cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effectiveness of Laser-Ablated Implant-Abutments to Promote Tissue Healing

The purpose of this study is to determine which implant-abutment design is more likely to promote early soft-tissue healing processes and/or will enhance longitudinal peri-implant bone and soft-tissue health.

The study will assess the integrity of the peri-implant oral soft-tissue attachment to implant abutments by comparing tissue responses to a laser-ablated implant-abutment and an implant-abutment manufactured with a smooth surface.

Investigators will assess the initial post-surgical peri-implant attachment-seal and will test whether or not the tissue-abutment interface re-forms with equal integrity when the abutment is removed and replaced with a new abutment.

Data will include histological, radiographic, clinical, and subjective aesthetics to compare the effectiveness of two abutment designs. Both devices are supplied by the BioHorizons Implant Systems Inc. of Birmingham, Alabama; the abutments are analogous in design and material except the test device has a laser-ablated surface and the control abutment is smooth.

Eligibility Criteria:
Inclusion Criteria:

1. At least 19 years old
2. Healthy enough to under go treatment
3. Have one or more edentulous sites that exhibit adequate natural bone and sufficient keratinized tissue
4. Demonstrated willingness to undergo study treatment and to comply with study timeline -

Exclusion Criteria:

1. Full edentulism
2. Any chronic health condition or medication that in the opinion of the investigators may adversely affect bone healing
3. Any indication of an inability to make autonomous decisions

   -
A Randomized Study of the Safety and Efficacy of FG-2216 in Subjects With Renal Anemia Not Requiring Dialysis and Not Receiving Recombinant Human Erythropoietin

The purpose of this study is to test the safety and efficacy of FG-2216 in the treatment of patients with renal anemia who are not receiving erythropoietin and who are not on dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Stage 3 or 4 chronic kidney disease
* appropriate hemoglobin levels

Exclusion Criteria:

* Neovascular age related macular degeneration requiring treatment
* Macular edema or proliferative retinopathy in diabetic subjects, requiring treatment
* Any history of malignancy
* Therapy with recombinant erythropoietin or red blood cell transfusion within 4 weeks
* Renal Transplant
Oxygen Reserve Index in Airway Surgery in Children

This study aimed to identify the effect of oxygen reserve index monitoring on the occurrence of oxygen desaturation (\<90%) in pediatric patients undergoing airway surgery.


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients receiving airway surgery

Exclusion Criteria:

* baseline oxygen saturation less than 95%
* patients diagnosed as respiratory distress syndrome, bronchopulmonary dysplasia, pneumonia requiring oxygen supplements
Goal Achievement and Patient Satisfaction in Benign Hysterectomy

This study evaluates patient goal achievement and satisfaction in benign hysterectomy. Patient's will state their goals prior to undergoing benign hysterectomy, and will receive a follow-up questionnaire 3 months post-operatively evaluating their perception of goal achievement and overall satisfaction. Goal achievement and satisfaction will be evaluated for association with surgical indication, surgical approach (minimally invasive vs abdominal surgery), and demographic information.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing hysterectomy for benign indication
* Age 18 or greater
* English speaking
* Access to communication via telephone

Exclusion Criteria:

* Patient undergoing hysterectomy for malignant or pre-malignant condition
* Non-english speaking patient
* Patient without telephone access
* Patient undergoing emergent or unplanned hysterectomy
* Vulnerable populations
Nigerian Breast Cancer Risk-Reduction Study

The study will be a randomized controlled trial. The aim of the study is to determine the Breast Cancer (BC) risk and to evaluate the effect of BC risk counseling on lifestyle changes and adherence to risk-reduction practices among first-degree female relatives of BC patients in South-West Nigeria. This study's research questions are:

* What are the Nigeria Breast Cancer Study (NBCS) and Gail models estimates of the BC risk of first-degree female relatives of BC patients in South-West, Nigeria?
* What are the effects of BC risk assessment and counseling on adherence to breast screening recommendations among first-degree female relatives of BC patients in South-West, Nigeria?
* What are the effects of BC risk assessment and counseling on adherence to lifestyle risk reduction recommendations among first-degree female relatives of BC patients in South-West, Nigeria?
* What is the knowledge, attitudes, and perception of first-degree female relatives of BC patients in South-West Nigeria towards genetic testing and BC etiology?
* What factors predict breast screening among first-degree female relatives of BC patients in South-West Nigeria?
* What factors predict the time to first BC screening (post-intervention) among first-degree female relatives of BC patients in South-West Nigeria?

Participants will be randomized into the control arm (standard care) and intervention arms of the study. The intervention arm of the study will have a BC risk assessment followed by individualized BC risk counseling. In addition, the intervention arm will receive BC awareness and MammaCare® BSE training. The control arm will receive only standard care comprising BC awareness and MammaCare® BSE training. Both study arms will receive BC screening recommendations and lifestyle modification recommendations.

