cyrilzakka/clinical-trials huggingface dataset:
Vaginal Electrical Stimulation for Postpartum Neuromuscular Recovery

For too many women, childbirth results in devastating consequences: involuntary loss of feces or urine (fecal or urinary incontinence). In fact, up to 50 percent of women with severe tears during childbirth may develop these problems. These new mothers avoid leaving home in order to stay close to a toilet, wear protective pads every day, and avoid activities they previously enjoyed such as exercise and sexual intercourse. It is not surprising that many of these women suffer from postpartum depression, and bonding with their newborns is compromised.

Fecal and urinary incontinence occur due to injuries to the pelvic nerves and muscles during childbirth. Many researchers have focused on what can be done to prevent these injuries; however, few have investigated how to help the countless women who have already suffered from these injuries to the nerves and muscles. In other fields such as orthopedics and neurology, research shows that electrical stimulation can provoke nerve regeneration after injury. Applying this technology to women who have recently suffered from nerve injury during childbirth could have profound and life-changing effects. Investigators hypothesize that electrical stimulation immediately postpartum will markedly help pelvic nerves regenerate, minimizing rates of fecal and urinary incontinence for this vulnerable population of new mothers.


Eligibility Criteria:
Inclusion Criteria:

* Primiparous (First delivery)
* Women who sustain Obstetric Anal Sphincter Injury (OASIS) during first vaginal delivery
* Between age of 18 - 50 years
* English speaking and reading

Exclusion Criteria:

* Implanted electrical device or cardiac arrhythmia
* Neurological disorder
* Inflammatory bowel disease
* Chronic Steroid Use
* Wound breakdown and infection
* Anticipated geographic relocation
Effect of Selective iNOS Inhibition During Human Endotoxemia

Sepsis or endotoxemia is manifested by hypotension, resistance to vasopressors, myocardial depression,and altered organ blood flow distribution. The mechanisms underlying the cardiovascular dysfunction during sepsis are complex; however, they are partially mediated by an uncontrolled production of NO by inducible NO synthase (iNOS).Control subjects received 2 ng/kg E. coli endotoxin, whereas the active intervention group received endotoxin in the presence of selective iNOS-inhibitor aminoguanidine. Hemodynamics, vascular responses to norepinephrine, acetylcholine and sodium nitroprusside, as well as circulating cytokines and other mediators of inflammation were measured. We tested the hypothesis that inhibition of NO-synthesis prevented the LPS-mediated insensitivity to noradrenalin and endothelial-dependent vasorelaxation. Furthermore, we tested whether NO participates in occurrence of the endotoxin tolerance in humans by using the iNOS inhibitor aminoguanidine on healthy volunteers with endotoxemia. At 0; 2 and 4 hours after the LPS challenge whole blood was stimulated with five TLR agonists in vitro and pro- and anti-inflammatory cytokines were measured.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* tendency towards fainting
* alcohol abuse
* nicotine abuse
* drugs abuse
The Effect of a Peat and Apple Extract on Muscle ATP and Exercise Performance

A study to test the hypothesis that a combined peat and apple extract will increase blood and muscle ATP, which will increase cycling performance


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 40
* Healthy
* Recreationally active (i.e. Participants will be deemed as too trained if they are defined as participating in structured resistance exercise 3 or more times per week for \>6 months or participating in structured endurance exercise for \>6h per week for \>6 months. Participants will be defined as too sedentary if they do not exceed the governments guidelines of 150 / 75 min per week of light / heavy exercise.)

Exclusion Criteria:

* Allergy to Lidocaine
* Any diagnosed metabolic health condition
* Pregnant
* Non-habitual caffeine intake
* Smoker
* Diagnosed Cardiovascular disease
* Beta-Blockers
* Recent history of musculoskeletal injury
Exercise and Weight Control

The purpose of this study is to research the effects of exercise on calories eaten and expended. The investigator expects to find out whether subjects change their eating and activity behaviors when starting an exercise program.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 40 years old
* BMI of 25.0 - 35 kg/m2
* willing to consent to study conditions
* not taking medications that affects energy expenditure or eating
* not using tobacco or nicotine products
* no food allergies or limitations to eating certain food that would prohibit them from eating the study foods
* not be dieting to lose weight
* no major health problems
* cannot have known cardiovascular, pulmonary or metabolic disease
* cannot be regularly exercising in an aerobic manner more than twice per week
* must have a liking of at least 5 out of 10 for 75% of the study foods

Exclusion Criteria:

* \< 18 or \> 40 years old
* BMI \< 25 or \>35 kg/m2
* currently pregnant or trying to become pregnant, or lactating
* currently using tobacco or nicotine
* taking medication that affects energy expenditure or eating
* food allergies to foods used in the study
* regularly exercising in an aerobic manner more than twice per week
* major health problems
Comparing Early Enteral Nutrition Versus Parenteral Nutrition After Pancreaticoduodenectomy

To prove that early enteral nutrition after pancreaticoduodenal operation is of great significance to improve the immune response, reduce the incidence of postoperative infection and other related complications, and shorten the length of hospital stay

Arm A: Total parenteral nutrition. TPN also started from POD 1 and was delivered through a central venous catheter. Target energy of 1.5 amino acids/kg/day reached 30 kcal/kg/day.

