cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Surgery Versus Robot Surgery for Right-side Colon Cancer: Short-term Outcome of a Randomised Clinical Trial

The recent introduction of robotic surgical system has revolutionized the field of minimally invasive surgery. The investigators hypothesized that adoption of a robotic surgical system for patients with right-side colon cancer seems appealing because This system provides high-definition three-dimensional vision, eliminates physiologic tremor, and better ergonomics. This randomized controlled trial was designed to determine the safety and efficacy of robotic right hemicolectomy in comparison with laparoscopic right hemicolectomy.


Eligibility Criteria:
Inclusion Criteria:

* primary cancer
* right-side located tumor (from cecum to proximal transverse colon)

Exclusion Criteria:

* tumor with obstruction
* tumor with perforation
* clinically advanced tumor (T4 stage)
* tumor with distant metastases
* synchronous tumor
Schizotypal Personality Disorder Risperidone

Neurophysiological indices of self-monitoring were assessed in a group of patients with Schizotypal Personality Disorder (SPD) and a control group. Both groups were assessed after the administration of risperidone and placebo.

The electroencephalogram (EEG) was recorder while participants (SPD participants and controls) performed a behavioral task: the Eriksen Flanker Task. The continuous EEG was segmented, corrected for artifacts and averaged. A component of the event-related brain potential known as the error-related negativity (ERN) was identified and its amplitude quantified in microvolts.

This procedure was conducted two hours after the administration of risperidone 1 mg and placebo (lactose) on two different experimental days and for each participant group (SPD patients and controls).

The amplitude of the ERN after placebo was compared between groups to test for baseline (non-drug-induced) differences between patients and controls.

The impact of risperidone on the amplitude of the ERN was compared between the two participant groups.

Eligibility Criteria:
Inclusion Criteria:

* Schizotypal Personality Disorder

Exclusion Criteria:

* Major Psychiatric Disorder
* Medical condition
Mayo Clinic Health Connection Discovery Trial

The MC Health Connection Discovery trial is designed to determine if a new health information system that delviers interactive care plans (delivered by mobile) to patients can impact post-surgical recovery.


Eligibility Criteria:
Inclusion Criteria:

Patients will be English speaking adults without visual or hearing impairments that would prevent use of the Ipad program. Target population will be older than 50 years of age. We will include patients who are undergoing coronary artery bypass grafting, valve repair or replacement or both at St. Mary's Hospital-Rochester, Minnesota. We will also be including family members 18 years of age and over, that may be the primary non-patient user of the iPad.

Exclusion Criteria:

Patients who do not meet inclusion criteria or who are predicted to have very short or very long hospital stays would not be candidates for the program which is designed for a standard 5, 6 or 7 day hospitalization.
Efficacy of Sirolimus-Based, Steroid Avoidance Immunosuppression African Americans

African Americans receiving a kidney transplant are considered at high risk for early rejection of their transplanted kidney and require more immunosuppression to maintain their kidney transplant function. This increase in immunosuppression puts this group at risk for drug-related toxicities and complications such as post-transplant diabetes.

This study will evaluate:

1. Whether a sirolimus based steroid avoidance regimen in African Americans may decrease the risks of drug-related toxicities,
2. Decreased rates of metabolic complications such as post-transplant diabetes,
3. The effect of Sirolimus plus a reduced dose cyclosporine on renal allograft function.

This is an open labeled prospective trial with race matched historical controls. The treatment group (experimental arm) will be African American de novo solitary renal transplant recipients. The control arm will consist of race matched solitary renal transplant recipients who received a Cyclosporine (CsA) -based immunosuppressive regimen. The subjects will be matched for organ source (living donor vs. cadaveric). The experimental treatment arm will have an immunosuppression regimen consisting of Sirolimus, Reduced dose cyclosporine, Thymoglobulin, and only 3 doses of steroids.

