cyrilzakka/clinical-trials huggingface dataset:
Tai Chi Versus Conventional Exercise to Alleviate Depression in Insomniacs

This study aims to examine the effectiveness of Tai Chi and conventional exercise in alleviating depressive symptoms in older insomniacs.

Chinese community-dwelling older adults with mild-to-moderate depressive symptoms and chronic insomnia will be recruited.

Eligible participants will be randomized to health education control, Tai Chi or conventional exercise interventions on a 1:1:1 basis after baseline assessment.

All interventions will last for 3 months. Outcomes will be assessed at baseline, at 3 months and at 6 months after the completion of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* 60 years or older
* Can communicate using Cantonese or Mandarin
* with mild-to-moderate depressive symptoms (HADS-depression score ≥8/21 and PHQ- 9 score ≤14/27)
* Fulfil the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for chronic insomnia including difficulties in initiating or maintaining sleep, early morning awakening with complaint of significant distress or impairment of daytime functioning, sleep difficulty occurring at least three nights per week and present for at least 3 months.

Exclusion Criteria:

* Somatic condition that prevents participation in tai chi or exercise
* Regular moderate-to-vigorous intensity exercise or mind-body training such as tai chi, yoga, qigong or meditation in the past 3 months
* Any form (or combination) of exercises amounting to 180 minutes per week in the past 3 months
* Dementia
* Diagnosis with schizophrenia or other psychotic disorders, bipolar disorders or alcohol/substance use/abuse
* Current usage or planning to use potentially confounding treatments, including herbal supplementations (e.g., St. John's Wort), acupuncture treatment, cognitive behavioral therapy or other psychotherapy, mind-body intervention (e.g., mindfulness training and muscle relaxation training) or muscle relaxants such as carisoprodol, cyclobenzaprine, diazepam
* Current suicidal or self-injurious potential that requires immediate clinical follow-up.
Single-centre, Randomised, Double-blind, Placebo-controlled, Four-way Crossover Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Doses of CM3.1-AC100 in Patients With Type 2 Diabetes

The primary objective of this study is to assess the safety and tolerability of the Glucagon-like peptide-1 (GLP-1) peptide analogue CM3.1-AC100 after single subcutaneous (sc) doses in patients with T2DM.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent prior to any study specific procedures
2. Type 2 diabetes mellitus patient, diagnostically confirmed since at least 6 months
3. Male or female patient aged 18 to 75 years at screening, both inclusive
4. BMI \>22 to ≤40 kg/m2 at screening

Exclusion Criteria:

1. Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, eg Cushings's syndrome and acromegaly
2. Fasting C-peptide \< 500 pM at screening
3. Acute gastrointestinal symptoms at the time of screening and/or Day -1
4. Any clinically relevant history or the presence of cardiovascular, bronchopulmonary, gastrointestinal or neurological diseases inclusive history of chronic pancreatitis or acute pancreatitis
Fear of Movement, Functionality and Quality of Life in Elite Athletes With an Ankle Instability History

Ankle sprain is frequently experienced by individuals participating in different sports activities. Ankle sprains have been shown to result in a decrease in level of physical activity and persistence of some symptoms for a long time. In this case, it is predicted that ankle sprains may affect the quality of life as well as functionality. Also, ankle sprain history may result in increased fear of movement, which may delay return to sports. This study aimed to examine the relationship between foot and ankle functionality, fear of movement and quality of life of elite athletes with a history of ankle sprain.


Eligibility Criteria:
Inclusion Criteria:

* No injury to the upper or lower extremities during data collection,
* Being older than 18 years of age,
* Individuals who volunteer to participate.

Exclusion Criteria:

. Having had ankle surgery,

* Has had an injury to his lower extremity in the last 3 months,
* Individuals with a history of neurological / neuropsychiatric disease or arthritis will be excluded from the study.
Molecular Characterization of Candida Auris

Candida auris is emerging fungal opportunistic pathogen in developing countries. Much studies has been conducted on Candida albicans. there was a dire need to investigate this alarming threat. Our hypothesis is that by recording the patients diagnosed with oropharygneal candidiasis and collecting clinical swab samples from these patients will be fruitful if microbiological isolation, identification and molecular characterization will be done. So this is the first study on C. auris in south punjab, Pakistan. Aim of this study is to collect epidemiological data of C. auris.


Eligibility Criteria:
Inclusion Criteria:

* Pre-diagnosed Patients of both gender from pre-selected localities

Exclusion Criteria:

* Healthy individuals or individuals having no oral fungal infection individuals above 100 years of age
Cross-Sectional Study of Oral Health in Patients After Parotid-Sparing Radiation Therapy for Head and Neck Cancer

The investigators are conducting research about oral health and saliva to find out more about the impact of radiation therapy on the oral health of patients.

