cyrilzakka/clinical-trials huggingface dataset:
PKP Assisted With MR Technology in OVCF With IVC

To prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC.

The study is to prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC. Forty cases of OVCF with IVC undergoing PKP were randomized into a MR technology assisted group (group A) and a traditional C-arm fluoroscopy group (group B). Both groups were performed PKP and evaluated by VAS scores, ODI scores, radiological evidence of vertebral body height and kyphotic angle(KA) at pre-operation and post-operation. The volume of injected cement and Operation time was recorded. And whether cement touching both endplates or not(non-PMMA-endplates-contact, NPEC) in radiological evidence were also recorded postoperatively. The clinical outcomes and complications were evaluated afterwards. All patients received 10 to 14 months' follow-up, with an average of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Single level OVCF in the thoracic and lumbar levels (T10-L4), suffering with severe back pain.;
* OVCF without damaged vertebral posterior wall and nerve lesion;
* The patient was over 50 years old and , the diagnosis of osteopenia or osteoporosis was confirmed by bone densitometry ;
* All patients underwent（received） plain radiography, computed tomography (CT) and MRI before surgery, and with IVC presented in MRI.

Exclusion Criteria:

-
Clinical Evaluation of Acupuncture on the Complications of Cerebral Vascular Accident

The lifestyle of Taiwanese people has been changed over the past decade with the improvement of economic growth, environmental sanitation and the quality of medical care. Now the investigators pay more attention to the increasing risk of people's diseases of civilization than people's malnutrition and poor quality of environmental sanitation. The cerebrovascular accident (CVA) leads to death and bio-psycho-social dysfunction. The medical care of the patient of cerebrovascular accident cause a lot of money and is a burden of our country.

Our study emphasizes that acupuncture change bio-psycho-social aspects of the patient with cerebrovascular accident. The investigators use some scales to assess efficacy of acupuncture, such as Barthel index, National Institute of Health Stroke Scale, Visual Analogue Scale, Instrumental Activities of Daily Living and Hamilton Depression Rating Scale.

Besides, the investigators notice that there are few journals about acupuncture effect of treating depression following cerebral vascular accident. The investigators may underestimate the amount of people having post-stroke depression. So the investigators use Hamilton Depression Rating Scale to Assess the post-stroke depression of cerebral vascular accident patient.

By assessing bio-psycho-social level of CVA patient, the investigators hope this study will offer them more "Holistic Health Care".

We want to assess the effect of acupuncture on stroke patients. The study is a double-blind randomized controlled trial. We need 80 patients altogether. The Inclusion Criteria:

(1)first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia

Exclusion Criteria:

(1)transient ischemic attack (2)brain tumor, brain trauma (3)recurrent stroke (4)multiple organs failure, cancer The whole course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.

The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen.

The investigators use Barthel index, National Institute of Health Stroke Scale, Hamilton Depression Rating Scale, Instrumental activities of daily living scale and Visual Analogue Scale to assess the effect of acupuncture on stroke patients. Four times of assessment are as below: baseline, after 8th treatment, after 16th treatment, after 24th treatment (the last time of treatment). The course of treatment should be completed within 3 months.

Eligibility Criteria:
Inclusion Criteria:

* first time stroke(ischemic or hemorrhagic stroke) with paresis or plegia

Exclusion Criteria:

* transient ischemic attack
* brain tumor, brain trauma
* recurrent stroke
* multiple organs failure, cancer
A Study Using [18F]F AraG PET to Evaluate Response to Checkpoint Inhibitor Therapy(CkIT) in Patients With Solid Tumors

In this study, patients with advanced solid tumors will undergo \[18F\]F AraG PET/CT imaging to assess for changes in tracer uptake following treatment with CkIT.

Up to 40 patients will be recruited to participate in this study. Two (2) target lesions per patient will be selected for radiomics and biopsy. Both lesions will be assessed for \[18F\]F AraG uptake before and after CkIT. Only one lesion will be biopsied twice (once before and once after CkIT treatment close to the time of imaging), and the other lesion will not be manipulated and used as a control.

