cyrilzakka/clinical-trials huggingface dataset:
Pacing in First-degree AV-block

The purpose of this study is to explore if there is a less harmful way to pace patients with first-degree AV-block to ensure that the negative effects inferred by the pacing do not outweigh the positive effects of AV-synchrony. The main hypothesis of the study is that His-bundle pacing will offer a more physiological mode of pacing in patients with first-degree AV-block than conventional pacing.

Patients scheduled for catheter ablation of atrial fibrillation (AF) in sinus rhythm, with first degree AV-block, normal QRS duration less than 120 ms and normal left ventricular ejection fraction will be included. During the AF ablation three different pacing modes (atrial, AV-synchronous and His-bundle pacing) at two different rates (5 to10 bpm above the basal rate and at 100 bpm) will be performed and evaluated using echocardiography. After the completion of all six pacing protocols (i.e., three modes at two different rates) the experimental part of the procedure ends.

The primary end-point will be echocardiographic evidence of dyssynchrony. Secondary end-points will include left ventricular ejection fraction, left ventricular volume, mitral regurgitation, septal to posterior wall motion delay and inter-ventricular wall motion delay. Since the research study is conducted in parallel with the standard catheter ablation, we do not anticipate any additional side effects as a result of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for catheter ablation of atrial fibrillation in sinus rhythm and PR prolongation exceeding or equal to 200 ms
* QRS duration less than 120 ms
* Normal left ventricular ejection fraction on echocardiography.

Exclusion Criteria:

* Any bundle branch block
* Second- or third-degree AV-block
* Congestive heart failure, cardiomyopathy, myocardial infarction or major surgical procedure.
N-acetyl Cysteine for the Prevention of Oral Mucositis After Autologous Hematopoietic Cell Transplantation.

Oral mucositis (OM) is a major source of morbidity in patients undergoing hematopoietic cell transplantation (HCT). N-acetyl cysteine (NAC) is an antioxidant, widely used as mucolytic agent or antidote of acetaminophen overdose hepatotoxicity. we intend to explore the safety and efficacy of NAC in the prevention of OM after high-dose chemotherapy and autologous HCT in a phase III, randomized, open label and multi-center study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple myeloma and lymphoma in partial response and complete remission.
* Undergoing high-dose chemotherapy with autologous transplantation.

Exclusion Criteria:

• Known sensitivity to NAC
Postoperative Pain Evaluation of Mineral Trioxide Aggregate and Propolis After Pulpotomy in Carious Primary Molars

The study will be self-funded by investigator and carried out on patients from outpatient clinic in Pediatric Dentistry and Public Health Department- Faculty of Dentistry, Cairo University- Egypt. The procedures will be carried out by postgraduate student Rawda Nader Fathy who has B.D.S. (2011) -Alexandria University- Egypt. The procedures will be carried out on a Knight Midmark Biltmore dental unit (Midmark Corporation 1700 S. Patterson Blvd. Suite 400 Dayton, Ohio 45409, USA) in the post graduate clinic of Pediatric Dentistry and Public Health Department- Faculty of Dentistry, Cairo University- Egypt.


Eligibility Criteria:
Inclusion Criteria:

1. Cooperative patient
2. Healthy 5-8 years old patient with at least one carious primary molar tooth at each side of the patient's mouth.
3. Presence of at least two-thirds of the root length radiographically.
4. Restorable tooth.
5. No signs of hyperemia and hemostasis will be adequately achieved with moistened cotton pellet within 5 minutes after coronal pulp amputation.

Exclusion Criteria:

1. Teeth showing clinical and radiographic evidence of pulp degeneration such as history of spontaneous or nocturnal pain, tenderness to percussion or palpation, pathologic mobility, swelling or fistulous tract, periodontal ligament (PDL) space widening, internal root resorption, external root resorption, furcal radiolucency/inter- radicular bone destruction and/or periapical bone destruction.
2. Patients eliciting history of known allergy to pollens associated with propolis.
3. Parent or guardian refusal to participate.
COPD and Inflammatory Mediators

Chronic obstructive pulmonary disease (COPD) is widely spread all over the world. It is predicted to be the third leading cause of death by 2020.

COPD is a common, preventable treatable disease that is characterized by an airflow limitation which is not fully reversible.Not only the long-term exposition to noxious particles and gases contributes to the development of COPD, but also many others factors such as genetics and cigarette smoking. Cigarettes are harmful and contribute to different extra pulmonary disorders. Although COPD affects lungs some extrapulmonary manifestations are prescribed such as muscle dysfunction, abnormal respiratory muscles and systemic inflammation. Indeed, the systemic inflammation\[6, 8\] is considered as a key process in the pathogenesis of COPD. It involves different cells and molecules; high levels of circulating of white blood cells, increased plasma c-reactive proteins (CRP), interleukin 6 (Il6) have been reported in.those patients.Likewise, systemic inflammation could worsen the comorbidities (cardiovascular, osteoporosis..) and may lead to the exercise limitation.

Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosed by pulmonary function testing
* Clinically stable
* Abscence of other obstructive diseases
* Signed written consent

Exclusion Criteria:

* Neuromuscular diseases -Severe psychiatric, neurologic or musculoskeletal conditions
* cardiovascular diseases.
* Contre-indications to physical therapy
* Acute exacerbations a month before the intervention
Reliability and Validity of the Surgimap Software for Measuring Quadriceps Angle in Healthy Subjects

The purpose of this study is to investigate the intra- and inter-rater reliability and concurrent validity of surgimap software for measuring the Q angle Surgimap (Nemaris Inc, New York, NY, USA) is a dedicated spine measurement and surgical planning software which is used in both the research works and the clinical rehabilitation. Q angle is considered to be an index of the vector for action of the patellar tendon and extensors mechanism which is highly affects the patellofemoral joint dysfunction and foot mechanics.

specialised software for assessing the sagittal plane has arisen. Digital measuring software of many types has been proved to be faster, more accurate, more precise, and less variable than manual procedures. Angle measurement software is available in different formats and applications. Surgimap is another programme used for measuring angles. The current software has proven to be a godsend and is currently being used in the medical industry to measure joint angles especially the spine alignment. The programme is also used for scientific reasons, such as digital photo analysis. A recent study discovered that Surgimap software is a viable approach for evaluating spinal postural angles in teenagers from varied standing position perspectives using digital pictures.

As there a lack of knowledge about the reliability and validity of the surgimap software to measure the Q- angle. Therefore, The study will investigate the inter-rater, intra-rater reliability and concurrent validity of the surgimap software for measuring the Q-angle.

Eligibility Criteria:
Inclusion Criteria:

* Both male \& female
* Aged 18:25
* BMI 18.5: 25
* Normal foot posture as assessed by foot posture index.

Exclusion Criteria:

* Subjects who have operations in the knee joint
* Subjects who have traumatic knee injury
* High arched or low arched foot.
Adolescent Transition To Adult Care for HIV-infected Adolescents in Kenya

This study evaluates an adolescent transition package (ATP) to support HIV infected adolescents transitioning form pediatric/adolescent care to adult care. Ten clinics will receive the intervention and 10 will receive standard of care transition services.

The Adolescent Transition Package (ATP) will include two components. The validated Namibia comic book for disclosure (to be used with children over 10 years of age) and transition booklet "Taking Charge" developed by stakeholders in Kenya.

The disclosure tool includes a cartoon book, readiness and tracking tools used in clinic and health care worker training material. The intervention progresses from incomplete to complete disclosure using a narrative about soldiers fighting the battle of infection as the rationale for taking medicine. This tool has been validated for use in Namibia.

The adapted transition toolkit includes a transition booklet, tracking tools to be used by health care workers and a readiness assessment checklist to be completed by study staff. The booklet has 4 chapters addressing key areas to support adolescents gain the knowledge and skills they need in adult care. The 4 chapters are: HIV treatment literacy, self management, communication and support.

Eligibility Criteria:
Inclusion Criteria:

* Facility leadership is willing to implement the intervention

Exclusion Criteria:

* Clinics already actively using transition or disclosure tools
The Ablate-by-LAW Study

Of all the determinants of lesion creation during atrial fibrillation (AF) ablation, left atrial wall thickness (LAWT), as measured with multi-detector cardiac tomography (MDCT) is one key element that has been evaluated in some retrospective analyses but is not yet used per protocol to modulate the radiofrequency delivery. Adapting ablation index (AI) to LAWT would be very useful in standardising the ablation procedure with parameters fitted to every patient, enabling the development of a personalized approach that will both: i) increase efficacy by performing transmural lesions to prevent the formation of conduction gaps in the initial lesion set, and ii) increase safety by preventing excessive RF delivery on thin wall areas related to procedural complications, such as cardiac perforation or atrio-esophageal fistula. The investigators sought to evaluate the feasibility, safety, efficacy and reproducibility of guiding AF ablation procedures with the integrated MDCT-derived LAWT information.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Indication for paroxysmal atrial fibrillation ablation.
* Signed informed consent.

Exclusion Criteria:

* Age \< 18 years.
* Pregnancy.
* Previous AF ablation procedure (REDO).
Study of CP-461 in Patients With Advanced Renal Cell Cancer

The purpose of this study is to determine the efficacy of CP-461 given twice-daily orally in locally advanced or metastatic renal cell cancer and to evaluate the safety profile of CP-461 in this patient population.