In order to better understand the role of saliva in maintaining oral health in these patients, the investigators will be collecting, storing, and analyzing the quality of saliva, including the protein content, collected from patients following radiation therapy as well as saliva collected from normal healthy adults.

Radiation-induced xerostomia is the most common long term complication of head and neck radiation, is usually permanent and is the most frequent reason for reduced quality of life in these patients. The loss of antimicrobial, buffering, cleansing and remineralizing effects of saliva markedly increases the risk for dental caries. Extractions of diseased teeth located in irradiated bone and dental infection involving the bone can trigger osteoradionecrosis (ORN), another serious complication of high dose radiation of the jaws. Therefore, current dental treatment guidelines recommend the extraction of diseased teeth and any teeth that might require extraction in the future, before radiation therapy. (NCI, 1990; Rankin et al, 2003; NIDCR, 2005) As a result, patients with head and neck cancer often have many or all teeth extracted, especially those patients who are judged unlikely to comply with lifelong, daily topical fluoride, oral hygiene practices and frequent professional dental care. (Bruins et al, 1999)

Eligibility Criteria:
Inclusion Criteria:

* All subjects who have been enrolled in a parotid-sparing IMRT protocol for head and neck cancer at University of Michigan.
* At least 6 months has elapsed since the completion of RT, at the time of assessment for this study.
* All subjects must sign a University of Michigan Health System- IRB approved informed consent.
* Documented Karnofsky performance status \> 60
* These subjects will all have American Joint Committee on Cancer (AJCC) Stage III or Stage IV disease. (Green et al, 2001) (Appendix 2); non-metastatic, curable disease

Exclusion Criteria:

* History of surgical removal of major salivary gland(s).
* Patients edentulous prior to radiation therapy.
* Pregnancy or lactation
* Patients residing in prison.
* Age\< 18 years.
Urinary Leakage in the Indwelling Urinary Catheterization

In the indwelling urinary catheterization (IUC), urinary leakage may develop around the catheter in the following days of catheterization. The volume and type of fluid used to inflate the catheter balloon has the potential to be a factor in the development of this problem.

In this study, the investigators aimed to investigate the effect of the type and amount of fluid used in inflating the silicone foley catheter balloon on the development of urinary leakage around the catheter. In addition to purpose, the following questions were answered to determine the optimal solution type and volume in inflating the balloon:

* What was the incidence of urinary leakage in IUC?
* Was there a relationship between catheterization time and urine leakage?
* Was there a relationship between the type of fluid used to inflate the foley catheter balloon and urine leakage?
* Was there a relationship between the amount of fluid used to inflate the foley catheter balloon and urine leakage?


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years,
* Patients with indication for IUC (presence of order),
* Patients eligible for the use of a 18 Fr silicone foley catheter,
* Patients who did not have a problem that could affect prostate hypertrophy and/or urinary system miction.

Exclusion Criteria:

* In the study, if urine leakage occurred within 12 hours after catheterization, it was assumed that the leakage was caused by the size of the catheter, and these patients/patients were excluded from the study.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery

The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute moderate to severe post-operative pain after open abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients who are 18 years or older
* Patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted) under general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
* Post-surgical patients who have been admitted to the PACU and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery.

Exclusion Criteria:

* Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
* Patients with an allergy or hypersensitivity to opioids.
* Female patients who are pregnant or breast-feeding
Prebiotic Effects on Gut Microbiota, Gut Comfort and Immune Function

Human Milk Oligosaccharides (HMOs) are the third most abundant class of nutrients in human milk. Studies investigating the effects of dietary HMOs in infants have shown various health and developmental benefits such as the development of the early gut microbiome (by favouring colonisation of beneficial Bifidobacterium, Lactobacillus, and Bacteroides), the development of the immune system, general infant growth, protection against infectious diseases and allergies, and stimulation of cognitive development. Only a limited number of studies have been conducted in adults, showing intake of HMOs stimulates the growth of gut Bifidobacterium in healthy adults.

