cyrilzakka/clinical-trials huggingface dataset:
Interoception and Body Scan

Body scan meditation has been assumed to be an interoceptive intervention, and the evidence for its effects on interoceptive processes is unclear. Although this mindfulness based exercise typically involves focusing on some interoceptive signals such as breath, it also involves other bodily cues, such as somatosensory cues. The present study aimed to (1) investigate the feasibility of three online delivered mindfulness practices that differ in the signals targeted: visceral body scan (VBS), somatosensory body scan (SBS), and external (non body) meditation (ECM), and (2) gain insight into the potentially different effects of these interventions on interoceptive and other psychological outcomes in order to inform future full scale randomized controlled trials (RCT).


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* being Spanish or English speakers
* Ability to use a computer or smartphone
* Daily access to computer or smartphone with an Internet connection

Exclusion Criteria:

* Being diagnosed with a severe psychiatric disorder (e.g., substance abuse, eating disorder, psychotic disorder)
* Severe visual or auditory difficulties that cannot be corrected with glasses or auditory aids
* Having a medical condition that prevents participation in this study
* Changes in psychotropic medication during the study
* Having been exposed to any extremely traumatic event that is being re-experienced or interfering during the last month
* Body image-related difficulties as indicated by scores above 3 on the Body Image as Source of Shame questionnaire.
* Regular meditation practice in the current moment
Whole Body Vibration Effects on Energy Expenditure in Obese Adolescents

The main aim of the present study is to evaluate in a group of adolescents with obesity, hospitalized for a period of integrated metabolic rehabilitation (calorie restriction, aerobic physical activity, psychological counseling, nutritional re-education) lasting 3 weeks, the effects produced from a period of training with vibration stimulation on vibration platforms (Whole Body Vibration Exercise \[WBVE\]) on the resting energy expenditure (REE), assessed through indirect calorimetry. The results will be compared with those obtained in a control group, subjected to integrated metabolic rehabilitation alone.

Secondary aims of the study are to evaluate the effects of training with WBVE also on cardiovascular and musculoskeletal parameters, evaluated through specific functional tests, comparing them with those obtained in the control group.

The main aim of the present study is to evaluate in a group of adolescents with obesity, hospitalized for a period of integrated metabolic rehabilitation (calorie restriction, aerobic physical activity, psychological counseling, nutritional re-education) lasting 3 weeks, the effects produced from a period of training with vibration stimulation on vibration platforms (Whole Body Vibration Exercise \[WBVE\]) on the resting energy expenditure (REE), assessed through indirect calorimetry. The results will be compared with those obtained in a control group, subjected to integrated metabolic rehabilitation alone.

Secondary aims of the study are to evaluate the effects of training with WBVE also on cardiovascular and musculoskeletal parameters, evaluated through specific functional tests, comparing them with those obtained in the control group.

Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age range 13-18 years
* Obesity (Body Mass Index Standard Deviation Score \> 2)
* Hospitalization for a multidisciplinary program of integrated metabolic rehabilitation at the Division of Auxology, S. Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo, Italy

Exclusion Criteria:

* Presence of cardiovascular, psychiatric, and musculoskeletal pathologies
* Absence of signed written consent
Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India

1. . Study Objective: The objective of this study is to determine the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in phacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the reduction of Intraocular Pressure, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.
2. . Study Design: The study is designed as a historical controlled study. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study. The allocation of subjects is non-randomized, and there is a single group for assignment.
3. . Follow-Up: This investigation is including 7 post-operative visits and follow-up within 6 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 14, 30, 60, 90 and 180. The visit window of ± 7 days is allowed for the 30, 60, 90 and 180 day visits. The further follow-up of subject after trial is continually tracked by the investigator.

ologen collagen matrix is applied for the phacotrabec surgery.

Eligibility Criteria:
Subject inclusion criteria:

1. Age 18 years or over.
2. At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
3. Visually significant cataract with visual acuity of less than or equal to 6/12.
4. Subject able and willing to cooperate with investigation plan.
5. Subject willing to sign informed consent form.

Subject exclusion criteria:

1. Known allergic reaction to collagen.
2. Subject is on Warfarin and discontinuation is not recommended.
3. Subject with normal tension glaucoma or aphakic glaucoma.
4. Subject with corneal disease.
5. Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.
6. Ocular infection within 14 days prior to phacotrabeculectomy.
7. Pregnant or breast-feeding women.
8. Monocular subject.
Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors

RATIONALE: An exercise program or health education program may help relieve fatigue and pain and improve the quality of life in women who are breast cancer survivors. It is not yet known whether an exercise program is more effective than a health education program or no program in reducing fatigue and pain in women who are breast cancer survivors.

