cyrilzakka/clinical-trials huggingface dataset:
Dietary Polyphenols and Glycation in Renal Insufficiency

Type 2 diabetes mellitus (T2DM) is associated with an increased risk of kidney failure, with high levels of glycohaemoglobin (HbA1c) presenting a sharper decline in renal function and an increase in the risk of mortality and end-stage renal disease (ESRD). Polyphenols may improve renal insufficiency in patients with diabetes with chlorogenic acids (CGA) one of the principle polyphenol groups in the diet - coffee/tea, stone fruits (especially plums/prunes) and some vegetables (artichoke, chicory). CGA (3-4 cups of coffee) has been associated with 25% lower risk of T2DM and a favourable reduction of HbA1c, blood pressure, and oxidative stress levels. This randomised controlled trial, therefore, aims to evaluate the effect of high CGA food on glycation and oxidative stress in T2DM subjects with early renal insufficiency (glomerular filtration rate of 35-60 mL/min) as well as progression of renal insufficiency and the risk of cardiovascular diseases.

The study will have two phases - phase I, an interventional study of 3 months followed by phase II, an observational study of 21 months.

In phase I, subjects will be randomized into 2 groups: CGA-enriched diet group, or control (habitual) diet group. The treatment group will be provided with a chlorogenic acid-rich food (coffee) with instructions to achieve an intake of 400 mg per day (equivalent to 3-4 coffee cups per day) for 12 weeks. The control group will receive a conventional coffee low in chlorogenic acid.

Participants will attend three sessions during phase I; baseline, 6 weeks, and 12 weeks. At baseline, general information, medical history, dietary habits and medication use will be recorded and a Food Frequency Questionnaire completed. Urine and blood samples will be collected and blood pressure, waist circumference, height and weight recorded. Participants' diet over the previous 3 days will be assessed by estimated food diary analysis.

In phase II, written dietary recommendations will be provided at three time points (months 6, 12 and 24) - treatment group to achieve a CGA-rich diet (total polyphenol intake of at least 1g per day, and at least 400mg per day of CGA) and standard dietary advice for the control group. Anthropometric/dietary data will be collected as well as blood and urine samples to assess markers of renal function, glycation and oxidative stress, and proteomic markers of cardiovascular disease, coronary artery disease and diabetes.


Eligibility Criteria:
Inclusion Criteria:

* type 2 Diabetes Mellitus
* chronic renal insufficiency with persistent eGFR of 35-60mL/min for at least three months
* fluent in English

Exclusion Criteria:

* dialysis therapy (current or previous)
* malignancy
* transplant recipient
* hyperthyroidism
* hypothyroidism
* high dose glucocorticoids (≥250 mg)
* body mass index (BMI) ≥ 45 kg/m2
* special dietary requirements
* take creatine, antioxidants or vitamin supplements
* smoker
* pregnant
* consume \>4 cups of tea/coffee per day
* consume \>5 portion of fruits and vegetables per day
Feasibility Study Incorporating Lung Function Imaging Into Radiation Therapy for Lung Cancer Patients

The proposed study is in the field of thoracic radiation oncology where radiation therapy is used to treat lung cancer. The primary objective of the early phase clinical trial will be to evaluate the safety of performing functional avoidance radiation therapy for lung cancer patients using 4D computed tomography (4DCT) ventilation imaging.

This study plans to learn more about radiation therapy. Radiation therapy is one of the main treatments used to treat lung cancer. One of the known side effects of this radiation therapy is scarring of the lungs and reduced lung function that can result in shortness of breath. At this time the radiation treatment plan does not take into account differences in lung function between one part of the lung and another. Studies have shown that lung function can vary substantially throughout the lungs. This study aims to plan the radiation therapy to be away from the highest functioning portions of lungs while still delivering the intended radiation dose to the tumor. This study will allow researchers to determine whether taking lung function information into account when designing radiation treatment plans can protect lung function after radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of pathologically confirmed lung cancer by tumor biopsy and/or fine-need aspiration
2. Lung Cancer patients that will undergo definitive radiation therapy defined as 45-75 Gy as part of standard of care for their disease
3. 18 years of age or older
4. Signed informed consent
5. Planned curative intent chemotherapy, delivered concurrently or sequentially in combination with radiotherapy
6. The patient's 4DCT-ventilation image meets image heterogeneity criteria

