cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Temporomandibular Joint Mobilization and Exercise in Individuals With Chronic Neck Pain

To examine the effects of temporomandibular joint mobilization and exercises added to the conventional physiotherapy program on posture, functionality and muscular endurance in individuals with chronic neck pain.

Our research is a randomized controlled trial. 50 participants will be included in the study, which will be conducted on individuals aged 18-65 years with chronic neck pain. Participants will be divided into 2 groups as experimental and control groups by simple randomization method. All patients will be treated with conventional physiotherapy methods for 4 weeks and 5 days a week. In addition to conventional treatment, temporomandibular joint mobilization techniques were applied to the experimental group; exercises will be given. In the study, temporomandibular dysfunction (TMD) Pain Screener, Neck Disability Index, and Visual Analog Scale questionnaires will be applied to the patients twice, before and after the treatment. Before and after the treatment, the cervical region's range of motion and muscular endurance will be measured by the physiotherapist. Pre- and post-intervention data were statistically analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65,
* Having neck pain lasting longer than 3 months,
* Absence of known systemic disease or trauma history,
* Volunteering to participate in the research.

Exclusion Criteria:

* Having a history of trauma in the areas that are the subject of the study, such as head and neck surgery, upper extremity, thoracic and cervical vertebrae,
* Disc displacement, osteoarthrosis, osteoarthritis signs and symptoms
* Having a neurological-psychiatric diagnosis that may affect the measurement results.
Study of Everolimus in de Novo Renal Transplant Recipients

In the present study, the investigators propose a conversion scheme with 50% reduction in CNI dosage until adjustment of everolimus dosage, in order to reach a trough blood level of 6-10 ng/mL, thus avoiding overimmunosuppression or alternatively breakthrough rejection episodes.

The hypothesis of this study is to demonstrate that the therapeutic regimen with Myfortic® and Certican® significantly improves renal function compared with the standard regimen of CNI.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant patients
* Age between 18 and 85 years
* Recipients of living or deceased donors
* Donor under the age of 85 years
* Panel Reactivity Antibodies (PRA) over or equal to 30%
* 4-5 months post-transplant
* CNI-based immunosuppressive regimen
* Stable graft function (creatinine lower than 2.0 mg/dl)
* No currently acute rejection
* Proteinuria lower than 800mg/d
* No laboratory or physical clinically significant signs presented for the last 2 months before screening.

Exclusion Criteria:

* Recipient of multiple organs
* Recipient with a history of focal segmental glomerulosclerosis or membranous glomerulonephritis
* Presence of uncontrolled hypercholesterolemia (≥350 mg/dL)hypertriglyceridemia (over or equal to 500 mg/dL)
* Patients with eGFR lower than 40 ml/min/1.73m2
* Evidence of acute rejection within 2 months before screening
* Thrombocytopenia (lower than 75,000/mm3)
* Neutropenia (lower than 1,500/mm3)
* Leukocytopenia (lower than 2500/mm3)
* Anemia (hemoglobin lower than 6.0g/dL)
* Severe liver disease (including transaminases or bilirubin equal or over 3 times normal)
* Proteinuria over 800mg/dL
* Systemic infection or pneumonia (active infection)
* Positive for Hepatitis B, Hepatitis C or HIV.
Major Outcomes in Elderly Patients With Self-Management of Oral Anticoagulation (SPOG60+)

Self-management is safe and reliable in patients with long-term oral anticoagulation (OAC). However, no study has yet assessed the safety and efficacy of OAC self-management in elderly patients with major thromboembolic and haemorrhagic complications as primary outcomes.

In this multi-centre, open, randomised controlled trial, patients aged 60 years or will be randomised into a self-management or routine care group and followed up for at least two years.

The primary hypothesis of the study is that self-management of oral anticoagulation is superior compared to routine control in terms of reducing thromboembolic events requiring hospitalisation and all major bleeding complications as the primary endpoint.

