cyrilzakka/clinical-trials huggingface dataset:
Economic and Clinical Outcomes of Attendance in Psychosis Services Using SMS.

The aim of this research is to find out if mobile phone text message reminders of appointments can help to address missed appointments in Psychosis Community Services. Another aim is to examine if fewer missed appointments result in clinical benefits for service users and in lower costs for Psychosis Community Services over a period of 6 months. 600 users from 2 London Psychosis Community Services will take part in this research. Each participant will be put into one of two groups, as s/he joins the study: In the first (experimental) group, each participant will receive appointment reminders for 6 months (7 and 1 day/s before each appointment), starting with the first available opportunity upon joining the study. In the second (control) group, each participant will not receive appointment reminders for 6 months. The choice of group for each individual will be made at random by a computer. Clinical information will be collected for 6 months from the time each participant joins the study, using, with his or her consent, their anonymised electronic medical records. The following clinical information will be compared between the experimental and control groups: Attendance of appointments, number of inpatient admissions, number of days in inpatient care, number of inpatient admissions under the mental health treatment act, number of referrals to a home treatment team, number of times patient has changed medication, health and social functioning. Service use, service costs and the cost-effectiveness of the reminder system will also be examined. Towards the end of their participation, service users, as well as mental health professionals, will be invited to express their views, concerns and suggestions in relation to the reminder service by completing a brief anonymised (service users) or anonymous (staff) questionnaire


Eligibility Criteria:
Inclusion Criteria:

* Be a user of Psychosis Community Services
* Manifest at least a basic level of comprehension of the study (including its nature, purpose, procedures and implications) prior to enrollment, and adequate capacity to consent, as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) scale.
* Own a mobile phone.
* Be willing to receive SMS reminders of appointments with the Psychosis Community Service.
* Provide written informed consent to participate in the study.

Exclusion Criteria:

* Is not a user of Psychosis Community Services.
* Cannot manifest at least a basic level of comprehension of the study (including its nature, purpose, procedures and implications) prior to enrollment, and/or adequate capacity to consent, as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) scale.
* Does not own a mobile phone.
* Is under 18 years of age.
Impact Advanced Recovery® for Radical Cystectomy (RC) Patients: a Pilot Study

The purpose of this study is determine if using Impact Advanced Recovery® before and after RC surgery helps reduce surgical complications.

Radical cystectomy (RC) is the removal of the entire bladder and nearby organs that may contain cancer cells. It is a major surgery that can lead to breakdown of proteins in the body and a decreased immune response, both of which increase the risk of illness and death. Poor nutrition status before RC surgery is linked to a higher rate of death after surgery. Therefore, it is important to eat a balanced diet before and after RC surgery to avoid negative outcomes.

Studies show that patients who drink a nutritional supplement that may enhance the immune system before and after gastro-intestinal surgery may have fewer infections and shorter hospital stays after surgery. Patients with cancer of the colon/rectum, stomach, and pancreas who drank a similar immune-enhancing nutritional supplement before and after surgery also had fewer infections.

The purpose of this study is to attain pilot data for a larger trial.

Eligibility Criteria:
Inclusion Criteria:

* Men undergoing RC surgery for primary bladder cancer

Exclusion Criteria:

* Patients with swallowing difficulties or unable to tolerate oral intake
* Evidence of metastatic disease
* Weight loss ≥ 10% (with respect to usual body weight) in the 6 months prior to surgery or BMI ≤ 18.5
* Patients undergoing cystectomy for non-bladder primary malignancy or cancer type other than urothelial
* Active viral infections such as Human immunodeficiency virus (HIV) positive, hepatitis, or who have a known immunodeficient state
* Prior history of gouty arthritis or uric acid stones
* Patients with milk, soy, or fish allergies
A Study of ResCure™ to Treat COVID-19 Infection

This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.

In this Phase I open-label interventional study we will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection. Patients being treated will have severe respiratory symptoms that are at or near requiring the patient be placed on a ventilator.

Eligibility Criteria:
Inclusion Criteria:

1. Critically ill patients with SARS from COVID-19 infection on respirators OR
2. Patients with SARS from COVID-19 infection prior or after being placed on respirator
3. Male or female patients 18 years of age and older

Exclusion Criteria:

1. Patients less than 18 years of age
Study In Patients With Type 2 Diabetes Who Are Taking Metformin And Sulfonylurea, Metformin And Insulin, Or Insulin

This study will use Magnetic Resonance Imaging (MRI) techniques to evaluate changes in fluid volume in the lower legs of diabetic patients who add either pioglitazone or placebo to their current diabetic regimen.