Exclusion Criteria:

1. Patients receiving Stereotactic Body Radiation Therapy
2. Patient receiving palliative radiation therapy (defined as less than 45 Gy)
IMPACT-AML: Randomized Pragmatic Clinical Trial for Relapsed or Refractory AML

The primary objective is to evaluate the efficacy and toxicity of high versus low intensity therapy options in patients with refractory forms and early relapses of acute myeloid leukemia (R/R AML) who are scheduled for allogeneic hematopoietic stem cell transplantation (alloHSCT).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Primary refractory AML;
* Early relapsed AML;
* A signed informed consent to participate in the study.

Exclusion Criteria:

* Late relapsed AML;
* Isolated extramedullary relapse;
* MRD relapse without development of bone marrow relapse of AML;
* Acute promyelocytic leukemia;
* Previous refractoriness or loss of response during ongoing venetoclax therapy;
* Previous alloHSCT;
* Pregnancy and/or lactation period;
* Refusal of patients with preserved reproductive potential to use highly effective methods of contraception during the period of participation in the study;
* Lack of signed informed consent to participate in the study;
* Failure of the subject to follow the study protocol;
* Participation in any other clinical trial;
* Uncontrolled infectious complications;
* ECOG ≥ 3;
* History of other malignancies within the past 3 years, excluding squamous cell and basal cell skin cancers, carcinoma in situ of the cervix, breast, or other non-invasive malignancies, which, in the opinion of the investigator, are considered adequately treated and have a minimal risk of recurrence within 3 years;
* Chronic kidney disease with GFR ≤ 30 ml/min/1.73 m2 (according to the CKD-EPI Creatinine Equation);
* Severe cardiac pathology:

  1. uncontrolled arterial hypertension;
  2. stable angina III-IV functional classes;
  3. unstable angina and/or myocardial infarction less than 6 months before inclusion in the study;
  4. heart failure stages IIb-III, NYHA functional classes III-IV
  5. uncontrolled cardiac rhythm disturbances (≥ 2 grade CTCAE 5.0) or clinically significant ECG abnormalities.
* Cirrhosis classes B-C according to the Child-Pugh classification
* Increased liver function tests above the following values:

  1. Total bilirubin \> 1,5 above the normal range;
  2. AST, ALT \> 10 above the normal range.
* Major surgical interventions underwent less than 14 days before inclusion in the study.
Cytokine Profile of Allergic Bronchopulmonary Aspergillosis

The main aim of this study is to determine whether the levels of different inflammatory cytokines in the serum and BALF (bronchoalveolar lavage fluid) are relative to the severity and exacerbations of ABPA (allergic bronchopulmonary aspergillosis).

The study would record patients' medical data at baseline and follow them up for different period of time. Updated data would be recorded and blood( or BALF) of the patients would be drawn for tests or stored as whole blood or serum at -80℃ when patients visit the hospital. Then the cytokine (A panel set by the manufacturer) of the serum and BALF would be tested . The secretion ability of peripheral blood mononuclear cells would also be verified. The investigators would then analyze the data and see if any cytokine is relative to the exacerbation or other indicators of the severity of ABPA.

Eligibility Criteria:
For ABPA patients

Inclusion Criteria:

* Patients diagnosed as allergic bronchopulmonary aspergillosis (ABPA). The diagnosis criteria of ABPA is as following: clinical diagnosis of asthma, elevated total IgE levels (\> 1,000 IU/mL), presence of specific IgE against A fumigatus detected (\> 0.35 kUA/L) or type 1 skin reaction to Aspergillus antigen. Other criteria(at least two of three): Presence of serum IgG antibodies (precipitins) against A. fumigatus; Radiographic pulmonary opacities consistent with ABPA(It might be transient consolidation, nodules, finger-in-glove opacities. Or it could be permanent bronchiectasis and pleuropulmonary fibrosis) Patients who sighed consent forms.