Oral anticoagulation (OAC) has been shown to be highly effective in preventing thromboembolic complications in patients for whom it is indicated. Numerous studies have documented that elderly patients seem to benefit most from OAC therapy. Atrial fibrillation (AF), the incidence of which increases with age and approaches 10% for individuals aged ≥ 80 years, carries the main risk for stroke, and among elderly patients without antithrombotic therapy,

Despite its proven benefit, numerous studies have reported reluctance in prescribing OAC due to a variety of barriers, especially in the elderly. Risk of haemorrhage, which is in fact twice as great in those over 70 years of age as in younger patients, is one of the major determinants of refusal to prescribe OAC therapy. The risk of stroke rises steeply in patients with atrial fibrillation when INR values are less than 1.8 and INR values greater than 4 to 5 are rapidly associated with increased bleeding rates. Due to relatively small therapeutic ranges, the reality is often that only a small percentage of the INR values have been found to be within the target range, which can be low as 29% of INR measurements, as seen in routine care patients prior to participation in a randomised self-management programme study.

One way to improve OAC care is by introducing patients' self-management of OAC therapy. In this context it is important to differentiate between INR self-testing alone, and full self-management. Self-management includes self-adaptation of the anticoagulation treatment based on self-monitoring results after the patients have participated in a structured instruction and treatment programme.

Our study aims to provide answers to this important medical question by examining elderly patients receiving long-term anticoagulation treatment and randomised into self-management versus routine-care groups, with thromboembolic and haemorrhagic complications as primary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* long-term anticoagulation
* either with phenprocoumon or acenocoumarol
* age ≥ 60 years
* written informed consent

Exclusion Criteria:

* previous participation in a self-management OAC programme
* severe cognitive
* terminal illness
Preventing Post-Vaccination Presyncope and Syncope in Adolescents Using Simple, Clinic-based Interventions: A Pilot Study

This is a randomized controlled open-label trial. During the study, adolescents scheduled to receive at least one intramuscular (IM) vaccine will receive either Buzzy®, Music, or Buzzy® and Music intervention(s) in addition to standard care to evaluate the feasibility and acceptability of these interventions prior to being used in a larger study to assess the effectiveness of the interventions in preventing post-vaccination presyncope and syncope. Feasibility will be assessed according to study staff ability to successfully administer the protocol specified clinic-based interventions and per both study staff and healthcare provider responses to written feasibility assessments. Acceptability will be assessed according to the participant's self-report. In addition, baseline needle phobia and anxiety, post-vaccination pain and presyncope symptoms, and pre- and post- vaccination state anxiety will be assessed per participant written self-report to standardized survey questions.


Eligibility Criteria:
Inclusion Criteria:

1. 10 years through 17 years of age
2. If 10 through 13 years of age, the subject must be receiving at least one vaccine delivered intramuscularly
3. If 14 through 17 years of age, the subject must be receiving at least two injectable vaccines one of which must be delivered intramuscularly
4. The parent/guardian must be willing and capable of providing written informed consent for the adolescent and the adolescent must be willing and capable of providing assent.
5. The subject must be willing to stay for the completion of all study-related activities.
6. Parent/guardian and adolescent must speak and read English by self-report

Exclusion Criteria:

1. Receipt of investigational or experimental vaccine or medication within the previous two weeks
2. Receipt of routine injectable medication
3. Permanent indwelling venous catheter
4. Blood drawn within the past hour or scheduled for a blood draw during the post-vaccination observation period
5. Injection of medication during the past hour or scheduled for injection of medication during the observation period.
6. Cold intolerance or cold urticaria
7. Raynaud's phenomenon
8. Sickle cell disease
9. Inability to hear
10. Significant visual impairment or blindness
11. Febrile or acutely ill individuals
12. Upper arm or shoulder pain or injury
13. Adolescent or parent/Guardian is an immediate relative of study staff or an employee who is supervised by study staff.
14. Any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol
A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina

The Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator is used to deliver an implant with medicine to the eye. AbbVie is updating the DEX PS DDS Applicator. This purpose of this study is to show that the updated DEX PS DDS Applicator works in adult participants with macular edema due to retinal diseases.