Eligibility Criteria:
Inclusion criteria:

* Must have been diagnosed with Type 2 diabetes at least three months prior to screening.
* Must be taking either metformin and a sulfonylurea, metformin and insulin, or insulin only, and doses of these medications must have been stable for at least three months.
* Must have a Body Mass Index (BMI) of between 24 and 35.
* If female, the subject must be post-menopausal.
* HbA1c levels must be between 7% and 10%.
* Subjects must be eligible for MRI scanning (ie, no metal implants, pacemaker, etc).

Exclusion criteria:

* Suffer from claustrophobia.
* Use of tobacco, nicotine, or illegal drugs of abuse.
* Use of caffeine within two days prior to each study visit.
* HIV, hepatitis, edema, untreated blood pressure problems, heart, lung, nervous system or kidney disease, history of blood clots in the legs, diabetic neuropathy, or untreated thyroid disease.
* Use of drugs or medications that affect the levels of fluid in the body, such as diuretics.
Evaluation of the Biomechanics of Crowding and the Energetic Cost of Endurance Runners Unilateral Transtibial Amputees.

Transtibial amputation accounts for 3,700 cases per year in France. Athletes can use sport blades made of carbon plate for improved energy restitution.

Sports blades are adjusted according to the manufacturer's recommendations and the subjective experience of the ortho-prosthetist and patient. These adjustments are designed to optimize performance and comfort while reducing the risk of injury. This risk is all the greater when asymmetries between the healthy and affected limbs are large, exposing the healthy limb to large and repeated reaction forces.

Furthermore, one of the performance criteria for long-distance running is energy cost. While a reduction in this parameter has been observed in bilateral amputees, heterogeneous data are reported in unilateral amputees, depending on the level of expertise and sports blade settings.

While studies have investigated the effects of running with a prosthesis under conditions representative of track running, few data are available on sports blades designed for long-distance running.

It therefore seems important to be able to objectively assess the effects of a change in the stiffness of the sports blade on the energetics and biomechanics of running, in order to optimize practice and prevent associated traumas.

Secondly, investigators believe it is important to verify that the biomechanical results obtained in the laboratory are applicable in the field, both on the road and on the unstable terrain encountered by trail runners.

Eligibility Criteria:
Inclusion Criteria:

* Male or female,
* Weighing less than 110 kg, in accordance with C-blade recommendations,
* Subjects who have undergone a unilateral transtibial amputation,
* Have been running with a sports blade for at least 3 months, over several sessions of at least 3 kilometers.
* Subjects who have signed a written consent form,
* Subjects affiliated or entitled to a social security scheme.

Exclusion Criteria:

* Subjects whose amputation is due to complications related to diabetes or atherosclerosis.
* Subjects with chronic or central neurological pathologies
* Subjects with cardiovascular disorders
* Subjects with alcohol or drug dependency.
* Pregnant or breast-feeding women
* Subjects under court protection.
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for Colorectal Cancer Liver Metastases

The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with colorectal cancer liver metastases (CRCLM).

The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with resectable CRCLM.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed adenocarcinoma
* Primary lesions (colorectal cancer) are resected
* Must have undergone prior complete resection of the primary tumor; liver metastases
* Must be resectable or accessible for radiofrequency ablation (Five or less lung metastases measuring 5 cm or smaller).
* Serum bilirubin level of 2.0 mg/dl or less.
* Performance status of 0 or 1.
* Expected survival of 1 year or more.
* Informed consent from the patient.

Exclusion Criteria:

* With extrahepatic metastases
* With other neoplastic disease that is measurable or being treated other than colorectal cancer.
Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer

Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.

The aim of the prospective, randomized study is to investigate the efficacy of PPI in prevention of ulcer recurrence for clopidogrel users. We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months. The ulcer recurrence rate between the treatment groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months.

Exclusion Criteria:

* 1.serious disease 2.refuse informed consent
A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities

The purpose of this study is two-fold. First, the investigator will develop a low-literacy Mobile Pain Coping Skills Training (mPCST) protocol for cancer patients with pain (i.e., therapist manual, patient manual including handouts, and the smartphone materials) as well as a beta version of the basic smartphone components with the assistance of experts in the field. Next, an iterative development design using focus groups with women who have breast cancer and pain accrued from medically underserved areas will be used to refine the developed mPCST protocol and basic smart phone components. The protocol-designed to reduce cancer pain and disability in patients with low literacy in medically underserved areas-will be delivered via tele-video conferencing sessions in the community clinic. The smartphone tools (e.g., simple text messages, images, and preloaded intervention content) will allow the intervention to extend into the patients' homes. The second study purpose is to pilot test the feasibility, acceptability, and efficacy of the developed protocol. The investigator will also obtain an estimate of the effect size of the developed protocol to decrease pain. Focus group data will be managed and evaluated in a systematic format using a grounded theory approach. Data analyses for the pilot testing period of the study will be assessed by examining accrual, attrition, and adherence to the intervention. Simple t-tests will be used to examine pre- to post-intervention differences in pain and the other outcomes of interest. There are minimal risk or safety issues related to this study.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of breast cancer within the last three years
* being \>21 years old,
* having a life expectancy of at least 12 months,
* having 1 clinical pain ratings of \>3 gathered as part of their routine clinic visits