Arm B: NJEEN was defined as providing at least 50% of the nutritional requirements through the nasojejunal tube prior to the 5th day after surgery (POD) and having no parenteral nutrition for 72 h or more.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years old, gender is not limited;
* All patients underwent pancreaticoduodenectomy;
* ECOG 0 \~ 2 for physical condition score;
* Imaging examination found pancreatic head, periampullary space, no distant metastasis and ascites;
* No bone marrow dysfunction;
* Those without obvious surgical contraindications;
* Expected postoperative survival ≥3 months;
* The study visit plan and other programme requirements are now available;
* Voluntary participation and signing of informed consent.

Exclusion Criteria:

* Patients with stage II and IV periampullary carcinoma of head of pancreas and periampullary carcinoma;
* Active infected persons;
* Distant metastasis or ascites were found in imaging examination;
* Patients with serious impairment of heart, liver and kidney function (grade 3 to 4, ALT and/or AST more than 3 times the normal upper limit, Cr more than the normal upper limit);
* patients with other malignant tumors or blood diseases;
* Pregnancy, planned pregnancy and lactation female patients (urine HCG \>02500 iu /L, diagnosed as early pregnancy);
Treatment of Chronic Post-Traumatic Headache With OnabotulinumtoxinA

This study will provide evidence on whether the use of an FDA-approved drug therapy for the treatment of chronic migraine (OnabotulinumtoxinA) shows similar efficacy for treatment of chronic headaches caused by traumatic injury to the brain (TBI) from a direct hit to the head, or a fall, or a motor vehicle accident, or some other traumatic event.

Headaches caused by trauma are called post-traumatic headaches (PTH). The Center for Disease Control estimates that between 1.4 and 1.8 million civilians in the US sustain a traumatic brain injury (TBI) each year. The objectives of the study will be evaluated in a civilian population which has sustained a mild Traumatic Brain Injury (mTBI). Research has found that the total cost due to headache in the US workforce is $20 billion per year, most of which is in the form of reduce productivity while at work. For patients with TBI who are already struggling with cognitive and health challenges in an effort to be productive, it seems reasonable to suspect that chronic PTH may slow rehabilitation efforts and successful re-entry into the work force and societal responsibility. Results from this study have the potential to contribute to recommendations for treatment of chronic PTH.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild traumatic brain injury (mTBI) within the past 15 months
* Suffer at least fifteen total headache days per month
* Ability to speak and read English

Exclusion Criteria:

* Subject with hypersensitivity reactions or other intolerance to OnabotulinumtoxinA
* Previous use of OnabotulinumtoxinA for treatment of headache
* Any medications commonly used as headache preventives started less than 3 months prior to enrollment
* Prior or current diagnosis of major psychiatric disorder or other central nervous system disorder
* Less than 80% compliance (recorded for less than 24 days) in the 30 day screening headache diary
* Subjects who are pregnant or trying to become pregnant within the timeframe of the study
Use of Continuous Glucose Monitors in Children and Adolescents With Obesity

To study if continuous glucose monitors are feasible for use in children and adolescents with obesity.

Various CGMs are approved by the U.S. Food and Drug Administration (FDA) for use in children and adults with diabetes. However, to date, little is known about how CGM technology can be integrated into weight management strategies for adolescents with obesity. No study to date has explored the effects of unblinded vs. blinded CGM use alone, without any other lifestyle modification recommendations. Thus, to address this question, this is a cross-over feasibility trial of blinded vs. unblinded CGM use in youth with obesity. This study hypothesizes that CGM will be a feasible and acceptable technology for youth with obesity, without diabetes, to utilize, and that access to daily glucose trends will facilitate positive changes in eating behavior and daily activity level compared to blinded CGM use. Thirty adolescents with obesity will be recruited into a six-week cross-over trial. All participants will be randomly assigned to either the blinded or unblinded group for three weeks. And then cross over to the other group for another three weeks. The primary endpoints are recruitment, retention, and adherence. While the secondary endpoints are glycemic variability, as captured on CGM, change in weight as an excess percentage of 95th percentile, sleep, dietary intake, physical activity, and eating behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Age 10-21 years BMI \>95th percentile

Exclusion Criteria:

* Previous diagnosis of Prader Willi Syndrome or hypothalamic obesity
* Intellectual disability
* Previous or planned bariatric surgery
* Hemoglobin A1c \>6.5 %
* Current use of medication that impacts weight
A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients

The purpose of this study is to comparing the Efficacy and Safety between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients.


