cyrilzakka/clinical-trials huggingface dataset:
Stand-Alone Cage Verus Anterior Plating for Anterior Cervical Discectomy and Fusion.

The purpose of this study is to compare the clinical results between two different techniques for ACDF: 1. Stand-alone ACDF, which means the placement of an interbody device (cage) without anterior fixation or plating; 2. ACDF with and interbody cage and anterior plating for fixation. Both of these procedures are commonly performed at Rush with unclear advantage of one procedure over the other. Both have been associated with good to excellent clinical outcomes. The devices used in this study are approved by the Food and Drug Administration (FDA).

Anterior cervical discectomy and fusion (ACDF) is one the most common procedures performed by spine surgeons. Although ACDF with autologous bone graft and anterior plating is commonly performed, this procedure may be associated with postoperative dysphagia, significant costs and adjacent segment pathology. To address these concerns, a number of surgeons have opted to utilize an interbody cage in a stand-alone fashion with good to excellent results. However, the published data is limited and currently there in no consensus among spine surgeons regarding the best technique to achieve fusion and improve clinical outcomes in patients with degenerative disc disease in the cervical spine.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a primary 1- to 2-level ACDF

  (a) Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
* Patients able to provide informed consent

Exclusion Criteria:

* Cervical spine trauma
Propofol Sedation vs. Anaesthetist Guided Anaesthesia in Oocyte Pickup

Patients undergoing their first course of in vitro fertilisation receive either gynaecologist guided propofol only sedation or anaesthetist guided full anaesthesia. Patient satisfaction and clinical outcome will be evaluated afterwards.


Eligibility Criteria:
Inclusion Criteria:

Patient undergoing first oocyte pickup Understands german language to fill out questionnaire

Exclusion Criteria:

BMI \>30 BMI \<17 Heavy endometriosis Patients undergoing a consecutive IVF attempt
AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area

Infants in malaria-endemic regions of Africa are an important target for vaccination against malaria in view of the enormous disease burden of malaria in this population. The purpose of this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP candidate vaccines in healthy children in a malaria endemic region. The regimen proposed here has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be protective against naturally acquired infection in the Gambia. Administration of AdCh63 ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two weeks from the administration of routine infant immunisations, given according to the Gambian EPI.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants aged 10 weeks and 5-12 months at the time of enrollment with consenting parents.

Exclusion Criteria:

* Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
* Severe malnutrition.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.
* History of splenectomy Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator
* Serum Creatinine concentration greater than 70 mol/L, where judged to be clinically significant in the opinion of the investigator
* Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator
* Blood transfusion within one month of enrollment.
* History of vaccination with previous experimental malaria vaccines. -Administration of any other vaccine or immunoglobulin less than two weeks before vaccination with the IMPs Current participation in another clinical trial, or within 12 weeks of this study.
* Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
* Likelihood of travel away from the study area
* Maternal HIV infection Positive malaria antigen test at screening
* Failure to have received, prior to enrollment, the routine EPI vaccinations due according to the Gambian EPI schedule.
Early Resistance Training Post Valve Replacement Surgery

Background: Recent recommendations from the European Society of Cardiology (ESC) are multidisciplinary cardiac rehabilitation including therapeutic exercises for patients after heart valve surgery unless there is insufficient evidence to decide whether therapeutic exercise cardiac training should be provided for such patients. As well, resistance training is an extremely safe systemic physical activity, and it has no contraindications if well-oriented, in addition to being the fastest-growing physical activity in the world in several practitioner settings.

Purpose: This study was conducted to investigate the effect of early resistance training on the fitness level (vo2 max) and (PR interval) of patients post-valve replacement surgery.

Method: Forty males post-valve replacement surgery participants' age ranged from 20 to 30 years old and were selected randomly from National Heart Institute (Imbaba), this study was conducted in the period between April and November 2022, and those participants were allocated randomly into two equal groups twenty in each group. Group A received aerobic and resistance training three sessions per week for one-month, and group B received aerobic training three sessions per week for one month. All demographic data was recorded and an ECG device was used to record HR and R-P Intervals, Six-Minute Walk Test (6MWT) was used to assess of cardiorespiratory fitness for all participants in both groups (A\&B)

Eligibility Criteria:
Inclusion Criteria:

1. Participants' age ranged from 20 to 30 years old,
2. Participants medically stable to do early resistance exercise in the first week after the operation.
3. Each participant had undergone valve replacement surgeries only,
4. Participants be able to do early resistance exercises in the first week after the operation.

