cyrilzakka/clinical-trials huggingface dataset:
Exercise in Breast Cancer Survivors

The purpose of this study is to compare the effects of aerobic exercise to usual care in women treated with chemotherapy and radiation therapy for non-metastatic breast cancer

In this study, we will compare the effects of exercise between women previously treated with breast cancer to women with no history of any cancers. Therefore, in addition to a randomized controlled trial in women with previous breast cancer (i.e., an exerciser group and a control group), we also include a reference group comprising age-matched women with no history of any cancer diagnosis. Women in the reference group will undergo a similar exercise intervention and the exercise group. This study recruits through invitation only.

The primary endpoint in this study is the change in cardiorespiratory fitness, measured as VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and cardiometabolic health, endpoints derived from the cardiopulmonary exercise test and lung function assessments, cellular muscle endpoints derived from muscle biopsies obtained from m. vastus lateralis, also patient-reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Eligible BCS must be listed in the Norwegian Cancer registry
* Female
* Adult-onset breast cancer diagnosis, diagnosed between 2008 and 2012
* 60 years or younger at the time of diagnosis
* received anthracycline-based chemotherapy as a part of their treatment history
* signed informed consent and medical doctors approveal of participation prior to inclusion

Exclusion Criteria:

* Received Herceptin
* Diagnosed with stage IV breast cancer
* Relapse since diagnosis
* A history, or current presence, of another diagnosis of invasive cancer of any kind
* Selfreported severe fatigue
* present with any uncontrolled- or recent cardiovascular disease, has undergone heart surgery or uses a pacemaker
* currently exercising more than 90 minutes per week
Relationship Between Gut Microbiome, Probiotics, and Mild Cognitive Impairment

This study is to evaluate whether the consumption of probiotics can improve the symptoms of patients with mild cognitive impairment; also evaluate the effects of probiotics on patients' blood, oxidation and stress related indicators.

Mild cognitive impairment (MCI) is the stage between the expected cognitive decline of normal aging and the more serious decline of dementia. It can involve problems with memory, language, thinking and judgment that are greater than normal age-related changes. Probiotics are regarded as active microorganisms. When consumed in sufficient amounts, participants can regulate intestinal flora, intestinal permeability, inflammation and antioxidant reactions in the body, and may produce host health, including delaying disease and regulating metabolic disease progression and prevent complications.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who is suffering from Mild Cognitive Impairment.
2. Clinical Dementia Rating (CDR) 0.5.
3. Age 40-80 and willing to sign the Informed Consent.
4. Education level is above the junior high school level.
5. Healthy control who is eligible judged by PI.

Exclusion Criteria:

1. Patients on antibiotics within the preceding one month.
2. Patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks.
3. Have undergone surgery of liver, bladder, or gastrointestinal tract.
4. Have current or history of inflammatory bowel disease.
5. Have history of cancer.
6. Known allergy to probiotics.
7. Dementia (MMSE ≤ 23).
8. Cognitive Impairment caused by head injury.
9. History of cerebral apocalypse.
10. Other possible diseases may cause cognitive impairment, such as: Parkinson's disease, cervical mass, hydrocephalus or epilepsy.
11. Severely depressed patients (sick person health questionnaire-9 (PHQ-9) ≥ 20).
12. Severe anxiety patients (Generalized Anxiety Dosorder 7-Item (GAD-7) ≧ 15).
13. Undergoing medication treatment for acute illness, Organic psychosis or diagnosed as psychiatric illness within 3 months or poor control of chronic psychiatric illness.
14. Undergoing parenteral nutrition.
15. Not eligible judged by PI.
AUTO-ACUSAR - Effects of Acupuncture on the Autonomic Nervous System in Seasonal Allergic Rhinitis Patients

There is inconclusive evidence whether acupuncture treatment is effective in the treatment of seasonal allergic rhinitis (SAR). Furthermore, the underlying mechanisms of acupuncture in SAR are only poorly understood. It was hypothesised that the therapeutic mechanism of acupuncture is related to changes in autonomic function. AUTO-ACUSAR is a sub-study of the DFG-funded three-arm randomized controlled trial ACUSAR trial investigating the efficacy of acupuncture vs. sham acupuncture vs. rescue medication in SAR. The aim of AUTO-ACUSAR was to investigate short and long-term effects of acupuncture vs. sham acupuncture on autonomic function in a sub-group of ACUSAR patients. Baseline values were compared to data from matched healthy controls.

