cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Effects of Zemplar Injection and Calcijex on Intestinal Absorption of Calcium

A study to investigate the effects of Zemplar and Calcijex on intestinal calcium absorption in hemodialysis subjects.


Eligibility Criteria:
Inclusion Criteria

* Subject is ≥ 20 years of age.
* Subject is diagnosed with ESRD, and must be on maintenance hemodialysis (HD) three times a week for at least 2 months prior to the Screening Phase and expected to remain on HD for the duration of the study.
* If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:

  * Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
  * Contraceptives (oral or parenteral) for three months prior to study drug administration
  * In a monogamous relationship with a vasectomized partner
* If female, subject is not breastfeeding and has a negative serum pregnancy test prior to the treatment phase.
* Subject had an intact PTH value \> 200 pg/mL.
* Serum calcium level \< 10.2 mg/dL at Screening visit.
* Serum phosphorus level \< 6.5 mg/dL at Screening visit.
* Ca´P product ≤ 65 at Screening visit.
* Must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the conduct of any study-specific procedure

Exclusion Criteria

* Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
* Subject has chronic gastrointestinal disease, which in the Investigator's opinion, may result in clinically significant GI malabsorption.
* Liver function defects defined as \> 2 times the upper limit of normal for liver enzyme or \> 1.5 times the upper limit of normal coagulation levels.
* Subject is taking maintenance calcitonin, glucocorticoids in an equivalent dose \> 5 mg prednisone, or other drugs that may affect calcium or bone metabolism, other than females on stable (same dose and product for 3 months) estrogen and/or progestin therapy.
* For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive pharmacological doses of vitamin D.
* Subject has received any investigational drug within 4 weeks prior to the Treatment Phase.
Effectiveness of an Adventure-based Training Programme

This study tested the effectiveness of an adventure-based training programme in promoting the psychological well-being of primary schoolchildren. A randomised controlled trial was conducted, with 56 primary school pupils randomly assigned to the experimental group participating in the adventure-based training programme and 64 to the attention placebo control group.


Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese primary pupils from forms 5 and 6 of two schools were invited to participate in the study.

Exclusion Criteria:

* those with a chronic illness or identified cognitive and learning problems were excluded.
Comparison of the Effects of Trendelenburg Position and Passive Leg Lift on Hemodynamics in Abdominal Surgery Patients

How to maintain the stability of circulation during anesthesia has always been a concern of clinicians, including shorting the preoperative fasting time under the condition of full preoperative preparation, and giving appropriate amount of nutrient solution in combination with the patient's situation 2\~4 h before surgery to reduce the blood volume insufficiency of patients before general anesthesia induction, vasoactive drugs, etc. Among them, passive leg lifting experiment is widely recognized in the world. Although passive leg lifting has many advantages, it still has some limitations in the operation process. This study tried to find the corresponding head low and foot high Angle corresponding to the same hemodynamic changes caused by passive leg lifting.

For low head and high feet, studies have shown that 20° can reduce the incidence of hypotension during the induction period of general anesthesia in patients undergoing gastrectomy and has therapeutic effect on it, as well as reduce the use of vasoactive drugs during the induction period of general anesthesia. There were no perioperative complications.

The passive leg lift test can be repeated and does not overload the patient with fluid. However, there is no relevant research on the relationship between the two, which is exactly the innovation of this topic.

Eligibility Criteria:
Inclusion Criteria:

* Age 18\~75 years old
* Good image of TTE can be obtained
* Sedative mechanical ventilation （Vt 8～10ml/kg）
* Circulation was relatively stable before the experiment began
* There is no contraindication to rehydration

Exclusion Criteria:

* TTE acquisition is not ideal
* Patients did not agree to participate in the experiment
* Diseases of the central nervous system，patients with increased intracranial pressure
* Arrhythmia patients;
* Patients with increased intra-abdominal pressure;
* Bedridden patients;
* Patients with venous thrombosis of lower limbs;
* Patients with venous foreign body of lower limbs;
* Patients with circulatory instability;
* Patients with obstructive shock;
* Patients with moderate or above heart valve reflux
Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode

To evaluate the effectiveness of an algorithm for Bipolar Disorder depressive episodes (BDD) using medications available in the Brazilian Public Healthcare System (SUS). Quality of life assessment of these patients was also employed.

A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of episodes of bipolar disorder depression episodes.