Exclusion Criteria:

* The study excluded the participant if has one or more of the following criteria:

  * sternal infection and delay sternal healing.
  * Patient with a musculoskeletal condition limiting the ability to exercise or a geographical residence and/or lack of access to transportation, thus preventing exercise session attendance.
  * The patient has an LV thrombus diagnosed by echocardiography, left ventriculogram, or other imaging.
  * The patient is known to have unprotected left main coronary artery disease (CAD) greater than 50%.
  * Patients have poor cognitive capabilities or poor mentality.
  * Patient who had valve and CABG surgery.
Observational Study on the Occurrence of Hepatosplenic T-cell Lymphoma in Patients of Netherlands

The purpose of this study is to examine reports of the cancer called hepatosplenic T-cell lymphoma (HSTCL) in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief or PALGA) during the years 1995 to 2008.

This is a observational, retrospective (a study in which the participants are identified and then followed backward in time, for the outcome of the study) study. In this study review of all reports of possible cases of hepatosplenic T-cell lymphoma (HSTCL) that were identified within the PALGA database of pathology results for The Netherlands from 1995 to 2008. All patients whose information is contained within the PALGA database were prescribed treatments by a physician on the basis of usual clinical practice or may have received other treatments, including experimental drugs, while participating in an interventional clinical study. The identified data on each of the patients with reports of HSTCL will be collected from the pathologist(s) who prepared the report and from the physician(s) who treated the patient at the time of diagnosis.

Eligibility Criteria:
Inclusion Criteria:

- Patients diagnosed with HSTCL in the Dutch National Database of Pathology (Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief) database during the years 1995 to 2008

Exclusion Criteria:

- Patients who are not diagnosed with HSTCL
An Evaluation of Virtual Reality in Labor Pain During Vaginal Childbirth

This study will be conducted to evaluate the effect of applying virtual reality among laboring women during first stage of labor

This study will be conducted to evaluate the effect of applying virtual reality among laboring women during first stage of labor

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-25 years old .
* body mass index (BMI) 25- 32 kg/m2 .
* Primiparous .
* Highly educated.

Exclusion Criteria:

* Laboring women with high risk pregnancy.
* Laboring women are taking pharmacological methods to relieve pain during first stage of labor.
* Low educated women
Integrated Treatment in FND (Functional Neurological Disorders)

The project will investigate the effectiveness of patient-centered integrated treatment.

The correlations between physiotherapy indices, non-invasive brain stimulation, connectivity and psychological support will be analyzed.

At the time of recruitment (T0) a multidimensional evaluation will be performed consisting of clinical, neuropsychological, neurophysiological, MRI, data obtained from peripheral blood sampling (10ml). After completing the program (12 weeks), the effect will be assessed according to objectives (T1). The study will also include a follow-up evaluation after 6 months (T2) and 12 months (T3) from the beginning of the treatment to evaluate the persistence of the beneficial effects after some time.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Diagnosis of Functional Neurological Disorder of movement clinically established according to DSM-5 criteria
* Age between 18 and 65 years (inclusive)
* Ability to participate in the study protocol

Exclusion Criteria:

* Inability to provide written informed consent
* Pregnant women
* In case of use of non-invasive brain stimulation techniques: the subjects must not present any of the contraindications specific to this method (for further specifications see the "Methods" and the "Stimulation Evaluation Questionnaire" attached to this proposal)
* Presence of unstable clinical conditions or infections
* In the case of the use of non-invasive brain stimulation techniques: concomitant use of drugs that can alter the transmission and synaptic plasticity (cannabinoids, L-dopa, antiepileptics, nicotine, baclofen, Selective Serotonin Reuptake Inhibitors (SSRI), botulinum toxin)
* Inability to support physiotherapy or psychotherapy sessions
Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes

Inadequate suppression of intramuscular and adipose tissue lipolysis, and consequent excessive delivery of fatty acids to ectopic tissues (e.g. muscle, pancreas and liver) could play an important role in the development and exacerbating of insulin resistance. Therefore, the investigators propose to study the regulation of adipose tissue and skeletal muscle lipolysis, as well as further characterize the intracellular lipolytic pathways within these tissues, in obese normoglycaemic versus long-term diagnosed type 2 diabetic subjects.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* Normal blood pressure (SBP 100-140 mmHg, DBP 60-90 mmHg)
* weight stable in last 3 months

Exclusion Criteria:

* Smokers
* people with intensive fitness training (e.g. athletes \> 3 times/week)
* History of cardiovascular diseases
* Bleeding disorders
* Use of medication interfering with the study endpoints/hypotheses (e.g. beta-blockers)
* Not to be able to understand the study information
* Subjects on a special diet or vegetarian
* Blood donation 2 months prior to the study and during the study
* Participating in an other study
Whey Protein Pre-load and Postprandial Glycemia in Pregnancy

This pilot study aims to investigate the intake of whey protein prior to carbohydrate intake as an approach to modulate postprandial glucose excursions during pregnancy.