The DEX PS DDS is approved for the treatment of macular edema. Participants will be placed into 1 of 2 groups, called treatment arms. Each group receives the same treatment drug delivered using different applicators. Around 54 adult participants with macular edema will be enrolled in the study in approximately 7-10 sites in the United States.

Participants will receive a single intravitreal (into the eye) administration of DEX PS DDS implant using either the currently-approved DEX PS DDS Applicator or the the updated Applicator. The participants will be observed for a duration of 7 days, with the DEX PS DDS implant received on day 1 and follow-up through day 7.

The updates being evaluated in this study are related to the DEX PS DDS Applicator only, with the safety and efficacy of the DEX PS DDS implant well characterized and the same as the currently marketed product. Participants will attend regular visits during the study at a hospital or clinic. The applicator function will be checked by medical assessment, checking for side effects, procedural complications and/or product complaints, and evaluating the administration procedure.


Eligibility Criteria:
Inclusion Criteria:

- Participants with macular edema due to retinal vein occlusion (branch retinal vein occlusion or central retinal vein occlusion) or diabetic macular edema.

Exclusion Criteria:

- Participants with ocular conditions in the study eye for which Dexamethasone Posterior Segment Drug Delivery System Implant is contraindicated.
Stem Cells for the Improvement of Erectile and Cardiac Function in Aging Men

Men who present with erectile dysfunction as defined as an IIEF (International Index of Erectile Function) score less than 21 will be evaluated for risk factors for cardiovascular disease (CVD). This is a single-blind study. Subjects will be randomized in a 2:1 fashion for treatment (ARM 1) versus placebo (ARM 2). Adipose tissue (fat) will be harvested from all patients and stem cells will be cultured. For those patients in the placebo arm the stem cells will be frozen for later use after one year when the patients cross over into the treatment arm.

Baseline assessment of patients will include completion of 6 questionnaires, EKG (electrocardiogram), vision testing using a standard eye chart, markers of endothelial dysfunction hormone evaluation, laboratory blood tests, vital signs, penile ultrasound (optional), echocardiogram, chest x-ray, and endothelial function assessment (Endopat).

The adipose tissue sample is sent to Celltex's state-of-the-art laboratory in Houston, Texas. For those subjects in the placebo arm, the stem cells will be frozen for later use after one year when the patients cross over into the treatment arm. The subject (patient) will receive an infusion of either autologous stem cells (cells made from his own fat tissue) or placebo every 2 weeks for 3 months. Placebo will be in the form of normal saline. Subjects will be closely monitored every two weeks for first 3 months and once the treatment is complete, subjects will be monitored every 3 months for the first year. Each of the previously mentioned tests will be performed at the 3, 6, 9, and 12 month mark. However, the penile ultrasound (optional) and the echocardiogram will be performed only at the 3 and 12 month mark.

Eligibility Criteria:
Inclusion Criteria:

* Men 40 years of age or older
* Men with erectile dysfunction as defined by IIEF score less than 21
* Men with endothelial dysfunction as defined as an RHI score less than 2
* Men with normal testosterone levels (300 ng/dl)

Exclusion Criteria:

* Men under the age of 40
* Men with normal erectile function
* Men with normal endothelial function
* Men with low testosterone levels (less than 300ng/dl)
Botulinum Toxin A & Weekly Serial Casting in ABI Inpatients With Lower Extremity Spasticity

Effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI.

The investigators will be studying the effects of Chemodenervation (Botulinum Toxin A) and Serial Casting vs Botulinum Toxin A and without serial casting in Lower Limb Spasticity following ABI.

patients are randomly divided into two groups: group 1 will undergo botox injection with weekly serial casting group 2 will undergo botox injection with physiotherapy The primary outcome is the effects of the proposed treatment with respect to passive dorsiflexion.