The study design was that of a pragmatic randomized clinical trial to evaluate the effectiveness of treatments for mood disorders in a public healthcare context in the city of Porto Alegre, in southern Brazil. The algorithm was originally developed for the treatment of bipolar disorder depressive episodes by a Delphi panel of experts from psychiatric associations in Brazil. All subjects provided an informed consent form, in writing, in order to participate in the study protocol, which was approved by the institutional ethics committee.

Procedures and measurements of the study:

The subjects under evaluation were selected and they followed the stages defined by the treatment protocol:

1. Sample selection by being referred from the primary healthcare clinics in the municipality;
2. Informative talk about mood disorders and the research, with the informed consent forms being provided to the subjects;
3. Screening for unipolar depression episodes with the use of the Patient Health Questionnaire (PHQ-9), and Hypomanic Symptoms Checklist Brazilian Version (HCL -32-BV);
4. Diagnostic evaluation through the Mini International Neuropsychiatric Interview (MINI) and clinical interview for individuals with positive results in the screening instruments;
5. Baseline and demographic assessments using standardized semi-structured interviews in the first and second visits;
6. In each clinic visit, the severity of the symptoms were evealuated using the Clinical Global Impression Scale (CGI), Hamilton Rating Scale for Depression (HRSD), and Young Manic Rating Scale (YMRS);
7. Biweekly follow-up, changed to monthly after stabilization - with a maximum follow-up period of 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. ages between 18 and 65;
2. BD current acute mixed episode;
3. total capacity to understand and respond to self-applied instruments;
4. the presence of symptoms in the last 30 days;
5. abstinence for at least 30 days for drug addicts.

Exclusion Criteria:

1. presence of Organic Brain Syndrome (OBS);
2. pregnancy or lactation;
3. criteria for psychiatric hospitalization. -
Anxiolytic Effects of Socio-aesthetics in Cancer Patients Undergoing Chemotherapy

The purpose of the study is to assess the average of the "State Anxiety" score of the State Trait Inventory Anxiety at the end of the third cycle of chemotherapy compared to the pre-treatment score (inclusion)

As part of this study, patients will be seen 6 times for the purposes of the study: on inclusion, during the first four courses of chemotherapy and at the end of chemotherapy.

The study is offered to the patient during the consultation with the oncologist before the start of chemotherapy. It may possibly be proposed at the latest when he enters hospitalization for chemotherapy.

Two cohorts of patients will be included:

* Patients treated with chemotherapy every 21 days for lung, breast, digestive, colorectal or gynecological cancer;
* Patients treated with chemotherapy every 14 days for digestive or other cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patient with cancer treated with adjuvant chemotherapy with an interval of 14 or 21 days for the first 3 cycles;
* Chemotherapy naïve patient;
* Patient speaking and understanding French and able to complete the questionnaires;
* Patient having been informed and having signed an informed consent form to participate in the study.

Exclusion Criteria:

* Patient who has already benefited from socio-aesthetic care;
* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
* Patient unable to understand the information related to the study (linguistic, psychological, cognitive reasons, etc.);
* Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
* Patient not benefiting from a social security scheme.
Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension

The REQUIRE STUDY is a multi-center, randomized, double-blind, sham-controlled study, which aims to confirm the efficacy and safety of PRDS-001 (ReCor Medical Inc. Paradise in Europe) for renal denervation therapy in patients with treatment resistance hypertension, in comparison with the sham procedure.

Patients with treatment resistance hypertension is defined patients being treated on 3 or more different classes of antihypertensive medications including diuretics.

Eligibility Criteria:
Inclusion Criteria:

* average office systolic BP of 150 mmHg or greater or office diastolic BP of 90 mmHg or greater (both in the sitting position)
* 24-hr ambulatory BP 140 mmHg or greater.

Exclusion Criteria:

* Secondary hypertension (sleep apnoea can be included.)
* Type I diabetes or uncontrolled Type II diabetes with HbA1c 8.4% or greater
* Known or concurrent chronic active inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis etc.)
* eGFR\<40 mL/min/1.73m2 (per predictive equation Japanese Society of Nephrology)
* Known severe cardiovascular events within 3 months or severe cerebrovascular events
* Patients those who are planned to receive PCI or other operation for iscaemic cardiovascular disease within 8 months
* Concurrent persistent atrial fibrillation
* Patients those who are on active implantable medical devices
* Primary pulmonary hypertension
* Patients those who are contraindicated to, or confirmed to have intolerable anaphylactic reaction or uncontrollable allergy to contrast media
Video-Based Intervention in Reducing Anxiety in Patients Undergoing Lung Cancer Screening

This pilot trial studies a video-based intervention in reducing anxiety in patients undergoing lung cancer screening. Giving a video-based intervention to patients prior to lung cancer screening may reduce anxiety and improve the well-being and quality of life.