There will be a pre therapy scan \[18F\]F AraG which will be administered anytime within a 14 day period prior to the initial Day 1 CkIT administration. There will also be a post therapy scan which will be performed within 3 to 6 weeks after the initial CkIT dose. The timing of the second \[18F\]F AraG scans may be altered based on preliminary results from the initial patient scan results, and could be obtained during the first 2 weeks after initiation of therapy.

The investigators will compare the \[18F\]F AraG activity (based on development of tumoral volumes of interest (VOIs) pre and post CkIT in both lesions.

Eligibility Criteria:
Inclusion Criteria:

* Solid tumor with planned CkIT
* Must be \>18 years old
* Signed Informed Consent Form
* Patient must have two qualifying lesions

Exclusion Criteria:

* Patient is pregnant or breast feeding
Mangafodipir as an Adjunct to FOLFOX6 Chemotherapy in Colon Cancer Stage Dukes' C

The present feasibility study is designed to find out whether pre-treatment with the compound mangafodipir lowers the frequency and severity of side effects during adjuvant chemotherapy according to the FOLFOX6 regimen in patients operated upon colon cancer in stage Dukes' C.

Mangafodipir, manganese (Mn) dipyridoxyl diphosphate, is a catalytic antioxidant and iron chelator recently (2006) suggested for cancer treatment in an Editorial in Journal of the National Cancer Institute. Preclinical research has shown that mangafodipir protects normal tissues without loss of anti-tumour activity during chemotherapy. Other advantages are that mangafodipir is already approved for use in patients as a contrast agent for magnetic resonance imaging (MRI) of liver, and that the experience for more than a decade reveals high safety with mainly minor and tolerable side-effects.

The present study will include 14 patients who will be followed throughout 3 treatment cycles. Each cycle will be preceded by infusion of mangafodipir or placebo in two groups, each consisting of 7 patients. The primary endpoints will be the most frequent manifestation of FOLFOX6, namely neutropenia and neurosensory toxicity. The secondary endpoints will be the frequency and severity of other FOLFOX6-related adverse events and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven colon cancer stage Dukes' C.
2. Patient over 18 years.
3. WHO performance status \<1.
4. Adequate haematological function (Hb ≥ 100 g/L, ANC ≥ 2.0 x 109/L, platelets ≥ 150 x 109/L)
5. Adequate renal and hepatic functions: serum creatinine and total bilirubin ≤ 1.25 times upper normal limits (ASAT and ALAT ≤ 3 times upper normal limits)
6. Clinical evaluation, haematology and biochemistry performed within 1 week prior to the start of chemotherapy
7. Use of adequate contraception (males with reproductive potential)
8. Written informed consent given

Exclusion Criteria:

1. Other tumour types than colon adenocarcinomas
2. Current severe neutropenia, leucopenia or thrombocytopenia
3. Severely reduced liver or renal function
4. Unresolved bowel obstruction or sub-obstruction, uncontrolled Crohn's disease or ulcerative colitis
5. Current chronic diarrhoea
6. Contraindication for corticosteroid administration
7. History of prior serious allergic or pseudo-allergic reaction
8. Any other serious illness or medical condition
9. Symptomatic peripheral neuropathy ≥ grade 2
10. Received mangafodipir ≤ 5 weeks before planned start of chemotherapy
11. Received any of the FOLFOX drugs ≤ 5 weeks before planned start of chemotherapy
12. Any plans of administered other anti-cancer therapy (including radiotherapy) concurrent with this study
13. Fertile females
14. Males with reproductive potential not implementing adequate contraception measures
15. Phaeochromocytoma
Fibromyalgia Sleep A to ZZZ Study

This research study is testing whether changes in sleep timing and morning light therapy may have an impact on symptoms related to fibromyalgia.

This study will test a consumer health light therapy device (Re-Timer)

Eligibility Criteria:
Inclusion Criteria:

1. Meets 2016 revised diagnostic criteria for fibromyalgia (FM)
2. Has access to video conferencing (including web cameras and audio) and a private space for the remote study visits.

