cyrilzakka/clinical-trials huggingface dataset:
Regenerative Surgical Treatment of Peri-implant Defects

Does submerged healing of implants improve clinical and radiologic outcomes for the treatment of peri-implantitis? A number of recent systematic reviews have shown that the prevalence of periimplantitisin the population is high.

Nevertheless, there appears to be no consensus on treatment standards for the management of peri-implant diseases. Also, the significant variation in the empirical use of the available therapeutic modalities seems to result in moderately effective treatment outcomes. Animal and human case series-studies have shown improved outcomes when using a submerged healing approach. However, there seems to be no randomized controlled clinical studies comparing submerged/non-submerged healing efficacy for the treatment of peri-implantitis. Since current modalities for the treatment of peri-implantitis seem to result inmoderately effective outcomes, there is an urgency to investigate treatment strategies that will result in improved patient's benefits in terms of health.

The present study will be double-blinded randomized controlled clinical trial. Patients requiring surgical treatment of peri-implantitis after non-surgical therapy will beassigned to either:

Test group: submerged healing or Control group: non-submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.

The primary aim of this study is to evaluate whether submerged healing of implants willsignificantly improve the changes in marginal bone levels measured on X-rays 12months post-treatment compared to a non-submerged healing approach for the treatment of peri-implantitis.

Secondary aims include changes in clinical attachment levels, changes in probing pocket depth, recession, keratinized tissue, occurrence of bleeding on probing, suppuration on probing (PUS), marginal gingival recession (REC), full mouth plaque score (FMPS), full mouth bleeding score (FMBS), type of peri-implant bone defect, frequency and type of complications and implant loss.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years.
* Systemically healthy patients.
* Presence of at least 1 implant diagnosed with peri-implantitis (peri-implant probing pocket depth ≥6 mm in at least 1 aspect of the implant with bleeding and/or suppuration on probing and radiographically documented marginal bone loss ≥3mm) according to Renvert et al. (2018), after non-surgical therapy of periimplantitis, and a 4mm deep intrabony component.
* Absence of mobility of the implants.
* Individual implant-supported crown or partial fixed implant supported restoration (removable prosthesis will be excluded).
* Patient's smoking ≤ 10 cigarettes/day.

Exclusion Criteria:

* Non-removable prostheses
Efficacy & Safety Study of Bilateral IVT Injection of GS010 in LHON Subjects Due to the ND4 Mutation for up to 1 Year

The goal of this clinical trial is to assess the safety and efficacy of GS010, a gene therapy, in improving the retina functional \& structural outcomes in subjects with LHON due to the G11778A ND4 mitochondrial mutation when vision loss duration is present up to one year.

GS-LHON-CLIN-05 is a Phase III, global, multi-center randomized, double-masked for the primary analysis, placebo-controlled, clinical study. As LHON is a neurodegenerative disease, the goal is to administer GS010 as soon as possible upon confirmation of the LHON diagnosis and the causative mutation.

Eligibility Criteria:
Main Selection Criteria:

* Age 15 years or older on the date of signed informed consent.
* Clinically manifested vision loss due to ND4 LHON, to any extent, in at least one eye.
* Vision loss duration of ≤ 365 days (i.e. ≤ 1 year) in each affected eye at Inclusion Visit (Visit 2).

Main Non-Selection Criteria:

* Contraindication to intravitreal injection in any eye.
* Subjects refusing to discontinue idebenone.
* Previous vitrectomy in either eye.
* Narrow angle in any eye contra-indicating pupillary dilation.
* Presence of known/documented mutations, other than the G11778A ND4 LHON-causing mutation, which are known to cause pathology of the optic nerve, retina or afferent visual system.
* History of recurrent uveitis (idiopathic or immune-related) or active ocular inflammation.