Eligibility Criteria:
Inclusion Criteria:

1. Measurable metastatic or locally advanced disease.
2. Histologically confirmed renal cell cancer.
3. No radiotherapy within 4 weeks prior to entering the study. No more than 1 prior systemic therapy for advanced disease. Prior adjuvant systemic therapy is allowed. Patients must have fully recovered from the acute effects of prior therapy.
4. Expected remaining life span \> or = three months.
5. ECOG performance status 0-2.
6. \> or = 18 years of legal age.
7. Male patients, or non-pregnant and non-lactating female patients who are either using adequate birth control, surgically sterile or post-menopausal.
8. Negative serum pregnancy test, if fertile female.
9. Willingness and ability to sign an informed consent document.

Exclusion Criteria:

1. Uncontrolled or symptomatic brain metastases.
2. Use of an investigational medication or device within one month of initiating study therapy.
3. Absolute granulocyte count \< or = 1500/mm3; Platelet count \< or = 100,000/mm3; total serum bilirubin above the upper limit of normal; serum creatinine \> or = 2.2 mg/dL; AST/ALT \> 2.5 ULN.
4. Any condition or any medication which may interfere with the conduct of the study.
5. Current active malignancy other than renal cell cancer.
Bilateral Total Knee Arthroplasty vs Unicompartment Arthroplasty Retrospective and Clinical Outcome Study

To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis who underwent a primary TKA one side and a primary UKA on the opposite side and are at a minimum of two years post-surgery. Patient reported outcomes and data with be analyzed along with all retrospective chart data.


Eligibility Criteria:
Inclusion Criteria:

1. Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF)
2. Ability to understand and provide written authorization for use and disclosure of personal health information
3. Subject who are able and willing to comply with the study protocol and follow-up visit
4. Must be 18 years or older to participate
5. Subjects must have a clinically documented osteoarthritis in both knees, single or multiple compartments
6. Subjects must have undergone a primary TKA and primary UKA in the contralateral knee
7. Must be a minimum 2 year (24 months) post-surgery on each knee
8. One or both TKA/UKA surgeries must have been performed by the Principal Investigator.
9. Subjects must be able to return for the follow-up appointment, and have the mental capacity to cooperate with PRO's, questionnaires, physical exam and radiographs

Exclusion Criteria:

1. Subjects who underwent UKA with Patella Femoral Joint (PFJ) replacement on the same side.
2. Women who are pregnant
Water- and Salt-homeostasis in Healthy Humans, and in Patients With Heart- or Lung Disease

The purpose of the study is to determine whether the excretion of renal water- and salt-channels in the urine reflects the handling of water and salt in the kidneys, and whether the excretion can be used to monitor and/or predict the effects of treatment of certain heart or lung diseases.

The purpose of the study is to determine whether the excretion of renal water- and salt-channels (Aquaporin-2 and Epithelial Sodium Channels) in the urine accurately reflects the handling of water and salt in the distal tubules af the kidneys, and whether quantification of these channels in the urine is useful to monitor and/or predict the effects of pharmacologic or surgical treatment of Heart Failure and heart failure-related diseases (Aortic stenosis, acute and chronic ischemic heart disease or pulmonary hypertension)

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic heart failure
* Severe valvular aortic stenosis
* Acute Coronary Syndrome
* Medically refractory chronic angina pectoris or pulmonary hypertension with preserved left ventricular function

Exclusion Criteria:

* Pregnancy
* Drug abuse
* Malignant disease
* Significant disease of other organs including endocrine diseases
A Trial for Patients With Gestational Trophoblastic Disease

This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.


Eligibility Criteria:
Inclusion Criteria:

* Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT)
* WHO score 2-6 (re-evaluated at the time of relapse
* Histologically confirmed complete or partial moles on initial evacuation
* Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.
* All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.
* Folic Acid (350-1000 micrograms) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.
* Vitamin B12 (1000 micrograms) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy.

Exclusion Criteria:

* Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/- folinic acid).
* Patients with more than 8 metastatic lesions identified
* Patients with metastases to liver, spleen, brain, kidney or GI tract
Testing an Arts-based Program to Reduce Nurse Stigma Towards Perinatal Substance Use

The goal of this pilot clinical trial is to evaluate the feasibility and limited effectiveness of a digital, arts-based educational intervention addressing nurse stigma towards perinatal substance use. The main questions it aims to answer are:

* What is the the feasibility of delivering the training through an asynchronous, web-based platform?
* What is the limited effectiveness of the program on nurse stigma towards perinatal substance use?