Exclusion Criteria:

1. Significant chronic disease
2. Severe hearing or memory problems
3. Pending medical leave applications at workplace
4. Current pregnancy, breastfeeding, or actively trying to get pregnant
5. Night work or travel outside the eastern time zone within 1 month of the study
6. Other research participation
7. Frequent number of special events during study period (weddings, concerts, exams, etc).
Effects of Tolperisone on Measures of Drowsiness and Cognitive Function

A Randomized, 4-Period, Crossover Study to characterize the effects of tolperisone 200 mg and 400 mg (supratherapeutic dose) three times a day (TID) over 3 days of dosing on measures of simulated driving performance, cognitive function and drowsiness and compared to placebo and cyclobenzaprine (single-day, residual effect, multiple-day).


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory male or female, between 21 and 65 years of age, inclusive, for the entire duration of the study (from Screening through Day 3 of last treatment period).
* Body mass index (BMI) range between 18.5 and 30.0 kg/m2, inclusive.
* Subject must possess a valid driver's license and be an active driver and have driven a minimum of 10,000 miles (about 16,000 km) per year for the previous 3 years.
* Subject must demonstrate simulator sickness questionnaire scores that are not indicative of simulator sickness as defined in the driving simulation operations manual.
* Subject must have a regular sleep pattern, not be engaged in shift-work, and in general, have at least 7 hours of sleep each night.

Exclusion Criteria:

* History of sleep disorders, including insomnia, sleep apnea, Restless Legs Syndrome (RLS), or narcolepsy, night-shift workers, routine daytime napping or oversleeping on weekends days (off work) or a score higher than 10 on the Epworth Sleepiness Scale (ESS) at Screening.
* A history of difficulty in falling asleep or staying asleep in the previous 3 months that is considered clinically significant by the Investigator.
* Subject has traveled across 2 or more time zones (trans meridian travel) in the last 2 weeks prior to randomization or is expected to travel across 2 or more time zones during the study.
* Subject has any physical condition (e.g., severe vision issues, hand use limitations) that would prevent the subject from performing the cognitive or drowsiness assessments.
* Subject has a presence or history of any medically diagnosed, clinically significant psychiatric disorder, including depression, anxiety, insomnia, schizophrenia, or bipolar disorder.
* Consumes more than 3 cups of coffee per day.
* Female subjects who are pregnant or lactating.
* Any clinically significant medical abnormality, any clinically significant chronic disease, or any clinically significant finding on physical examination.
* Subject with a genotype status of poor-, ultrarapid-, or indeterminate- metabolizers of cytochrome CYP2D6.
* Subject is unable to remain in the research unit for each of the treatment periods.
* Subject has visual or auditory impairment which in the opinion of the Investigator would interfere with study related procedures or study conduct.
Effect of Uterine Artery Ligation Prior to Uterine Incision in Women With Placenta Previa

Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.

* The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
* Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged.
* Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.
* Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
* Closure of the anterior abdominal wall in layers

Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.

* The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
* Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged.
* Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.
* Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
* Closure of the anterior abdominal wall in layers In the control group, lower segment caesarean section is without uterine artery ligation

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with placenta praevia antenatally
* plan is elective caesarean section
* Gestational age \>34 weeks

Exclusion Criteria:

* Fetal distress
* medical disorders as hypertension or Diabetes Mellitus
* Coagulation defects.
* Emergency Cesarean section
* women with antepartum hemorrhage
* patients with marked ahdesions or those with non possible uterine artery ligation
Reinforcement Learned Automatic Anesthesia System During Painless Gastrointestinal Endoscopy

The goal of this clinical trial is to compare the performance difference between trained model and clinical professionals in anesthesia control during gastrointestinal endoscopy. The participants would include adults aged between 18-65 years old with ASA scores I-II. The main questions it aims to answer are:

* Can AI model successfully and safely perform anesthesia during gastrointestinal endoscopy?
* Researchers hypothesis that anesthesia performed by professionals is not inferior to those performed by AI model.

The researchers will compare the results of the AI group with the traditional group to see if both groups have similar success rates in performing anesthesia.

