cyrilzakka/clinical-trials huggingface dataset:
Whole Body Vibration in Obese Female Students

Obesity is a global public-health issue, with rising incidence and prevalence, significant expenditures, and poor results. Obesity has become a worldwide epidemic in both developed and underdeveloped countries. A body mass index (BMI) of 30 kg/m2 is required for class I obesity, a BMI of 35 - 39.9 kg/m2 is required for class II obesity, and a BMI of 40 kg/m2 is required for class III obesity (morbidly obese). Obesity will be the likely situation for the majority of the adult population during the next two decades due to an abundance of calorie-rich food and apathy toward exercise.

Obese and overweight young people swayed at a higher rate than people of normal weight. Two hypotheses have been offered to explain the negative effect of weight on balance control. The first is decreased plantar sensitivity as a result of hyper-activation of plantar mechanoreceptors caused by the constant pressure of supporting a heavy burden. The second theory is that there is a higher mechanical demand owing to the big body mass itself, as well as a non-negligible amount of body mass further away from the axis of rotation (i.e., ankle joint in an inverted pendulum model) that creates a higher gravitational torque. As a result, in order to maintain an upright posture, the gravitational torque that accelerates the body must be opposed by muscle torques.

WBV is a mechanical stimulation characterized by oscillatory motion supplied from a platform to the entire body. The current devices employ two distinct systems: (a) a vertical vibration, in which the entire plate oscillates uniformly up and down with only a vertical translation; and (b) reciprocating vertical displacements on the left and right sides of a fulcrum, which increases the lateral accelerations. WBV training includes biomechanical characteristics such as body position, amplitude, frequency, magnitude, and duration.

Eligibility Criteria:
Inclusion Criteria:

* Female students
* BMI ≥ 30
* Aged from 18 to 25 years old

Exclusion Criteria:

* Pregnancy
* Musculoskeletal disorders
* History of spinal surgery
* Epilepsy
* Medications that could affect the musculoskeletal system
* Performing regular exercise of more than 3 times a week
* Metal plates in the body
* Ligament sprain
* Medical history such as cardiovascular disease, or diabetes mellitus
Treatment of Bacterial Vaginosis in Early Pregnancy in Skaraborg and the Effect on Spontaneous Preterm Delivery

Bacterial vaginosis (BV) is a known risk factor for preterm delivery. This study was conducted in an attempt to investigate if treatment of bacterial vaginosis in early pregnancy could reduce the risk for preterm delivery.

Women were screened for bacterial vaginosis during the first visits at the maternal health care unit with a vaginal sample that were taken by the midwife or by herself. After the vaginal samples was air dried it was sent to the gynaecological department and was investigated using Hay/Ison classification. Eligible women were those who had lived in Skaraborg and delivered at Skaraborg hospital.

The study has started 2007 and will continue until 2014. Pregnant women that will come to the maternal health care units in gestational week 8-11 will be offered to be screened for bacterial vaginosis. A vaginal sample will be taken by the midwife or by the women herself. The vaginal sample is air-dried and sent to the gynecological. There it is investigated using Hay/Ison classification for the diagnosis of bacterial vaginosis.

Women with bacterial vaginosis will be offered treatment with topical clindamycin treatment for 7 days if the women has passed the 12th gestational week. A control sample for the test of cure will be done after 10 week. If not cured of BV she will be offered a new treatment.

All women will be followed until delivery.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women screened for bacterial vaginosis in early pregnancy

Exclusion Criteria:

* women not delivered at Skaraborg hospital.
A Novel Balance Program to Improve Balance in People With Parkinson's Disease

The purpose of this exploratory single-blinded randomized control trial is to explore the effects of a lateral stepping program integrated into an existing community-based group exercise program for people with PD. The researchers hypothesize that participation in a lateral stepping program a minimum of 2 times/week for 8 weeks, in addition to RSB class participation, will decrease fall risk factors, increase balance confidence, and decrease fear of falling in participants in the experimental group compared to the control group. The researchers also hypothesize that the integration of this program into an existing community-based RSB program will be deemed feasible as shown by the number of sessions attended by each participant and their satisfaction


Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of idiopathic PD stages I, II, or III of the Hoehn and Yahr scale
2. 50-85 years inclusive
3. Subjects must be enrolled in RSB at NY Tech and attend at least 1 day per week for a minimum of 4 weeks prior to the first baseline assessment
4. English speaking.
5. Stable PD medication regime.