PRIMARY OBJECTIVES:

I. Test the feasibility and acceptability of the video-based intervention.

SECONDARY OBJECTIVES:

I. To describe incidence, degree, and duration of screen-related anxiety among individuals scheduled to undergo low-dose computed tomography (CT) scan (LDCT) for lung cancer screening (LCS).

II. To describe baseline patient characteristics and pre-screening anxiety levels.

III. To describe the preliminary outcomes on screen-related anxiety for patients both not in the intervention group and those in the intervention group.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I: Patients receive standard of care following LCS consisting of routine visits and telephone contact with the LCS program nurse practitioner and coordinator.

GROUP II: Patients undergo a video-based intervention prior to undergoing LCS. Patients watch a 5-minute video that focuses on preparing patients for LCS by providing information on the following: program team and contact information; reason to be screened; screening eligibility; how screening is performed; what to expect on the day of screening; what to expect after screening; what to expect if result is positive; what to expect if result is negative; and risks of screening. Patients also receive an educational handbook. Patients with positive scans (a Lung-Imaging Reporting and Data Systems \[RADS\] 3 or 4) receive additional brochure and nursing support within 1 week after notification of scan results.

After completion of LCS, patients are followed up at 1 week and then at 3 and 7 months.

Eligibility Criteria:
Inclusion Criteria:

* This study will be conducted in people scheduled to undergo baseline LDCT as part of the City of Hope (COH) LCS program
* There are no restrictions related to performance status and life expectancy
* All subjects must have the ability to understand and the willingness to participate in the informed consent process, although a waiver of written informed consent is obtained for this study

Exclusion Criteria:

* Patients who do not speak or read, because all intervention materials, including the video and written materials are in English
* Subjects, who in the opinion of the investigator, may not be able to comply with study procedures
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months

The purpose of this study is to determine if the risk of recurrent venous thromboembolism (VTE) after stopping therapy is low and acceptable in patients with a first unprovoked proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) who have completed 3 months of therapy and who have a negative D-dimer test on therapy and 1 month after stopping therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Be \>= 18 years of age
2. Have had ONE episode of unprovoked proximal DVT and/or PE
3. Have completed 3 uninterrupted months of warfarin therapy (target INR of 2.0-3.0)

Exclusion Criteria:

1. Another indication for long-term anticoagulation (e.g., atrial fibrillation)
2. A high risk of bleeding as evidenced by any of the following:

   * Age greater than 75 years
   * Previous episode of major bleeding where the cause was not effectively treated
   * Known chronic thrombocytopenia with a platelet count of less than 120,000 x 10\^9 /L
   * Known chronic renal impairment with a creatinine of more than 150 mumols /litre (1.7 mg/dl)
   * Known chronic liver disease with a total bilirubin of more than 25 mumols /litre (1.5 mg/dl)
   * Active peptic ulcer disease
   * Poor compliance with, or control of, anticoagulant therapy during initial treatment
   * Requires dual antiplatelet therapy (e.g. aspirin and clopidogrel)
3. A vena caval filter
4. Has had D-dimer testing performed within 2 months of potential enrollment other than for evaluation of suspected recurrent VTE that was not confirmed
5. Has a life expectancy less than 5 years
6. Is unable to attend follow-up visits because of geographic inaccessibility
7. Is participating in a competing clinical investigation
Effect of Consuming Beans for One Month on Blood Lipids, Satiety, Intake Regulation and Body Weight

This project investigates the effect of regular consumption of commercially available processed white beans (5 cups per week) on food intake, body weight, blood pressure, satiety hormones and glycemic response over a 4-week period. We have chosen to provide participants with canned white beans, the most accessible and frequently consumed bean in North America. They are inexpensive, a good source of high quality nutrients and ready to eat. Based upon published literature and short-term studies conducted in our laboratory, we hypothesize that regular consumption of commercially available canned beans will increase satiety and improve the control of food intake, body weight, blood glucose and blood lipids.

The metabolic syndrome is a clustering of chronic disease risk factors, including abdominal obesity, dyslipidemia, elevated blood pressure and elevated fasting blood glucose.

A main treatment for metabolic syndrome is lifestyle modification (alterations in diet and/or physical activity patterns) resulting in weight loss.

Beans are easily incorporated into the diet and may lead to the attainment and maintenance of healthy a body weight and improved metabolic control.

Canned baked navy beans (with tomato sauce) have a low glycemic response following consumption, however, whether this effect has long-term benefits on glycemic control requires further investigation.