PURPOSE: This randomized clinical trial is studying an exercise program to see how well it works in reducing fatigue and pain compared to a health education program or no program in women who are breast cancer survivors.

OBJECTIVES:

* Determine whether a moderate-intensity exercise program comprising cardiorespiratory and resistance training of the legs, back, abdominal, trunk, and arm musculature vs a control group attenuates fatigue and pain in breast cancer survivors.
* Determine whether this exercise program will significantly improve the quality of life of these patients.
* Determine whether this exercise program can significantly reduce the number of days of absenteeism from work in these patients.
* Determine whether this exercise program can significantly attenuate mood disturbances in these patients.

OUTLINE: This is a randomized, controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.

* Arm I (exercise program): Patients participate in an exercise program comprising cardiorespiratory (walking on a treadmill) and resistance training for 1 hour, 3 times weekly for 12 weeks.
* Arm II (control): Patients undergo no intervention. In both arms, patients complete questionnaires regarding general health, mood, work attendance, and physical activity before the start of study treatment and then every 3 weeks for 12 weeks. Patients also complete a 7-day physical activity diary and sleep diary every 3 weeks.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Breast cancer survivor
* Received adjuvant chemotherapy or radiotherapy for breast cancer only

  * Must have completed treatment 2-6 months ago
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified
* Hemoglobin ≥ 11 g/dL
* Able to read English
* No high-risk for cardiovascular problems during exercise, including any of the following:

  * Unstable heart disease
  * Unstable angina
  * Chronic respiratory disease
  * Dizziness
  * Uncontrolled hypertension
* No severe respiratory disease requiring oxygen therapy
* No history of anorexia (body mass index \[BMI\] \< 18.5) or severe obesity (BMI \> 35)
* No history of multiple cancers
* No shortness of breath or hypotension
* No sudden swelling of the ankles, hands or face
* No palpitations or arrhythmias
* No persistent and intolerable pain
* No major acute illness (e.g., fever or respiratory infection)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Bobath and Vojta Therapy for DS

Different physiotherapy approaches and education programs are applied to minimize motor and mental impairment in children with Down syndrome (DS). The present study was conducted with the aim of comparing the effectiveness of two different physiotherapy approaches in babies with Down syndrome in the early period.

A total of 23 babies with DS aged between 0-24 months were included in the study. Infants were randomly divided to two groups: Bobath therapy (BT) group included 12 infants (6 girls and 6 boys) and Vojta technique (VT) group included 11 infants (4 girls and 7 boys). The infants were applied a total of 12 sessions of physiotherapy (twice weekly during 6 weeks). Alberta Infant Motor Scale (AIMS) was used for comparison of motor development level before and after the therapy. Emotional status of the mothers was evaluated with Beck Depression Scale (BDS) and quality of life was evaluated with Nottigham Health Profile (NHP).


Eligibility Criteria:
Inclusion Criteria:

* being between 0 and 2 years
* being diagnosed with DS

Exclusion Criteria:

* having an additional neuro-motor disease
Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

Majority of healthcare authorities believe that due to the methodological weakness and small number of patients in conducted therapeutic trials, the evidences are insufficient to support the efficacy of intravenous immunoglobulin (IVIG) in prevention of preterm neonatal sepsis. The objective of this research is to determine the effect of intravenous immunoglobulin in prevention of preterm neonatal sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Born alive before 37 weeks of pregnancy (preterm neonates)
* Under 2500 g at birth

Exclusion Criteria:

* lethal anomaly
* congenital heart disease
* TORCH infection
* severe asphyxia
Study of High-dose Chemotherapy (HDC) Combined With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients

To access the effectiveness of High-dose Cyclophosphamide Combined Chemotherapy combined with adoptive cellular therapy with dentritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients

1. Metastatic breast cancer patients should be definitively diagnosis based on histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative
2. All the patients enrolled will be given standard HDC and cellular therapy.HDC and cellular therapy consisting of one cycle of HDC followed by an apheresis and ex vivo cultures to generate DC and CIK. DC-CIK infusions were given to each patient, followed by two cycles HDC, plus low-dose Oral Cyclophosphamide.
3. PET-CT scans were done on each patients at baseline and after chemotherapy. The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
4. Estimate time to progression, survival rates and clinical benefit response on patients.
5. Find biomarkers associated with drug response.

Eligibility Criteria:
Inclusion Criteria:

* Failure to anthracycline and/or taxol chemotherapy;
* metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative;
* Metastatic tumor can not be removed through surgery procedure;
* Metastatic tumor measured by PET-CT scan is at least 1cm;
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* Normal cardiac, hepatic, renal and bone marrow functions;
* Life expectancy ≥3 months.