We hope that the BC risk counseling will improve BC screening practices and modification of risk behaviors and this hypothesis will be tested.


Eligibility Criteria:
Inclusion Criteria:

1. First-degree female relatives of histologically diagnosed BC patients in the study sites
2. Women aged 20 to 75 years of age
3. Willingness to be contacted after six months for follow-up

Exclusion Criteria:

1. Personal history of BC
2. Previous exposure to breast cancer risk assessment and counselling
3. Absence of intact breasts
Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation

This single-center, randomized controlled trial is to investigate the impact of remote ischemic preconditioning (RIPC) on the risk contrast-induced acute kidney injury and its long-term impact on renal function for patients with diabetes undergoing percutaneous coronary intervention.

Patients with diabetes undergoing elective percutaneous coronary intervention in Beijing Anzhen Hospital were enrolled, and all the eligible participants were randomized to either remote ischemic preconditioning (RIPC) group or control group. Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at \< 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times. Control participants did not experience this procedure of transient upper-limb ischemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes undergoing percutaneous coronary intervention were included.

Exclusion Criteria:

1. emergency PCI,
2. baseline troponin value \> 0.04 ng/mL,
3. nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively),
4. patient on dialysis,
5. patients who had some inability to cooperate with the trial,
6. those who could not give informed consent, and (7) second procedure of staged elective PCI in this hospitalization.
Pharmacodynamic Effects of Cangrelor in ACS or CCS Patients Undergoing PCI (POMPEII Registry)

This prospective registry was designed to carefully investigate the pharmacodynamic (PD) effects of cangrelor in all patients undergoing percutaneous coronary intervention (PCI).

There is huge interest in achieving fast and immediate antiplatelet effect at the time of PCI, particularly in acute myocardial infarction and Cangrelor is an intravenous antagonist of the P2Y12 receptor characterized by rapid, potent, predictable, and reversible platelet inhibition. However, there are limited pharmacodynamic data exploring the effects of this drug in the various clinical settings at the approved dosages and with current gold standard methods for testing platelet reactivity. More importantly, there are no data on rates and predictors of high residual platelet reactivity (HRPR) in patients treated with cangrelor. Therefore the present study aims at building up a large prospective registry of pharmacodynamic data obtained by light transmittance aggregometry (LTA), multiplate analysis and verifynow system in patients undergoing PCI and receiving cangrelor.

This study is designed as a single-center prospective registry. Investigators at University Hospital of Naples Federico II will enroll patients, collect blood samples, perform platelet function tests and collect clinical and demographic information.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing PCI and receiving cangrelor administration will be eligible for inclusion in the study.

Exclusion Criteria:

* only those not providing consent to blood/data collection will be excluded.
Capravirine (AG1549) in Combination With Viracept and Two NRTIs in HIV Infected Patients Who Failed an Initial NNRTI Containing Regimen

This is a 48 week study that is intended for HIV Infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now failing that regimen. They must be currently on their failing regimen to be eligible.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years old
* HIV RNA level \>1000 copies/mL at screening
* CD4 \>50 cells/uL at screening
* Patient is currently taking a regimen that includes an NNRTI plus 2 NRTIs for at least 28 days and is currently failing this regimen
* Patient has adequate hematology tests (absolute neutrophil count \>1000/uL, Platelets\>75,000uL, hemoglobin 9g/L)
* Patient has adequate renal function (serum creatinine of \<1.5 upper limit of normal)
* Patient has adequate liver function (AST, ALT, and bilirubin \< 2.5 upper limit of normal)

Exclusion Criteria:

* Previous use of protease inhibitors (except if patient has short duration of PI and was switched for tolerability reasons when viral load was \<50 copies) This exception does not include Viracept
* Women who are pregnant or lactating
Supporting Women Towards Risk Reduction and Management of Gynecological and Obstetric Issues

The health of women who use drugs is a real public health issue where the midwife has an important role to play in the multidisciplinary support of the Center for Care, Support and Prevention in Addictology (CSAPA).

The main objective is to identify the needs and expectations of the women received in terms of reducing risks and damage at the gynecological and obstetric level.


Eligibility Criteria:
Eligibility Criteria:

* Adult women (≥ 18 years old)
* Followed at the Center for Care, Support and Prevention in Addictology (CSAPA) of the University Hospitals of Strasbourg
* Speaking and understanding French
* Agreeing to participate anonymously in this study

Exclusion Criteria:

* Refusal to participate in the study
Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery

To assess and compare the short-term post-operative continence recovery rate in two cohorts of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo RARP with Vattikuti Institute technique or Retzius sparing technique.

