cyrilzakka/clinical-trials huggingface dataset:
Randomised Controlled Trial of a Literacy Sensitive Decision Aid for Bowel Cancer Screening

The purpose of this study is to evaluate a decision aid (written information booklet designed to facilitate informed decision making) to help people aged 55-64 years, with low levels of education and literacy, make an informed choice about bowel cancer screening, using faecal occult blood testing.

Several countries have recently implemented national bowel cancer screening programs. To ensure equal access to screening, consumer information is needed to suit adults ranging in literacy level. Decision aids (DAs) are tools which have been developed to assist patients and consumers make informed health decisions and encourage active participation in health care decisions. Their use in a wide range of clinical settings has increased dramatically. However, most DAs are highly dependent upon high levels of literacy and numeracy, and few have been developed for low literacy populations.

This primary aims of this study are to assess the impact of the decision aid on (1) the proportion of adults who make an informed choice about bowel cancer screening (using faecal occult blood test) and, (2) the level of involvement in screening decisions among adults with lower levels of education and literacy.

There are three secondary aims of the study. First, to measure the effect of the decision support tool on decisional conflict, decision satisfaction, anxiety, and bowel cancer worry. Second, to identify participant's screening interest, intentions and behavior. Thirdly, we will explore participant's reactions towards the information materials they receive and whether the doctor influenced their screening decision.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 55-64 years
* Lower levels of education
* English as a main language spoken at home
* Average risk of bowel cancer

Exclusion Criteria:

* Higher levels of education
* Invitation to take part in bowel cancer screening in last two years
* Personal or strong family history of bowel cancer
* Had a bowel cancer screening test in the last two years
Effect of Exercise or Metformin on Nocturnal Blood Pressure and Other Risk Factors for CVD Among Obese Adolescents

The objective is to, among obese adolescents, study impact of regular physical activity or metformin therapy on nocturnal blood pressure and related cardiovascular disease risk factors.

Forty subjects will be assigned to the exercise intervention group, thirty to the metformin therapy group and thirty to the control group. Group I will be treated daily with metformin. Group II will perform exercise (endurance) three times/week with a personal coach and group III will serve as control. All participants will be examined at baseline, after 3 months of intervention, after 6 months of intervention and after one year of intervention. Examination includes anthropometric measures, measures of ambulatory 24-h blood pressure and insulin sensitivity, measures for function and structure of the heart and vessels, analysis of atherogenic factors in the blood, aerobic fitness testing and measurement of daily physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Age 13-19 years old at inclusion date
* Obesity according to gender and age specific BMI (Cole 2000)
* Reduced nocturnal systolic blood pressure fall (\< 10%)
* Signed informed consent by patient and parents

Exclusion Criteria:

* Cardiovascular disease
* Insulin dependent diabetes mellitus
* Patient on medications that are contraindicated during Metformin treatment
* Pregnancy
* Mental or physical conditions limiting the ability to participate
COX-2 Inhibitor With Concurrent Chemoradiation in Locally Advanced Head & Neck Carcinoma

chemotherapy- and radiotherapy-induced oral mucositis represents a therapeutic challenge frequently encountered in cancer patients.This side effect causes significant morbidity and may delay or interrupt the treatment plan, as well reduce therapeutic index. cyclo-oxygenase 2 (COX-2) is an inducible enzyme primarily expressed in inflamed tissues and tumor. COX-2 inhibitors have shown promise as radio- and chemosensitizer and reduce radio-induced toxicities.

we have conducted a phase III, randomized double blind clinical trial to evaluate the toxicity and efficacy of celecoxib, a selective COX-2 inhibitor, administered concurrently with chemotherapy, and radiation for locally advanced head and neck cancer.


Eligibility Criteria:
Inclusion Criteria:

* stage III/IV (locally advanced) carcinoma of oropharynx, oral cavity, hypopharynx, larynx, or nasopharynx
* primary treatment with chemoradiation

Exclusion Criteria:

* distant metastasis
* incomplete treatment
* adjuvant chemoradiation after surgery without apparent tumor
Phase II Study of High-Dose Cyclophosphamide in Patients With Severe Autoimmune Hematologic Disease

OBJECTIVES:

I. Determine the response rate and 1-year event-free survival in patients with severe autoimmune hematologic disease treated with high-dose cyclophosphamide.