In AUTO-ACUSAR a subsample of ACUSAR patients from acupuncture or sham acupuncture groups were included. Tests of autonomic functions included measurement of heart rate variability during paced breathing, blood pressure, heart rate and salivary alpha amylase response to a cold pressure test (CPT) and cortisol awakening response before the first and the last of twelve treatment sessions. Healthy matched controls underwent the same measurement once only

Eligibility Criteria:
Inclusion Criteria:

* Female or male patients (aged 16-45 years) with seasonal allergic rhinitis, clinically positive and test positive (skin-prick test and/or RAST) to grass and birch pollen
* Patients with \>2 years of moderate to severe SAR
* Positive skin-prick test and/or RAST (at least class 2) results
* Visual analogue scale \>40mm and \<80 mm for SAR symptoms during the past year
* Patients must be able to complete a diary for self-evaluation of symptoms and recording use of anti-symptomatic medication
* Use of, or indication for, oral antihistamines as anti-allergic medication
* Written informed consent

Exclusion Criteria:

* Perennial SAR or other types of chronic rhinitis
* Allergic asthma and/or moderate to severe atopic dermatitis
* Active tuberculosis
* Auto-immune disorders
* Severe chronic inflammatory diseases
* History of anaphylactic reactions
* Hypersensitivity to Rescue medication or related drugs used in study related drugs
* Specific immunotherapy \>3 years
* Simultaneous participation in other clinical trials
* Serious acute or chronic organic disease or mental disorder
* Pregnancy or breast feeding
* Allergy desensitisation therapy (current, during the past two years, or planned in the next two years)
* Blood coagulation disorder and/or current use of anticoagulants
* Previous acupuncture treatment for SAR
* Any Complementary and alternative medicine treatment at the moment, in the last three months or planned in the next two years

  * intake of Beta-Blocker Medication
  * use of pacemaker
Peristeen Bowel Irrigation System in Cauda Equina

To compare the Peristeen Anal Irrigation System with conservative bowel management in a prospective study among spinal cord injured patients with lower motor neuron neurogenic bowel dysfunction.

People with spinal cord injury (SCI) often have severe problems with management of bowel function, including incontinence, impaction, lengthy bowel routines and extremely slow transit times.The anal irrigation system is a recently available system to help patients with bowel dysfunction empty their bowels by using pulse water irrigation. The system consists of a rectal balloon catheter, manual pump and water container.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \>18 years or older
* Cauda equina spinal injury at least 12 months previously, with lower motor neuron bowel dysfunction and at least one of the following symptoms:
* Spending 30 minutes or more attempting to defecate each day or every second day
* Episodes of fecal incontinence once or more per month
* Abdominal discomfort before or during defecation

Exclusion Criteria:

* Coexisting major unresolved physical problems due to the injury
* Performance of transanal irrigation on a regular basis
* Evidence of bowel obstruction or active inflammatory bowel disease
* History of cerebral palsy, stroke, multiple sclerosis or diabetic polyneuropathy
* Previous colorectal or perineal surgery(excluding minor surgery such as hemorrhoidectomy)
* Pregnancy or lactation
* Immunosuppression
* Prior implant for sacral nerve stimulation
Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers

The primary purpose of this study is to assess the safety and tolerability of AB598 in participants with advanced malignancies.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Prior systemic radiation or whole brain radiation therapy must have been completed at least 4 weeks before investigational product (IP) administration. Other palliative radiotherapy must be completed 2 weeks before investigational product administration, if radiation therapy-related AEs have resolved to Grade ≤ 1.
* Monotherapy-specific criteria for dose escalation and PD cohorts:

  * Dose Escalation: Participants may have any pathologically confirmed advanced or metastatic solid tumor for which standard therapy has proven ineffective, intolerable, or is considered inappropriate.
  * Pharmacodynamic Cohorts: Participants may have any pathologically confirmed advanced or metastatic solid tumors for which standard therapy has proven ineffective, intolerable, or is considered inappropriate. Participants must be able to undergo collection of a fresh frozen biopsy during screening, as well as provide an on-treatment fresh frozen biopsy.
* Dose Expansion cohort criteria:

  * Histologically confirmed, documented diagnosis of HER2-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.
  * No prior systemic treatment for locally advanced unresectable or metastatic disease.
  * Cannot have progressed within 6 months of prior platinum-based chemotherapy for earlier stage disease.

Key Exclusion Criteria:

* Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of study
* Underlying medical conditions or AEs that, in the investigator or sponsor's opinion, will make the administration of the study drugs hazardous
* Any active or documented history of autoimmune disease including but not limited to inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment
* History of trauma or major surgery within 28 days prior to the first dose of study drug
* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment with certain protocol specified exceptions

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Geri-TBI: A Prospective Multi-center Evaluation of Geriatric Patients With Traumatic Brain Injury

This multicenter prospective observational study is designed to prospectively record data on patients who are managed per institutional standard of care. The objectives of this study are to establish an aggregate database of information on baseline clinical and demographic characteristics, medication use, markers of frailty, injury characteristics, management strategies, and outcomes following TBI in geriatric patients, determine best practices for management of geriatric patients with TBI, and establish how markers of frailty correlate with outcome in geriatric patients with TBI.

This is a prospective multi-center observational study of geriatric patients with TBI. Data collected will be purely observational and involve no study-based therapeutic interventions or alterations in patient care. Due to the purpose of this study being the creation of a registry and the absence of demographic information being collected, all patients meeting the inclusion criteria will be enrolled without informed consent. We plan to complete the data collection and analysis by 12/31/2018.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥40
* CT-verified TBI

Exclusion Criteria:

1. Any other body region injury AIS \>2
2. Presentation at enrolling center \>24 hours after injury
3. Pregnant women
4. Prisoners
Combined Effects of Energy Density and Eating Rate on Appetite

This study will examine the independent and combined effects of energy density and eating rate on appetite and endocrine mediators of appetite. Increasing eating rate and energy intake are expected to additively increase energy intake.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18-27 kg/m2
* Weight stable

Exclusion criteria:

* Chronic used of OTC or prescription drugs known to affect metabolism
* Chronic disease
* Gastric bypass surgery
* Disordered eating
* Pregnant or breastfeeding
Different Perineal Preparations Before Vaginal Birth to Maternal/Neonatal Infections and Cost Effectiveness

The vaginal microbiome plays a crucial role in women's health, primarily composed of beneficial bacteria such as Lactobacillus, which help maintain an acidic environment in the vagina, preventing the growth of pathogens. Research indicates that the vaginal environment during pregnancy is more conducive to the growth of Lactobacillus. Traditionally, perineal disinfection is performed during vaginal delivery; however, studies have shown that excessive use of disinfectants like povidone-iodine may reduce the presence of Lactobacillus in the vagina. Furthermore, not using perineal disinfection does not increase the risk of postpartum infections for mothers and infants, and may even benefit the development of the newborn's microbiome. Considering the medical costs and nursing labor involved, this study aims to compare the effects of different perineal preparation methods on postpartum infection rates and medical costs, with the goal of improving maternal and infant care quality during delivery and reducing healthcare costs.