Main Inclusion Criteria:

* Vision loss duration of ≤ 365 days (i.e. ≤ 1 year) in each affected eye at Inclusion Visit (Visit 2).
* Each eye of the subject must maintain at least Hand Motion (HM) visual acuity, as defined by the study's SOP for visual acuity testing.
* Documented results of genotyping showing the presence of the G11778A mutation in the ND4 gene and the absence of the other primary LHON-associated mutations (ND1 or ND6) in the subject's mitochondrial DNA.

Main Exclusion Criteria:

* Light Perception (LP) or No Light Perception (NLP) visual acuity in any eye, as defined by the study's standard operating procedure (SOP) for visual acuity testing.
* Presence of active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.
* Presence of alcoholism, alcohol dependence, or alcohol or drug abuse (excluding nicotine).
Efficacy Of Platelet Rich Plasma In The Treatment Of Hemiplegıc Shoulder Pain

In this study assessing whether platelet rich plasma injections(PRP) are effective in the management hemiplegic shoulder pain, 55 patients with hemiplegic shoulder pain was recruited to this randomized controlled study. Patients were randomized into two groups, first getting PRP injections, and other group taking sham injections.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were being an adult stroke patient with more than two weeks of shoulder pain and restriction, and not having a history of stroke before the recent incident.

Exclusion Criteria:

* Patients with aphasia, severe cognitive or psychiatric disorders, history of trauma, recent injection (\<3 months) or surgery on the affected joint, complex regional pain syndrome, infections, pregnancy, thrombocytopenia(\<150000 per microliter) or coagulation disorders or severe spasticity of the affected limb(Modified Ashworth Scale \>3) were excluded from the study
Impact of Nurses´ Solution-focused Communication on the Fluid Adherence of Adult Patients on Hemodialysis

Aim: To test the hypothesis that fluid adherence in patients on hemodialysis can be improved through nurses´ solution-focused communication with patients on issues of adherence.

Design: Single-group quasi-experimental study. Method: A one-month baseline of inter-dialytic weight gain was taken for a group of 36 adult patients in a hospital hemodialysis unit. Then, the nurses of the unit received an 5-hour training in solution-focused communication on issues of fluid adherence and applied it with the patients of the sample. Inter-dialytic weight gains (IDWG) were measured during another month. Six months after the training, IDWG was again measured during one month.

Design A single-group quasi-experimental design was carried out. The IDWG was the dependent variable, expressed as the weight gain in kilograms between dialysis sessions. A base-line was established by taking IDWG data for one month; after the nurses training, IDWG data were taken for another month. Follow-up was carried out six months later.

Methods

Participants 36 patients of a hemodialysis unit in a public hospital were invited to participate in the study. All accepted and gave written informed consent. Nurses were two women (39 and 37 years old) and one man (30 years old).

The intervention Training. Two two-hour training modules were designed by two recognized solution-focused therapy experts. In each module, participants watched videos that illustrated solution-focused communication on fluid adherence, and practiced the skills in role-plays.

Solution-focused communication on IDWG. In the case of IDWG improvement, nurses were trained to congratulate the patient and then to explore in detail, from a stance of curiosity, how nurses had accomplished the weight reduction. Nurses were trained to invite patients to share specific behavioral details and also to describe their own behavior from the perspective of significant family members. Nurses were also taught to compliment patients on their accomplishments and to invite them to keep track of anything else they might find useful to control fluid intake over the next days.

In the case of IDWG worsening, nurses were encouraged to validate patients´ difficulties and empathize with their predicament.

A repeated measure analysis of variance (ANOVA) and Student's t were used to analyze the changes in patient's IDWG over time.

Eligibility Criteria:
Inclusion Criteria:

* 0

Exclusion Criteria:

* 0
VERifynow in DIabetes Non-responsiveness: a Study on Switching From Clopidogrel to Prasugrel

The purpose of this study is to determine if, in type 2 diabetic patients undergoing treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of 75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.