Eligibility Criteria:
Inclusion Criteria:

* African American recipient race
* Solitary cadaveric or living donor renal transplantation
* Age ≥18years at the time of transplantation
* Negative pregnancy serum test in females with childbearing potential

Exclusion Criteria:

* Age \< 18 years at the time of transplantation
* Multi-organ transplant recipient
* Currently taking steroids
* White Blood Cell Count \< 3,000
* Platelet count \< 100,000
* Triglycerides \>400mg/dL
* Cholesterol \> 350 mg/dL
* Unwillingness to comply with study procedures
* Allergic reaction to sirolimus Allergy to polyclonal antilymphocyte drugs (Thymoglobulin)
Pattern Recognition Prosthetic Control

Many different factors can degrade the performance of an upper limb prosthesis users control with electromyographic (EMG)-based pattern recognition control. Conventional control systems require frequent recalibration in order to achieve consistent performance which can lead to prosthetic users choosing to wear their device less. This study investigates a new adaptive pattern recognition control algorithm that retrains, rather than overwrite, the existing control system each instance users recalibrate. The study hypothesis is that such adaptive control system will lead to more satisfactory prosthesis control thus reducing the need for recalibration and increasing how often users wear their device. Participants will wear their prosthesis as they would normally at-home using each control system (adaptive and non-adaptive) for an 8-week period with an intermittent 1-week washout period (17 weeks total). Prosthetic usage will be monitored during each period in order to compare user wear time and recalibration frequency when using adaptive or non-adaptive control. Participants will also play a set of virtual games on a computer at the start (0-months), mid-point (1-months) and end (2-months) of each period that will test their ability to control prosthesis movement using each control system. Changes in user performance will be evaluated during each period and compared between the two control systems. This study will not only evaluate the effectiveness of adaptive pattern recognition control, but it will be done at-home under typical and realistic prosthetic use conditions.


Eligibility Criteria:
Inclusion Criteria:

* Subjects have an upper-limb difference (congenital or acquired) at the transradial (between the wrist and elbow), elbow disarticulation (at the elbow), transhumeral (between the elbow and shoulder), or shoulder disarticulation (at the shoulder) level.
* Subjects are suitable to be, or already are, a Coapt pattern recognition user (Coapt Complete Control Gen 2).
* Subjects are between the ages of 18 and 70.

Exclusion Criteria:

* Subjects with significant cognitive deficits or visual impairment that would preclude them from giving informed consent or following instructions during the experiments, or the ability to obtain relevant user feedback discussion.
* Subjects who are non-English speaking.
* Subjects who are pregnant.
Low-level Laser Therapy on Inflammatory Mediators During Chemotherapy-induced Oral Mucositis

The aim of the study is to evaluate the effect of low-level laser therapy (LLLT) on the severity of oral mucositis (OM) and inflammatory mediators (pro- and anti-inflammatory cytokines, metalloproteinases and growth factors) levels in saliva and blood; furthermore, analyze the effect of LLLT in product modulation of oxidative stress and cell damage from the oral mucosa transplant patients.

This is a randomized clinical trial in which the proposed analysis will be performed from saliva samples of patients transplanted bone marrow, divided into two different groups (control and laser) and collected at different times during the hospitalization of the patient. the group laser receive prophylactic laser therapy, in order to evaluate the effects of LLLT in inflammatory mediators (cytokines pro- and anti-inflammatory) as well as their effect on modulation of oxidative stress products and cell damage (nitric oxide, myeloperoxidase, interleukin-8).

Eligibility Criteria:
Inclusion Criteria:

* Schedule to receive myeloablative conditioning regimens using chemotherapy; oral mucosa lining intact on the first day of the conditioning regimen;

Exclusion Criteria:

* Patients who presented with oral oral ulceration or erosion, active oral, viral, bacterial, or fungal infections on admission, or active oral bleeding which was uncontrollable during laser therapy or had required oral tracheal intubation during hospitalization in the HSCT Unit.
Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep Anesthesia

Background: Serious adverse cardio-respiratory events (SCRE) occur during super selective ophthalmic artery chemotherapy for retinoblastoma in children. SCRE mechanism remains unclear but may be attributed to an autonomic nervous reflex induced by catheterization of the ophthalmic artery. The investigators hypothesize that inadequacy between depth of anesthesia and catheter stimulation might be a support cause of these SCRE.

