cyrilzakka/clinical-trials huggingface dataset:
Prospective Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy

This study examines Limited versus extended pelvic lymphadenectomy.

This study is meant to show if the extension of lymphadenectomy during prostatectomy has an influence of outcome of patients. Patients with indication to prostatectomy due to prostate cancer will be included.

Both extensions of lymphadenectomy are used in hospitals as a free choice. This study shell show if one method is more effective than the other.

Eligibility Criteria:
Inclusion Criteria:

* stamp bioptic secured prostate cancer with intermediate or high risk profile (defined as Gleason-Score 7-10 or PSA \> 10 ng/ml)
* locally-operable tumor according to DRU/TRUS
* negative bone scan
* negative CT abdomen / pelvis
* general condition according to Karnofsky \>/= 80%
* written consent of the patient
* adequate hematological, renal and coagulation physiological functions
* Patient compliance and geographic proximity to allow adequate follow-up

Exclusion Criteria:

* Manifest secondary malignancy
* Secured metastasis by histologically or by imaging
* Myocardial infarction or stroke within the last 6 months
* Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 \<60 mmHg), renal, hepatic or hematopoietic (eg severe bone marrow aplasia) diseases
* Severe active or chronic infections (eg pos. HIV-Ab test, HBs-Ag detection in serum and / or chronic hepatitis)
* severe psychiatric disease
* prior chemotherapy (allowed is a preoperative antiandrogen therapy ≤ 3 months)
* previous pelvic radiotherapy
* Patients in a closed institution according to an authority or court decision
* People who are in a dependent relationship or working relationship with the sponsor or investigator
* simultaneous participation in another clinical trial
Responses to Information on Treatments for Depression

The purpose of this study is to determine the impact of different messages about depression treatments.

Participants recruited through Amazon Mechanical Turk (MTurk) will complete a screening questionnaire and provided the opportunity to consent to participate. Upon entry to the study, eligible participants will complete several questionnaires pre- and post-randomization. Randomization will be to view either a video detailing a type of depression treatment (cognitive behavioral therapy, antidepressant medication, or the combination of both treatments) with and without an emphasis on personalization. A no video condition is also included.

Eligibility Criteria:
Inclusion Criteria:

* PHQ-9 Score indicating a history of elevated depression symptoms
* A high MTurk completion rate
* Must pass all attention checks inserted into the questionnaires
* No history of treatment for depression

Exclusion Criteria:

* none
Metaplasticity Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change

The overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in healthy human participants.

The overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in healthy human participants. Our primary objective is to compare pre- and post-measures of cortical excitability before priming tDCS (anodal, cathodal or sham) \[M1\], directly after priming tDCS \[M2\], directly after inhibitory rTMS \[M3\], and 10 minutes after inhibitory rTMS \[M4\]. Our secondary objective is to evaluate the sensitivity of motor excitability outcome measures response to the noninvasive neurostimulation (e.g. rTMS and tDCS). We also aim to compare pre- and post- measures of cortical excitability after inhibitory and excitatory priming of the motor cortex, and to evaluate the sensitivity of motor outcome measures to changes in cortical plasticity.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age (all genders, races, ethnicity)
* Must have no current psychiatric or neurologic issues
* Must not have any conditions listed in exclusion criteria
* Must be fluent in English

Exclusion Criteria:

* History of major psychiatric illness
* Actively using neuropsychoactive medication
* Legal or mental incompetency
* Substance use disorder, abuse or dependence, with active use within the last three months
* Significant medical or neurological illness
* Prior neurosurgical illness
* Prior neurosurgical procedure
* History of seizure
* History of ECT or TMS treatment within the past there months
* Presence of a pacemaker, implanted medical pump or device, metal plate, or metal object in skull or eye (including shunts, dental implants, facial tattoos with metallic ink)
* Pregnant women
Koji Product Supplementation' s Study

The present project is to identify the effect of black soy beans Koji product supplementation on nutrients absorption and anti-aging effect in elderly.