Exclusion Criteria:

* metastases to the brain,
* presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent) that would contraindicate safe participation in the study as indicated by the medical chart, treating oncologist, or interactions with the medical/study staff,
* current or past (\<6 months) engagement in PCST for cancer.
Randomised Controlled Trial of Electroconvulsive Therapy (ECT) in Relapse Prevention of Depression

The purpose of the study is to determine if continuation electroconvulsive therapy (ECT) is safe and effective in relapse prevention of depression.

Randomized multicenter clinical trial with two parallel groups. Patients with major depression (unipolar or bipolar), who have remitted with electroconvulsive therapy (ECT) are eligible. All patients receive pharmacotherapy (venlafaxine target dose 300mg/day, and lithium target dose 0,5-0,8 mmol/L). The intervention is continuation unilateral ECT weekly for the first 6 weeks thereafter every 2 weeks for one year. Depressive relapse is the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

1. MINI-PLUS verified major depressive episode (unipolar or bipolar).
2. ECT within the last 3 weeks.
3. Either Remission defined as MADRS \< 10 or
4. Response defined as MADRS \< 15 combined with patient assessed CGI-I of at least much improved

Exclusion Criteria:

1. Schizophrenia or Schizoaffective disorder
2. Addiction or Dependence
3. Kidney disease that contraindicates lithium treatment
4. Vascular or heart disease that contraindicates venlafaxine treatment
5. Uncontrolled Epilepsia
6. Age less that 18
7. Pregnancy or Lactation
NeuroRegen Scaffold™ With Bone Marrow Mononuclear Cells Transplantation vs. Intradural Decompression and Adhesiolysis in SCI

The purpose of this study is to investigate the efficacy and safety of NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) on neurological recovery following chronic and complete spinal cord injury, compared to the treatment of surgical intradural decompression and adhesiolysis only.


Eligibility Criteria:
Inclusion Criteria:

1. Completely spinal cord injury at the thoracic level as assessed by magnetic resonance imaging (MRI) and electrophysiology.
2. ASIA Impairment Scale (AIS) grade A.
3. Male or female, 18-60 years old.
4. No significant further improvement after injury and rehabilitation.
5. Patients with normal peripheral nerve function and without muscle atrophy.
6. Cardiovascular, respiratory, liver, kidney functions and laboratory examinations are within normal ranges.
7. No brain disease or mental disorder.
8. Ability and willingness to regular visit to hospital and follow up during the protocol procedures.
9. Patients signed informed consent.

Exclusion Criteria:

1. A current diagnosis of any primary diseases affecting limb functions (e.g., traumatic brain injury, cerebral hemorrhage, cognitive disorders or other central nervous system diseases).
2. Patients without any rehabilitation train after injury.
3. Remarkable muscle atrophy or fibrosis.
4. Degeneration of peripheral nerve function.
5. Allergic constitution.
6. Participation in any immunomodulator therapy or experimental drug treatment within 60 days prior to study.
7. Suffering diabetes, autoimmune diseases, tumor or severe hypertension.
8. Patients with severe heart, lung, liver or renal dysfunction are unable to meet the surgery standards.
9. Severe bleeding tendency or abnormal coagulation function.
10. Inflammation or skin ulcers at the surgical site.
11. Lactating and pregnant woman.
12. Poor compliance, difficult to complete the study.
13. Any other conditions that might increase the risk of subjects or interfere with the clinical trial.
Dietary Salt and Microvascular Function

It is well accepted that high-salt (HS) intake is an essential risk factor in development and progression of hypertension. Results of some recent studies suggest that some of the deleterious effects of a HS diet are independent of elevated blood pressure (BP) and may occur in normotensive individuals and are associated with impaired endothelial function. However, the effects of acute salt loading on endothelial function and vascular reactivity in young healthy individuals are still scarce and inconsistent.

The purpose of present study is to determine whether one week of HS intake affects microvascular reactivity in young healthy subjects without changes in BP. In addition, the investigators sought to evaluate if potential HS diet-induced microvascular dysfunction is associated with changes in oxidative stress level and/or with modification of immunological response in young healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

- healthy volunteers

Exclusion Criteria:

* oral contraceptives
* drugs that could affect the endothelium
* hypertension
* coronary artery disease
* diabetes
* hyperlipidaemia
* renal impairment
* cerebrovascular and peripheral artery disease
The Effect of Cognitive Rehabilitation on Epileptic Pateints Under Treatment

It is clear that studies on cognitive rehabilitation in epilepsy patients mostly focus on patients undergoing epilepsy surgery and are largely classified according to the type of epilepsy. The main purpose of this study is to determine whether cognitive impairments associated with antiepileptic drugs develop in epilepsy patients using neuropsychological tests and event-related potentials, and if such an impairment is present, to investigate whether cognitive rehabilitation is beneficial.