Eligibility Criteria:
Inclusion Criteria

* Patients with Acquired Brain Injury (ABI) including but not limited to stroke, traumatic and anoxic brain injury in ABI unit of RRC
* Dorsiflexion limitation of \< 10 degrees from neutral and Modified Ashworth Score (MAS) of 2 or 3
* Patients that are on Oral Medication for Spasticity Tx are still allowed to participate (ie. Baclofen)
* Patients both with Bilateral or Unilateral Lower Limb Spasticity are included
* There will be no sex or age restrictions

Exclusion Criteria

* Patients cannot have had Botulinum Toxin A Injections in their Lower Extremities within the past 6 months
* Patients cannot have had any sort of custom bracing or serial casting previously
* Patients with MAS of 4
* Patients with generalized spasticity that require other alternative treatment such as intra-thecal baclofen or surgical intervention
* Patients need to be medically stable (all co-morbidities under control via medical/pharmacological therapy), patients with ongoing co-morbid medical condition that are unmanaged will be excluded.
* Patients whom have skin breakdown in their lower extremities prior to the study will be excluded
* Patients who develop Skin breakdown (Grade 2 or higher) during the course of the study will be removed automatically
A Survey to Assess Participants' and Physicians' Knowledge, Attitudes and Behavior When Using GATTEX

The main aim of this study is to document the level of knowledge and assess attitudes and behaviors of both participants and physicians regarding the risks and safe use of GATTEX. The survey will be done via internet, telephone, or paper and both physicians and participants will be able to choose the method that is preferred. No study medicines will be provided to participants in this study.


Eligibility Criteria:
Participant inclusion criteria:

Participants who are 18 years of age and who have taken GATTEX in the 60 days prior to survey implementation are eligible to participate in the survey. A caregiver may participate in this survey on behalf of a patient who is eligible but unable to complete the survey. Note: Participants who have previously participated in a GATTEX Patient Knowledge, Attitudes and Behavior (KAB) Survey, are eligible.

Prescriber inclusion criteria:

HCPs (adult and pediatric) in the United States who can provide a 10-digit National Provider Identifier (NPI) number and who have prescribed GATTEX at least once regardless of their completion of the voluntary GATTEX REMS training (Prescriber Education Slide Deck) are eligible for participation in the survey. Note: HCPs who have previously participated in a GATTEX HCP KAB Survey, are eligible.

Participant and Prescriber exclusion criteria:

* Respondents who do not agree to participate in the survey.
* Respondents who are currently working for and/or whose immediate family members who are currently working for Takeda Pharmaceuticals U.S.A., Inc., NPS Pharmaceuticals, Inc., Shire, UBC, or the Food and Drug Administration (FDA) are not eligible to participate in the survey.
* Respondents who reported having a conflict of interest.
* HCPs who have opted out of receiving communications about the GATTEX HCP KAB Survey for the current wave

Further details associated with respondents who do not meet the exclusion criteria established above, will be provided in the assessment report.
Effectiveness of Yoga on Ambulatory Blood Pressure in Patients With Pre- and Stage I Hypertension

The proposed study will compare a well defined and integrated yoga practice (postures/breath control/meditation) to a conventional exercise program in reducing hypertension. The expected outcomes include data on the effects of yoga on ambulatory blood pressure, psychosocial stress, and the autonomic system in individuals with pre- and Stage I hypertension. The information gained in this study will have a positive impact by providing critical preliminary and feasibility data to support a larger multi-ethnic randomized clinical trial on the effects of yoga on individuals with hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Age: 21-64; Pre- or Stage I hypertension with mean office blood pressure (two measurements using aneroid sphygmomanometer) of systolic between 120 and 159 mmHg or Diastolic between less than or equal to 80 and 99 \[1\]
* Medically stable on any current medications; BMI (kg/m2) between 18.5 - 40
* English speaking

Exclusion Criteria:

* Taking anti-hypertensive medication; Current use of insulin or oral hypoglycemic agents
* Previous cardiovascular event (prior myocardial infarction, stroke, or angina pectoris)
* Current or previous cancer diagnosis
* Congestive heart failure
* History of kidney disease
* Signs or symptoms of significant peripheral vascular disease
* Significant co-morbidities that preclude successful completion of the study
* Yoga practitioner (participated in more than 3 yoga sessions within the last year)
Stereotactic Body Radiation for Consolidation After Standard Chemoradiation for Stage 3 Lung Cancer

The purpose of this study is to evaluate the efficacy and toxicity stereotactic body radiation (SBRT) as consolidation following standard chemoradiation for patients with stage III non-small cell lung cancer.