PROTOCOL OUTLINE: Patients receive high-dose cyclophosphamide IV on days 1-4 and filgrastim (G-CSF) starting on day 10 and continuing until blood counts recover.

Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of severe autoimmune hematologic disease Autoimmune hemolytic anemia OR Immune thrombocytopenia
* Failure of at least 2 standard treatment approaches (e.g., prednisone therapy, splenectomy, intravenous immunoglobulin, or other immunosuppressants)
* Inability to taper prednisone dose to less than 10 mg/day OR Autoimmune neutropenia including the following: Felty's syndrome OR Disorders of large granular lymphocytes with recurrent infections or absolute neutrophil count less than 200/mm3

--Prior/Concurrent Therapy--

* See Disease Characteristics

--Patient Characteristics--

* Age: Not specified
* Performance status: Not specified
* Hematopoietic: See Disease Characteristics
* Hepatic: Not specified
* Renal: Creatinine no greater than 2.5 mg/dL
* Cardiovascular: Ejection fraction at least 40%
* Pulmonary: FVC, FEV1, or DLCO at least 50% predicted

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Not preterminal or moribund
Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord

The purpose of the Protocol is the prevention of pelvic pressure ulcers within a care network of SCI patients whose general organization refers to the medical literature and the recommendations of the ministerial circular of 18 June 2004. A conceptual framework for work (CFW) will be set up and semi-structured interviews will be conducted with patients and professionals. They will confirm or dismiss the CFW gradually with a refined coding As of domains and sub-domains of the skin preventing spinal cord injury related to the perceptions and behaviors of those involved in the sector. Quality control will be provided by experts in qualitative research and interviews will be stopped when the analyzes will further refine the domains and subdomains. A final framework will be validated to modulate our organization.


Eligibility Criteria:
Inclusion Criteria:

* - Paying patients:
* Spinal cord injured person from any level of injury and any post-traumatic period
* Age 18 to 65 years inclusive
* Person affiliated to the social security or receiving such a plan
* Main ambulation mode: Wheelchair
* Agreeing to participate in interviews

  -- Professional side:
* Medical and paramedical health professionals involved in the care sector or studied various professionals (administrators, insurers, ...) involved in the studied care sector
* Agreeing to participate in interviews

Exclusion Criteria:

* Minors or patients older than 65 years
* Person unable to consent
* Who do not speak the French language
* Person refusing to attend meetings
* Hospitalized person without consent
* Cognitive pathologies incompatible with interviews
* Main wandering mode of patients: walking
* Protected adults
Pharmacokinetics and Pharmacodynamics of Higenamine in Chinese Healthy Subjects

The purpose of this study is to assess the pharmacokinetics and pharmacodynamics of higenamine in healthy Chinese subjects


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all the following inclusion criteria to be eligible to participate in this study:

1. Chinese healthy adult males, female subjects (either gender the proportion of not less than 1 / 3).
2. Age: 19 to 45 (including 19, 45) years old.
3. Male body weight ≥ 50kg, female body weight ≥ 45kg, and body mass index within the normal range (weight (kg) / height 2 (m2) = 18-25).
4. Informed consent form is obtained.

Exclusion Criteria:

Subjects will be excluded from entry if any of the criteria listed below are met:

1. Presence or history of any disorder of cardiovascular system, respiratory system, digestive system, urogenital system, endocrine system, allergy / immune system, blood system, nervous / mental system, musculoskeletal system, skin diseases.
2. History of any drug hypersensitivity.
3. Female urine pregnancy test was positive.
4. Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and/or hepatitis C virus (HCV) antibodies.
5. Acute disease state or infection associated with prescription drugs within 1 month before study day 1.
6. Taking any drugs, including over-the-counter drugs and herbal supplements within 7 days before study day 1.
7. History of alcohol abuse (consuming greater than 14 glasses of alcoholic beverages each week, 1 glass is approximately equivalent to: beer 284 mL, wine 125 mL, or distilled spirits \[25 mL).
8. History of drug abuse.
9. Smoker or subjects quitting smoking less than 1 month before study day 1.
10. Participating other trials within 1 month before study day 1.
11. Donating blood (\> 400 mL) within 1 month before study day 1.
12. During screening, alcohol breath test result \> 0.000.
13. Systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg.
14. Heart rate was lower than 45 beats per minute (bpm) and/or higher than 90 bpm during rest.
15. The investigator thought the subjects might not be able to complete the study or comply with the requirements of the study (due to management reasons or other reasons).
Using Tailored Emails to Motivate Healthy Behavior Among Employees

The purpose of this research is to evaluate the efficacy of a multi-component email health promotion program on employee adoption of health promoting behaviors and secondarily on health status, work productivity and health care costs.

The Specific Aims are:

* To demonstrate the feasibility and assess the acceptability of email health promotion among diverse employee groups;
* To evaluate short and intermediate-term changes in health behaviors (e.g., daily fruit/vegetable intake, weekly physical activity) at 6 and 12 months;
* To assess change in health status (SF-12), work productivity, and healthcare costs among email program users and controls;
* To identify person predictors of sustained voluntary participation in a 6 month email health promotion program among the workforce population;
* To disseminate the results to maximize influence on e-health promotion, employer health promotion programs, health insurance policy, and research.

Eligibility Criteria:
Inclusion Criteria:

* Adult employee of participating worksite
* Access to desktop computer

Exclusion Criteria:

* Under 18 years of age
Expectation and Response to Levodopa and Acupuncture in Parkinson's Disease

To investigate how levodopa and acupuncture affect fatigue and muscle function in people who suffer from Parkinson's disease. Subjects may choose to participate in levodopa or acupuncture part, or both. Study procedures include an exercise protocol, transcranial magnetic stimulation (a non-invasive type of brain stimulation that cause small muscle twitch), a blood draw, and personality surveys.

Subjects will answer surveys, have their blood drawn, undergo TMS and perform an exercise. The TMS/exercise task will measure fatigue and muscle response. The surveys will describe personality and measure fatigue. The CTRC will do genotype studies on the blood to look for genetic differences. Each subject is eligible to receive both study treatment types (levodopa and acupuncture). Depending upon the study treatment type they choose, each subject will be randomly assigned to one of six possible subject groups:

Ia. Full expectancy; levodopa: Subjects will be told that they are taking levodopa.

Ib. Half expectancy; levodopa: Subjects will be told that they have 50% chance of receiving levodopa or placebo.

Ic. No expectancy; levodopa: Subjects will be told that they are receiving placebo levodopa.

IIa. Full expectancy; acupuncture: Subjects will be told that they are receiving real acupuncture.

IIb. Half expectancy; acupuncture: Subjects will be told that they have 50% chance of receiving real or sham-acupuncture.

IIc. No expectancy; acupuncture: Subjects will be told that they are receiving sham-acupuncture.

Subjects will attend four visits for the levodopa part and/or three visits in the acupuncture part. On the first visit, subjects will answer questionnaires and have samples of their blood collected. On the other visits, subjects will undergo TMS while they perform a repetitive exercise task. Subjects will then either wait for 30 minutes or receive the investigative intervention that they have been randomly assigned for that particular visit, and then repeat the TMS/exercise task.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Parkinson's disease
* Able to withdraw Parkinson's disease medication for 12 hours prior to a study visit
* Must be currently using levodopa to qualify for the levodopa part of the study

Exclusion Criteria:

* History of seizures
* Presence of any metal in the body, including DBS stimulators, pacemakers, metal plates or pins
* Severe cognitive deficits or psychosis
* Evidence of any clinically unstable disease, such as cancer, HIV/AIDS; unstable heart condition or other conditions that might require hospitalization
* Evidence of another neurological disease, such as multiple sclerosis, amyotrophic lateral sclerosis, or Huntington's disease
Exercise Training on Metabolic Syndrome Severity in Employees

Hypothesis: An occupational 6 months physical exercise training will lead to better health behaviour and improve the severity of the metabolic syndrome.