The VERDI study consists on a randomized, mono-center study comparing the treatment plan of a loading dose of prasugrel as opposed to the standard dose in type 2 diabetic patients, who suffer acute coronary syndrome, revascularized through an invasive percutaneous strategy with a stent. The aim of this study is to determine if, in type 2 diabetic patients undergoing treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of 75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetic patients with acute coronary syndrome with non-ST segment elevation who are undergoing a percutaneous coronary intervention (PCI) with a coronary stent.
2. Patients who are non-responsive on the platelet anti-aggregation test with standard doses of clopidogrel will be randomized.
3. Participants must sign an informed consent document.

Exclusion Criteria:

1. Age \<18 years or \>80 years.
2. Patients with acute coronary syndrome with ST segment elevation.
3. Pregnancy previous to or during the study.
4. The use of oral anticoagulants in the last 10 days with an INR \>1.5 or who plan to use them during the follow-up period (1 year).
5. Antithrombotic treatment with GP IIb/IIIa inhibitors.
6. Contraindication for the use of prasugrel and/or clopidogrel and/or aspirin:

   * Antecedents of pharmacologic allergy to thienopyridine derivatives or aspirin.
   * Antecedents of clinically significant or persistent thrombocytopenia or neutropenia.
7. Active bleeding or significant increase of risk of hemorrhage such as severe hepatic insufficiency, peptic ulcer present, proliferative diabetic retinopathy, antecedents of severe systemic bleeding, gastrointestinal bleeding, macrohematuria, intraocular hemorrhage, hemorrhagic stroke, or intracranial bleeding), or other antecedents of bleeding diathesis or coagulopathy.
8. Patients with previous TIA or CVA.
9. Patients weighing \<60 Kg.
10. Hemoglobin \<10.5 g/dl, or Hematocrit \<30%.
11. Severe left ventricular systolic dysfunction, EF \<35%.
12. Renal insufficiency with creatinine levels \>2 mg/dl.
13. Previous inclusion of the patient in another study.
14. Treatment in research (medication or device) in the last 30 days prior.
15. Medical, geographical, or social factors that would make participation in the study impractical, such as the incapacity to provide written informed consent and to understand the complete meaning of informed consent, or the refusal of the patient to participate in the study.
Spanish Translation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

The purpose of this study is to see if questions in English about symptoms that patients may have during cancer treatment are understandable when translated into Spanish. These questions will later be used in future studies to give a better understanding of patient symptoms".


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years or older and be able to provide informed consent.
* Participants must be patients being followed for clinical care at one of the collaborating sites, and must be either currently undergoing or having completed treatment (chemotherapy or radiation therapy) for cancer in the previous 6 months.
* Participants must be native Spanish-speakers.
* Participants must be able either to read and understand the items in Spanish or to hear and understand and respond to the items when read to them verbatim in Spanish.

Exclusion Criteria:

* Cognitive impairment as determined by the patient's Physician or Nurse which or study coordinators renders them unable to understand the items or report on his/her symptoms from the last 7 days.
* Participants who have only received surgery are not eligible
* If participants request to have the consent form in English, they will not be eligible for participation in this study.
Papilla Suture Design Affects Papillary Postsurgical Dimensions

The current prospective, randomized, controlled clinical trial aimed at comparing the impact of papillae suture technique on interdental papilla dimensions after periodontal surgery using a novel 3D intraoral scanning technique.

Scientific rationale for study: Choosing the appropriate suture design for periodontal surgery may affect post-surgery tissue dimension. This is a critical issue in periodontal surgery due to the grave impact papilla play on soft tissue esthetics.

Principal findings: using the novel 3D scanning of the gingiva tissue show that simple interrupted suture negatively affect post-surgery papillary height and recession adjacent to the suture compared with vertical internal mattress suture.