Previous studies show that supplementation of soy protein can effectively increase muscle mass and protein utilization. Besides, soy extracts and isoflavones can stimulate muscle growth by activating the anabolic pathway of muscle tubules. Black soybean is known to be rich in legume protein and isoflavones.We speculate that black soybean supplementation can improve the nutritional status and muscle mass of elderly people, thereby delaying the deterioration of muscular dystrophy in the elderly. Reduce the occurrence of debilitation in the elderly.

Eligibility Criteria:
Inclusion Criteria:

* 1-2 items are necessary, 3-5 can match one item

  1. Age above 65 years
  2. Oral intake
  3. Walking speed: ≤ 0.8 m/s (measured by time for a 5-meter usual gait)
  4. Handgrip strength: Men: \<26 kg Women: \<18 kg (measured by electronic hand grip dynamometer)
  5. Calf circumference: Men: ≤ 34 cm Women: ≤ 33 cm

Exclusion Criteria:

1. Participant in a moderate or strenuous exercise
2. Unable to walk
3. Unable to take in food from the mouth
4. People who can't record or communicate.
5. Refuse to accept the 3-day diet record
6. Allergic to black soybeans or legumes
7. Allergic to egg or milk
8. Infected with disease and had to be hospitalized for treatment before 4 weeks of the intervention test start
9. A patient who has been diagnosed with a malignant tumor or has a history of malignancy in the past year.
10. The estimated glomerular filtration rate (eGFR) is less than 60 ml/min/1.73 m2 in the past three months.
11. Hypothyroidism
12. People who often have symptoms of gastrointestinal upset.
CXCL9 and CXCL11 Levels in Patients With Autoimmune Thyroiditis and Habitual Abortions

The purpose of this study is to measure serum CXCL9 and CXCL11 levels in patients with autoimmune thyroiditis and habitual abortions


Eligibility Criteria:
Inclusion Criteria:

* non-pregnant women with euthyroid autoimmune thyroiditis and a history of first trimester recurrent spontaneous abortions

Exclusion Criteria:

* 1) presence of acute or chronic systemic diseases; 2) other autoimmune diseases; 3) pregnancy and lactation over the previous 6 months; 4) evidence of infectious diseases in the last 3 months; 5) treatment with drugs known to interfere with cytokine release, such as corticosteroids, immunosuppressors, or nonsteroidal antiinflammatory drugs, amiodarone, and lithium; 6) clinical history of hyperthyroidism and/or the presence of anti-TSH receptor antibodies.
A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL

This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of de novo or transformed DLBCL, or follicular grade 3b lymphoma.
* Received at least four cycles of first-line therapy with R-CHOP, or equivalent.
* Best clinical response to first-line therapy of stable disease, partial response, or complete response.
* At least one measureable lesion that is both greater than or equal to 1.5cm by radiographic imaging and by positive FDG-PET scan.

Exclusion Criteria:

* Leptomeningeal or central nervous system lymphoma.
* Received any therapy for relapsed or progressive disease except for local radiation, steroids, or rituximab.
* Received a hematopoietic stem cell transplant.
An Exploratory Study on the Safety and Effectiveness of Paliperidone in Patients With Schizophrenia

The purpose of this study is to assess the safety, effectiveness, and plasma concentration of paliperidone (an antipsychotic medication) given once daily in the treatment of patients with schizophrenia