312 subjects will be assigned to either an intervention or a waiting-control-group. The intervention group will receive instructions with the aim to perform 150 min exercise training per week. Exercise consists of endurance, strength and coordination training. A feedback system guided by sports scientists will be installed for all subjects in the intervention group using activity monitoring (wearable). After 6 months training subjects from the intervention group will be assigned to one of the following groups for follow-up observation from month 6 to months 12:

* training with personal/individual feedback from sport scientist
* training with automated feedback using activity monitoring Tools (wearable)
* training without further feedback Subjects assigned to the control group will be provided with information on low intensity motion exercises. After 6 months in the control group subjects will be provided with the same exercise intervention as the intervention for a duration of 6 months.

Study visits will be conducted at month 0, month 6, month 12, and a long-term follow-up at month 24..


Eligibility Criteria:
Inclusion Criteria:

* 3 out of 5 parameters of the metabolic syndrome

Exclusion Criteria:

* ongoing participation in occupational health service
* clinical relevant acute or chronic infections
* pregnancy
* surgery dating back less than 8 weeks
* artificial joint replacement dating back less than 6 months
* tumor disease dating back less than 5 years
* every other disease or relevant functional disorder not allowing to participate in regular physical exercise
Effects of Specific Thoracic Spine Mobilizations on Muscle Activity in a Healthy Volunteer Population

In this study, the investigators will examine the effect of manual therapy on the thoracic spine and its impact on the muscular strength gain of the thoracic extensors. Treatment with manual therapy, as described by Maitland, consists of a specific mobilization of the thoracic spine in the postero-anterior direction on the transverse and spiny processes of the thoracic vertebrae. To ensure the relevance of the measures, and to better control the occurrence of biases inherent to the practice of manual therapy, the investigators constituted three distinct groups: an intervention group, a control group and a group without intervention. In short, this methodology will allow us to explore in detail the effects of specific spinal mobilization on motor control, while taking into account placebo response elements and natural variations in the results


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 65,
* healthy volunteer,
* membership in a social security scheme

Exclusion Criteria:

* Severe spinal trauma within the last 6 months
* history of low back pain, back pain, and/or neck pain within the last 6 months,
* history of spinal surgery,
* history of chronic systemic disease (cardiac, respiratory, diabetes, etc.),
* volunteer with Pacemaker, history of rheumatological pathology (rheumatoid arthritis, ankylosing spondylitis, Scheuermann's disease, etc.),
* patient under guardianship,curatorship, safeguard of justice, patient deprived of liberty, pregnant woman and patient without Red Flags Social Security described in literature.
Contraceptives Containing Drospirenone and Blood Pressure

Background: Drospirenone (DRSP) seems to have a favorable effect on blood pressure (BP); however, when associated with ethinylestradiol (EE), this effect does not seem to occur. This study has the objective to assess possible differences in BP associated with the use of COCs containing DRSP with different doses of ethinylestradiol.

Materials and methods: This open-label parallel-group randomized clinical trial involved women randomized to use either 30 mcg of EE+DRSP (n=22) or 20 mcg of EE+DRSP (n=22). Daytime, nighttime and 24-hour BP were evaluated by ambulatory blood pressure monitoring (ABPM) at the beginning of the trial and six months after drug therapy.


Eligibility Criteria:
Inclusion Criteria:

* sexually active women who did not wish to become pregnant,
* aged between 18 and 35,
* with menstrual cycles lasting between 24 and 32 days,
* body mass index (BMI) between 18.0 and 29.9 kg/m2

Exclusion Criteria:

* smoking,
* use of drugs and/or alcohol,
* clinical and/or laboratory signs of hyperandrogenism,
* use of hormonal contraception within six months before the initiation of the study,
* presence of chronic and/or acute inflammatory processes,
* use of medications with endothelial effects (e.g., statins),
* breastfeeding or having stopped breastfeeding within two months before the initiation of the study,
* medical conditions classified as category 3 or 4 according to the WHO medical eligibility criteria for contraceptive prescription
The Efficacy and Safety of Intradermal Acupuncture for Acute Herpes Zoster

Herpes zoster (HZ), also commonly known as shingles, is characterized by a bandlike rash in the dermatome that corresponds to the affected nerve. Pain is prevalent in HZ patients, which may be provoked by light touch. Postherpetic neuralgia (PHN) is one of the most common complications of HZ and it is generally intractable to treat.