Exclusion Criteria:

1. Any cardiovascular or other medical condition that would affect participation
2. Any hip and/or knee surgery or other injury that would prevent full participation in the intervention
3. Neurological conditions other than PD
4. Montreal Cognitive Assessment of ≤21
5. Pain that interferes with testing 13
6. Current participation in other strengthening, stretching or balance programs other than Rock Steady Boxing at NY Tech
7. Inability to understand and fully participate in this study
Ketamine Infusion for Sickle Cell Pain Crisis

The purpose of this study is to prospectively study the efficacy of low dose ketamine infusions in treating patients who are admitted to the hospital with a sickle cell pain crisis. Participants will be prospectively randomized in unblinded fashion in the first 12 to 24 hours of an inpatient admission for sickle cell pain crisis to receive pain management without ketamine infusion (Group A) versus pain management that includes low-dose ketamine infusion starting at 0.2mg/kg/h (Group B). The effect of this intervention on various pain management and healthcare utilization outcome measures will be recorded and analyzed to determine whether or not there is a measurable benefit of using ketamine infusions in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Have a pre-existing/known diagnosis of sickle cell disease, prior to the current presentation
* Admitted to Duke University Hospital with a clinical diagnosis of sickle cell crisis
* Are at least 18 years old at time of admission
* Have been admitted to any hospital for sickle cell pain crisis at least twice in the last year
* Have documented severe pain at time of admission, requiring intravenous opiates
* Must be able to speak English

Exclusion Criteria:

* Are greater than 70 years old at time of admission
* Carry a diagnosis of cirrhosis, elevated intracranial pressure, elevated intraocular pressure, active coronary artery disease, and psychiatric disorders with history of psychosis
* Are pregnant or breastfeeding
* Are concomitantly admitted for another medical or surgical problem in addition to sickle cell pain crisis
* Have been admitted to any hospital for a sickle cell pain crisis greater than 10 times in the last year
* Were admitted to any hospital for sickle cell pain crisis within the last 30 days
* Are able to fully and properly consent for their own medical care, with no restrictions or limitations
Comparison of the Effects of Phenylephrine and Norepinephrine on Cardiac Function During Carotid Artery Surgery

This will be a prospective, randomized, double-blinded, cross-over clinical trial to compare the effects of phenylephrine or norepinephrine on cardiac function during carotid artery surgery in patients under general anesthesia. The effect of the vasopressor on cardiac function will be measured using electrocardiography, transesophageal echocardiography and cardiac troponin I intraoperatively and postoperatively. We will use a cross-over pattern since both drugs exhibit rapid onset and short duration of action. We hypothesize that there will be less myocardial ischemia associated with the use of norepinephrine when compared with phenylephrine during carotid artery surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elective carotid endarterectomy under general anesthesia
* \> 18 years old
* Written informed consent

Exclusion Criteria:

* Contraindication to general anesthesia
* Contraindication to transesophageal anesthesia
* esophageal disease
* esophageal stricture
* history of esophageal or gastric bleeding
* esophageal anatomic abnormality
* past esophageal or gastric surgery
* severe dysphagia
Routine Or Selective Stress Testing After Revascularization: ROSSTAR Trial RCT Outline

The ROSSTAR trial is a pragmatic trial that will directly compare the strategies of routine and selective stress imaging testing (with radionuclide imaging (RNI)) late after PCI or CABG in asymptomatic patients. The study will be a single center trial based at the Jewish General Hospital (JGH), a McGill University teaching hospital (Montreal, Quebec). A total of 1100 patients who are either \>5 years post-CABG or \>2 years post-PCI will be randomized. Half of the patients will be randomized to a routine RNI testing, and the other half to selective RNI testing.

There is no consensus in current guidelines regarding the role of stress imaging testing late after revascularization. The issue to be resolved by the trial is whether routine stress imaging testing (stress test with nuclear perfusion imaging) benefits patients late after percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG).

What are the principal research questions to be addressed?

1. Is a strategy of routine stress imaging testing late after PCI or CABG associated with lower clinical event rates than a strategy of selective stress imaging testing?
2. Is a strategy of routine stress imaging testing late after PCI or CABG associated with better quality of life than a strategy of selective stress imaging testing?
3. What are the resources utilization associated with routine vs. selective stress imaging testing?

What is the primary hypothesis? The primary hypothesis is that routine stress imaging testing late after PCI or CABG is associated with lower clinical event rates than a strategy of selective stress imaging testing.

Eligibility Criteria:
Inclusion Criteria:

* 1.Patients who have undergone CABG or PCI.
* 2.CABG surgery occurred \>5 years and PCI \>2 years prior to randomization.
* 3.Patients must have had at least one SVG in the CABG group.
* 4.Patients are asymptomatic or have minimal chronic anginal symptoms.

