cyrilzakka/clinical-trials huggingface dataset:
Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage

The purpose of this research is to compare patients with aneurysmal subarachnoid hemorrhage on dexmedetomidine compared to propofol to assess if one group has decreased inflammation. The investigators hypothesis is that the group assigned to receive dexmedetomidine will have a more profound decrease in markers of inflammation over time.


Eligibility Criteria:
Inclusion Criteria:

* Aneurysmal subarachnoid hemorrhage
* World Federation of Neurological Surgeons (WFNS) grade 4-5 (see table below)
* Surgical intervention with clip or coil
* Placement of cerebrospinal fluid drain (lumbar or ventricular)
* Mechanically ventilated at start of infusion

Exclusion Criteria:

* Hemodynamic instability (SBP \< 100, HR \<60, or on continuous infusion of catecholamines) at screening
* Heart failure class III or IV (New York Heart Association)
* Renal failure (RIFLE classification - see table below)
* Liver failure (serum protein \< 3 g/dL and total bilirubin \> 5 mg/dL)
* Known or suspected brain death
* Pregnancy
* Unable to receive dexmedetomidine within 48 hours of injury and 4 hours of surgery
* Allergy to dexmedetomidine
* Prisoners
Pancreatic Duodenal Homeobox Factor-1 (PDX-1) and Neurogenin-3 (NGN-3) in Gestational Diabetes

Introduction: Depletion of the ability of the cells ß to secrete the amount of insulin required by pregnancy, increasing the risk of develop Gestational Diabetes Mellitus (GDM). The aim was to contrast the messenger RNA (mRNA) expression of the pancreatic duodenal homeobox factor-1 (PDX-1) and Neurogenin-3 (Ngn-3) in peripheral blood of pregnant women with GDM versus women with normal pregnancies.

Material and methods: This was a prospective, clinical and cross-sectional study, conforming two groups of pregnant women: a) patients with a healthy gestation and b) patients with GDM. Besides anthropometry and routine laboratorial test, real-time polymerase chain reaction (Real-Time PCR), was used to quantify the expression of PDX-1 and NGN-3.

Pregnant women attended in the Maternal-Fetal Medicine Service of the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital, were invited to participate. Those with autoimmune diseases, heart disease, nephropathy, liver disease or any other chronic condition were excluded and those with incomplete clinical files were discarded from the final analysis. Two groups were integrated: a) patients with a healthy gestation and b) patients with GDM.

From all patients the next information was captured in an excell sheet: weight, height, Body Mass Index, blood pressure, albumin, creatinine, electrolytes, glucose, total cholesterol, triglycerides, transaminases and relative expression of PDX-1 and NGN-3.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women older than 18 years old.

Exclusion Criteria:

* Those with autoimmune diseases, heart disease, nephropathy, liver disease or any other chronic condition.
Evaluation of 3D Michigan Appliance

* 20 patients will be divided into 2 groups
* Group 1 : in which conventional appliance will be constructed after alginate impression
* Group 2 : in which 3d printed appliance will be constructed after intra-oral scanning


Eligibility Criteria:
Inclusion Criteria:

* Patient with bruxism
* Trigger points
* Medically stable

Exclusion Criteria:

* • absence of other TMJ problem
First in Human Study of Winsor Laser Catheter: A Prospective Registry to Evaluate The Safety and Performance of the Winsor Laser Catheter in the Treatment of In-Stent Restenosis

The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)


Eligibility Criteria:
Inclusion Criteria:

1. Patient age ≥ 18 years.
2. Rutherford Category 2-4.
3. Subject has been informed of the nature of the study, agrees to participate and has signed an Ethics Committee approved informed consent form.
4. Documentation of significant ISR defined as \>50% stenosis and \>5 cm in length determined by diagnostic angiogram or duplex ultrasound.
5. A previously deployed bare nitinol stent(s) in the femoropopliteal segment extending from the ostium of the SFA to 1 cm above the tibioperoneal trunk. A guidewire has successfully traversed the target treatment segment, or is able to cross using standard support catheter crossing techniques, is angiographically documented to be within true lumen and not placed through stent struts. Guidewire access may obtained via contralateral, ipsilateral or retrograde approach. If a retrograde guidewire approach is used to cross the target lesion, guidewire exchange and an antegrade approach is required prior to treatment with the Winsor Laser Catheter.
6. One or more patent tibial vessel(s) defined as \<50% stenosis thoughout the segment with outflow to the foot.
7. Successful treatment of any inflow lesion(s) defined as final residual stenosis \<30%.