This protocol will investigate the potential role of SBRT for patients with stage 3 NSCLC. Eligible patients will first have received standard 50.4 Gy chemoradiation. Patients entering the study will have the opportunity to receive SBRT as a noninvasive option as compared to surgical resection. For patients who are not surgical candidates, SBRT after 50.4 Gy chemoradiation represents a technique of radiation consolidation that may be more effective and less toxic than standard conventional fractionated radiation

Eligibility Criteria:
PATIENT ELIGIBILITY Conditions for Patient Eligibility (Inclusion)

* Pathologically or cytologically confirmed NSCLC
* Stage III NSCLC according to the AJCC 7th edition staging criteria. Stage II (T1-3N1) patient that are deemed medically inoperable are also eligible.
* Concurrent chemoradiation to a radiation dose of 50.4 Gy.
* residual tumor volume after concurrent chemoradiation that is appropriate for SBRT:

  * Primary tumor \<120cc (approximately 6cm diameter).
  * Mediastinal/Hilar disease: 1-2 involved regions \<60cc (approximately 5cmx3cmx3cm)
* Absolute neutrophil count ≥ 1,000/uL, platelet ≥ 60,000/uL.
* Total bilirubin ≤ 2x upper institutional limit of normal (ULN), and AST or ALT ≤5x ULN.
* ECOG performance status 0 to 2
* Minimum life expectancy of 12 weeks.
* Age older than 18 years.
* Voluntary, signed written informed consent.
* Women of childbearing potential must have a negative pregnancy test
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 1 months thereafter.

Conditions for Patient Ineligibility (Exclusion)

* Disease progression during or after standard chemoradiation to 50.4 Gy
* Prior thoracic radiation other than the pre-operative radiation not greater than 50.4
* Metastatic disease
* Uncontrolled severe, intercurrent illness.
* Women who are breast-feeding.
* No chemotherapy within 2 weeks from the first SBRT treatment.
* Concurrent anticancer therapy.
* Prior complete resection of all NSCLC.
Reduction of Bedrest Time of Post Percutaneous Renal Biopsy Patients

To compare the reduction of the bedrest time of the patient after percutaneous renal biopsy from 24 hours to 8 hours in relation to the occurrence of complications evaluated by the Nursing Outcome Classification (NOC) indicators.

Percutaneous renal biopsy (BRP) is an important procedure for the diagnosis, prognostic evaluation and therapeutic orientation of several kidney diseases. Although it is considered a safe procedure, BRP complications can occur and, most of the time, are related to the risk of bleeding and the main consequence of BRP. Complications include macroscopic hematuria and hematoma requiring blood transfusion, surgical intervention, or invasive procedure. Since hemorrhagic complications continue to be the highest risk after BRP due to severity and potential life-threatening risk, there is an effort to minimize the risk of bleeding by checking blood clotting markers prior to the procedure, uncontrolled hypertension and the use of antiplatelet drugs and anticoagulants. The relevance of this study is to seek better evidence for clinical practice, considering the lack of Brazilian studies on the subject and the positive impact on patient comfort, besides the reduction of costs for the institution and overload in the work of the multidisciplinary team. In addition, it will contribute to the strengthening of the use of NOC in clinical practice and to the improvement of nursing knowledge.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing renal biopsy at Hospital de Clínicas de Porto Alegre (HCPA);
* Both sexes;
* Aged 18 years or older.

Exclusion Criteria:

* Patients with the following risk factors for complications;
* More than two punctures during the procedure;
* Larger gauge needle;
* Uncontrolled blood pressure;
* Blood clotting disorders and use of antiplatelet agents (aspirin or clopidogrel), or use of anticoagulants;
* Bedridden patients and patients unable to adequately to ambulate.