Exclusion Criteria:

* 1.Participation in a conflicting clinical study.
* 2.RNI testing already planned or performed within the past 12 months.
* 3.Unable to give informed consent.
* 4.Contraindications to or inability to perform exercise treadmill testing or pharmacological testing.
* 5.Medical condition with a prognosis of less than 3.25 years.
* 6.Likely to be unavailable for follow-up.
* 7.Unable to read and understand English or French.
Assessment of Two Postoperative Techniques Used to Predict Voiding Efficiency After Gynecologic Surgery

After gynecologic surgery, it may be difficult to void (urinate). This problem is usually short-term with normal function returning within a few days to a few weeks. For this reason, patients may require drainage of their bladder with a catheter immediately after surgery. Currently in our office, we use two different tests to see how well you are able to urinate and how quickly the catheter can be removed. The purpose of this study is to see which voiding test is better after gynecologic surgery.

Postoperative voiding dysfunction is commonly encountered following gynecologic surgery. This dysfunction is usually short term, with normal function returning within a few days. Following uro/gynecologic surgery, most patients require drainage with either a transurethral or suprapubic catheter in the immediate postoperative period. Within our practice, we prefer drainage with a transurethral catheter.

At some point after surgery, the urethral catheter is removed and normal bladder function allowed to resume. At present, there is no generally accepted regimen to assess voiding efficiency. In our practice, we currently employ two regimens to both assess voiding efficiency and expedite catheter removal. In one technique, the catheter is removed and the patient's bladder is allowed to fill spontaneously. Patients are asked to void when they experience a strong urge. The voided volume is recorded and a post-void residual (PVR) is then measured by transurethral straight catheterization.

In the second technique, the patient's bladder is retrogradely filled with 300 cc of sterile fluid and the catheter removed. They are asked to void within 15 minutes of instillation and the voided volume is measured. The PVR is then obtained by transurethral straight catheterization.

In both cases, if the patient voids \>2/3 the total volume (voided volume + residual) the trial is considered "passed" and the catheter is removed. If a patient voids \< 2/3 of the total volume, the trial is considered "failed" and indicative of urinary retention. In this case the catheter replaced.

We aim to assess the ability of these techniques to accurately predict voiding efficiency and to determine if one technique is superior to the other.

Eligibility Criteria:
Inclusion Criteria:

* All women \> 18 years of age presenting to the Division of Urogynecology at the University of Rochester Medical Center/Strong Memorial Hospital and undergoing gynecologic surgery which requires postoperative placement of a transurethral catheter.
* Subjects must be competent to give informed consent.

Exclusion Criteria:

* Any patient less than 18 years of age.
* Patients with suprapubic catheters postoperatively.
* Patients undergoing surgery that does not require transurethral catheterization postoperatively.
* Patients not competent to give informed consent.
* Patients who are pregnant.
* Patients undergoing procedures requiring prolonged bladder decompression (i.e. fistula repair).
Neural Respiratory Drive in Pulmonary Hypertension

Investigating neural respiratory drive by examining parasternal EMG measurements in patients presenting for assessment of presumed pulmonary hypertension.

NRD can be assessed by measuring parasternal electromyogram (EMG). Readings are taken by applying two small electrodes in the second intercostal space either side of the sternum and one to the shoulder. The electrodes are similar to those used in ECG acquisition. Measurements are then taken during normal breathing and also during maximal breathing effort ('sniff' procedure). Tests may be taken with patient recumbent at 45 degrees and supine. The test is non-invasive, has been safely performed in patients in previous studies and is not anticipated to cause any harm or distress. The total time for measurements will be around 20 minutes per patient.

NRD will be calculated as root mean square of normal tidal breathing as a proportion of maximal inspiratory effort (maximum inspiration from functional reserve capacity, taken as a sniff manoeuvre). Measurements will be performed in a ward based setting at the patient's bedside.

At the end of the inpatient stay for diagnosis, some patients are commenced on treatment and followed up in clinic. It would be the intention of the investigators to reassess these patients at clinic to test NRD and compare how this changes over time compared to other clinical parameters.

In addition, we will collect further readings of NRD in these patients when they attend for their standard follow up appointment. For the majority of patients, this will be after 3-4 months. For a subset of patients with chronic thromboembolic pulmonary hypertension, this may be up to one year after initial readings because these patients may be suitable for surgical intervention, which is not done locally and usually takes place 6-12 months after diagnosis at SPVU.

As such, the investigators intend that a patient will take part in the study for 52 weeks maximum, with most patients taking part for 16 weeks, and the study will not require them to have any additional attendances at hospital outwith their standard hospital admission for diagnosis and clinic follow up.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Being investigated for pulmonary hypertension

Exclusion Criteria:

* Patient is pregnant
* Patient has a diagnosed neuromuscular disorder
Intravenous Esketamine on Prevention of Postoperative Depression in Patients Undergoing Cardiac Surgery

Esketamine is a general anesthetic with anti-depressant effects at subanaesthetic doses. This study hypothesized that intraoperative administration of ketamine would prevent or mitigate postoperative depressive symptoms in surgical patients.