Gestational diabetes (GDM) has transgenerational health consequences and increases the risk of type 2 diabetes mellitus in both mother and child. However, there is a lack of practical nutritional concepts for the prevention and treatment of GDM. This randomized controlled pilot study investigates whether the intake of a protein drink before carbohydrate intake lowers postprandial blood glucose levels of pregnant women. Therefore, two 75g oral glucose tolerance tests are performed in 20 pregnant women in a cross-over design, whereby a whey protein solution is drunk 30 minutes before one of the oral glucose tolerance tests (OGTT). If a clinically relevant effect on blood glucose levels is identified, this project can clarify whether the reduction in postprandial glycemia was caused by changes in the secretion of insulin and incretins.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 24+0 and 27+6 (+/- 7 days) weeks of pregnancy after menstruation
* BMI before pregnancy: 18 - 29.9 kg/m2
* No known underlying diseases
* Understanding and voluntary signing of a consent form before study-related examinations

Exclusion Criteria:

* Age \< 18 years
* Diabetes mellitus type 1 or type 2
* Drug therapy that raises or lowers blood sugar, e.g. steroids, antidiabetics, insulin.
* Endocrine disorders (e.g. hyperthyroidism, polycystic ovary syndrome (PCOS), ...)
* Current depression or other mental illnesses
* Eating disorder
* Regular intake of medication other than vitamins/trace elements during pregnancy
* Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m²
* C-reactive protein \> 10 mg/l
* Transaminase elevation of 2 times the upper norm
* Pre-existing cardiac diseases
* Drug and/or alcohol abuse
* Hb \< 12 g/dl
* No consent to be informed about incidentally discovered pathological findings
* Any other (clinical) condition that would endanger participants safety or question scientific success according to the physicians opinion.
Spatial Neglect and Bias in Near and Far Space

The purpose of this research study is to learn how people distribute their visual attention when looking at objects nearby versus far away, and why vision may become distracted at near versus far distances.

Visual distraction is a problem that more often occurs people who have suffered strokes than in the general population. Problems of visual attention generally appear immediately following a stroke, and may impair driving and other functions. While it is thought that there is a natural course of improvement over time, little is known about how this improvement occurs. Some studies suggest that recovery is only partial, meaning certain aspects of visual attention may improve while other aspects remain but escape notice.

The purpose of this study is to examine the effect of stroke on a person's visual attention when looking at objects nearby versus far away, and to learn why a person's visual attention may become more distracted at near versus far distances. The purpose of this study is also to understand how modeled interventions, such as eye patching or prism goggles, affect impairment measures of visual attention.

After an initial screening (including attention, thinking, memory, and visual judgment tests), participants will be given a neurological examination. Participants may be asked to perform visual tasks while wearing an eye patch or prism goggles. Next, they will be asked to perform a line bisection task by looking at lines on a video screen either at close or far distances and, using a laser pointer, marking the center of the lines as they appear on-screen. Participants may be asked to perform other, similar visual tasks as well.

Duration of the study for participants varies, ranging from 1 or 2 sessions totaling approximately 2 hours to multiple sessions spanning a year.

Research from this study may help researchers better understand problems associated with stroke and may lead to therapies designed to promote improved visual attention.

Eligibility Criteria:
Inclusion Criteria:

* The subject has a history of stroke.
* The subject is 18 to 100 years old.
* The subject is able to give Informed consent.
* The subject is post-Stroke with left-hemisphere injury and has no spatial neglect (no attentional imbalance).
* The subject is post-stroke with right hemisphere damage and has spatial neglect (attentional imbalance).
* Healthy subject with no brain injury.
* The subject is post stroke and has hemianopia (a "visual field cut").
* The subject is able and willing to comply with the study protocol, including availability for all scheduled clinic visits.

Exclusion Criteria:

* Subjects with brain tumors, head injury with loss of consciousness, visual disorders other than corrected near or far-sightedness, history of learning disabilities, dementia or Alzheimer's Disease.
Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement

This is a single site, randomized, double-blind, placebo-controlled, within-subjects study design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using functional magnetic resonance imaging (fMRI) to determine central nervous system engagement. Safety and tolerability also will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female, 18 - 45 years
* Fluent and literate in English and able to provide written informed consent
* BMI between 18.5 and 38.0 kg/m2 and minimum body weight of 50 kg

Exclusion Criteria:

* Recent exposure to any investigational product
* Previous exposure to relevant fMRI task(s)
* Considered medically unsuitable for participation
* Has any contraindication for BOLD fMRI
Silodosin vs Tamsulosin as MET

The spontaneous passage rate for ureteral stone less than 1cm causing acute ureteral obstruction is about 50%. Previous Cochrane review has concluded that alpha blocker is likely to increase stone passage rate, reduce time to stone passage, analgesic use and hospitalisations. The European Association of Urology Guideline also recommends giving alpha blockers as Medical Expulsive Therapy to patients with distal ureteric stones \>5mm. However there is heterogeneity in different alpha blockers.

