cyrilzakka/clinical-trials huggingface dataset:
Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium

Postoperative cognitive dysfunction (POCD) and postoperative delirium occurs mainly in aged patients. POCD and POD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to previous study, the neuroinflammation is the main reason both for POCD and POD. Minocycline is a tetracycline derivative. Due to it's lipophilic structure, it is easy to pass through blood brain barrier and attenuate neuroinflammation. It's neuroprotective effects has been proven in many experimental animal models such as Alzheimer's disease, Huntington's disease and Parkinson's syndrome. In present study, the investigators hypothesized that minocycline would attenuate the incidence of POCD and POD in the aged patients.


Eligibility Criteria:
For the placebo and minocycline group;

Inclusion Criteria:

1. Elder than 65 years old
2. Speak Chinese Mandarin
3. Those who will undergo major general surgery like colorectal cancer excision, major urinary surgery like radical prostatectomy and radical nephrectomy
4. Signed the inform consent
5. American Society of Anesthesiologists classification I to III

Exclusion Criteria:

1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
3. Severe audition or vision disorder;
4. Unwillingness to comply with the protocol or procedures.
5. Cannot communicated with Chinese Mandarin
6. With severe skin disease
7. Serious heart or liver or renal insufficiency patients
8. Had surgery in the past 30 days
9. Allergy to tetracycline or minocycline

For the health volunteers;

Inclusion Criteria:

1. Elder than 65 years old
2. Speak Chinese Mandarin
3. Signed the inform consent
4. No major disease health people

Exclusion Criteria:

1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
3. Severe audition or vision disorder;
4. Unwillingness to comply with the protocol or procedures.
5. Cannot communicated with Chinese Mandarin
6. Drug abuse, alcoholism
7. Serious heart or liver or renal insufficiency patients
8. Had surgery in the past 30 days
9. Plan to undergo surgery in the following 3 months.
Rectal Short Chain Fatty Acids Combinations and Substrate and Energy Metabolism

Gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. The role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by microbial fermentation of fiber, is still controversial. One study found that an increase in the formation of SCFA stimulated energy extraction from diet, with subsequent weight gain. In contrast, supplementation of non-fermentable carbohydrates, which lead to an increase in SCFA formation, had beneficial effects on body weight control and insulin sensitivity. Of note, a study showed that butyrate supplementation in mice prevented diet-induced obesity and insulin resistance. At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited. Yet, in light of the health claims of certain dietary fibers (prebiotics), a detailed picture of the physiology of human SCFA metabolism and its interaction with the microbiome is of pivotal importance. We hypothesize that the differential availability of SCFA impacts human metabolism differently. To determine whether rectal administration of SCFA is a good model for studying the metabolic effects of SCFA we first have performed a pilot study (METC 11-3-079). In this pilot study we have determined if rectal administration of sodium acetate has the same effects on substrate and energy metabolism compared to proximal administration. Our results indicate that the primary outcome parameter fat oxidation was significantly changed during post-absorptive conditions, when sodium acetate in a concentration of 180mM was administered in the distal part of the colon. In contrast, no effect on energy expenditure or substrate oxidation was seen when sodium acetate was administered in the proximal colon. Consequently, the distal part of the colon seems to be a good model to determine effects of gut-derived SCFA on the human substrate and energy metabolism. Therefore, we will administer in this study the SCFA rectally by using enemas. We will administer different combinations of SCFA to healthy, overweight male volunteers and examine effects on metabolism. This study is an important part of a Gastrointestinal Health TIFN project (GH003 WP 1.2), which will provide more insight in how increased availability of a beneficial SCFA mixture might serve as a basis for rational nutritional strategies in the prevention and treatment of obesity and type 2 diabetes mellitus. To obtain rational nutritional strategies, a next step in this TIFN project will be focusing on dietary ingredients modulating intestinal microbiota and subsequent SCFA production.


Eligibility Criteria:
Inclusion Criteria:

* Overweight
* Obese men

Exclusion Criteria:

* Athletes
* Diabetes mellitus
Observational AVODART (Dutasteride) Study In Benign Prostatic Hyperplasia Subjects - OASIS

This study was designed to assess the effectiveness of dutasteride in the actual clinical practice of prostate assessment clinics in the UK in accordance with best practice over a 12-month period.


Eligibility Criteria:
Inclusion Criteria:

* Patients who not have received any pharmacological treatment or surgical interventions for BPH (Benign Prostatic Hyperplasia).
* Patients should be prescribed dutasteride in compliance with the UK SmPC and BAUS guidelines on the treatment of BPH.
* Patients must only enter the study after the decision to prescribe dutasteride has been undertaken.