Exclusion Criteria:

1. Patient is pregnant.
2. Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.
3. Any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention.
4. Crossing devices other than guidewire support catheters.
5. Type 4 or 5 stent fracture as assessed by angiography.
6. Target lesion is located within a covered stent.
7. Acute limb ischemia
Bevacizumab Intravitreal for Myopic Choroidal Neovascularization

To evaluate the clinical results of anti-VEGF intra-vitreal injections (IVT) in CNV secondary to pathologic myopia (PM-CNV).

Nineteen consecutive patients (19 eyes) with subfoveal PM-CNV, 18 of whom had been unsuccessfully treated with Visudyne PDT, were treated with IVT of 1.25 mg bevacizumab or 0.5mg ranibizumab. ETDRS best corrected visual acuity, macular thickness on OCT scans, and angiographic features were recorded and evaluated. The aspect of OCT scans passing across the PM-CNV was also analyzed. IVTs were repeated only in case of persistent angiographic leakage and if OCT scans showed retinal thickening or edema and serous retinal detachment. The follow-up period was at least 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Myopic CNVM,

Exclusion Criteria:

* Patients with poor compliance
* Patients with uncontrolled diabetes and hypertension or any other medical condition that increase the risk of complications like recent history of Stroke or myocardial infraction (\< one year). (Physician clearance was obtained for all patients).
* Age related macular degeneration with Juxtafoveal and Subfoveal CNVM: Recurrent CNVM following PDT and TTT with IVTA. Patient who could not afford PDT, Macugen or Lucentis which is FDA approved.
* Patients who had undergone major surgery 28 days before, were excluded from the study and it was also suspended prior to elective surgery.
* Refractory macular oedema due to vein occlusion, Pseudophakia, Clinically significant macular oedema (CSME) etc. that affects vision and does not respond adequately to usual treatment methods.
* Proliferative diabetic retinopathy, non-resolving vitreous haemorrhage with PDR.
* Idiopathic CNVM, Inflammatory CNVM and other conditions associated with CNVM.
Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study

This clinical study will verify the clinical and radiographic performance of the prosthesis when used in human subjects over a period of 10 years. All complications will be documented.

The clinical evaluations will be based on standard, functional and pain parameters Harris Hip Score pre-operatively, and at 6 months, 3, 5, 7.5 and 10 years post-operatively. Postal Oxford questionnaire preoperatively, and yearly thereafter. The objective of this study is to analyse the clinical and radiographic responses and the complication rates for patients undergoing primary total hip arthroplasty using the Anthology Hip Replacement System (Anthology Hip System).

Eligibility Criteria:
Inclusion criteria:

1. Those presenting with primary or secondary osteoarthritis or avascular necrosis of the femoral head or patients suitable for a primary total hip replacement. This is the patient group that will benefit from operative surgery to treat osteoarthritis.
2. Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme. Patients capable of giving informed consent are eligible for inclusion into the study.
3. Participants who signed the Ethics Committee approved specific Informed Consent Form prior to surgery. Patients who have not given informed consent will not be eligible for inclusion into the study.

Exclusion criteria:

1. Patients whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
2. Patients not suitable for primary hip replacement.
3. Patients with active or suspected infection.
Lung Cancer Screening Protocol

The successful implementation of lung cancer screening across diverse setting requires working with the community and primary care practices. Collaborating across diverse community-based sites will employ local knowledge and culture in the understanding of the health problem and identifying and implementing solutions that are appropriate for all partners (patients, primary care, referral centers). Enhanced, culturally-competent communication with patients at high risk for lung cancer can narrow inequities in screening awareness, referral, and utilization, as well as improve lung cancer outcomes across diverse patients and communities. Promoting partnerships among physicians, staff, and patients; creating routines; and tailoring materials to each clinician's situation have been show to increase the proportion of patients receiving screening.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible to participate in the trial, screening centers have to be existing members of the BJC Collaborative.
* Primary Care Providers have to have a referral relationship with the screening center; serve adult patients who may be screening-eligible, and are willing to interact with the referral site to implement referral for LDCT.