Participants will access and complete the training, including completion of a perinatal substance use stigma scale at baseline, immediately post, and 1-2 months month later. Participants will also be invited to participate in an interview.

Researchers will compare the intervention and control groups to see if the training reduces nurse stigma towards perinatal substance use.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Licensed as a registered nurse
* Works at least part time
* Works on a labor, postpartum, nursery, neonatal intensive care, or pediatric unit in one of the participating hospitals

Exclusion Criteria:

* Works as per diem or agency nurse
* Not employed by a participating hospital
* Not a perinatal/pediatric nurse
A Trial of Skin Care Protocols for Facial Resurfacing

The aims of the Skin Product Assessment Research study were to (1) develop an infrastructure and process for industry-sponsored, Plastic Surgery Educational Foundation (PSEF) research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System (ODNS) and conventional therapy as treatment adjuncts in ablative facial resurfacing.


Eligibility Criteria:
Inclusion Criteria:

* patients with moderate to severe photo damage and rhytids, undergoing full or partial face resurfacing with chemical peel or ablative laser.
* Fitzpatrick I-IV skin types

Exclusion Criteria:

* patients unable to complete the regimen or who had used topical prescription steroids, retinoids, depigmentation products or other products containing hydroquinone and polyhydroxy acids within 8 weeks of enrollment.
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures

This research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction.

This is a multi-center, single arm, open label registry investigating anterior cruciate ligament reconstruction (ACLR) procedures where the tissue graft is augmented with BioBrace®. Subjects meeting the inclusion/exclusion criteria will be enrolled retrospectively or prospectively. Clinical evaluations will be conducted at baseline (pre-operatively) and at 6 months, 1-, 2-, and 3-years post-operatively using various patient-reported outcome measures to assess pain, function, return to activity, and safety post-surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Underwent ACL reconstruction with a tissue graft augmented with BioBrace® within the past 24 months from study start date or scheduled to undergo ACL reconstruction with a tissue graft augmented with BioBrace®.
2. Between 14 and 70 years old at the time of surgery.
3. Can understand the content of the subject information / Informed Consent Form (ICF) for the prospective portion of the study.
4. Is willing and able to participate in the prospective data collection protocol and comply with the required data collection.
5. If the subject has already undergone ACLR within the past 24 months, subject must have at least two (2) of the following measures at baseline and 1 year post-operatively:

   1. International Knee Documentation Committee (IKDC)
   2. Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)
   3. Patient-Reported Outcomes Measurement Information System (PROMIS-10)
   4. Tegner Activity Scale (TAS)
   5. Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)
6. Positive diagnostic imaging by MRI at baseline indicating an ACL tear

Exclusion Criteria:

1. Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study.
2. Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 3 years following enrollment into the study.
3. Underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn MCL is treated non-operatively).
4. Females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.
The Effects of Dietary Changes on Gut-bacteria and Fibromyalgia Symptoms

The purpose of this study is to evaluate the efficacy of two diets - gluten-free and low-FODMAP diet- in relieving symptoms of fibromyalgia, and study whether these changes could be associated with changes in the gut microbiome (gut bacteria).


Eligibility Criteria:
Inclusion Criteria:

1. Women over the age of 18, diagnosed with FM.
2. Chronic widespread pain index \>= 9 and pain intensity \>= 6.
3. Able to read and write in either French or English.

Exclusion Criteria:

1. Any major illness (e.g. malignancy, active inflammatory disease, metabolic disease, etc.)
2. Inflammatory bowel disease.
3. Severe depression (HADS score for depression \> 10).
4. Current use of LFD or GFD.
5. Pregnancy
6. Vegan diet

The inclusion/exclusion criteria were set to reduce the risk of confounding factors that could affect gut microbiota composition. To date, information on microbiome alterations in individuals with fibromyalgia is only available for female patients, and thus recruitment will be limited to women.
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block

This is a single-center, randomized controlled study. The aim of this study is to compare the impact of left bundle branch area pacing versus traditional right ventricular pacing on the incidence of atrial fibrillation in patients with atrioventricular block.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18-85;
* AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)\> 40%, including (a) third-degree AV block; (b) second degree AV block (type II); (c) intermittent advanced AV block with expected VP\>40%; (d) symptomatic first degree AV block and PR interval on ECG \> 300ms;
* Signed informed consent;

Exclusion Criteria:

* Baseline echocardiographic assessment of patients with impaired LV function (LVEF\<50%);
* Patients with the history of atrial fibrillation;
* Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;
* Pacemaker replacement without new implanted ventricular electrodes;
* Surgery is required within 1 year due to severe structural heart disease;
* Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc);
* AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM), (b) ventricular septal defect repair, and those who are unlikely to achieve successful LBBAP procedure.