OBJECTIVE

To determine the effect of consuming 5 cups per week of commercially available canned navy beans over 4 weeks on risk factors associated with the metabolic syndrome.

Subjects

Inclusion criteria: Men and women (n=16) between 35 and 55 years of age with a body mass index (BMI) of 27 to 40 kg/m2.

Exclusion criteria: smoking or any major surgery/medical condition within the last 6 months, use of medications that could interfere with the study outcomes, gastrointestinal, liver or kidney disease and women who were pregnant/lactating

Eligibility Criteria:
Inclusion Criteria:

* BMI 27-40 kg/m2

Exclusion Criteria:

* smokers and individuals who have prescribed medications over the past 6 months that could interfere with the study outcomes (i.e. statins, metformin). Breakfast skippers, those on a restricted energy diet or pregnant/lactating women
Association Between ALDH2 Gene Polymorphism and Atrial Fibrillation

This study is a case-control study. In this study, 2ml of vein blood samples were collected from patients with atrial fibrillation undergoing radiofrequency ablation and those in the control group who underwent electrophysiological examination alone and confirmed no arrhythmia. The purpose of this study is to identify the relationship between the aldehyde dehydrogenase 2 (ALDH2) gene polymorphism and susceptibility to atrial fibrillation, and to explore the relationship between the genotype of ALDH2 SNP and the prognosis of patients with atrial fibrillation undergoing radiofrequency ablation.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent;

  * Age 18-85 years old, gender is not limited; ③ Case group: patients with clinical diagnosis of atrial fibrillation who underwent radiofrequency ablation; control group: patients with no arrhythmia confirmed by electrophysiological examination; ④ Able to communicate well with investigators and comply with the entire trial requirements.

Exclusion Criteria:

* Those who cannot understand or refuse to sign the informed consent or follow-up; ②Pregnant women, mentally retarded, mental/cognitive insufficiency and other possible vulnerable groups
Saphenous Nerve Block vs. Femoral Nerve Block for Total Knee Arthroplasty

Currently, the regional anesthetic standard of care for total knee replacement surgery is combined spinal/epidural to provide long-lasting pain relief with or without a femoral nerve block (FNB). The femoral nerve block refers to a technique that your anesthesiologist can use to numb the thigh muscle for approximately 18 hours after surgery. While this technique offers significant pain relief, it is possible it may cause muscle weakness and increase patients' recovery times. Hence there is a need for an alterative anesthetic technique, one that may help minimize postoperative pain as effectively as a femoral nerve block, while not causing weakness of the thigh muscle.

The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it is hypothesized by "blocking" or anesthetizing the saphenous nerve with local anesthetic closer to where it branches off, the area around and below the knee will feel numb. Yet unlike the femoral nerve block, the thigh muscle itself will still be able to function.

For patients undergoing two total knee replacements at one time or bilateral total knee replacement, they will be randomly assigned to receive a femoral nerve block on one leg and a saphenous block on the other. Pain levels will be measured and thigh muscle strength will be tested using a dynamometer before surgery, 6-8 hours following anesthesia administration, and on postoperative days 1 and 2.


Eligibility Criteria:
Inclusion Criteria:

* All patients ages 40-80 undergoing Bilateral Total Knee Replacement
* Planned use of neuraxial anesthesia
* Ability to follow study protocol

Exclusion Criteria:

* Contraindication to a spinal or epidural anesthestic
* Not a candidate for bilateral total knee replacement
* Chronic opioid use (defined as daily or almost daily use of opioids for \>3 months)
* Hypersensitivity and/or allergy to local anesthetics
* Intraoperative use of any volatile anesthetic
* Patients with pre-existing neuropathy on the operative limb
* Contraindication to femoral nerve block or saphenous nerve block
* Allergy to any of the study medications
* American Society of Anesthesiologists (ASA) Class 4-5
* Non-English speaking patients
Non-invasive Imaging Technique for the Study of Lordosis in Pregnant Women and Its Relationship to Birth Outcome

The study consists of collecting measurement data of the rachis in pregnant women and the subsequent outcome of her delivery.

This will make it possible to validate a non-invasive imaging technique through software that can be used to study this anatomical curve proposing a new measurement method for the angle of lordosis.

Finally, with the research data, the investigators will try to find a correlation between these variables (angle of lordosis and delivery outcome.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women between 20 and 40 years old with a low-risk pregnancy

Exclusion Criteria:

* Pregnant women under 20 years and over 40 years of age or with a significant lumbar pathology or with a very high-risk pregnancy or with IMC \>35