Exclusion criteria: None specified
Mindfulness-based Stress Reduction in Multiple Sclerosis

This application concerns a proposed randomised controlled trial evaluating the use of Mindfulness-based stress reduction (MBSR) in people with Multiple Sclerosis (MS) in secondary care.

MS is an inherently stressful condition, and stress is thought to exacerbate MS. Mental health problems are common in MS, can impair quality of life, and lead to higher rates of suicide.

Prior research has shown that cognitive behavioural therapy (CBT) can help mitigate stress and diminish disease activity in MS, but effects are short-lived and there is thus a need to explore whether other psychological approaches might be more beneficial in this regard.

MBSR is another psychological stress reduction technique that is thought to operate differently to CBT, via cultivating a state of "meta-cognitive awareness" and has shown to be helpful when used in other long term conditions, such as chronic pain and anxiety, whilst Mindfulness-based cognitive therapy (MBCT - a derivative of MBSR) is effective in treating recurrent depression. All of these conditions are common in MS. However, mindfulness based interventions have not been well studied in MS.

The investigators propose to carry out a feasibility study to assess how acceptable and accessible MBSR is as a stress reduction technique in people with MS. The investigators would seek up to 50 participants who would then be randomly assigned to receive MBSR or their usual care. The investigators would seek measurements of health and wellbeing before, immediately following, and 3 months following the MBSR intervention. This would include basic demographic information (age, gender, ethnicity), measures of mental health, and physical health, as well as qualitative semi-structured interviews with selected participants. After this we would offer MBSR to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Having at baseline a Neurologist confirmed diagnosis of MS
* Can understand spoken and written English
* Score of less than or equal to 7 on the Expanded Disability Status Scale

Exclusion Criteria:

* Potentially life threatening physical or mental health comorbidities or conditions expected to significantly limit participation and adherence
* Current receipt of another form of psychological intervention (non-pharmacological)
INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)

The INCH-HD trial will test if incremental HD preserves the quality of life of patients and families and is a safe, practical, cost effective treatment option.

Kidney failure is a growing public health problem and fatal unless treated with dialysis or transplantation. Haemodialysis is the most common treatment for kidney failure in Australia and globally. Patients find haemodialysis extremely burdensome due to symptoms like fatigue, pain, cramps and poor quality of life that generally equates to \<60% of full health. Furthermore, haemodialysis is associated with an extremely high mortality (\<50% survive 5 years), particularly in the first 3-6 months of starting haemodialysis, which is likely linked to the rapid loss of patients' own kidney function when starting haemodialysis abruptly at three sessions/week. Observational studies suggest that starting haemodialysis incrementally at two sessions/ week is associated with lower mortality and better preservation of patients' remaining kidney function while offering many patient-important advantages, including dialysis free time and ability to work. However, robust evidence to recommend this incremental approach is lacking.

The INCH-HD study is an investigator-initiated, international, multicentre, prospective, adaptive, randomised, open-label, parallel group, non-inferiority trial. The primary objective of the study is to demonstrate whether incremental HD is non-inferior to conventional HD for the patient-important outcome of quality of life measured using Kidney-specific component of the Kidney Disease Quality of Life - Short Form measurement (KDQOL-SF) at 6 months from dialysis commencement.

The study will recruit a total of 372 participants across HD centres in Australia, and Canada. The outcomes of this trial will will provide urgently needed high quality evidence on whether starting haemodialysis incrementally at two sessions/week compared to the conventional three sessions/week can safely reduce the physical, financial and quality-of life burden on patients, lower early mortality rates and slow loss of kidney function while increasing haemodialysis capacity and reducing costs.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (≥ 18 years of age) and
2. Commencing HD as their initial dialysis therapy and
3. Able to give informed consent

Exclusion Criteria:

1. Urine output \<0.5Litres/day
2. Unlikely to be on HD for ≥1 year.
Efficiency and Safety of Prophylactic Use of Antibiotics in Endoscopic Injection of Tissue Adhesive in Gastric Varices

The purpose of the study is to assess the efficiency and safety of prophylactic use of antibiotics in endoscopic injection of tissue adhesive in gastric varices.

At present, there is still a controversy about the application of antibiotics in the treatment of patients with non acute hemorrhage of esophageal varices. This study is a randomized controlled trial. Patients randomly enter two treatment groups:

1. the prophylactic use of antibiotics group

   and
2. the non-prophylactic use of antibiotics group

Treatment allocation is by block randomization with an equal number for both groups. The incidence of infection after endoscopic treatment will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Capable of understanding the purpose and risks of the study and informed consent to participate in the study;
* age between 18-75 years old;
* Diagnosis of esophageal gastric varices by gastroscopy
* Preparation of endoscopic injection of tissue adhesive

Exclusion Criteria:

* No esophageal gastric varices bleeding history;
* Esophageal varices or gastric varices which temporarily won't be treated by endoscopic therapy;
* The cefotiam contraindications: such as allergies, pregnancy etc;
* Patients with the other malignant tumor except liver cancer;
* The preoperative diagnosis of infection;
* The large amount of ascites;
* The acute bleeding period (\< 5 days);
* Patients refused to participate in the study.
The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain

The findings from this project may result in pain reduction and improved mobility in pregnant women with pelvic girdle pain in their second and third trimester.