5、 Method This study employs an experimental research design. After obtaining informed consent from participants, they will be randomly assigned to either the control group or the experimental group using a random number table. The control group will undergo perineal preparation using clean water, while the experimental group will use povidone-iodine for disinfection. The study will document patient demographics, prenatal vital signs, maternal and infant postpartum temperatures, blood test results, and oral bacterial culture outcomes to monitor postpartum infection rates. The REEDA scale will be used to assess perineal wound healing.

6、Expected results： The anticipated results indicate that using clean water for perineal preparation will not increase the risk of postpartum infections for mothers and infants, while also saving medical costs. Additionally, water disinfection may allow newborns to acquire beneficial bacteria such as Lactobacillus from the mother's vagina during delivery, promoting healthy gut microbiome development.


Eligibility Criteria:
Inclusion Criteria:

Maternity:

* Born after 37 weeks of pregnancy;
* Pregnant women with low-risk pregnancy;
* Be able to communicate in Mandarin and Taiwanese, and be able to read Chinese;
* A single fetus with a cephalic position;
* Aged 18 years or above (inclusive) with clear consciousness and no cognitive impairment;
* Do not use antibiotics during pregnancy;
* There are no fetal diagnostic abnormalities during pregnancy check-up.

Newborn:

* Newborns over 37 weeks
* Apgar Score is greater than 7 points in the first minute of life
* Having given birth to a newborn and undergoing perineal cleaning/disinfection methods specified in the study during the second stage of labor

Exclusion Criteria:

* The mother's water broke for more than 18 hours during labor;
* Mother had a fever;
* Used vacuum suction during delivery;
* Shoulder dystocia;
* Fetal distress;
* A perineal wound of 3 degrees or above
Evaluating an Online Acceptance and Commitment Training Program for Individuals with Chronic Health Conditions

Chronic health conditions (CHC) commonly share the challenge of impaired health-related quality of life, negatively impacting the lives of millions of people in the United States. Long term effects for living with a chronic health condition are likely to include poor self-management behaviors, which are related to avoidance of disease related thoughts and feelings (e.g., health anxiety) and can be addressed directly with psychosocial interventions. With the focus on fostering values driven and meaningful behavior while accepting thoughts and feelings, ACT may prove to be a particularly effective approach for individuals coping with the challenging symptoms and effects of having a chronic health condition. Previous web-based ACT interventions for CHCs have focused on building ACT skills for a narrow subset of CHCs (e.g., breast cancer, diabetes, tinnitus). While there is added benefit for a self-help program for populations with specific stressors or conditions, there is also a high prevalence of comorbidity in CHCs, shared challenges in illness management and coping, and clear evidence that ACT works effectively across CHCs to improve quality of life. Thus, our goal of this research project is to evaluate a new 6 session, online, self-guided ACT program for adults with chronic health conditions broadly to improve their quality of life and wellbeing through a randomized controlled trial. The specific aims are:

1. To evaluate the feasibility of an initial prototype of ACT program for adults with CHC's as indicated by recruitment, retention, and adherence rates.
2. To evaluate the acceptability as indicated by self-reported program satisfaction and qualitative feedback following the course completion.
3. To identify ways to further refine the program based on participant self-reported satisfaction with sessions and open-ended text-based feedback.
4. To test the efficacy of the program on improving quality of life among adults with CHC's.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Currently living in the U.S.
* Self-report having at least 1 chronic health condition (e.g., cardiovascular disease, cancer, diabetes, chronic pain, rheumatoid arthritis, HIV, Parkinson's disease, irritable bowel syndrome, Crohn's disease, chronic obstructive pulmonary disease, multiple sclerosis)
* Self-report having had the chronic health condition for ≥ 3 months
* Can access the internet via computer, mobile phone, or tablet
* Have an interest in using an online mental health intervention

Exclusion Criteria:

• Not fluent in reading English (at this point the online program can only be feasibly and competently delivered in English)
Assessment and Digital-health Based Intervention on Subclinical Organ Damage and Cardiovascular Risk in Chinese

To comprehensively evaluate subclinical organ damage of Chinese adults and its association with future cardiovascular disease and events.