Methods: Children requiring super selective ophthalmic artery chemotherapy for retinoblastoma are prospectively included in this observational study. Endovascular procedures are performed under standardized and deep general anesthesia with sevoflurane, sufentanil and rocuronium. SCRE are strictly pre-defined and included arterial hypotension, bradycardia and bronchospasm. SCRE are recorded and the factors influencing their occurrence are investigated.


Eligibility Criteria:
Inclusion Criteria:

* superselective ophthalmic artery chemotherapy for retinoblastoma required

Exclusion Criteria:

* no
SBRT With DIBH for HCC After TACE and Lipiodol Marking

Stereotactic Body Radiation Therapy (SBRT) for hepatocellular carcinoma (HCC) with radical dose achieved similar results with radiofrequency ablation (RF) and radical surgery, according to previous studies. For tumors near great blood vessels or with a diameter more than 2cm, SBRT performs even better than RF. In current clinical practice of SBRT for small HCC, registration is achieved by planting metal markers near the tumor, which has several disadvantages: 1. the operation is invasive, increase the risk of bleeding in patients with cirrhosis; 2. the operation is of no therapeutic value; 3. metal markers can only be planted outside the tumor to avoid transplantation, which compromises the accuracy of registration via CBCT. This study aims to adopt a new method of registration, transcatheter arterial chemoembolization (TACE) and lipiodol marking, to analyze the recognition and clarity of lipiodol on CBCT images, set-up errors and treatment efficacy. Therefore to provide data to support TACE and lipiodol marking over metal marker planting.


Eligibility Criteria:
Inclusion Criteria:

1. Clinically or pathologically confirmed hepatocellular carcinoma.
2. ECOG 0-1.
3. BCLC C
4. Liver-GTV \>700ml; intrahepatic metastasis allowed but only one tumor is to be treated with SBRT and others stable for more than 3 months; distant metastasis allowed but stable for more than 6 months.
5. Expected gastric/duodenum/small intestine Dmax 25-35Gy; colon Dmax 28-38Gy. Prescription dose 40Gy/5-10f.
6. DIBH training prior to SBRT to achieve 36 seconds breath hold.
7. Life expectancy \> 3 months.
8. Child-Pugh A5, A6 or B7.
9. Liver function: ALT within 1.5 times of upper limit; ALT within 0.5 times of upper limit and AST within 6 times of upper limit, excluding cardiac infarction; ALT within 0.5-1.5 times of upper limit and AST within 1.5 times of upper limit
10. Normal ECG, without severe cardiac dysfunction
11. Kidney function: CRE, BUN within 1.5 times of upper limit.
12. CBC: Hb≥80g/L，ANC≥1.0×109 /L，PLT≥40×109 /L
13. Without hemorrhagic tendency.
14. Voluntarily participate in this trial and sign consent form.

Exclusion Criteria:

1. Participants of other clinical trials.
2. History of abdomen radiation therapy or liver transplantation.
3. History of severe cardiovascular, kidney or liver disease.
4. Pregnancy or lactation.
5. Suspected or confirmed of drug or alcohol abuse.
6. History of severe mental or neurological disease, compromising the ability to consent and/or AE diagnosis.
7. Allergic to lipiodol.
The TOTOM Trial: Tai Chi to Optimize Transplant Outcomes for Multiple Myeloma

The current proposal aims to test the feasibility of immune function analysis for Tai Chi Easy (TCE) intervention in multiple myeloma (MM) patients undergoing autologous stem cell transplantation (ASCT) with concurrent exploration of health related quality of life (HRQOL).

The current proposal aims to test the feasibility of immune function analysis for TCE intervention in MM patients undergoing ASCT with concurrent exploration of HRQOL. The data obtained from this trial will provide supporting data for a future randomized clinical trial evaluating the impact of TCE on immune function (incidence of ASCT related infectious complications, natural killer cell phenotype and activity, and myeloma remission rate (clonal plasma cell % at day 100, minimal residual disease (MRD)), with the evaluation of efficacy on improving HRQOL during ASCT. Successful completion of this CROC project will provide necessary data to support future grant applications, in particular the feasibility of immunoassay evaluation of MM patients undergoing ASCT.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Multiple Myeloma planned to undergo bone marrow transplant
2. 18 years or older
3. English speaking
4. General proficiency to read/write in English
5. Able to attend TCE training session per study protocol
6. ECOG performance status 0-1
7. Able to return to study center for routine post-transplant follow up (approximately Day 30 and Day 100)