For asthma patients:

Diagnosis according to GINA.

For healthy control:

People with ongoing chronic allergic disease such as allergic rhinitis, asthma and allergic dermatitis are excluded.

Exclusion Criteria:

* Patients who are unwilling to sign the consent form.
The Effect of Education on Self-Efficacy and Adaptation to Stoma of Individuals With Stoma

The aim of this study is to determine the effect of stoma care training given at home via videoconferencing after discharge on the self-efficacy and compliance with stoma of individuals with stoma. In addition to the main purpose, it is aimed to determine whether stoma care education given via video conference at home has an effect on individuals with stoma to perform their own stoma care.

After discharge, the individuals in the experimental group were given training by the researcher through training booklets prepared by the Association of Wound Ostomy Incontinence Nurses and video conference in four interviews. The first interview was done on the 5th day after discharge, the second on the 10th day, the third on the 15th day, and the fourth on the 2nd month. Individuals with stoma in the control group received the training routinely given in the hospital. Self-efficacy and compliance with stoma were measured at baseline and at 2 months. The ability to care for one's own stoma was evaluated at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Opening stoma for the first time,
* Stoma opening surgery Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, 3rd Floor Surgical Oncology Clinic,
* Whether the opened stoma is a colostomy or an ileostomy,
* Able to speak and understand Turkish,
* be over 18 years old,
* Not having any mental problems that prevent them from being trained and practiced on stoma care,
* Not having an obstacle to performing stoma care on their own in terms of vision, hearing and motor skills,
* Possibility of meeting via video conference,
* He voluntarily agrees to participate in the research.

Exclusion Criteria:

* Previous stoma opening experience,
* Not being discharged within 10 days after the operation,
* Refusal to participate in the study.
To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain

This was a single-center, randomized, open-label, controlled exploratory study conducted in Chinese patients. The study planned to enroll Chinese patients to evaluate the efficacy and safety of tegileridine and oliceridine injection in the treatment of postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

1. Accept elective laparoscopic combined thoracic surgery under general anesthesia, surgery time ≥ 1 h;
2. 18 years old ≤ age ≤70 years old, regardless of gender;
3. 18 kg/m2≤BMI≤30 kg/m2;
4. American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ;
5. Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;
6. Before starting trial-related activities, participants should voluntarily sign the informed consent form, fully understand the purpose and significance of this trial, and voluntarily abide by the trial procedures.

Exclusion Criteria:

1. Patients with a previous history of difficult airway (obstructive sleep apnea syndrome), severe respiratory depression such as oxygen saturation \< 90%, or a history of acute or severe bronchial asthma;
2. Patients with a history of severe cardiovascular and cerebrovascular diseases (such as myocardial infarction or unstable angina pectoris, or severe arrhythmia such as atrioventricular block of degree Ⅱ or above, or ischemic stroke in NYHA class Ⅱ or above);
3. Known or suspected gastric bowel obstruction, including paralytic ileus patients;
4. Patients with allergy to opioids or any component of the trial drug;
5. Subjects with previous psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive impairment;
6. With late-stage malignant tumors or with extensive metastasis of malignant tumor patients;
7. Subjects with other somatic pain that may affect postoperative pain assessment;
8. A history of drug, drug, and/or alcohol abuse within 1 year before randomization;
9. Pregnant or lactating female subjects;
10. Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
Safety and Effectiveness of Three Anti-HIV Drugs Combined in One Pill (Trizivir)

The purpose of this study is to look at the safety and effectiveness of a pill called Trizivir that is a combination of three anti-HIV drugs (zidovudine, lamivudine, and abacavir). Zidovudine and lamivudine are often given combined in one pill (Combivir). In this study, Trizivir will be compared to Combivir plus abacavir.