Single subanaesthetic doses of i.v. esketamine may significantly improve symptoms in psychiatric patients with major depression.

In patients undergoing cardiac surgery, postoperative depressive symptoms are common.

This study hypothesizes that low-dose esketamine has a preventive effect on postoperative depression. However, evidence in this aspect is insufficient. The purpose of this study is to investigate the effect of a subanaesthetic dose of ketamine on POD for patients undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* 1:Patients scheduled for heart surgery
* 2:Moderate to severe depressive symptom measured by the qualified psychiatric doctors
* 3:Over 18 years of age
* 4:American Society of Anesthesiologists physical status I-III

Exclusion Criteria:

* 1:History of epilepsy
* 2:Major depression disorder patients undergoing antidepressive therapy within 2 weeks
* 3: Psychiatric illness
* 4: Drug abuse
* 5:History of allergy to esketamine
* 6:Hyperthyroidism
* 7:Patients can not cooperate with investigators on psychiatric assessments
* 8:Pregnant or breastfeeding woman
* 9:refuse to sign informed consent.
Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke

The purpose of this study is to determine whether a culturally-sensitive multipronged post-discharge intervention can significantly reduce blood pressure, enhance achievement of guideline recommended targets for risk factor control, and lower recurrent vascular events in a low-income and middle-income (LMIC). The study will have 2 Phases - a qualitative phase (Phase 1) lasting less than one year involving development of the intervention through focus group methodologies and structured interviews, and a clinical trial phase (Phase 2)lasting 3 years involving a randomized trial testing the efficacy of the intervention.

This research seeks to develop an effective and sustainable way of reducing the devastating and deadly impact of stroke in a low-income region of the world with poor medical infrastructure. It will do so by focusing on improving the treatment of the condition most closely tied to stroke, hypertension, using novel methods that incorporate the input of the local community. If successful, the strategy could serve as a ready model to be adapted by decision-makers in other under-resourced areas for lessening the burden of stroke(and other major public health challenges).

Eligibility Criteria:
Phase 1: Inclusion Criteria:

Age ≥ 18 years Stroke within one year access to mobile phone.

Exclusion Criteria:

Any medical condition that would limit participation in follow up assessments, Severe cognitive impairment/dementia (MMSE ≤24) Severe global disability (modified Rankin Score ≥ 3).
A Prospective Study of Tocilizumab in the Treatment of Idiopathic Retroperitoneal Fibrosis

This is a prospective study to investigate the treatment response of Tocilizumab on patients with idiopathic retroperitoneal fibrosis（IRPF）.

Methods: All the patients fulfilling diagnostic criteria of IRPF would be enrolled. The IRPF patients will accept Tocilizumab or Glucocorticoid monotherapy for 3 months.

Endpoints: The primary endpoint is to investigate the response of Tocilizumab on IRPF patients; the secondary endpoints include the decrease of inflammatory markers, side effect.


Eligibility Criteria:
Inclusion Criteria:

* age 18-75 diagnosed as IRPF: The diagnosis of idiopathic retroperitoneal fibrosis is based on the following aspects :(1) the swelling of retroperitoneal tissue , which seems neoplastic; (2) A large number of lymphocytes proliferated and infiltrated in the affected tissues and organs, and tissues showed inflammation, fibrosis and sclerosis, in which IgG4-positive cells accounted for less than 50% of plasma cells; (3) Increased inflammatory markers, such as ESR and CRP; (4) Good response to glucocorticoid therapy.

Exclusion Criteria:

* malignancy retroperitoneal fibrosis secondary to other diseases or drug treatment or abdominal surgeries.
Efficacy and Safety of Rivaroxaban for the Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).

Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

Eligibility Criteria:
Inclusion Criteria:

* 20 years or older
* Japanese male or female
* Non- valvular atrial fibrillation documented by ECG
* Patients with a risk of stroke and non-CNS systemic embolism

Exclusion Criteria:

* Significant mitral stenosis
* Patients in whom anticoagulants are contraindicated
Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.


Eligibility Criteria:
Inclusion Criteria:

* Participants who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and received Bimatoprost SR.
* Participants who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and received DURYSTA.

Exclusion Criteria:

* Female participants who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study.
* Concurrent or anticipated enrollment in another investigational drug or device study during the present study.
* Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study.
* Participants who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092.
* For patients from the ARGOS lead-in study: history of prior incisional glaucoma surgeries and/or minimally invasive glaucoma surgical procedures in the study eye or treated fellow eye.