At present, common treatment methods for HZ include anti-inflammatory, antiviral, analgesic, and neuroleptic regimens. Nevertheless, the application of these therapies can sometimes be limited by side effects. In this scenario, it is urgent to seek alternative non-pharmacological therapies for treating HZ.

Intradermal acupuncture (IDA) is a common type of acupuncture. By retaining the needles for a much longer duration than other common modalities of acupuncture, IDA can prolong the sustained effect of acupuncture. In addition, characterized by mild pain during the insertion of intradermal needles, IDA is more suitable for patients who fear conventional acupuncture and it is also easy to operate by practitioners. Therefore, concerning the treatment of pain conditions, such as acute HZ, it may have certain advantages over conventional acupuncture. Thus, The aim of this trial is to evaluate the efficacy and safety of IDA for acute HZ.

This randomized controlled trial will enroll 72 eligible patients with acute herpes zoster. Participants who are confirmed eligibility will be randomly allocated to either the IDA group or the sham IDA group in a 1:1 ratio. The duration of the trial will include two study phases, including a 1-month intervention phase and a 3-month follow-up phase.

Eligibility Criteria:
Inclusion Criteria:

1. Participants have confirmed diagnosis of herpes zoster;
2. Herpes zoster is in the acute stage and participants have not yet received antiviral treatment or analgesic treatment;
3. 18≤Age≤80 years, regardless of gender;
4. Significant pain with a visual analog scale (VAS) score ≥ 4;
5. Absence of other diseases causing skin temperature change;
6. Participants can understand the study procedure and agree to sign the informed consent form.

Exclusion Criteria:

1. Participants have some specific types of herpes zoster, such as disseminated herpes zoster; or herpes zoster is located on regions that are not suitable for intradermal acupuncture, such as the head, face, or perineum.
2. Pregnant or lactating subjects;
3. Participants have scar constitution or have severe cardiovascular, hepatic, renal, and hematopoietic system diseases that result in bleeding tendency, thereby making them unsuitable for intradermal acupuncture;
4. Participants with severe cognitive impairment who are unable to fully understand the trial protocol;
5. Participants are taking part in other trials.
Solo and Non-solo Approach for Laparoscopic Appendectomy (SOLOAP)

To determine the safety and feasibility of solo laparoscopic appendectomy, which is defined as the application of solo surgery to laparoscopic appendectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Laporoscopic appendectomy usually requires three surgeons, including an operator, a camera assistant, and other instrument assistant. Recent advancement of technology made it possible to develop the conveniently adjustable holders for camera and other laparoscopic instruments. The application of these instruments enables "solo-surgery" wherein an operation is driven by single surgeon. During surgery, human assistant(s) are helpful because of their instant assistance according to the operation's need. Therefore, the utilization of instruments instead of human assistants would be cumbersome. However, the utilization of instruments would be helpful by enabling operation-driven repositioning of the camera and instrument(s). Currently, no attempt has been made to objectively compare the merits and demerits of these two procedures. Therefore, this study was conducted to determine the safety and feasibility of solo laparoscopic appendectomy, which is defined as the application of solo surgery to laparoscopic appendectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Eligibility Criteria:
Inclusion Criteria:

1. The patients planned to undergo elective laparoscopic appendectomy
2. Benign gallbladder diseases requiring surgery
3. The patients who are indicated for single-port laparoscopic appendectomy.

Exclusion Criteria:

1. the patients with complicated cholecystitis
2. the patients with the gallbladder with a thickness more than 4mm.
3. the patients who are expected to have severe peritoneal adhesion.
4. the patients with malignant gallbladder diseases.
5. the patients whose operation appears to need human assistant(s)