cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Osteopathy in the Preoperative Treatment of Postoperative Pain in Patients Undergoing Total Knee Replacement

Osteopathy is an alternative healthcare that seems effective in relieving the pain of patients. The main purpose of this study is to evaluate the efficacy of preoperative osteopathic care in patients undergoing total knee arthroplasty (TKA) for osteoarthritis. The secondary objectives are to assess pain during the first postoperative month on a VAS and knee function and quality of life at 6 months and 1 year. Our hypothesis is that osteopathy will decrease postoperative pain and increase knee function.


Eligibility Criteria:
Inclusion Criteria:

* Primary total knee arthroplasty (TKA)
* For osteoarthritis of the knee
* Without surgical history on the operated knee

Exclusion Criteria:

* Previous surgery on the operated knee
* Bilateral TKA
* Patient refusal
Confocal Microscopy Dual Band in the Management of Bladder Cancer

Bladder cancer is one of the most common cancer worldwide and the second most frequent urological cancer. The photodynamic diagnosis technique (PDD) currently used (Hexvix®) has improved tumor detection but with a high false positive rate. Indeed, the main limitation of the PDD is its lack of specificity, ranging from 35 to 66%. The association of this technique with new technologies such as the Cellvizio Dual Band featuring simultaneous dual wavelength illumination and detection, could improve the identification of tumoral lesions. The objective of this study is to demonstrate the efficacy of Cellvizio dual band technique for the diagnosis of tumors bladders.


Eligibility Criteria:
Inclusion Criteria:

* Patients having 18 years old or more
* Patients with a bladder carcinoma and with indication of tumor resection under Hexvix procedure.
* Patients giving consent to participate in the study

Exclusion Criteria:

-No consent to participate in the study
Growth and Asymmetric diMethylArginine

Principal objective : Validation of a handy biochemical parameter, plasma concentration of Asymmetric DimethylArginine (ADMA), based on a recognize biochemical parameter, the dilation of the brachial artery, at ultrasound examination, after the deflation of a cushion to evaluate artery dysfunction (vascular suffering) in growth diseases, growth hormone deficiency (GHD) and intrauterine growth retardation (IUGR)

Secondary objectives:

* Comparison of ADMA plasma concentrations with dose of matched healthy control children
* Investigation of the mechanisms of arterial dysfunction, inflammation, oxidative stress and insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Group A: GHD, defined by 2 GH peaks less than 6.6 ng/ml (20 mU/L) at two stimulation tests
* Group B: IUGR, defined by a birth length and/or a birth weight inferior to - 2 SD for gestational age according to Usher and McLean charts
* Group C: Control children matched to children matched to subjects of groups A and B, according to gender and age
* Informed consent signed by representative of the parental authority

Exclusion Criteria:

* Chronic disabling disease (ex: diabetes, severe asthma)
* Evolving cancer
* Severe psychiatric disorder (ex: autism, schizophrenia; severe depression)
* Hypothalamic tumor (ex: craniopharyngioma)
* Anamnesis of cranial irradiation
* Overweight, obesity or thinness
* Precocious puberty
* Non-replacing therapy by glucocorticoids or sex steroids less than 1 month before the exploration
* Anterior treatment by recombinant human GH
* Other conditions, treatments or habits impacting arterial reactivity: acrocyanosis, cryoglobulinemia, beta adrenergic blocking habits, tobacco smoking or other drug addictions, dyslipidemia
* Pregnancy or lactation
* Acute infection less than three weeks before the investigation
* Participation to a therapeutic protocol
* Impossibility for the representatives of the parental authority to understand the objectives of the protocol
* Absence of social security coverage. Refusal by the parents to sign the informed consent or oral refusal by the child to participate to the study
Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism

The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.

Single masked, open label, randomized, bilateral, crossover study design comparing comfilcon A against lotrafilcon B lenses over 1 month of daily wear for each study lens. Each subject will be randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft toric contact lens wearer
* Has a contact lens spherical prescription between +6.00 to - 10.00 (inclusive)
* Have no less than 0.75diopter (D) of astigmatism and no more than 2.25D in both eyes.
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter.
* Patient contact lens refraction should fit within the available parameters of the study lenses.
* Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so).
* Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Has a contact lens prescription outside the range of the available parameters of the study lenses.
* Has a spectacle cylinder less than -0.75D or more than -2.25 D of cylinder in either eye.
* Has a history of not achieving comfortable contact lens wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
* Presence of clinically significant (grade 2-4) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
* Slit lamp findings that would contraindicate contact lens wear such as:

  * Pathological dry eye or associated findings
  * Pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GCP) worse than grade 1
  * Anterior uveitis or iritis (past or present)
  * Seborrheic eczema, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea.
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
* Has undergone corneal refractive surgery.
* Is participating in any other type of eye related clinical or research study.
COMbination of Clopidogrel and Aspirin for Prevention of Early REcurrence in Acute Atherothrombotic Stroke

Primary objective:

* Comparison of efficacy of the combination therapy (clopidogrel plus aspirin) and the aspirin alone (main comparison) to prevent any recurrent ischemic lesion .

Secondary objectives:

* Comparison of Modified Rankin scale (mRS) scores;
* Comparison of the Incidence of all kinds of stroke and vascular death;
* Comparison of the Incidence of bleeding episodes (major and minor) and symptomatic intracerebral hemorrhages during the follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke diagnosed within 48 hours from symptom onset;
* Cerebral ischemic lesion observed on diffusion-weighted magnetic resonance imaging (DWI MRI);
* Relevant atherothrombotic lesions on magnetic resonance angiography (MRA) or computed tomography angiography (CTA);
* Study drug administration within 48 hours from symptom onset;
* mRS score is 0-2 before the stroke.

Exclusion Criteria:

* Evidences of other relevant brain lesions such as Intracerebral hemorrhage (ICH) or brain tumor;
* Suspicious of stroke due to small-vessel occlusion;
* Stroke due to cardioembolism;
* Clinical necessity of conventional angiography or intervention before the end of study;
* Past history of ICH;
* Bleeding diathesis or coagulopathy;
* Chronic anemia (Hb\<8.0) or thrombocytopenia (PLT\<100K);
* Chronic liver disease (AST\> 100 or ALT\>100);
* Any other clinically relevant serious disease, including renal failure ( creatinine clearance\<30mL/min);
* Allergy to Aspirin or clopidogrel;
* Subjected to intervention or surgical treatments within 3 months;
* Thrombolysis performed with rt-PA or UK after the stroke;
* Participation in another clinical study within the previous 30 days;
* Suspicious of poor drug compliance and requirements of the protocol;
* Females who are pregnant, breast-feeding, or childbearing potential and not using medically acceptable and effective contraception.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Pulmonary Determinants of Cardiorespiratory Fitness in Fontan Patients

This study will examine and record the patient's medical information and medical records (patient files, computer records, etc.). Physical examination, echocardiographic, electrocardiographic, laboratory, radiological, etc. evaluations are made during the routine controls of the patients. Within the scope of this study, no attempt will be made on the patients, no additional tests will be performed, or treatment changes will not be made in the patients because they are included in this study. After these records, KPET will be performed by a specialist doctor and physiotherapist for the patients who are directed to the Faculty of Physical Therapy and Rehabilitation Cardiopulmonary Rehabilitation Unit. Pulmonary function tests and respiratory muscle strength measurements will be performed on patients who have adequate rest after CPET.


Eligibility Criteria:
Fontan Group Inclusion Criteria:

* Be between 8-55 years old
* Having undergone a Fontan operation
* Clinical stability of the patients (preserved ventricular function)
* No change in ongoing drug therapy that adversely affects clinical stability
* At least 1 year after the operation

Fontan Group Exclusion Criteria:

* Neurological and/or genetic musculoskeletal disease
* Having orthopedic and cognitive problems that prevent testing
* The patient's and/or family's unwillingness to participate in the study

Control Group Inclusion Criteria:

* Not have cardiovascular, neurological, and/or genetic musculoskeletal disease
* Not having orthopedic and cognitive problems that prevent testing
* The patient's and/or family's willingness to participate in the study
Topical Tranexamic Acid Plus Bilateral Uterine Artery Ligation During Cesarean Delivery

Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 200 live births. It is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy. PPH due to PP typically starts during cesarean section (CS) in the placental bed, at the lower uterine segment mostly after placental separation. Proceeding for cesarean hysterectomy can be the only effective line of management in spite of the associated high morbidity rate.

Various conservative measures have been developed to avoid hysterectomy and preserve fertility in patients with PP. Bilateral Uterine artery ligation (BUAL) is one of the reported surgical procedures carried out in these cases as it is easy and quick. It can be used alone or with adjunctive measures with a fair success rate. The aim is to reduce the blood supply to the uterus and to prevent postpartum hemorrhage.