The primary objective of this unblinded randomized controlled trial is to determine whether superficial cryotherapy results in improved Numeric Pain Rating Scale (NPRS) scores among pregnant women with posterior pelvic girdle pain. The investigators hypothesize that superficial cryotherapy, in addition to receipt of an educational pamphlet, will result in improved NPRS scores compared to receipt of an educational pamphlet alone.

This study will include English-speaking pregnant women presenting to Loyola University Medical Center obstetrics or rehabilitation clinics in their second or third trimester with posterior pelvic girdle pain, defined as an NPRS score \> 2 onset within the past 3 months and pain experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the \[pubic\] symphysis. NPRS scores will be measured as a continuous, numerical integer ranging from a value of 0 (No pain) to a value of 10 (Worst possible pain).

Eligibility Criteria:
Inclusion Criteria:

* English speaking pregnant women presenting in their second or third trimester with acute posterior PGP (occurring within the last 3 months). Trimester will be determined from the date of last menses or ultrasound date.
* Current VAS pain score between 2-4
* Written informed consent

Exclusion Criteria:

* Non-English speaking pregnant women \<18 or \>50 years old
* Women presenting with low back pain, or posterior pelvic pain in the first trimester (\<13 weeks gestation).
* Women with acute low back pain in 2nd and 3rd trimester
* Women with anterior pelvic girdle pain (pubic symphysis) alone
* Chronic low back pain (current or past history, defined as \> 6 weeks of low back pain)
* History of lumbar or pelvic fracture; degenerative disc disease; neoplasm; inflammatory disease; active urogenital infection or active gastrointestinal illness; previous surgery of the lumbar spine, pelvic girdle, hip joint or femur
* History or signs of radiculopathy or other systemic neurologic disease
* Narcotic medication use
Assessing Consumer's Characterization of the Term Natural in a Food Context

The purpose of this project is to gain a better understanding of the underlying consumer motivations associated with choosing foods labeled as "natural"; and further, how the use of this term impacts the amount of food consumed.

This study is a randomized, 1-arm, parallel trial design focused on determining the types of food labels people associate with 'natural.' A planned sample size of 100 will be enrolled into the study. This study will require one initial screening visit and 1 Study Day. This study will take approximately 1 day to 1 week per subject to complete.

The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, and exercise habits.

If willing and eligible to participate, subjects will be invited to participate in the study for 1 Study Day that participants can choose to continue on to after the Screening visit.

Subject will arrive at the center in a fasted. During the Study Day, each participant will be asked to complete a health and mindfulness questionnaire. After completing the questionnaire, participants will be confronted with 7 bowls of granola, each with a different food label. The participant will be asked to choose the most natural granola to eat with the yogurt. After the participant chooses, the participant will then have a selected amount of time to consume the food and then after complete a debrief questionnaire regarding their intake choice. Subjects will be randomized to receive the food items labelled in different orders. The sequences of receiving the food items will be randomly assigned to one of sequences.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20-65 years' old
* Able to provide informed consent and comply with study procedures

Exclusion Criteria:

* Special dietary patterns that may interfere with study results
* Have allergies/intolerances to foods consumed in the study
* Have uncontrolled high blood pressure at screening visit
* Have uncontrolled elevated fasting blood glucose concentration at screening visit (≥126 mg/dL)
* History of eating disorder
* Planning to become pregnant, pregnant and/or breast-feeding
AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.


Eligibility Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the breast
* Subjects with early stage disease who are estrogen receptor positive and who have completed their treatment pathway (surgery, chemo-therapy, radiation, and/or hormone therapy) and are currently on or will initiate aromatase inhibitor therapy, and are expected to stay on aromatase inhibitor therapy for the duration of the 24-month study
* All treatment pathway must be completed ≥ 4 weeks prior to study entry, and all acute toxic effect of any above therapy must be resolved to ≤ Grade 1 by National Cancer Institution (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
* Female \> 18 years of age
* ECOG Performance status 0 and 1
* Lumbar spine, total hip or femoral neck BMD equivalent to a t-score classification of -1.0 to -2.5
* Subject is willing and able to provide signed consent before any study-specific procedure

Other criteria also apply.
Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia

To compare Bispectral index and entropy during maintenance of anesthesia

Several monitors are currently proposed to evaluate the depth of hypnosis. Among them, Bispectral Index (BIS) is a well known and widely used parameter derived from the patient's electroencephalograph (EEG). Spectral entropy relies on the extent of disorder in both EEG and electromyography (EMG) signals and returns 2 values: State Entropy (SE) and Response Entropy. SE is computed over the frequency range of 0.8-32 Hz and reflects the level of hypnosis while Response Entropy is computed over the frequency range of 0.8-47 Hz and reflects also EMG activity. BIS and SE are dimensionless numbers scaled from 100 to 0 for BIS and from 91 to 0 for SE.