Practical implications: the study provide evidence that allows the clinician to better choose the suture design that will allow optimal healing of the papilla. Furthermore, the study presents a novel 3D scanning method to analyzed dimensional changes in the soft tissue.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Systemically healthy (based on health questionnaire prior to treatment)
* Willingness to participate in the study
* Clinical requirement for periodontal\\ implant surgery

Exclusion Criteria:

* Diagnosis of diabetes/heart disease, thrombocytopenia\\ coagulation factors deficiency
* Chronic use\\abuse of drugs\\ alcohol
* Pregnancy Smoking more than 10 cigarettes per day Antibiotic consumption in the last 3 months.
Study to Evaluate Esmolol (Brevibloc) to Manage Cardiac Function in Patients With Subarachnoid Hemorrhage

The purpose of this study is to evaluate the clinical effect of esmolol treatment on cardiac function and electrophysiology; to assess the effects of esmolol treatment on serum adrenergic and cardiac biomarkers; to explore the safety of esmolol treatment shortly after subarachnoid hemorrhage (SAH). Patients will be followed for a maximum of 1 month after the index SAH. The primary outcome will be change in systolic function - ejection fraction by Simpson's rule (baseline versus Day 7 +/- 2 after SAH).

Subarachnoid hemorrhage (SAH) remains one of the most devastating forms of stroke. Over 25% of all stroke related potential years of life lost are from SAH. Outcomes are adversely affected by secondary ischemia from cerebral vasospasm, along with cardiac complications. Trials performed in patients with SAH have demonstrated benefit after the administration of beta blockers - reducing mortality nearly in half; but concerns over diminishing cerebral perfusion inhibited the widespread adoption of this therapy. Our specific aims are as follows: 1. To evaluate the clinical effect of esmolol treatment on cardiac systolic and diastolic function, along with cardiac electrophysiology; 2. To assess the effects of esmolol treatment on serum adrenergic and cardiac biomarkers; 3. To explore the safety of esmolol shortly after SAH. The primary outcome will be change in systolic function - ejection fraction by Simpson's rule (baseline versus Day 7 +/- 2 after SAH).

Eligibility Criteria:
Inclusion Criteria:

* Subarachnoid hemorrhage presumed to be the result of ruptured aneurysm
* Age 18 years old or greater
* Able to enroll within 24 hours of onset of symptoms
* Systolic blood pressure over 140 mm Hg OR administration of antihypertensives after presentation

Exclusion Criteria:

* Withdrawal of life support imminent (within six hours)
* Known heart failure or cardiomyopathy AND ejection fraction 35% or below
* Prisoner or pregnant female
* Ongoing vasopressor administration to maintain SBP, or clinical suspicion of left ventricular failure
* Clinically important arrhythmias (history of cardiac arrest or ventricular arrhythmias), conduction abnormalities (Mobitz Type 2, 3rd degree AV block, or symptomatic Mobitz 1 without pacemaker), clinical cardiogenic shock, or overt clinical heart failure
* Active bronchospastic disease (ongoing bronchospasm after SAH presentation or current treatment with oral corticosteroids for asthma or obstructive lung disease)
* End stage renal disease
Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial

The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone.

Muscle relaxants have been used extensively for neck and back pain since muscle spasm is thought to play a role in the cycle of pain and spasm. However, prior studies have conflicting results regarding their additive effect when given in addition to analgesics such as the NSAIDs. Because they have the potential to lead to adverse events their efficacy should be clearly demonstrated before their routine use.

Eligibility Criteria:
Inclusion Criteria:

* neck pain within 24 hours of injury

Exclusion Criteria:

* Children, allergy or contraindication to any of the study drugs
Hemodynamic Measurements in Women With Serious Preeclampsia

This trial is examining hemodynamic measurements in women with serious preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* Women with serious preeclampsia
Comparison Between Two Different Volumes of Anesthesia Drug in Forearm Surgery

Hospitalized patients for superior member surgery have different types of anesthesia.Forearm and/or arm surgery could be done under general anesthesia, but in the most of the cases, this surgery was done under locoregional anesthesia.Several injections of local anesthesia at the nerves axilla are used with the used of ultrasonography.