The current study aims to investigate the effects of a 4-week intervention with two HMOs on gut microbiome composition, immune function and gastrointestinal symptoms in healthy adults with mild to moderate gastrointestinal complaints. The study will be conducted as a partially decentralized, double-blind, randomized, placebo-controlled, parallel group design.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 and ≤ 55 years
* Male/female
* Total score of \>2 on the Gastrointestinal Symptom Rating Scale (GSRS)
* Body Mass Index 18-30 kg/m2
* Stable body weight (± 5%) for at least 6 months
* Stable lifestyle and dietary habits within the 4 weeks prior and during study period
* Owns device (computer, smartphone, tablet) with access to the internet
* Adequate fluency in the English language to understand the inform consent process, study instructions and study assessments
* Sufficient vision and hearing to complete study procedures
* Willing and able to participate, follow the study procedures and to give written informed consent

Exclusion Criteria:

* History (\< 6 months prior to the study) or presence of severe gastrointestinal, metabolic, immunological, psychiatric disorder, or major surgery
* Current or past (\< 4 weeks) use of prescription, over-the-counter, or traditional medication, or dietary supplements with a relevant impact on GI system or on visceral motility
* Having received antibiotic treatment \< 4 weeks prior to study
* Alcohol intake \>1 units/day
* Currently pregnant or pregnancy in past 6 months
* Use of pro/prebiotics \< 4 weeks prior to study start
* Fully vegetarian/vegan diet \< 4 weeks prior to study start
* High habitual vegetable and fruit intake (\> 2 servings of fruits and \>2 servings of vegetables per day) \< 4 weeks prior to study start
* Lactose intolerance
* Maltodextrin allergy
* Members of the research team or their immediate family members. Immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted
A Study of IW-6463 in Healthy Volunteers

Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects

Stage 2: To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 tablets administered orally to healthy subjects

Stage 3: To assess the safety and tolerability of a single dose of IW-6463 when administered to health subjects in fed vs fasted states and explore the effects of food on IW-6463 pharmacokinetics (PK)


Eligibility Criteria:
Inclusion Criteria:

* Subject is an ambulatory adult between 18 and 64 years old at the screening visit with the exception of the elderly cohort, who must be 65 years or older at the screening visit.
* Subject is in good health and has no clinically significant findings on physical examination
* Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 3 months after the final dose of study drug
* Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 3 months after the final dose of study drug
* Other inclusion criteria per protocol

Exclusion Criteria:

* Any active or unstable clinically significant medical condition
* Use of any prescribed or non-prescribed medication
* Other exclusion criteria per protocol
Comparision of Various Biomarkers Between Peripheral and Pulmonary Blood

Lung cancer is a leading cause of cancer death worldwide. Early diagnosis is linked to a better prognosis. Further, surgical resection at the early stages of non-small cell lung cancer (NSCLC) results in markedly improved survival rates. Computed tomography (CT)- or bronchoscopy-guided needle biopsies are standard definitive diagnostic procedures for lung cancer and are used to obtain tissue for pathological examination. However, these procedures are invasive, difficult to repeat, expensive, and risk exposure to radiation. Conversely, liquid biopsies, such as circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and extracellular vesicles (EVs), are simple and less invasive procedures that can be repeated more frequently than tissue biopsies.

This study is a retrospective blood sample obtained and prospectively comparative analysis of various biomarkers (cancer markers, and exosome markers) derived from peripheral blood and pulmonary venous blood from patients who underwent lung cancer surgery.

And treatment monitoring using biomarkers compare with peripheral and pulmonary blood.


Eligibility Criteria:
Inclusion Criteria:

* Adults with Korean nationality
* Patients who did not receive neoadjuvant therapy before surgery
* Patients not diagnosed with any other cancer before surgery
* Patients who agreed to the consent form for a donation of human materials during surgery

Exclusion Criteria:

* Patients who do not meet the inclusion criteria
Compound Xiwujia Granules Treat Chronic Fatigue Syndrome

To observe the improvement of Chalder scale score in patients with chronic fatigue syndrome treated by compound Ciwujia granules. Improvement =\[(baseline score - post-treatment score)/baseline score\]\*100%

After being informed of the study and potential risks, all subjects who have given informed consent undergo a 2-week screening period to determine eligibility, and on day 0, subjects who meet eligibility requirements will be randomly assigned in a double-blind way. The patients were treated with compound Xiwujia granules + Guipi granules/placebo (experimental group) and compound Xiwujia granules/placebo + Guipi granules (positive control group) at a ratio of 1:1 for 6 weeks. Compound Ciwujia granules/placebo 8g per bag, 2 times a day, 1 bag each time, Guipi granules, 3g per bag, taken with boiling water. 1 bag (3g) at a time, 3 times a day.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria of Western medicine for chronic fatigue syndrome;
* Meet the diagnostic criteria of spleen and kidney deficiency syndrome or heart and spleen deficiency syndrome of traditional Chinese medicine;
* Chalder scale score greater than 12 points;
* Age 18-70 years old, gender is not limited;
* Agree to participate in this clinical study, voluntarily sign informed consent, and agree to participate in visits, examinations, and treatments according to the requirements of the research protocol.