The BIS and Entropy manufacturers claim that adequate level of anesthesia is defined by a BIS or SE value between 40 and 60. But some observations have shown that the monitors provided different information. These observations led us to carry out this prospective observational study designed to study the comparability between BIS and SE during the maintenance period of propofol-sufentanil anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years,
* American Society of Anesthesiologists physical status 1-3,
* surgery under general anesthesia using propofol, sufentanil, and a relaxant agent,
* surgery lasting more than one hour,
* tracheal extubation planned at end of surgery

Exclusion Criteria:

* pregnant women,
* allergy to propofol,
* neurological or muscular disorder,
* treatment with opioids or any psychoactive medication,
* cardiac surgery,
* thyroid disorder,
* emergency surgery,
* prone or lateral decubitus position (difficulty to have a correct probe position)
Obesity Treatment With a Very Low Energy Diet in Mexican Adults

Clinical practice guidelines recommend behavioral change protocols for obesity treatment, such as the Diabetes Prevention Program, which involves a low-energy diet, physical activity recommendations, behavioral therapy, and frequent visits. Weight losses of 7-9% per year have achieve with this type of intervention. However, evidence suggests that a very low-energy diet may reach 10-15% weight loss and conduce superior clinical effects. Therefore, the objective will be to evaluate the efficacy of the Diabetes Prevention Program with a very-low energy diet and a low-energy diet on body weight change at four months in Mexican adults with obesity. The study will be a randomized controlled trial. Participants will be randomized to an intensive lifestyle change program with a very low-energy diet or an intensive lifestyle change program with a low-energy diet. The primary outcome will be a change in body weight. Secondary outcomes will be changes in waist circumference, body mass index, total body fat, fat-free mass, abdominal fat, blood pressure, and quality of life. Data will be analyzed on an intention-to-treat (ITT) using Student's t-tests or Mann-Whitney's U-test. The protocol was performed following the SPIRIT guidelines. Ethical approval was obtained from the Research Ethics Committee of the Department of Medicine of the University of Sonora.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 and ≤55 years of age).
* Residents of the city of Hermosillo, Sonora.
* BMI ≥ 30 and ≤ 40.
* Availability of time to participate in the study, including initial and final measurements.
* Have a device with access to the internet
* Availability and possibility to acquire the indicated diet
* Send a report of food consumption for three days

Exclusion Criteria:

* Being a participant in a weight loss program.
* Weight loss major than 5% in the last six months.
* Have type 2 diabetes or hypertension (previous).
* Use of drugs with an effect on body weight ( steroids, injectable progestins, lithium, valproic acid, carbamazepine, antipsychotics, antidepressants, thiazolidinediones, levothyroxine, metformin, and anorexigenic drugs).
* Have a history of coronavirus disease with hospitalization or the presence of sequelae that prevent the intervention from being carried out.
* Have cancer, kidney disease, eating disorders, psychiatric disorder (depression) or other serious diseases, active biliary disease, or known asymptomatic gallstones.
* Pregnancy or breastfeeding.
* Use of medications for obesity.
* Use of illegal substances harmful to health (drugs).
* Illiteracy.
Cefepime and Unictam on Preventing Post-Cesarean Surgical Site Infections

the aim of this study is to evaluate the efficacy of employing cefepime (CFM) versus ampicillin/sulbactam (AMS) in lowering the rate of post-cesarean surgical site infections.

A prospective randomized clinical study conducted in the department of obstetrics and gynecology of Beni-Suef University Hospital . A total of 213 women were assessed for eligibility, 13 of which were excluded. A total of 200 pregnant women who were eligible for elective cesarean sections (CS). The overall median duration of postoperative followed up was from 10 days to one month to determine the surgical site infection (SSI).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women within age group more than18 years.
* Pregnant women with elective cesarean delivery.
* Previous and primary cesarean delivery.

Exclusion Criteria:

Severe hepatic disease women Emergent cesarean deliveries. Women with medical disorders as pre-gestational diabetes, anemia, hypertension, or preeclampsia.

Women who had a skin infection adjacent to the operative site.