Exclusion Criteria:

There are not any exclusion criteria for the study
Regulation of Bone Formation in Renal Osteodystrophy

To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests of children with kidney failure

Pediatric patients treated with CCPD who displayed biochemical and bone biopsy proven secondary hyperparathyroidism were randomly assigned to one of 2 vitamin D analogues (calcitriol or doxercalciferol) and one of two phosphate binders (sevelamer or calcium carbonate) in a two by two factorial designed prospective trial. Serum biochemical measurements were obtained at baseline and monthly throughout the 8 months of the trial. Bone biopsy was obtaine at baseline and repeated at study completion.

Eligibility Criteria:
Inclusion Criteria:

* Stable end-stage kidney disease treated with continuous cycling peritoneal dialysis,
* Biochemical evidence of secondary hyperparathyroidism (PTH\>400 pg/ml) with bone biopsy evidence of high turnover bone disease

Exclusion Criteria:

* History of parathyroidectomy
* Growth hormone
* Prednisone, or other immunosuppressant medication within the past year.
* Recent history of medication non-compliance.
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4) inhibitor, as monotherapy or in combination with fulvestrant, letrozole, or other combination partners in Chinese participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed locally advanced or metastatic solid tumors associated with CDK4 dependency, including HR+/HER2- breast cancer. Participants must have received prior standard-of-care therapies for their disease, unless the therapy is not available or not tolerated, or is determined not appropriate based on the investigator's judgment.
* Phase 1b (Dose Expansion): Participants with selected solid tumors including locally advanced or metastatic HR+/HER2- breast cancer.
* Female participants with metastatic HR+/HER2- breast cancer will be required to have ovarian function suppression using gonadotropin-releasing hormone (GnRH) agonists such as goserelin or be postmenopausal.
* Male participants with HR+/HER2- breast cancer will be required to have gonadal suppression using GnRH agonists when being treated with letrozole or fulvestrant.
* Patients must have ≥1 measurable lesion per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
* Adequate organ function without symptomatic visceral disease.

Exclusion Criteria:

* Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy is permitted).
* Known leptomeningeal disease or uncontrolled untreated brain metastasis.
* Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
* Uncontrolled diabetes.
* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection. Patients receiving prophylactic antibiotics (eg, for prevention of urinary tract infection, chronic obstructive pulmonary disease, or for dental extraction) are eligible. Patients who have recovered from symptomatic COVID-19 infection can be rescreened for this study.
* Untreated chronic hepatitis B or active hepatitis C infection.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Patient Satisfaction With Different Numbers of Implants

the goal of this randomized controlled trial aimed to assess patient satisfaction for completely edentulous patients with implant overdenture retained by ball attachment over a single symphyseal , or four interforaminal implants when compared to two interforaminal ones

48 edentulous patients were recruited and randomized to receive either 1,2 or 4 implants for a mandibular overdenture,3 months later implants were uncovered, and ball attachments were torqued, and all overdentures were picked up ,patient satisfaction questionnaires were recorded for all patients 2 weeks after pickup 3 months ,6 months, 9 months and 1year.

Eligibility Criteria:
Inclusion criteria

* completely edentulous patients with restorative space of 12-15 mm,
* keratinized gingiva of 5 mm

Exclusion criteria

* Exclusion Criteria:
* uncontrolled diabetes
* bruxers
* smokers
Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)

To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.

Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebo (CALISTO). An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications

Eligibility Criteria:
Inclusion criteria:

* Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long diagnosed by compression ultrasound.

Exclusion criteria:

* Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,
* deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism within last 6 months, treatment for cancer during last 6 months,
* anticoagulant medication for more than 48 hours prior to inclusion,
* need for oral non-steroidal anti-inflammatory drugs during the study, significant bleeding event during past month,
* major surgery within last 3 months, low platelet count (below 100×109/L),
* kidney disease (Calculated creatinine clearance \< 30 mL/min), woman of child-bearing potential not using reliable contraceptive method
Alternative Application Methods of Pre-procedural Povidone Iodine Mouthrinse

To compare the iodine remaining in saliva between gargle method and swab method

separate the participant in 2 groups group 1 use iodine gargle with gargle method, after 48 hours use iodine gargle with swab method group 2 use iodine gargle with swab method, after 48 hours use iodine gargle with gargle method The researcher will collect saliva before use iodine gargle and after use at time 0, 5, 10, 20, 30, 60, 120 minutes

Eligibility Criteria:
Inclusion Criteria:

* Thai people
* no underlying disease, no pregnant
* at least 24 teeth
* No use iodine gargle
* No allergy to iodine and seafood
* No orthodontic and prosthetic treatment
* No ulcer and edentulous area
* Saliva flow rate in male (0.57+-0.3 ml/minute), in woman (0.41+-0.27 ml/minute)
* PI score lower than 0.6 (Green and vermillion index)

Exclusion Criteria:

* treatment orthodontic or prosthetic treatment currently
* Allergy to iodine between reach
* Can not participate
Pilot Study of Growth Hormon to Treat SMA Typ II and III

The purpose of this study is to determine whether Growth hormon can increase strength in spinal muscular atrophy type II and III.