Silodosin is a recently introduced selective alpha blocker which has a much higher selectivity for the alpha-1-A receptor (17-fold compared with tamsulosin). From previous animal studies, ureteral contraction is mainly mediated by the alpha-1-A receptor, hence silodosin maybe more effective in increasing stone passage compared with tamsulosin.

Previous studies and meta-analysis has shown superiority of silodosin over tamsulosin on earlier stone passage and less pain. However, there is no data on Chinese population.

The investigators would like to compare the efficacy and side effect profile of Silodosin versus tamsulosin on improving stone passage rate and hence reduce rate of further intervention for stone clearance.


Eligibility Criteria:
Inclusion criteria:

* Presented with radio-opaque ureteric stone of size 5mm to 10mm on KUB
* Patients who can understand the study protocol and comply with the followup schedule

Exclusion criteria:

* Radiolucent stone
* Paper thin cortex
* Non-functioning kidney
* Renal insufficiency (serum creatinine greater than 1.8 mg/dl or 160umol/dL)
* Concurrent urosepsis
* Current \[alpha\]-blocker usage, Ca channel blocker, steroid
* Pregnancy
* Age \< 18
* History of ureteral stricture
* History of ureteric stone treatment within 2 years
* Allergic reaction to the study medication
* Unable to Consent
* Patient on JJ stent or PCN drainage
Long-term Extension Study of BEMA™ Fentanyl

This study is designed to provide continued access to BEMA Fentanyl for those subjects who previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the treatment of their breakthrough cancer pain.

This was an open label, long-term, extension study designed to provide continued access to EMA Fentanyl to those patients with breakthrough cancer pain who were treated for at least 2 weeks in FEN-202, the long term safety study used for worldwide registration. Patients were followed in an outpatient setting. Use of BEMA Fentanyl and occurrence of serious adverse events (SAEs) were monitored. Throughout the study, all patients continued their background opioid regimen and were permitted to use their rescue medication if adequate pain relief was not realized within 30 minutes following application of BEMA Fentanyl.

Eligibility Criteria:
Inclusion Criteria:

1. previously qualified for and participated in study FEN-202 for at least 2 weeks,
2. wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and
3. provide signed informed consent at screening prior to any study procedures.

Exclusion Criteria:

1. they have developed a new medical condition after initial enrollment in FEN-202 which, in the opinion of the investigator, would preclude safe and appropriate use of BEMA Fentanyl or participation in this study, or
2. there is evidence of improper use of the study drug.
MT2014-14 IT-MSC for Advanced Cerebral Adrenoleukodystrophy (cALD)

The purpose of this study is to determine the maximum tolerated dose (MTD) of mesenchymal stem cells (IT-MSC) in patients with active, advanced cerebral adrenoleukodystrophy (cALD).

This is a single-institution dose escalation study to determine the maximum tolerated dose (MTD) of intrathecally administered allogeneic, 3rd party mesenchymal stem cells (IT-MSC) in patients with active, advanced cerebral adrenoleukodystrophy (cALD).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 4 years at time of study enrollment
* Diagnosis of ALD - the diagnosis of ALD can be made by either biochemical or molecular/genetic evidence (plasma VLCFA or ABCD1 mutation analysis) supportive of ALD as the cause of cerebral demyelination
* Evidence of active cerebral disease - defined as the presence of gadolinium enhancement on a single brain MRI study - MRI used for eligibility determination may be performed at an outside institution; the most recent MRI used to determine eligibility must be within 2 calendar months of the date of enrollment on this study
* ALD MRI (Loes) score ≥ 10
* Off of N-acetylcysteine, systemic immunosuppressive drugs or any other therapeutic intervention (except hydrocortisone and/or fludracortisone for the treatment of adrenal insufficiency) for ≥ 10 days prior to the first IT-MSC dose
* Life expectancy of \>6 months as determined by the enrolling researcher and documented in the medical record
* Voluntary written consent provided by parent(s)/guardian(s)

Exclusion Criteria:

* A candidate for allogeneic hematopoietic stem cell transplantation as determined by the University of Minnesota Inherited Metabolic and Storage Disease group
* Inability to undergo sedation, lumbar puncture or MRI studies for any reason
* Inability to stay in Minnesota for therapy through the day 28 evaluation