Exclusion Criteria:

1. Currently performs Tai Chi, QiQong, or Yoga at least once weekly or more
2. Syncopal event in prior 60 days
3. Concurrent major depressive disorder or anxiety disorder (DSMIV) as determined by treating provider
4. Chronic dizziness or vestibular disorders
5. History of recurrent falls (\>2 in the prior year)
6. Grade 3 or greater neuropathy
7. Grade 3 or greater spinal fracture
Effect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery

A Randomized, controlled clinical trial and split-mouth design was performed to assess and compare the effect of platelet-rich fibrin (PRF) on soft tissue healing, periodontal pocket depth and alveolar bone height distal to second molar of the study and control groups after third molar surgical removal.

Sample include of participants who had indication of impacted lower third molars extraction on both sides with symmetrically orientation and same difficult index. All participants had same extraction protocol on both side at Department of Oral surgery, Faculty of Odonto-stomatology, University of Medicine and Pharmacy, Ho Chi Minh City.

Soft tissue healing, periodontal pocket depth and distal bone height were evaluation by an independent investigator.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old.
* Good general health.
* Bilateral lower third molars equivalent in inclination and Pell and Gregory's impaction classification (classification II, III and B, C). The assessment of equivalence between two mandibular third molars was determined on the panoramic radiograph.
* The difference of third molar inclination on both sides not greater than 15 degrees.
* The patient consented to participate in the study after hearing clearly the explanation of purposes and requirements of the study.

Exclusion Criteria:

* Patients with any systemic disease contraindicated for surgery.
* Presence of acute inflammation or infection at third molar areas.
* Patients refused to participate in the study, did not comply with treatment or did not come to the follow-up examination as required.
* The difference in surgical time between the two groups was more than 10 minutes.
Immediate Effects of Manual Therapy Versus TENS in Patients With Knee Osteoarthritis

Patients with knee Osteoarthritis have high prevalence of pain , requiring ever more precise interventions in their management. This study aims to investigate the immediate effects of manual therapy and TENS on pain in patients with knee Osteoarthritis. Knowledge of best interventions favors reducing spending on health and safety for the patient.

This study aims to compare the efficacy of manual therapy and TENS for immediate control of pain in patients with knee osteoarthritis. They will be included 62 patients with clinical and radiological diagnosis of knee osteoarthritis, presenting pain of at least 3 in VAS, which are recruited from rheumatology and geriatrics clinics in Fortaleza / CE through a prior screening.

Will be three assessments, prior to the intervention, immediately after it and after 72 hours. The data collected shall appear in individual printed records. Participants will be divided into two therapy groups, of which one will be applied manual therapy and other TENS. There will be randomisation allocation of individuals in the groups and because of the nature of the interventions only the evaluator may be blind.

In manual therapy group will be assigned a protocol with manual passive stretching for the quadriceps muscles, hamstrings, triceps surae, adductors and abductors of the hip; myofascial release peripatellar; joint mobilization grades 1 and 2 for tibiofemoral joint and femoro - patellar in the affected knee.

In TENS group will be applied to continuous current mode, frequency 100Hz and pulse width of 50μs for 40 minutes in a single application. The intensity will be defined by the patient, should the stimulus be considered intense, but pleasant to it.

The Kolmogorov - Smirnov test is used to verify the data distribution normality. The characterization of the participants is performed by means of descriptive statistical analysis. Parametric or non-parametric tests will be used according to the data distribution normality for comparison between groups at baseline. The evaluator blinding will be tested using the chi -square test by comparing the randomization code with the evaluator opinion. The difference between the groups and their respective confidence intervals will be calculated by linear mixed models using interaction term of "time versus group."