Eligibility Criteria:
Inclusion Criteria:

* Untreated CD20-positive DLBCL confirmed by histopathology or cytology.
* 18 years to 75 years; Male or female patients.
* International Prognostic Index (IPI) score of 0 to 2.
* Signed an informed consent.
* At least one measurable lesions: for nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; for extranodal tumor mass, more than 1.0 cm in the long axis.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
* More than 6 months life expectancy.

Exclusion Criteria:

* Participation in another interventional clinical trial in the past 3 months.
* Known allergic reactions against monoclonal antibody or rituximab.
* Contraindication to any component of CHOP regimen.
* Previous treatment for DLBCL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, or surgical treatment (excluding tumor mass biopsies and surgical resection for non-lymphoma lesions), or prior use of any monoclonal antibody within 3 month.
* History of cytotoxic drugs treatment or anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis).
* Primary central nervous system (CNS) lymphoma, secondary CNS involvement, primary testicular lymphoma.
Metabolic Abnormalities and Intestinal Microecology in Patients With Chronic Disorders of Consciousness

Following severe traumatic brain injury, patients may remain unconscious for many years. It is the intestinal microbiome and metabolomics analysis comparing differentially intestinal microflora and metabolites between patients with chronic disorder of consciousness and controls so far. The investigators have mature data analysis technology. The obtained results provide new insight into understanding the molecular mechanisms underlying the chronic disorder of consciousness

Objective:To determine differences in metabolic profiles and Intestinal microbial abundance among healthy human individuals and patients in a vegetative state (VS) and minimally conscious state (MCS) and to identify metabolites in human plasma that can accurately distinguish VS patients from MCS patients.

Method: Plasma samples and fecal sample were obtained from patients with chronic disorder of consciousness, and healthy volunteers. A comprehensive metabolic profile was obtained with targeted metabolomics analysis and untargeted and targeted lipidomics analysis, as well as intestinal microbial abundance from 16S rRNA gene amplicon sequencing.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ages 18 to 80 years old;
2. Patients had a history of severe Traumatic brain injury (TBI);
3. Patients had awakened from a coma (indicating preserved sleep-wake cycles), including vegetative state and minimally consciousness state;
4. Patients stay unconscious for more than 1 month.

Exclusion Criteria:

1. Patients with disorders of consciousness caused by other inducements;
2. Other neurological or psychiatric conditions prior to the current brain injury;
3. Persistent seizure-like activity, inhibition or seizure inhibition;
4. The patients had taken a sedative barbiturate neuroleptics or antidepressants within one month;
5. The clinical state is unstable, and there are signs of spontaneous recovery or deterioration within 1 week;
6. The patients have taken gastrointestinal motility drugs or other drugs affecting gastrointestinal motility in the past month;
7. Had taken antibiotics and probiotics in the past month;
8. Patients with intestinal diseases such as colon cancer, ulcerative colitis or crohn's disease;
9. Patients with acute infectious diseases or liver dysfunction
Effects of Denosumab Therapy for Japanese

In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of denosumab in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.

The main objective of this study is to investigate effects of denosumab. The researchers also investigate the effects of Effects of previous osteoporotic therapy to denosumab treatment. In this study, the investigators analyse the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.

Registry criteria: Patients treated in the investigators hospital using denosumab. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (\< young adult mean 65%).

Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants

Eligibility Criteria:
Inclusion Criteria:

* Osteoporotic patients

Exclusion Criteria:

* cancer, hypercalcemia, etc (i.e. patients who could not use denosumab)
The Relationship Between Risperdal Treatment and Quality of Life in Patients With Alzheimer's Disease and Behavioural and Psychological Symptoms of Dementia (BPSD)

To evaluate the relationship between Risperidone Treatment, Treatment Discontinuation Rate, and Quality of Life of patients with Alzheimer's Disease and BPSD.

This is an interventional, placebo-controlled, double blind, prospective study. The total duration of this study will be 12 weeks. (1). Baseline Phase: Subjects diagnosed as Alzheimer's Disease and BPSD will be evaluated for entry to the trial. Subjects must meet the inclusion/exclusion criteria before entering the treatment phase. After obtaining informed consent, a physical examination, brief neurologic examination, and clinical laboratory tests appropriate are recommended. (2). Treatment Phase: All patients enrolled will be randomized to treatment with Risperdal Oral Solution or Placebo. The dosage of treatment medication will begin with 0.5 ml/ per day (0.5mg) (as the local product information leaflet). Investigators can titrate dosage according to patients' clinical situation. The maximum dose will be 2ml/ per day. The standardized assessments include NPI, which covers 12 domains of behavioral and neuro-vegetative symptoms, CASI for cognitive function test, and SF-36 for Quality of Life. Adverse events will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients whose age 60 years or older diagnosed with Alzheimer's disease and BPSD without exposure to any antipsychotics within 1 month prior to study start.
2. Subjects and subjects' relatives or legal representatives have signed the informed consent form, in accordance with the regulations of the local ethical committee.
3. Subjects must remain in good health, as determined by medical history, complete physical examinations, laboratory tests and ECG.