Tranexamic acid is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the binding of plasmin and plasminogen to fibrin. The rationale for its use in the reduction of blood loss depending on the implication of the coagulation and fibrinolysis processes implicated in the control of PPH. However, concerns about possible thromboembolic events with parenteral administration of TA have stimulated increasing interest in its topical use.

Study inclusion criteria will be women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures Eligible participants were allocated to one of two groups. Group (I): patients managed by bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures. Group (II): patients received 1 gm TA (2 ampoules of Capron® 500 mg /5 ml; Cairo, Egypt) topically applied to the placental bed plus BUA when not respond to uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures.

Eligibility Criteria:
Inclusion Criteria:

* women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures

Exclusion Criteria:

* patients with the high possibility of morbid adherent placenta
* those presented with severe antepartum hemorrhage
* Patients with cardiac, hepatic, renal, or thromboembolic disease;
* hypersensitivity or contraindications of use of tranexamic acid
* patient refuses to consent
Neuromuscular Electrical Stimulation and Ultrasound Therapies , Knee Osteoarthritis

To determine the effects of ultrasound therapy and neuromuscular electrical stimulation on the muscle architecture and functional capacity of patients with knee osteoarthritis.

All participants who were satisfied with the inclusion criteria were randomly assigned to one of two study groups: Group 1- ultrasound therapy group; Group 2 - the neuromuscular electrical stimulation group. Group allocation was randomized in two blocks of 30 sealed envelopes without external marks, which were mixed and numbered from 1 to 30, containing a piece of paper with the group allocation. The researchers responsible for outcome measures and ultrasonograhic measurements were blinded to the patients' diagnosis or intervention.

Eligibility Criteria:
1. Inclusion Criteria:

   Clinical diagnosis of knee osteoarthritis
2. Exclusion Criteria:

Cardiovascular diseases

Inflammatory diseases

Infectious diseases

Lower extremity weakness

Tumoral diseases

Knee surgery in the past six months

Intra-articular injection in the past six months
Determination of Catheter Contact by Evaluation of Microelectrode Near-Field Signals

Successful radio frequency (RF) cardiac catheter ablation requires the creation of lesions by delivering energy while maintaining adequate catheter contact with the endocardium. Unfortunately, it is difficult to identify contact intraoperatively as a typical RF ablation catheter lacks clear indications of contact. We propose to use the Boston Scientific IntellaTip MiFi catheter to explore whether characteristics of the electrograms produced by the mini-electrodes on the ablation tip could help confirm tissue contact. Using an ultrasound catheter to define instances of clear contact and non-contact, we will determine whether the micro-electrodes produce sufficient information to confirm catheter contact. We propose that the MiFi catheter produces sufficient signal characteristics that can be used as an effective surrogate for adequate tissue contact.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of typical atrial flutter
* Subject is clinically indicated for right sided atrial flutter ablation
* Patient is willing and able to understand and sign the informed consent document
* Patient is over 18 years of age
* Patient is willing and able to comply with the study protocol

Exclusion Criteria:

* Patient has one of the following cardiac comorbidities: hypertrophic cardiomyopathy, structural heart disease, congestive heart failure
* Patient has history of the following arrhythmias: ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White syndrome
* Patient has a contraindication to right atrium ablation, including but not limited to: right atrial thrombus, active systemic infection, or a coagulopathy.
DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty

This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a drug used in patients with bleeding disorders. It works by activating molecules in the blood stream called platelets that promote clotting. In the study, participants who are have cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive medication. Photographs taken before and shortly after surgery will be evaluated for the amount of bruising and swelling. Patients with heart, lung, kidney, or liver problems are not eligible to participate.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing Rhinoplasty where nasal bone osteotomy is necessary

Exclusion Criteria:

* Heart Disease
* Renal Disease with decreased GFR
* Liver Disease
Efficacy Vulvovaginitis Candida

To compare the therapeutic efficacy of 10 mg, 40 mg, 80 mg, 160 mg and 320 mg of albaconazole, as a single oral dose, in women affected by acute non-complicated vulvovaginitis due to Candida spp.

Multi-center, open-label, randomized study, controlled with fluconazole.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients over 18 years of age, with a vaginal score sum ³ 2 and KOH fresh examination positive for yeasts (hyphae, pseudohyphae). The diagnosis must be later confirmed with a positive Candida spp. culture.