Exclusion Criteria:

* Do not finish twice PET-CT scan;
* Central nervous system metastases;
* Serious or uncontrolled concurrent medical illness;
* History of other malignancies;
* Having been enrolled in some other clinal trials within a month;
Effect of a WeChat Platform-based Management Intervention on Blood Pressure Control

WeChat is the largest and most popular social media platform in China, In this study, investigators will evaluate the use of management program delivered via WeChat platform in patients with hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years with confirmed diagnosis of hypertension
* Office systolic blood pressure (SBP)≥140 mmHg and/or diastolic blood pressure (DBP)≥90 mmHg, or ambulatory blood pressure monitoring (ABPM) indicating 24- hour SBP ≥130 mmHg and/or DBP ≥80 mmHg and/or daytime SBP ≥135 mmHg and/or DBP ≥85 mmHg and/or nocturnal SBP ≥120 mmHg and/or DBP ≥70 mmHg.
* Patients have smart phone and often use WeChat to communicate with others (including written interaction)
* Patients are willing and able to give informed consent for participation in the trial

Exclusion Criteria:

* Secondary hypertension
* Hypertensive emergency: defined as severe elevations in BP (SBP ≥180 mmHg and/or DBP≥120mmHg) associated with evidence of new or worsening target organ damage, including hypertensive encephalopathy, intracranial hemorrhage, cerebral hemorrhage, subarachnoid hemorrhage, cerebral infarction, heart failure, acute coronary syndrome (unstable angina, acute myocardial infarction), aortic dissection, perioperative hypertension, preeclampsia, and eclampsia
* Refractory hypertension: defined as failure to control BP despite lifestyle changes and use of at least 5 antihypertensive agents of different classes, including a thiazide-type diuretic and a mineralocorticoid receptor antagonist
* Pregnancy or lactation or having pregnancy plan during the study period
* Life expectancy less than 1 year
* Participation in another clinical study or clinical trial in the 3 months prior to the confirmation of eligibility or current user of WeChat platform provided by hypertension center of the first affiliated hospital of Wenzhou medical university
Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis

This is a prospective, multicenter, observational study with a planned follow-up period of 10 years to confirm the safety and performance of the GEMINI SL Fixed Bearing PS knee prosthesis in longterm follow-up under routine conditions. Primary outcome of the study is the 10-year survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis with revision for any reason as the endpoint.

The GEMINI SL Fixed Bearing PS knee prosthesis combines clinical proven design features with state-of-the-art-technology in order to achieve a high standard clinical performance, surgical efficiency and safety. Currently, no mid- and longterm clinical data are available for the GEMINI SL Fixed Bearing PS knee prosthesis. Therefore, the study is designed to generate clinical data of the GEMINI SL Fixed Bearing PS knee prosthesis in the 10-year follow-up under routine condition.

Eligibility Criteria:
Inclusion Criteria:

* Signed patient informed consent
* Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis
* Age between 18 and 80 years

Exclusion Criteria:

* Body Mass Index (BMI) \> 40 kg/m²
* Foreseeable life expectancy under 5 years
* Comorbidities and known medical circumstances which would affect the clinical or functional outcome after implantation of the knee prosthesis (e.g. neurological or musculoskeletal diseases) at the time of implantation
* Patient who is mentally not able to understand the study and the study conduct
* Patients who will be foreseeable non-compliant to the planned routine interventions and study related follow-ups
* Prisoner
* Pregnant women
TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion"

REBOOT clinical trial will study whether long-term maintenance beta-blockers therapy results in a clinical benefit after heart attack without reduced left ventricular function. Half of the participants will be randomized to receive long-term beta-blocker therapy and the other half to no beta-blocker therapy after hospital discharge. All patients will be followed up for up to 5 years to determine the occurrence of adverse events (all cause mortality, re-infarction, and heart failure admission).

Pragmatic, controlled, prospective, randomized, open-label, blinded endpoint clinical trial testing the benefits of beta-blocker maintenance therapy in patients discharged after an acute myocardial infarction (MI). Patients being discharged after an acute MI, with or without ST-segment elevation, and with a left ventricular ejection fraction \>40%, and without history of heart failure (HF) prior to study inclusion, will be recruited. At discharge, patients will be randomized (1:1) to receive beta-blocker therapy (agent and dose according to treating physician) or no beta-blocker therapy. Primary outcome is the 5 years incidence of MACE (all cause mortality, reinfarction, heart failure admission).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Admitted for STEMI or NSTEMI and invasive management (i.e. coronary angiography during index hospitalization).
* LVEF\>40% as evaluated by any imaging technique anytime during hospitalization.
* Signed informed consent