Eligibility Criteria:
Inclusion Criteria:

* Knee osteoarthritis diagnosed by clinical criteria established by the American College of Rheumatology and radiological criteria of Kelgren-Lawrence
* Age over 50 years
* Pain intensity above 2 on the VAS

Exclusion Criteria:

* Other systemic inflammatory disease
* Changes in sensitivity
* Use of anti-inflammatory steroids, tranquillizers and/or antidepressants in the last month
* Analgesic in last 24 hours
* Use of cardiac pacemaker
The Effect of Menstruation on Food Preference and Balance

Menstruation period, which is accepted as the symbol of fertility, and some problems related to this process covers half of a woman's life. During this period, various changes occur in the female body, especially in the endocrine system. These changes in the menstrual cycle can affect women physiologically and psychologically.

Premenstrual syndrome (PMS) is an important health problem and negatively affects the quality of life of many women around the world. It usually begins 2 years after menarche and is known to worsen with age.It is known that approximately 80%-95% of women experience various degrees of PMS-related complaints. It has been reported that Premenstrual Syndrome can occur with more than 300 symptoms. The symptoms of PMS can be experienced in varying degrees, such as mild, moderate, and severe. The rate of those experiencing severe symptoms in PMS varies between 3-8%. Among the symptoms, psychological symptoms take the most important place. These; symptoms such as irritability, depression, anxiety, restlessness, nervousness, irritability, outbursts of anger and crying spells, feeling of loss of control, difficulty concentrating, laziness, insomnia or hypersomnia. The most common physical symptoms are joint, muscle, headache and abdominal pain, acne, edema, dizziness, libido and appetite changes, gastrointestinal disturbances, bloating, weight gain, breast fullness and tenderness.

Eligibility Criteria:
Inclusion Criteria

* Having completed the age of 18,
* Not over 45 years old and not in menopause,
* Not having any diagnosed psychological disease,
* It was determined as women who are healthy and have menstruation every month. Exclusion Criteria
* Individuals who menstruate with medical treatment every month,
* Individuals with lower extremity disability,
A Retrospective Multicenter Study to Determine 5-Year Clinical Outcomes in Subjects Previously Enrolled in the CTOT-01 Study

This study is a multicenter, non-randomized, retrospective study to collect long term (5 years post-transplant) clinical outcome data to test whether the results of the noninvasive immune monitoring test strategy performed in the parent study (CTOT-01, NCT00308802) in first six-month post-transplant is predictive of 5-year outcomes. Each center will complete a retrospective chart review for the data on patient survival, graft survival and renal function.


Eligibility Criteria:
Inclusion Criteria:

* Participants previously enrolled in the CTOT-01 study.
* Participants who are at least 5 years post-transplant (+/- 6 months), no later than March 31, 2014.

Exclusion Criteria:

* Withdrawal of consent to continue in the CTOT-01 study.
Effect of a Multi-component Education Program on Salt Reduction in Adults

Excess salt intake is a major contributor to high blood pressure, the leading individual risk factor for cardiovascular events, such as stroke, myocardial infarction and heart failure. According to PHYSA study, salt intake in Portugal remains much higher (10.7 g) than recommended by the international health organisations, indicating the need for effective implementation of salt reduction interventions. In Portugal the main source of daily salt intake is added salt during cooking, and salt content in bread, cheese and processed meat.

The objective of this study is to determine the effectiveness of a dietary education program tailored for salt reduction. To assess the effectiveness of the salt reduction program the investigator's will measure changes in salt consumption levels, by evaluating the 24 h urinary sodium excretion.

This study is a consortium-initiated, randomised, simple-blinded, controlled trial designed to assess the effectiveness of a salt reduction program versus generic healthy lifestyle program in the Lisbon Metropolitan Area.


Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 20 and 70.
* Subjects with or without hypertension, not medicated or medicated with medication and diet stabilized for at least 3 weeks.
* Responsible for the purchase and confection of their meals.
* Available to comply with study protocol and sign informed consent.

Exclusion Criteria:

* Pregnant, breastfeeding or planning to become pregnant within the study period.
* Subjects with current or previous cardiovascular disease (ischemic cardiovascular disease, angina stable or unstable; myocardial infarction, stroke or symptomatic peripheral arteriosclerosis).
* Subjects with liver or kidney diseases or cancer.
* Subjects with history of drug, alcohol or other substances abuse, or other factors limiting their ability to cooperate during the study.
* Subjects with special dietary needs.
* Health condition that prevents compliance with study requirements.