The purpose of this study is to show that the anesthesia efficiency is the same with 40 or 25 ml of Xylocaine 1.5% Adrenalin in Forearm or Arm Surgery.

Inclusion criteria :

* age \> 18 years old
* patient who must have a non emergency surgery of the forearm or the hand
* ASA I or ASA II
* informed consent
* Ensured patient

Exclusion criteria :

* pregnancy
* respiratory insufficiency
* cardiac insufficiency
* hepatic insufficiency
* renal insufficiency
* ASA III or IV
* contraindications to the locoregional anesthesia
* contraindications to the xylocaine used
* patient participate to an another clinical study
* guardianship patient

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* patient who must have a non emergency surgery of the forearm or the hand
* ASA I or ASA II
* informed consent
* Ensured patient

Exclusion Criteria:

* pregnancy
* respiratory insufficiency
* cardiac insufficiency
* hepatic insufficiency
* renal insufficiency
* ASA III or IV
* contraindications to the locoregional anesthesia
* contraindications to the xylocaine used
* patient participate to an another clinical study
* guardianship patient
Stem Cell Transplantation for Sickle Cell Anemia

This protocol will be investigating the use of stem cell transplantation, in related donors, to cure sickle cell disease. Sickle cell disease is a recessive disorder caused by a point mutation that results in the substitution of valine for glutamic acid at the sixth position in the B-chain of hemoglobin. This leads to sickling of the red blood cells under many conditions, such as hypoxia, dehydration, and hyperthermia. The sickling leads to vaso-occlusion, which causes irreversible damage in almost all systems in the body, including the central nervous system (CNS), lungs, heart, bones, eyes, liver, and kidneys.

Primary objective:

1) To determine disease free survival (DFS) at two years after matched sibling transplant using bone marrow (BM) after a conditioning regimen consisting of distal timed Alemtuzumab, Fludarabine, and Melphalan for patients 2-30 y/o

Secondary objectives:

1. Overall survival
2. Rate of neutrophil and platelet engraftment for BM
3. Incidence of graft failure
4. Incidence of grade II-IV and grade III-IV acute graft vs host disease (GVHD)
5. Incidence of chronic GVHD
6. Incidence of other transplant complications, such as veno-occlusive disease, central nervous system (CNS) toxicity, and idiopathic pneumonia syndrome (IPS)
7. Incidence of reactivation of CMV, EBV, adenovirus, BK/JC virus
8. Incidence of invasive fungal disease
9. Time to immune reconstitution via monitoring of lymphocyte subpopulations and immunoglobulin levels

Eligibility Criteria:
Inclusion Criteria:

* Patient Eligibility

  1) Matched sibling donors (9-10/10 marrow/PBSC or 5-6/6 UCB (single or double) with a total TNC dose of greater than 5 x 107/kg recipient weight)
  1. Age 2-30
  2. Hb SS, S-thal0, S-thal+, SC
  3. Evidence of ongoing hemolysis: Hb\<10, retic \>5%, LDH \> 500, TB\>2
  4. Karnofsky/Lansky score \>50
  5. LVSF\>26% or LVEF\>40%
  6. DLCO \>40% or O2 sat \>85% for those patients that can't perform PFTs
  7. GFR \>70 and serum creatinine \< 1.5 \* ULN for age
  8. ALT and AST \< 5 x ULN, direct bilirubin \<2 x ULN
  9. If the patient has been on chronic transfusion or has a ferritin \>1000, liver biopsy should be done and show no evidence of bridging fibrosis or cirrhosis
* Exclusion criteria

  1. Evidence of uncontrolled bacterial, viral, or fungal infection within one month prior to initiation of the conditioning regimen
  2. Pregnant or breastfeeding
  3. HIV positive
  4. Written informed consent not obtained