Paliperidone is an extended-release tablet. Paliperidone is an active metabolite of risperidone, not approved for the treatment of schizophrenia in Japan. This is a multicenter, open-label, parallel-group, fixed dose study to evaluate the safety, effectiveness, and plasma concentration of paliperidone taken once daily in patients with schizophrenia. The patients will receive a fixed dose of paliperidone (3, 9, and 15 mg) for 6 weeks and its effectiveness and safety will be observed for an additional 2 weeks.. Efficacy will be measured by determining changes throughout the study in the Positive and Negative Syndrome Scale (PANSS) score, a scale for the measurement of symptoms of schizophrenia, and the Clinical Global Impression (CGI) score. In addition, the study also assesses the relationship between dose/plasma drug concentration and dopamine D2 receptor occupancy in patients who consent to receive positron emission tomography (PET). Safety evaluations (symptoms, physical exams, electrocardiograms, laboratory tests, Drug-Induced Extrapyramidal Symptoms Scale \[DIESS\] results, and adverse event monitoring) will be conducted throughout the study. The study hypothesis is that paliperidone will be effective in the treatment of schizophrenia, and that it will be well-tolerated. The patients will receive either 3, 9, or 15 mg of paliperidone, taken once daily by mouth for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV
* taking not more than one oral antipsychotic medication within 28 days of study entry
* a score below 120 at pre-treatment on the Positive and Negative Syndrome Scale Score (PANSS), a scale for the measurement of symptoms of schizophrenia

Exclusion Criteria:

* Diagnosis of psychiatric disease other than schizophrenia according to the diagnostic criteria of DSM-IV
* history of Parkinson's disease, seizure disorder, cerebrovascular accident, diabetes mellitus, clinically significant gastrointestinal disorders, or severe impairment of the liver or kidneys
* drug allergy or hypersensitivity to antipsychotics
The Validity of the Thai Version of the Confusion Assessment Method

The purpose of this study is to determine the validity and reliability of the Thai version of the Confusion Assessment Method for the intensive care (CAM-ICU) in the elderly and the prevalence of delirium in elderly.

The incidence of delirium in intensive care unit varied between 20 and 80% depending on many factors such as types of study, diagnostic tools, severity of patients.The occurrence of delirium is common in elderly patients. However, the prevalence of delirium in the intensive care has not been reported in Thailand. There is no common tool used for detecting delirium in Thai ICU. Currently, CAM-ICU has been developed for nonpsychiatric physician and other health care professionals to detect delirium. The sensitivity and specificity of CAM-ICU was 91-93% and 89-100% respectively. In addition, it has been translated to many version to diagnose deliriums for all over the world. In Thailand, there is no common tool used for detecting delirium in ICU. The use of CAM-ICU may be useful in Thai ICU settings.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 55 years old

Exclusion Criteria:

* Severe visual or auditory impairment
* Comatose or moribund patients
* Unable to communicate with Thai language
Hypnofertility for Women Undergoing In Vitro Fertilization (HWUIVF)

This randomized controlled study aimed to specify whether the interventions based on Hypnofertility would lead to increased fertility preparedness and pregnancy outcomes, decreased cortisol levels of women undergoing In Vitro Fertilization (IVF) treatment.

Objective: To specify whether the interventions based on Hypnofertility would lead to increased fertility preparedness and pregnancy outcomes, decreased cortisol levels of women undergoing In Vitro Fertilization (IVF) treatment.

Design: Randomized, controlled, prospective study. Setting: University Hospital Fertility Center in Izmir. Patients: Sixty-one women with unexplained infertility undergoing IVF treatment.

Interventions: Interventions based on Hypnofertility including affirmations, visualization, dreaming and relaxation from the first day of treatment to the day of pregnancy test.

Main Outcome Measures: Fertility preparedness and cortisol levels (primary outcomes), pregnancy rate (secondary outcome).

Eligibility Criteria:
Inclusion Criteria:

* primary infertility,
* unexplained infertility,
* going to undergo IVF treatment,
* fresh embryos,
* under 39 years of age
* having a smart phone

Exclusion Criteria:

* participated in any program to reduce stress
* having any psychiatric disorder
An Immunogenicity and Safety Trial of MVA-BN in Adults Living with HIV for the Prevention of Mpox Infection, in Kinshasa, DRC

This is an open-label, phase 2, immunogenicity and safety trial of the MVA-BN vaccine for the prevention of mpox in adults living with HIV with different level of CD4 counts in Kinshasa, DRC.