Exclusion Criteria:

1. Neurodegenerative disorders such as Parkinson's disease, Pick's disease or Huntington's chorea, Down's syndrome, Creutzfeldt-Jacob disease.
2. One of the following conditions possibly resulting in cognitive impairment:

   Acute cerebral trauma caused by post traumatic brain injury, subdural hematoma and injuries secondary to chronic trauma; hypoxic cerebral damage;; cerebral neoplasia;; mental retardation or oligophrenia
3. Multi-infarct dementia or clinically active cerebrovascular disease
4. Subjects with the severe co-existing medical conditions.
5. Current clinically significant cardiovascular disease that would be expected to limit the subject's ability to participate in and complete a 3-month trial.
6. History of drug or alcohol abuse within the last year.
7. Female subjects of childbearing potential without adequate contraception.
8. History of severe drug allergy or hypersensitivity; including recorded hypersensitivity to Risperidone.
9. Participation in a clinical trial of any investigational drug within 1 month (30 days) prior to study entry.
IgE-mediated Allergies Among Type 1 Diabetes Mellitus Children, Single Centre Observational Study

an interviewer-administrated questionnaire was designed to take history of allergy in diabetic child come to outpatient clinic fulfilling inclusion criteria and used to collect data. Skin prick testing was performed to all diabetic children with history of allergy. Laboratory assessment of Serum Total IgE, IL5 and eosinophils%.


Eligibility Criteria:
Inclusion Criteria:

* Children with at least 2 Years duration of diabetes diagnosed by Criteria for the diagnosis of diabetes mellitus (ISPAD 2018) that include:
* Classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/L (200 mg/dL).
* Fasting plasma glucose ≥7.0 mmol/L (≥126 mg/dL). Fasting is defined as no caloric intake for at least 8 hours.
* Two-hour post load glucose ≥11.1 mmol/L (≥200 mg/dL) during an oral glucose tolerance test (OGTT).
* HbA1c ≥6.5%.

Exclusion Criteria:

* presence of other chronic disease associated with DM.
Transcranial Magnetic Stimulation Treatment for Alzheimer's Disease

In this research study we want to learn more about the effects of non-invasive brain stimulation on memory and brain-network function in cognitively unimpaired older adults and in patients with amnestic mild cognitive impairment (aMCI).

This study will use a form of non-invasive brain stimulation called repetitive Transcranial Magnetic Stimulation (rTMS). rTMS will slightly alter activity in an area of your brain that controls memory. Changes resulting from this stimulation will be measured with behavioral tests of memory and general cognition, as well as by taking images of your brain with Magnetic Resonance Imaging (MRI).

Participants will come in for one baseline visit followed by 10 days of daily rTMS study visits (Monday through Friday) and an evaluation visit. Then, there will be a 2-week break. After this break, they will return for another baseline visit, an additional 10 days of rTMS, and a final evaluation visit.


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 40-99
2. Native English speakers
3. Willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points
4. Patients with PPA will be asked to bring a study partner to all visits
5. Patients with very mild or mild PPA, patients with amnestic mild cognitive impairment and cognitively unimpaired participants with preclinical AD will be included.

Exclusion Criteria:

1. History of head trauma involving loss of consciousness or alteration in consciousness
2. Another major neurologic or psychiatric condition
3. Known presence of a structural brain lesion (e.g. tumor, cortical infarct)
4. Any contraindication to MRI, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
5. Longstanding premorbid history (i.e. longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed
6. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol.
7. Unwilling to return for follow-up, undergo neuropsychological testing, TMS, and MR imaging
8. History of unprovoked seizures (i.e., seizures that occur in the absence of a clear provocation such as hyponatremia, hypoglycemia, etc.).
9. Subjects who have a first degree relative (e.g., father, mother or sibling) with a seizure disorder.
10. Subjects currently taking, or plan to take, medications which are highly epileptogenic. These include: clozapine, high doses of bupropion (i.e., greater than 400mg daily), diphenhydramine, cyclosporine, isoniazid, imipenem, chloroquine, tramadol and theophylline.
11. Subjects actively on anti-amyloid treatments. This is because they are at risk for bleeding due to amyloid-related imaging abnormalities (ARIA) that could provoke seizures.