Traditionally, RARP is performed using a trans-peritoneal technique that pass anteriorly to the bladder. This technique necessitates the dissection and/or manipulation of many structures, which might compromise post-operative urinary continence recovery. These structures include the pubo-prostatic ligament, Santorini plexus, neurovascular bundle, and veil of Aphrodite. Recently, a "Retzius-sparing" technique to perform RARP has beed described. This approach passes posteriorly to the bladder, through the space of Douglas, which should minimize the damaged to the aforementioned structure. Theoretically, the latter technique should improve post-operative urinary continence recovery. However, a randomized comparison between the "traditional" RARP and "Retzius-sparing" RARP is still lacking.

Eligibility Criteria:
Inclusion Criteria:

* All patients with newly diagnosed prostate cancer undergoing robotic-assisted radical prostatectomy at the Vattikuti Urology Institute (performed by single surgeon, MM) as the primary treatment modality
* Be able to read and speak English and be able to provide written informed consent

Exclusion Criteria:

* patients with high risk prostate cancer,defined as a biopsy Gleason score ≥8 and/or a pre-operative prostate specific antigen value ≥20 ng/ml.
* evidence of clinical nodal involvement (cN1) or metastatic disease (M1)
* patients participating in a competing study
* patients with pre-operative urinary incontinence.
Substrate Ablation and Remodelling in Non-paroxysmal Atrial Fibrillation (AF)

The investigators hypothesise that modification of the Atrial Fibrillation (AF) substrate by radiofrequency ablation would improve single procedure success rates for Radio Frequency Ablation (RFA) for Non-paroxysmal AF when compared to that achieved with short-term peri-procedural anti-arrhythmic drug therapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Ongoing symptoms (European Heart Rhythm Association Class 2 or above) in spite of treatment with rate control medication
* Non-paroxysmal atrial fibrillation, as pre-classified as

  * Persistent AF: AF requiring Electrical/ Chemical cardioversion or that lasting \>7 days. These patients may be in AF or in sinus Rhythm at the time of their initial assessment and/ or at the time of their ablation.
  * Continuous Persistent AF: These patients are persistently in AF with or without antiarrhythmic drug therapy, as confirmed on a 24 hour Holter. They may have undergone previous cardioversion(s).
  * Sustained Paroxysmal AF with underlying substrate: Patients with Individual AF episode(s) lasting \>12 hours but less than 7 days plus one or more of the following:

    * Age \>65 years 21
    * Individual AF episode(s) lasting \>24 hours
    * Significant left atrial dilatation of \>45 mm on Echo (Parasternal Long Axis view)
    * Obesity (Body Mass Index \>30), and/ or history suggestive of sleep apnoea
    * Diabetes Mellitus requiring hypoglycaemic drugs and/or Insulin

Exclusion Criteria:

* Inability or unwillingness to receive oral anticoagulation with warfarin
* Previous Ablation procedure for AF
* Unwillingness or inability to complete the required follow up arrangements
* Presence of long standing persistent AF with continuous AF longer than 12 months. This includes patients in whom sinus rhythm may have been maintained following electrical cardioversion for a period of less than 1 week at a stretch.
* Documented typical atrial flutter
* Prior prosthetic mitral valve replacement or severe structural cardiac abnormality
* Contraindications and/ or prior intolerance to both Amiodarone and Flecainide.
* Reversible cause for atrial fibrillation
* Known hypertrophic or infiltrative cardiomyopathy
Health Literacy Multi-media Study

Cancer patients are presented with a lot of information about their diagnosis and different treatment options, which can be confusing. The purpose of this study is to see if a simple video explanation of six words used to describe cancer treatment improves patient understanding of these words.

Cancer patients are presented with a lot of information about their diagnosis and different treatment options, which can be confusing. The purpose of this study is to see if a simple video explanation of six words used to describe cancer treatment improves patient understanding of these words.

Participants will be interviewed and asked the meaning of six words related to cancer treatment. Following the interview, participants will be shown a video about the meaning of the words. After viewing the video, participants will be re-interviewed to test how effective the video was at explaining the six words.

Eligibility Criteria:
Inclusion Criteria:

* Patients at Grady Memorial Hospital who is offered a consent to receive chemotherapy

Exclusion Criteria:

* Profession as a physician or nurse
* Non English speaking
A Study of Herceptin (Trastuzumab) Combination Therapy in Patients With Metastatic Urothelial Cancer

This study will evaluate the efficacy and safety of a chemotherapy regimen of intravenous Herceptin, cisplatin and gemcitabine in patients with metastatic urothelial cancer. The anticipated time on study treatment is until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* adult patients with \>=18 years of age;
* metastatic urothelial carcinoma;
* measurable metastases or local recurrent disease;
* no prior chemotherapy for metastatic disease;
* HER2 overexpression (IHC \[2+\] or \[3+\]).