Exclusion Criteria:

* Known allergy or intolerance to beta-blockers
* Absolute contraindication to beta-blocker therapy according to treating physician judge
* Prior history of HF, Killip class on admission or during hospitalization ≥ II
* Severe valvular heart disease (\> 3+ for aortic or mitral insufficiency, aortic or mitral valve area ≤1.0 cm2).
* Any condition (appart from AMI) that requires beta-blocker prescription on discharge according to treating physician judge
* Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year),
* Patients participating in other clinical trials
A Study to Assess CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose

A Study to Assess the Effect of CT-868 and the Relationship Between Insulin Secretory Response and Ambient Blood Glucose in Obese Male Subjects and Subjects with T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Part 1: Obese Otherwise Healthy Males
* Part 2: Males or Females with T2D
* Part 1: BMI 30.0-35.0, inclusive
* Part 2: BMI 27.0-45.0, inclusive
* 18-65 years old, inclusive
* Stable body weight for 2 months

Exclusion Criteria:

* Significant medical history
* Uncontrolled hypertension
* History of malignancy
Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision

The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms (rNENs) undergoing laparoscopic total mesenteric excision (TME). The hypothesis is that the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection.

This study is a prospective single-arm clinical study. 30 patients with rNENs undergoing TME are planned to be included in the study. The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in (rNENs) undergoing laparoscopic TME. The primary endpoint is the rate of lateral pelvic lymph nodes metastasis. The primary hypothesis was the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection.

This study seeks to report for the first time the true status of lateral pelvic lymph node metastasis in these patients. In addition, the proportion of patients with radical resection (R0), surgical complication profile, and quality of life (QoL) are also secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy proven rectal neuroendocrine neoplasm (neuroendocrine tumor and carcinoma);
2. Meets any one of the following conditions:

   * Preoperative imaging examinations reveal that the maximum diameter of the tumor is greater than 2cm.
   * Preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and the clinical staging is T2 or higher.
   * Preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and is categorized as Grade 3 differentiation.
   * Recurrence after local excision under endoscopy.
3. Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;
4. Written informed consent;

Exclusion Criteria:

1. Complete intestinal obstruction;
2. Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
3. Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation；
4. Pregnancy or breastfeeding;
5. Alcohol abuse or drug addiction;
6. Concurrent uncontrolled medical condition;
Bicalutamide in Treatment of Androgen Receptor (AR) Positive Metastatic Triple Negative Breast Cancer

Compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast

This is a phase III,Multi-center,prospective,randomized clinical trials. The objective compare the efficacy of bicalutamide with conventional chemotherapy (Treatment of Physician's Choice,TPC) in first-line treatment of AR positive metastatic triple negative breast cancer.Primary endpoint is 16-week clinical benefit rate (CBR).By centre randomized grouping bicalutamide (experimental Group) or TPC (Control Group).

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-70 years old, female
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* Confirmed by pathology or organizing cytology AR positive(IHC：≧10%)triple negative breast cancer
* For the first time recurrence or newly diagnosed advanced breast cancer,Disease-free survival time 12 months above
* Measurable disease per RECIST version 1.1,or immeasurably lesions bone metastasis
* After Recurrence has not received cancer treatment
* Life expectancy of at least 6 months
* Signed and dated an informed consent form

Exclusion Criteria:

* ECOG score ≧2
* Only brain metastasis or meningeal metastasis
* Receiving other anti-tumor treatment
* Heart,lung,liver,kidney,bone marrow,and other functions badness
Kerecis Fish Skin Grafts With and Without Platelet Rich Plasma (PRP)

This prospective, randomized pilot study compares the use of a xenograft with PRP to a xenograft alone for chronic, nonhealing wounds.


Eligibility Criteria:
Inclusion Criteria:

* Patient is over the age of 18 years;
* The targeted wound is deemed a chronic, nonhealing wound after six weeks of treatment; - - Patient of Dr. Eldridge, Dr. Glenn, or Dr. Worley;
* Target wound size must be between 2 cm x 2 cm x 0.1 cm deep and 10 cm x 10 cm x 5 cm deep;
* Surgical candidate for standard of care Kerecis® xenograft surgery.

Exclusion Criteria:

* Patient with hemoglobin values less than 6.9 g/dL drawn at least 30 days prior to the Kerecis® xenograft surgery;
* Patient with a known allergy or other sensitivity to fish material;
* Patient is currently undergoing chemotherapy or radiation therapy;
* The targeted wound is of autoimmune origin; and Non-English-speaking patients.