This pilot study is planned as a placebo-controlled cross-over trial in a limited number of patients. It is the aim to investigate the effect of GH on the short-term changes of strength and to investigate the tolerability of the treatment. If the results of the study are positive, further studies of longer duration addressing the development of motor function and quality of life could follow

Eligibility Criteria:
Inclusion Criteria:

* genetically confirmed diagnosis of Spinal Muscular Disease
* Spinal muscular atrophy type II or III
* age between 6 years and 35 years
* ability to perform the tests for measurement of muscle strength (handheld myometry)
* informed consent of the patient and/or parents

Exclusion Criteria:

* pregnancy or lactation
* woman with child bearing potential without contraception
* overweight or BMI over 30 kg/m²
* Treatment with other drugs, that can influence strength 8 weeks before participation in the study or during participation
* medical history or evidence of a malignant or cerebral tumor
* cardiovascular, intestinal, endocrinologically or airway disease
* Hypertension
* growth hormone deficiency
* hypersensitivity to one component part of the study medication
* participation on a clinical trial during the study or 3 month before
* abuse to drugs or alcohol
* patient incapable of contracting or not able to understand the character, meaning and consequences of the clinical trial
ZAGAL Study: Evaluating Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs

The purpose of this study is to acquire additional information about the appropriate level of dosing of Zonisamide when it is prescribed for patients with partial onset epileptic crisis who are already being treated with two other antiepileptic drugs.

Patients from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial onset epileptic crisis defined according to the International League Against Epilepsy (ILAE) criteria, with a minimum of two seizures within the 4 previous weeks, a stable treatment with two antiepileptic drugs for at least 12 weeks, and capable and willing to give their informed consent, will be included in the study.

To these patients, physicians will prescribe zonisamide in the following manner: Titration period of 12 weeks, at the end of which all patients must be taking 300 mg. Maintenance doses period of 12 weeks, at the beginning of which, physicians will decide to keep the 300 mg dose from the titration period, lower it to 200 mg, or take it up to 400 mg. Six weeks later within this period, a decision will be made to raise the 400 mg doses up to 500 mg if considered necessary and tolerable.

Drugs will be prescribed by the physician and purchased by the patient.

Eligibility Criteria:
Inclusion Criteria:

Patients from both sexes, 18 to 65 years of age, diagnosed with simple or complex partial onset epileptic seizures defined according to the International League Against Epilepsy (ILAE) criteria, with a minimum of two crises within the 4 previous weeks, a stable treatment with two antiepileptic drugs for at least 12 weeks and capable and willing to give their informed consent, will be included.

Exclusion Criteria:

Those who do not fulfill the Inclusion requirements.
Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants

The purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace and the Pavlik harness. The investigators hope to learn which brace treatment is best for a definable population so the appropriate brace can be chosen initially avoiding the time, expense, and frustration of a failed technique.


Eligibility Criteria:
Inclusion Criteria:

1. 0-2 months of age
2. Nonterratological developmental dysplasia of the hip diagnosed by physical exam and standard of care ultrasound

Exclusion Criteria:

1. Ages greater than 2 months
2. Neurological condition
3. Terratological congenital dysplasia of the hip diagnosed by physical exam and standard of care ultrasound
4. Chromosomal abnormality
The Effect of Group Exercise in Children With Special Needs

Thirty children with special needs were included in the study. Participants engaged in group exercises twice a week for four weeks, including warm-up and cool-down periods, with the goal of improving balance. The participants' balance was assessed using the Bruininks-Oseretsky Motor Proficiency Test Short Form (Balance Parameters), Pediatric Balance Scale; functional mobility was evaluated using the Timed Up and Go Test, and attention level was assessed using the Stroop Test before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-15 years with special needs
* Able to walk independently

Exclusion Criteria:

* Children with visual problems,
* Any orthopaedic, rheumatic or neurological problems affecting balance,
* Any contraindication to exercise