To observe the significance of intervention based on digital health in preventing the onset and/or progression of subclinical organ damage and cardiovascular disease and events.

In this project, we will register outpatients with cardiovascular diseases and healthy subjects for cardiovascular health check-up in the cardiovascular research clinic of our hospital, comprehensively evaluate their cardiovascular risk factors, subclinical organ damage and cardiovascular diseases at baseline. For participants who is willing to go further, a digital-based intervention will be provided for them to improve their knowledge and behaviour on cardiovascular health. For all participants, their status on subclinical organ damage, cardiovascular diseases and events will be followed within five years. The primary outcome is the composite endpoints of cardiovascular adverse events including acute coronary syndrome, myocardial infarction, heart failure, cardiovascular death. The secondary outcomes include individual cardiovascular adverse events, all-cause mortality, subclinical organ damage including cardiac damage (left ventricular hypertrophy and diastolic dysfunction), renal damage (chronic kidney disease, microalbuminuria), and vascular damage (arterial stiffness, plaques, intima-median thickening, retina arteriosclerosis). By doing these, we will be able to build a registry study and to reveal the epidemiology of subclinical organ damage, validate the association between subclinical organ damage and cardiovascular events in Chinese, and explore the significance of digital-based intervention in the prevention from subclinical organ damage and cardiovascular diseases and events.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* willing to participate the study and sign informed consent
* available for long-term follow-up

Exclusion Criteria:

* severe heart disease (NYHA IV)
* stage 4 or 5 CKD
* malignant tumors or with life expectancy less than 5 years
* stroke within 3 months
* refuse to participate the study or not available for long-term follow up
Randomized Study of Nimodipine Versus Magnesium Sulfate in the Prevention of Eclamptic Seizures in Patients With Severe Preeclampsia

OBJECTIVES:

I. Determine the effectiveness of nimodipine versus magnesium sulfate in the prevention of eclamptic seizures in patients with severe preeclampsia.

PROTOCOL OUTLINE: This is a randomized, international, multicenter study. Patients are randomized to receive either nimodipine or magnesium sulfate.

Arm I: Patients receive nimodipine by mouth every 4 hours. Treatment is continued until 24 hours post-partum.

Arm II: Patients receive a loading dose of magnesium sulfate IV for 20 minutes, followed by continuous infusion of magnesium sulfate. Treatment is continued until 24 hours post-partum.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Histologically diagnosed severe preeclampsia at risk for eclamptic convulsions with the following criteria:
* Blood pressure greater than 160/110 mmHg OR Mean arterial pressure of 126 mmHg
* Proteinuria greater than 5 g/24 hr
* Epigastric pain OR Right upper quadrant pain AST/ALT greater than 70 U/L
* Severe headache and/or scotomata
* Thrombocytopenia as evidenced by: Platelet count less than 100,000/mm3 Disseminated intravascular coagulation Microangiopathic hemolytic anemia Oliguria (less than 400 mL/day or 30 mL/hr)
* Pulmonary edema

--Prior/Concurrent Therapy--

* No prior/concurrent magnesium sulfate or dihydropyridine agents
* No other concurrent antiseizure medications

--Patient Characteristics--

* Age: Not specified
* Performance status: Not specified
* Hematopoietic: See Disease Characteristics
* Hepatic: See Disease Characteristics
* Renal: No severe renal failure See Disease Characteristics
* Cardiovascular: No history of angina or myocardial infarction No cardiac dysfunction No history or sign of congestive cardiac failure No arrhythmia with ventricular rate less than 60 bpm See Disease Characteristics
* Pulmonary: See Disease Characteristics

--Other:--

* No severe mental or physical disorder that may affect therapy
* Not allergic to drugs with chemical structure similar to nimodipine or magnesium sulfate
* No evidence of fetal distress or fetal anomalies