The study team aims to investigate whether the administration of 2 standard subcutaneous doses of the Modified Vaccinia Ankara of Bavarian Nordic (MVA-BN) vaccine given 28 days apart, is immunogenic and safe when administered to People Living with HIV (PLHIV) with different levels of CD4 counts in the Democratic Republic of the Congo (DRC).

Enrollment will be stratified according to three different subgroups based on CD4 counts assessed during visit 1A: \<200 cells/µL; 200 to 499 cells/µL; ≥ 500 cells/µL. A total of 600 participants will be included in the trial, with 200 participants per subgroup.

All participants will be invited to 6 trial visits over a period of 7 months.

This study will take place in cooperation with the National Programme for the Fight against AIDS (PNLS), the 'Programme Elargi de Vaccination (PEV)' and the 'Institut National de Santé Publique (INSP)'. As part of the response to the current mpox epidemic in DRC, a large cohort of about 10,000 individuals living in Kinshasa will be vaccinated in this program. Vaccination will take place in the Centre Hospitalier Kabinda (CHK) and the Pakadjuma Health Centre. All people living with HIV (PLHIV) with the intention to be vaccinated in the CHK, will be asked for their willingness to participate in the MBOTE-HIVAX clinical trial until the sample size of 600 participants needed for this clinical trial is reached.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 45 years at time of informed consent
* Able and willing to provide written informed consent
* Infected with HIV and receiving combination antiretroviral therapy (ART) for ≥ 8 weeks prior to study entry and vaccination
* Preparedness to follow the study schedule
* Willingness to use contraception for 1 month after each vaccination (only for women of childbearing potential)

Exclusion Criteria:

* A known history of mpox and/or smallpox
* A known history of vaccination with 1st, 2nd or 3rd generation smallpox vaccines, or vaccine platforms that contain MVA as a vector
* Planned MVA-based vaccination (other than study vaccination) during the trial
* Close contact to a confirmed mpox case in the 3 weeks prior to study enrollment
* Uncontrolled severe infection or other condition requiring hospitalization
* Pregnancy
* History of anaphylaxis or severe allergic reaction to any vaccine or known allergy to one of the components of the study vaccine
Effect of the Mobile Self-input Tool of Incentive Spirometer (RCT)

This study evaluates the effectiveness of the mobile self-input tool providing alarm and visual motivation, how much more it can encourage practicing of incentive spirometer undergoing post-operative patients under general anesthesia. Half of participants will receive the mobile self-input tool providing alarm, and their practicing rate will be sent to Nurse's Dashboard. While the other half will receive the mobile self-input tool, but it won't contain alarm function and their practicing rate won't be sent to Nurse's Dashboard, either.

1. Background : Active respiratory therapy like incentive spirometer is needed to prevent pulmonary complications for patients undergoing post-operative under general anesthesia. But in many cases, patients don't practicing it for their pain, or they just forget doing it. And medical staffs are having difficulties in checking how well the patients follow the directions for doing incentive spirometer. Insufficient practicing incentive spirometer and deep breathing cause delay their health recovery.

   Therefore, we want to make some tools which can encourage the patients' practicing for incentive spirometer and also supply the objective achievement of patients to medical staffs.
2. Objective : This study evaluates the effectiveness of the mobile self-input tool providing alarm and visual motivation, how much more it can encourage practicing of incentive spirometer undergoing post-operative patients under general anesthesia.
3. Design: RCT (randomized controlled trial)
4. Setting: In the Department of Gastrointestinal Surgery at the Samsung Medical Center
5. Enrollment : 44 patients undergoing gastrectomy.
6. Intervention 6-1) For study group : participants on study group are received self-input tool with alarm system on tablet.

   Alarm is provided only if insufficient practice (less than 10 times/hour) from 9am to 9pm. The practicing rate is sent to Nurse's Dashboard.