Patients are randomized to receive either the triple combination tablet (Trizivir) or to receive Combivir plus abacavir as a separate tablet. Patients take their study medications for 24 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are at least 18 years old.
* Are HIV-positive.
* Are currently receiving one of the following anti-HIV drug combinations: Combivir plus abacavir, Combivir plus abacavir plus a protease inhibitor, or Combivir plus abacavir plus a non-nucleoside reverse transcriptase inhibitor (NNRTI). Patients must have been taking this drug combination for at least the past 16 weeks. This also must be the first anti-HIV drug combination the patient has received.
* Have a viral load (level of HIV in the blood) less than or equal to 400 copies/ml.
* Have CD4+ cell count greater than 200 cells/mm3.
* Agree to use effective methods of birth control.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have been diagnosed with AIDS.
* Have a gastrointestinal disorder that makes it difficult for patients to absorb food or to take medications by mouth.
* Have hepatitis.
* Have a serious medical condition, such as diabetes, congestive heart failure, or other heart disease.
* Are allergic to any of the study drugs.
* Abuse alcohol or drugs.
* Will not be available for the entire 24-week study period.
* Are pregnant or breast-feeding.
* Have taken or will need to take certain medications, including radiation therapy, chemotherapy, drugs that affect the immune system (such as interleukin), an HIV vaccine, foscarnet, and hydroxyurea.
* Are enrolled in another experimental drug study.
Behavior Therapy for Irritability in Autism

This is a clinical trial of a novel intervention, Behavioral Therapy for Irritability and Aggression (BTIA), for adolescents on the autism spectrum. The main goals of BTIA are to help adolescents develop emotion regulation skills to handle frustration and to strengthen skills for navigating the challenging and diverse experiences associated with the transition to adulthood. The study will test whether BTIA can be helpful to adolescents on the autism spectrum and to their families.

This is a randomized controlled study of BTIA versus a supportive therapy control condition in 126 adolescents (ages 12 to 18 years) with a diagnosis of autism spectrum disorder and significant levels of disruptive behaviors such as aggression, anger outbursts, and oppositional behavior. BTIA consists of 15 ninety-minute weekly sessions that will be conducted with the teens and their parents by therapists using a structured, detailed manual. The effects of BTIA on the reduction of behavioral problems will be rated by an experienced clinician who does not know which treatment each participant is receiving (a "blinded" evaluator). Study participants will receive a thorough diagnostic assessment of autism spectrum disorder and other forms of psychopathology that may co-occur with ASD. In addition to testing the effects of BTIA on disruptive behavior, the changes in adaptive functioning, or children's ability to function competently in their everyday environment, will be examined before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls, ages 12 to 18 years inclusive
* Diagnosis of autism spectrum disorder
* Presence of disruptive behaviors such as irritability and anger outbursts
* No planned changes in the intensity of current treatment(s)
* Medication free or on stable medication
* Sufficient language for participation in verbal therapy
* Lives within driving distance from New Haven, CT

Exclusion Criteria:

* Presence of a medical condition that would interfere with participation in the study
* Presence of a current psychiatric disorder that requires immediate clinical attention
Stress-Reactivity and Cannabis Use in Cannabis-Using Older Adults

The goal of the study is to evaluate how cannabis use affects memory and thinking skills and response to stress in older adults. The study will also relate cannabis use to Alzheimer's Disease (AD) biomarkers (measurable substances in blood that indicate condition), and test whether sex and hormones play a role in these effects. The study is recruiting adults between the ages of 50 and 80 who use cannabis products on a regular basis. Study participation will last about two weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-80.
* Women must be \>1 year post-menopausal.
* English as a first/primary language.
* Functional visual and auditory acuity (aided or unaided) to complete tests.
* Capacity to independently provide informed consent and function at an intellectual level sufficient to allow completion of all instruments.
* Currently meets DSM-5 criteria for CUD or uses cannabis at least 4 days per week
* Consent to abstain from alcohol and cannabis use for \>12 hours prior to Study Visit (Day 0), and TSST (Day 8).
* Consent to abstain from all drugs other than cannabis or nicotine for the duration of the study.