Exclusion Criteria:

* concomitant chemotherapy or immunotherapy;
* active or uncontrolled infection;
* solely CNS metastases;
* clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
* co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.
A Multinational Survey-based Study to Understand the Real-world Awareness and Perceptions of Systemic inFLAMmation and rolE of hsCRP as a Biomarker in Patients With AtheroSclerotic CardioVascular Disease and Chronic Kidney Disease Among Cardiologists

The purpose of this survey is to collect information for scientific research and to better understand the role of systemic inflammation in identification, treatment and management of patients with ASCVD and CKD.

This study is a cross-sectional design conducted among cardiologists in United Kingdom, Italy, Germany, Brazil, Saudi Arabia, Japan, Australia, China, India and France, treating ASCVD and CKD patients. Study participants will be recruited to complete an approximately 20-minute self-administered online survey. Recruitment will be conducted through email and phone. Data is collected though online data collection using a programmed survey.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal to 18 years at the time of signing informed consent.
3. Is a Cardiologist.
4. Has been in practice greater than or equal to 3 years.
5. Sees at least 15 ASCVD and CKD patients per month.

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Does not meet inclusion criteria requirements
Gonadotropin-releasing Hormone Agonist Prior to Myomectomy

Fibroids are common in the West Indian population (30-40% of reproductive women).Fibroids are benign growth in the womb or uterus and in order to preserve the fertility of women they, require an operation called myomectomy or shelling out of the fibroid. This procedure can be associated with large blood loss.

In current practice some obstetricians use a gonadotropin releasing hormone agonist prior to the operation to reduce blood loss. Gonadotropin releasing hormone agonist is used in current gynaecological practice to treat women with heavy periods.

In this study the investigators randomised women to either 2 or 3 doses of the gonadotropin agonist prior to their operation and no treatment. The intraoperative blood loss was measured. The study hypothesis: To determine whether administration of gonadotropin releasing hormone agonist prior to myomectomy reduces intraoperative blood loss.

Variables noted preoperatively:

* Age
* Parity
* Ethnicity
* Ultrasound findings

Variables noted intra-operatively:

* Size of largest fibroid
* Estimated blood loss

Eligibility Criteria:
Inclusion Criteria:

* Women between the age of 20 and 45
* Symptomatic fibroids
* Presence of regular menstrual cycles
* Ultrasound confirmation of fibroids
* Normal cervical smear

Exclusion Criteria:

* Pregnancy
* The length of hospital stay was calculated in number of days from the date of the to the date of discharge
* Presence of endometriosis Previous myomectomy Ovarian, uterine or cervical malignancy female factor for subfertility
Intensive Gait Training Rehabilitation Protocol After Surgery in Cerebral Palsy

In the context of cerebral palsy, rehabilitation post Single-Event Multi-Level Surgery (SEMLS) is a long process. One year after surgery and rehabilitation, the functional benefits are usually less improved than the gait pattern. This may be caused by a lack of intensity in the final rehabilitation steps. Thus we created an intensive gait training rehabilitation protocole. This protocole associates 4 weeks of intensive rehabilitation in a healthcare center followed by 2 weeks of intensive rehabilitation at home. The objective of this study is to evaluate the efficiency of this protocol to improve walking speed and endurance, gross motor function et muscular strength.


Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy
* Age between 10 and 20 years
* Single-Event multi-level surgery more than one year ago
* GMFCS I to III
* Capacity to understand simple instructions
* Volontary consent

Exclusion Criteria:

* injuries or pain in lower limbs
* toxines or surgery less than one year before the study
Westeinde Brachialgia Study

The Westeinde Brachialgia Study (WEB) is a randomized controlled trial to establish the effect of cervical collar or physiotherapy compared to a wait-and-see policy in patients with acute cervical radiculopathy.

Cervical radiculopathy caused by spondylosis or disc protrusion is a common disorder with a usually benign natural course. Often, physiotherapy (exercise programs) and/or cervical collar are prescribed. However, there are no reliable data on the effects of these conservative therapies.

In this study, patients with acute cervical radiculopathy, defined by clinical criteria, are randomized for cervical collar, physiotherapy or a wait-and-see policy.

Eligibility Criteria:
Inclusion Criteria:

* Cervical radiculopathy defined by neck pain irradiating to one arm with at least one of the following: provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm; or muscle weakness in one or more adjacent myotomes.

Exclusion Criteria:

* Arm pain existing longer than one month
* Clinical signs of spinal cord compression
* Previously treated with physiotherapy or a cervical collar