Participants will fast for 8 hours before the procedure, and drinking water will be prohibited for 2 hours after taking the intestinal purgatives.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status class I-II

Exclusion Criteria:

* arrhythmia
* allergies to opioids, or ciprofol ingredients
* history of narcotic abuse
* breastfeeding or pregnant status
* body mass index (BMI) \> 30 kg/m\^2
* participation in any pharmacological clinical trials within the last 3 months
* painless gastrointestinal endoscopy duration of longer than 60 min
Essential Coaching for Every Mother in Tanzania

The purpose of this study is to evaluate a text message intervention called Essential Coaching for Every Mother in Tanzania to improve mothers' access to essential newborn care information during the immediate six-week postnatal period.

This is a 2-group parallel arm randomized controlled trial. Participants will be randomized into either the intervention or a control group. No changes to in-person care will occur.

This study will be conducted in Dar es Salaam, Tanzania with mothers recruited from a Tanzanian postnatal ward who have recently given birth at four different hospitals. Participants in the intervention group will start receiving the Essential Coaching for Every Mother program based on their delivery date up to six weeks postpartum. Mothers in the control group will not receive any text messages. Both groups will be asked to complete a survey at enrolment and six-weeks postpartum.

The investigators aim to recruitment 124 participants in total, 62 per group.

Eligibility Criteria:
Inclusion Criteria:

* have recently given birth within the hospital within 48 hours
* have daily access to a mobile phone with text message capabilities
* are over 18 years of age
* speak and read English or Swahili.

Exclusion Criteria:

* newborns die or are expected to die prior to leaving the hospital
* they have no access to mobile phone, either personal or shared
* unwilling to receive text messages
* decline to participate
* are experiencing major postnatal complications expected to impact learning or ability to consent while in the hospital (e.g., postpartum hemorrhage, seizures)
* participated in Phase I of this project.
Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.


Eligibility Criteria:
Inclusion Criteria:

* Be of legal age (i.e. 18 years)
* Be of Asian descent and have -Asian eye‖ identifying features (see Appendix A)
* Be mentally competent, willing and able to sign a written informed consent form.
* Have contact lens distance sphere requirement in the range 1.00D to 6.00D.
* Have spectacle astigmatism \<1.25D in each eye
* Currently wear soft contact lenses (for at least 3 months prior to the trial ) without experiencing difficulties or contact lens related complications
* Have had an oculo-visual examination within the previous 12 months.
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

  * No evidence of lid abnormality or infection
  * No conjunctival abnormality or infection
  * No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
  * No other active ocular disease

Exclusion Criteria:

* Requires concurrent ocular medication.
* Clinically significant (Grade 3 or 4) corneal staining (FDA scale), corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Has had refractive surgery.
* Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrolment for this study.
* History of abnormal lachrymal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Extended lens wear in last 3 months.
* PMMA, hybrid or RGP lens wear in the previous 8 weeks
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Has diabetes
* Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* History of chronic eye disease (e.g. glaucoma or ARMD).
* Pregnancy, lactating, or planning a pregnancy at the time of enrolment.
* Participation in any concurrent clinical trial or in last 30 days.
* Family member or employee of the clinical site, investigator or other study staff.
* Currently wears habitual contact lenses on an EW basis.
A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

Antiepileptic Drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects from 16 to 75 years, both inclusive
* Well-characterized focal epilepsy or epileptic syndrome
* Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period
* Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50% of the minimum recommended maintenance dose

Exclusion Criteria:

* Seizure type IA non-motor as only seizure type
* History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline
* Other serious uncontrolled disease
Community Pharmacy Assisting in Total Cardiovascular Health

Despite proven benefits in reducing morbidity and mortality, many patients become nonadherent to statin therapy within the first year of starting. Due to their accessibility and frequent patient contact, pharmacists are well-positioned to improve medication adherence.

The purpose of this study is to determine whether a simple intervention by community pharmacists can improve statin adherence in new statin users.


Eligibility Criteria:
Inclusion Criteria:

* Pharmacies must fill at least 85 statin prescriptions in a six-week period
* CPATCH intervention was given priority over other study initiatives offered by the pharmacy
* All members of pharmacy staff provided informed consent