ 38 weeks and 5 days

Exclusion Criteria:

* Fetal malformations
* Symptomatic uterine contractions
* Contraindication for vaginal delivery
* Medical indication of induction of labor or elective cesarean delivery
* Maternal desire to induce labor
* Maternal negative to enrollment
* Language barrier
* Inability to give consent

Specific Exclusion Criteria for Pregnolia System (if any of these criteria is present, the measurement of cervical stiffness using Pregnolia aspiration device will not be performed):

* Müllerian anomalies with two cervices
* Severe vaginal bleeding
* Cervical dilatation
* Known HIV
* Visible, symptomatic cervical or vaginal infections
* If one of the following conditions is present on the cervix at the 12 o'clock position:

  * Nabothian cyst
  * Cervical myomas
  * Cervical condylomas
  * Squamous intraepithelial lesion
  * Conization/LEEP2/LLETZ3
  * Cervical endometriosis
  * Cervical tears
  * Cervical dysplasia
  * Large ectopy, for which it is not possible to find a suitable location near the ectopy where native tissue is present
  * Large scar tissue, for which it is not possible to find a suitable location near the scar where native tissue is present.
Developing A Validated Measure of the Impact of Psoriasis on Chronic Quality of Life

Objective of the study is to create and validate Chronic Quality of Life (CQOL) index that explores habits, career paths and other life choices psoriasis patients make as a result of coping with their disease that may not be impacted by therapy implemented at a given point in time.

- The investigators think this data will show that patients who were diagnosed at a young age will have worse chronic quality of life.

As a visible disease, psoriasis can be embarrassing and psychosocially stressful in addition to physically uncomfortable. Patients' lives are affected in physical, psychological, social, sexual and occupational aspects. These burdens may cause patients to assume maladaptive habits and coping mechanisms, leading to a downward spiral in functioning within society, prohibiting patients from achieving their highest potential quality of life.

The investigators' study goal is to create and validate Chronic Quality of Life (CQOL) index that explores habits, career paths and other life choices psoriasis patients make as a result of coping with their disease that may not be impacted by therapy implemented at a given point in time. In creating this questionnaire and validating it the investigators will collect preliminary data. The investigators think this data will show that patients who were diagnosed at a young age will have worse chronic quality of life. In the long run, the investigators will use the CQOL index in studies in which patients are treated for psoriasis to determine which treatments can change a psoriasis patient's chronic quality of life. This information will be used to create guidelines for treatment focused on achieving a patient's optimal quality of life.

Another aspect that the investigators would like to look at is the skin carotenoid levels in the psoriasis population. Previous studies showed that psoriasis patients had lower levels of skin carotenoids when compared to healthy volunteers. This observation was not statistically significant perhaps due to a small sample size (21 subjects in the psoriasis group and 35 subjects in the control group). Skin carotenoid levels measurement is optional for study subjects.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign informed consent
* Able to read English
* Able to comply with study procedure
* Male or female of at least 18 years of age
* Has a diagnosis of psoriasis

Exclusion Criteria:

* Has any medical condition that might interfere with ability to complete CQOL survey
The Effect of Placental Spontaneous Delivery Versus Manual Removal on Blood Loss During Cesarean Section. A Comparative Study

The mode of placental delivery may contribute to an increase or decrease in the morbidity associated with CS, and many studies have shown it to be a key role in determining the blood loss during CS. Manual removal of the placenta has been implicated in increased blood loss during CS. However, other researchers concluded that it had no detrimental effect on blood loss


Eligibility Criteria:
Inclusion Criteria:

* Age (18 - 35) years.
* Primigravida.
* Unscarred uterus.
* Singleton pregnancy.
* Living baby.
* Body mass index (18 - 30) 37-40 weeks

Exclusion Criteria:

* Emergency cesarean section due to possibility of maternal distress and blood loss.
* Cesarean hysterectomy as the placenta will be removed with the uterus.
* Abnormally adherent placenta: Placenta accrete, percreta or placenta previa due to failure of placental separation.
* Previous cesarean section as the previous scar may affect placental separation.
* Body mass index less than 18 and more than 30 as extremes of body weight may be associated with increased risks of anemia, bleeding and/or infection.
* Suspected chorioamnionitis to decrease the risk of disseminated infection.
* Bleeding disorders to decrease blood loss.
* Multiple pregnancy due to larger placental volume and blood loss compared with singleton.
* Any pelvic surgery (Appendix - Ovarian cyst. - Ectopic Pregnancy - pelvic abscess)
* Women with medical illness e.g. pre-eclampsia, anemia (Hb less than 11 gm/dl), DM, Cardiac, Renal ...etc. to decrease the risk of maternal morbidity.
Glucocorticoid-induced Osteopenia in Children

The purpose of this study is to characterize the skeletal deficits and risk factors for impaired skeletal development in children requiring glucocorticoid therapy.

We will compare the bone health of children treated with prednisone for nephrotic syndrome (NS with those treated with prednisone for Crohn's Disease (CD). Childhood NS usually responds to prednisone and is not characterized by pathologies that can impact on bone. In contrast, CD is treated with prednisone, but is independently associated with poor growth and maturation, nutritional deficiencies and inflammation. Due to the differences in the diseases, this comparison will allow us to distinguish between the prednisone-related and disease-related effects on bone in the two disease states.

Prednisone, a glucocorticoid medication, is widely used for many pediatric disorders. Studies have shown that this drug decreases bone formation, decreasing bone density and bone thickness in children. Prednisone induced osteopenia, or low bone density, can be worsened by the effects of the underlying disease, such as delayed growth and maturation, malnutrition, and increased bone resorption (removal) by inflammatory compounds. The combined effects of decreased bone formation and increased resorption may be particularly detrimental to the growing skeleton.

Subjects will include 15 newly diagnosed NS patients, 60 patients with pre-existing NS, 90 patients with newly diagnosed CD, 45 patients diagnosed within the last two years and 200 healthy controls of similar age, gender and ethnicity. Participants will visit the Children's Hospital of Philadelphia (CHOP) three times over a 12-month period for assessment of bone mineralization and turnover, fracture history, dietary calcium intake, physical activity, growth, body composition, muscle strength and glucocorticoid exposure.

Eligibility Criteria:
Inclusion Criteria:

* ages 5-21
* clinical and pathological diagnosis of Crohn's Disease within the last 2 years
* clinical diagnosis of nephrotic syndrome and taking corticosteroids within the last year
* normal renal function GFR\>75 ml/min/1.73m2
* healthy controls

Exclusion Criteria:

* other major medical conditions affecting growth and/or bone health
* significant cognitive or developmental disorders (if child is unable to cooperate sufficiently)
* nonambulatory
Comparison of Noninvasive Vs. Invasive Hemodynamic Measurements

Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.

The conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. To overcome this challenge, a new technology to assess CVP non-invasively using an oscillometric method is being developed. It is called enclosed zone central venous pressure (ezCVP). A comparison study of ezCVP and CVP is needed to determine accuracy and reproducibility.

Eligibility Criteria:
Inclusion Criteria:

1. Adult age over 18 years.
2. Arm circumference is 18 cm to 55 cm
3. Subject will have an existing indwelling central venous catheter during their ICU stay
4. Subject or legally authorized representative (LAR) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent
5. Subject or LAR is willing and able to comply with protocol procedures

Exclusion Criteria:

1. Finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff.
2. Pregnant (self-reported)
3. Upper extremity deep venous thrombosis currently being treated
4. Severe skin disease involving the upper arm(s)
5. Study investigator may exclude patients based on clinical judgement