   6-2) For control group : participants on control group are received self-input tool without alarm on tablet. Their practicing rate is not sent to Nurse's Dashboard.
7. Scoring by practicing incentive spirometer from 9 am to 9 pm. (Only when a subject practiced more than 10 times per hour, the subject get 10 points) (Full score 240)
8. Study period : for 48hrs from one day to 3rd day after patient's operation
9. Satisfaction survey (SUS) after study(3rd day after operation)

Eligibility Criteria:
Inclusion Criteria:

* A subject undergoing total gastrectomy or subtotal gastrectomy by robotic surgery, laparoscopic surgery or open surgery
* A subject who got surgery under general anesthesia
* A Subject receiving a prescription of using incentive spirometer
* A subject who voluntarily agrees and signs

Exclusion Criteria:

* Disorientation
* Unscheduled emergency surgery
* a subject who has difficulty in active breathing exercise due to problems such as heart disease, brain disease, chronic lung disease, etc.
Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist

Primary Graft Dysfunction (PGD) respresents the leading cause of mortality in early post-operative period of Lung Tranplantation (LTx). Protective ventilatory strategy could potentially reduce the risk of PGD in these patients. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode that could allow to adopt this strategy. Aim of the study is to assess the feasibility of NAVA in the early post-LTx phase and to describe the breathing pattern and the physiological relationship between neural respiratory drive and different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback.

Lung transplantation (LTx) is an important treatment option for select patients with end-stage pulmonary disease. Primary Graft Dysfunction (PGD) is the main cause of death; in the early period following LTx a protective ventilatory strategy (tidal volume - Vt of 6 mL/Kg + Positive End Expiratory Pressure) could potentially reduce the risk of PGD in these patients. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode in which neural inspiratory activity is monitored through the continuous recording of electrical activity of the diaphragm (EAdi). Actually, Guidelines about the adoption of a protective ventilatory strategy in the early post-opeartive period are lacking.

NAVA, because of its intrinsic properties (proportionality between respiratory drive and level of assist, prevention of diaphragm atrophy), could allow to reach the afore mentioned ventilatory strategy. So, aim of the study, is the evaluation of patients' neural breathing pattern during NAVA, in early post-operative period of LTx

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 y.o.
* Admission to ICU for post-operative monitoring after LTx
* Presence of spontaneous breathing activity
* Sedation titrated to a target RASS between 0 and -2
* Written informed consent obtained

Exclusion Criteria:

* Contraindication to nasogastric tube insertion (gastroesophageal surgery in the previous 3 months, gastroesophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma)
* Increased risk of bleeding with nasogastric tube insertion, due to severe coagulation disorders and severe thrombocytopenia ( i.e., INR \> 2 and platelets count \< 70.000/mm3)
* Severe hemodynamic instability (noradenaline \> 0.3 μg/kg/min and/or use of vasopressin)
* Postoperative extracorporeal respiratory support (ECMO)
* Pre-operative reconditioning of the transplanted lungs by means of ex-vivo lung perfusion (EVLP)
* Lung retransplantation
* Failure to obtain a stable EAdi signal
Effect of Music Therapy on Patients Undergoing Intravitreal Injections

Multiple studies in various specialties, including ophthalmology, are reported in the literature that show that playing music during a procedure (dubbed music therapy) increases patient satisfaction and may reduce patient anxiety and stress levels.

There is no study in the literature that assesses the effects of listening to music in patients undergoing intravitreal injections. This study aims to assess whether listening to music improves patient satisfaction or reduces their anxiety levels in subjects undergoing intravitreal injections.


Eligibility Criteria:
Inclusion Criteria:

* Those patients at least 18 years old already scheduled for intravitreal injections.

Exclusion Criteria:

* Those patients not interested in participating in the study or not capable of filling out the questionnaire secondary to limited mental capability.
* Non- English speaking subjects will be excluded from the study.
* Those patients that participated in the study will not be allowed to participate a second time.