Exclusion Criteria:

* Combined with mental disorders such as severe anxiety and severe depression;
* Secondary fatigue caused by drugs or other reasons;
* Patients with serious primary diseases such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system, malignant tumors, and other serious complications; Abnormal liver and kidney function ALT, AST≥ 1.5 times the upper limit of normal value, Cr \> the upper limit of normal value;
* Women who are pregnant, breastfeeding or who may become pregnant in the study and cannot use effective contraception;
* Have received relevant treatment and may affect the observed effect indicators;
* Suspected to have a history of drug abuse or other patients who do not meet the eligibility criteria;
* Allergic physique and allergic to the drug;
* Uncontrolled hypertension (DBP \> 100mmHg or SBP \> 160 mmHg);
* Diabetic patients;
* Those that the researcher thinks are not suitable for participating in this study.
Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients

This pilot trial will test feasibility and acceptability of a primary care-based intervention that aims to increase the portion of patients who enter evidence-based behavioral weight loss treatment.

This trial is a pilot, pragmatic cluster randomized trial conducted in primary care clinics to determine intervention acceptability and the feasibility of proposed study protocol.

Eligibility Criteria:
Primary care provider Inclusion criteria:

* Employed by Duke PCRC clinic as primary care provider at least ½ FTE.
* Has a primary adult panel
* Has worked at Duke PCRC clinic for at least one year

Patient inclusion criteria

* BMI ≥ 30 kg/m2 as measured at any clinic in previous 12 months.
* English speaking
* Self-report BMI ≥ 29 kg/m2 (to allow for under-reporting)
* Regular email usage, defined as accessing email 3 or more times per week (on home or work computer or cell phone)
* Age 18-75
* Clinical appointment (well visit or chronic care visit) with enrolled Duke provider in 2-6 weeks of record review.
* At least one prior appointment with the provider they are scheduled to see at target clinical appt.
* Has a valid email address in electronic health records.

Patient exclusion criteria:

* In weight loss treatment program in past year
* Unable to read content on websites without any assistance
Procalcitonin and Brain Natriuretic Peptides in Patients With Chronic Kidney Disease.

The study is being conducted to determine if the blood test Brain Natriuretic Protein (BNP) can demonstrate the presence of extra fluid in patients with chronic kidney disease treated by hemodialysis. It will also try to determine the blood test Procalcitonin (PCT) can help identify the cause of the fever, specifically if a fever is caused by a bacterial infection. It will also evaluate whether new blood tests in the future (such as DNA, RNA, metabolite, and protein based tests) can be developed to help predict other complications in patients with chronic kidney disease treated by hemodialysis.

The study has three purposes:

1. To establish a procalcitonin (PCT) algorithm to assist in the identification of bacterial infection in patients with fever and chronic kidney disease (CKD) being treated by hemodialysis;
2. To establish an algorithm to assist clinicians in distinguishing infection from fluid overload in patients with CKD treated by hemodialysis with shortness of breath using PCT and brain natriuretic peptide (BNP);
3. To allow for evaluation of new tests, such as DNA, RNA, metabolite, and protein based tests, which might prove useful in the evaluation of clinical complications encountered by patients with chronic kidney disease treated by hemodialysis including infections and fluid overload.

Baseline Visit:

1. Review of medical and medication history
2. A physical exam and routine clinical laboratory tests (hematology and chemistry) will be performed.
3. PCT and BNP levels will be measured twice prior to hemodialysis (HD) treatment to establish baseline levels.
4. Optional: If the subject consent, samples will be obtained for genetic tests (DNA, RNA, metabolite and proteins) for new tests to be developed in the future.

Follow Up:

1. A physical exam, routine clinical laboratory tests (hematology and chemistry) and medical and medication review will be obtained monthly.

If a subject develops signs of infection or shortness of breath during the course of the study, additional research blood samples for procalcitonin, brain natriuretic peptide, and for genetic testing (Optional) will be obtained as follows:

1. For patients with suspected infection, PCT levels will be drawn at the time of suspected infection and again at the start of the next HD treatment.
2. For patients with shortness of breath, PCT and BNP levels will be drawn at the time of the complaint and again at the start of the next HD treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, 18 years and older.
2. Subject is receiving hemodialysis.
3. Able to provide informed consent.

Exclusion Criteria:

1. Subject is unable or unwilling to provide informed consent.
The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients

It's a prospective, non-interventional, observational Post-marketing Surveillance..

It's a prospective, non-interventional, observational Post-marketing Surveillance, the aim of the surveillance is to observe the safety and overall effectiveness of Latuda® in the treatment of Chinese patients with schizophrenia for 12 weeks in real clinical practice, as well as the dose of Latuda® for monotherapy or combination therapy.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia Patients who begin to receive Latuda®

Exclusion criteria:

* No exclusion criteria