Exclusion Criteria:

* Patients with recurrent disease, prior treatment with antifungal agents within the last 7 days, immunosuppression, pregnant or lactating women, other vulvovaginal diseases, other systemic diseases, hypersensitivity to azole derivatives.Number of patients: 78 patients included to obtain 60 evaluable patients
Advanced Gastrointestinal Endoscopic Imaging

To develop new methods to detect malignant and premalignant conditions of the gastrointestinal tract.


Eligibility Criteria:
Inclusion Criteria:patients be at least 18 years of age,

Either genders

All ethnic backgrounds will be considered.

Patients who are scheduled for endoscopy by one of the investigators will be asked if they are interested in participating in the study.

The study will be open to all patients undergoing endoscopy that do not have exclusion criteria. We will ask all patients if they are participating in any other studies. If they are participating in any other study then we will ask them for more information to determine whether there could be any harm from participating in both studies and if there is then they will not be enrolled. Exclusion Criteria:Patients with unstable vital signs will not be included.
Efficacy and Safety Study of VB-1953 Topical Gel for Inflammatory Facial Acne Vulgaris

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Dose-ranging Study in the Treatment of Acne Vulgaris,

This will be a Phase 2, multicenter, randomized, double-blinded, dose-ranging, parallel arm comparison study in male and non-pregnant female subjects, 9 through 45 years of age (inclusive) with facial acne vulgaris. This dose-ranging study, intended to identify the dose(s), will consist of 7 study visits over 14 weeks:

Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females 9 to 45 years of age (inclusive) at the time of consent/assent.
* Have a clinical diagnosis of moderate to severe (Grade 3 or 4) facial acne vulgaris, as determined by the Investigator's Global Assessment (IGA).
* Have 20 to 50 inflammatory lesions (papules, pustules) on the face.
* Have 20 to 60 non-inflammatory lesions on the face.

Exclusion Criteria:

* Has more than two (2) facial nodulocystic lesions.
* Female subject is pregnant, lactating, or is planning to become pregnant during the study.
* Has active nodulocystic acne or acne conglobata, acne fulminans, or other forms of acne (e.g., acne mechanica). In the opinion of the Investigator, the subject has a skin pathology or other medical condition that is clinically significant (e.g., obesity) and will preclude participation in the study.
* Has presence of any skin condition on the face (e.g., rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acnetiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis) in the opinion of the Investigator that could interfere with the diagnosis or assessment of acne vulgaris or evaluation of the investigational product (IP) or requires the use of interfering topical or systemic therapy.
* Not willing to minimize or avoid natural and artificial sunlight exposure during treatment.
A Randomized Comparison of Intraoperative Warming With the LMA PerfecTemp and Forced-air

Recently, a novel posterior heating system has been developed that provides enhanced pressure relief: the Laryngeal Mask Airway (LMA) PerfecTemp. Anactodal experience with this FDA-approved system suggests that the PerfecTemp warmer is effective, even in open abdominal surgery. The investigators therefore propose to test the hypothesis that intraoperative distal esophageal (core) temperatures with PerfecTemp warming are non-inferior to upper-body forced-air warming in patients undergoing open major abdominal surgery under general anesthesia.

Secondary hypotheses include that:

1. intraoperative core temperatures are superior with PerfecTemp than upper-body forced-air warming
2. final intraoperative core temperature is non-inferior with PerfecTemp than upper-body forced-air warming
3. final intraoperative core temperature is superior with PerfecTemp than upper-body forced-air warming.


Eligibility Criteria:
Inclusion Criteria:

* Body-mass index 20-36 kg/m2
* Age 18-75 yrs
* ASA Physical Status 1-3
* Supine position (with or without lithotomy)

Exclusion Criteria:

* Pre-operative fever
* Serious skin lesions
* And contraindication to either PerfecTemp or forced-air warming
Dosage Study for Vigamox Eye Drops Prior to Intravitreal Injections

Antibiotic eye drops are being used before and after intravitreal injections. Currently there is no study indicating the benefit of there usage or their dosage.

In this study we compare the efficacy of Vigamox eye drops (antibiotic)starting 3 days prior to the injection versus 1 day prior to intravitreal injection.


Eligibility Criteria:
Inclusion Criteria:

* Patient who need intravitreal injections patients who are willing to participate in the study

Exclusion Criteria:

* Patients who are allergic to Vigamox or who have taken any eye drops within the past 3 weeks