Patients who were planned to start monotherapy were first included in the study by performing a face-to-face MoCA test. After the MoCA test, experienced neurologists measured event-related potentials, including P300 and N200 potentials and N2P3 amplitudes, in the electrophysiology laboratory. Patients for each drug were randomly assigned to the no cognitive rehabilitation group (A) or the cognitive rehabilitation group (B). At the end of the second month, MoCA test and event-related potential measurements were performed again in both groups, and the results were analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosis of epilepsy, -
* Before monotherapy had started

Exclusion Criteria:

* diagnosis of psychogenic non-epileptic seizures,
* epileptic patients currently receiving antiepileptic drugs,
* epileptic patients exhibiting cognitive dysfunction
* epileptic patientswith dementia
Does Bloody Urine Predict Urethrovesical Anastomosis Leakage After Radical Prostatectomy

Traditionally the watertightness of urethrovesical anastomosis after robotic radical prostatectomy is controlled by cystogram. However, clinical observations and one previous study showed that patients with anastomotic leakage have red coloured urine. If the investigators can verify this finding, the most of the cystograms can be avoided. In this study the investigators estimate urine colour after cystogram and take a picture from urine collecting pag. Later on the pictures are digitally analyzed and compared to cystogram finding.


Eligibility Criteria:
Inclusion Criteria:

* Previous robotic radical prostatectomy
* Catheter removal visit

Exclusion Criteria:

* No urine in urinary collecting bag
Acupuncture for Whiplash Associated Disorder

The purpose of this study is to determine whether acupuncture is effective and safe therapeutic method in the treatment of cervical pain, shoulder and upper extremity pain and discomfort due to Whiplash associated disorder. (Traumatic car accidents)

We recruit 40 participants who had cervical, shoulder and upper extremity pain and had discomfort due to Whiplash associated disorder. And then we check initial data of 40 participants (Pain;VAS, Cervical ROM, SF-36, SDS, CMI)

40 participants were randomly allocated to two groups ; acupuncture group or waiting-list group.

Acupuncture group: participants were given acupuncture treatment three times a week during 2 weeks, for 15 minutes at each session. After 6 times acupuncture treatments, we check information of participants again after 2 weeks(VAS, ROM, SF-36, SDS, CMI)

Waiting-list group : The waiting-list group did not receive acupuncture treatment. After 2 weeks we check information of participants again (VAS, ROM, SF-36, SDS, CMI)

The waiting-Patients in both groups were permitted to receive usual care including physical therapy and exercise and were not permitted to take analgesics and antiphlogistics during the trial periods.

We recruited participants through advertisements in local newspapers or on the homepage of a Kyung-hee Medical Centre during December 8, 2009 to October 14, 2010.

Patients who met eligibility criteria were randomly allocated into either acupuncture treatment group or waiting-list group. Random sequences were generated by computerized number table. Allocation was concealed using sealed envelopes. According to priority, sealed envelope was matched when the patients had given informed consent.

The method of acupuncture: participants were given acupuncture treatment three times a week during 2 weeks, for 15 minutes (Needle retention time) at each session. (Total 6 times)

We select about ten acupuncture points

* Local Acupoints : SI14, SI15, BL10, BL12, BL13, BL14, TE15, GB20, SI9
* Distal Acupoints :

  * Upper extremities: LU6, LU7, LU9, LI11, HT3, SI2, SI3, SI5, SI7, PC4, PC6, TE5
  * Lower extremities: SP3, SP4, BL59, BL60, BL61, BL62, BL66, KI3, KI4,KI6, KI7, GB40, GB41, LR4

All Acupuncture points were prepared with 70% alcohol pads, and disposable stainless steel needles were used. Most of acupuncture were inserted vertically 1\~2cm in depth until patient can feel De-Qi. (No more additional stimulation)

Eligibility Criteria:
Inclusion Criteria:

* The patients who suffer cervical pain, limitation of cervical ROM, discomfort sensation due to traffic accidents (Whiplash associated disorder)
* The patients who had no effect with 3 months orthopedical treatment.
* willing to give their permission approval.
* patients of at least 20 years of age (Both men, women)

Exclusion Criteria:

* Cervical fracture
* Cervical spondylosis
* suspect malignant disease(ex. tumor, stroke, etc)
* suspect hemorrhagic disease infection disease, inflammatory disease
* unable to communicate with Korean
* The patients who had conscious disorder
* Any other conditions deemed unsuitable for trial as evaluated by Physician-in-charge.