Exclusion Criteria:

* Meet DSM-5 criteria for moderate or severe alcohol or substance use disorder (other than nicotine or cannabis) within the last 12 months.
* History of major neurocognitive disorder or developmental disorder per DSM-5.
* A Telephone Interview for Cognitive Status (TICS) score of less than or equal to 22.
* Significant or unstable medical condition/s that impact cognition as deemed by study investigators, such as active significant cardiac, cerebrovascular, neoplastic, infectious, or metabolic disease, or longstanding and intractable severe mental illness (e.g. schizophrenia spectrum disorder, bipolar disorder).
* Daily use of medications that adversely impact cognition in aging (i.e. anticholinergics and sedatives).
* Current suicidal or homicidal ideation/risk.
* Unable to complete/comply with procedures or pose threat to research staff.
* Standard MRI contraindications (e.g., implants, claustrophobia).
* Women who are pregnant, nursing, or of childbearing potential and not practicing and effective means of birth control.
Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-Stage Surgery

The primary objective of the study is to evaluate the long-term survival rate of implants and prostheses when treating totally edentulous upper jaws with Fixture MicroThread (Micro-Macro) using a one-stage surgical procedure.

Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age
* Sufficient amount of bone to give good support for implants of at least 9 mm length.
* Willing to give signed informed consent

Exclusion Criteria:

* Any systemic disease or condition that would compromise post-operative healing and/or osseointegration
* Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* Unable or unwilling to return for follow-up visits
Adenoma Detection Rate With Position Change at Colonoscopy

The hypothesis to be tested is that position changes during the withdrawal phase of colonoscopy leads to a higher adenoma (polyp) detection rate because of better distension of the colon. Since adenomas are precancerous lesions the enhanced adenoma detection will increase the success of colorectal cancer screening programmes. This study will provide evidence for the value of position changes and encourage endoscopist to adopt position change as a routine in their practice.

May 2007: protocol amendment to include additional prospective analysis using High Definition TV (HDTV).

Colorectal cancer is the second commonest cause of cancer death. In a majority of cases it is preceded by a precancerous lesion called an adenoma (commonly known as polyp). Detection and removal of adenomas at colonoscopy has been shown to reduce mortality from colorectal cancer. The success of the impending colorectal cancer screening programme to reduce cancer mortality in an average-risk population depends on optimal adenoma detection at colonoscopy. The detection of adenomas has been shown to vary between different endoscopist. Some of the factors that have been reported to affect adenoma detection rates included the time spent viewing, the adequacy of the bowel preparation and the time spent cleaning the colonic mucosa of excess fluid. Careful examination of proximal side of flexures, folds and valves by the endoscopist is equally important. However, even with careful examination adenoma detection rates have been shown to vary between endoscopist from 8.6% to 15.9%. Previous experience and training may be contributed to this difference. Some endoscopist adopt regular changes in position during the procedure to maximize distension of the colon. Better luminal distension enhances mucosal views for detection of the smaller adenomas. The validity of this approach has never been tested and we propose that this factor may contribute to the differences in adenoma detection rates.

Patients will be randomised to either position 1 first then position 2 or vice versa and examined twice. During one withdrawal the colon will be examined with the participant in the left lateral position only (position 1) or with position changes (position 2)or vice versa.

May 2007: protocol amendment to include additional prospective analysis using High Definition TV (HDTV). No further patient data collection involved.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred ot colonoscopy, age between 50 - 70 years

Exclusion Criteria:

* Patients with colorectal cancer, previous colonic surgery, active colitis and musculoskeletal problems Patients may also be excluded after the first insertion, if painful, routine care will proceed