cyrilzakka/clinical-trials huggingface dataset:
ASAP Study - Hospital-Based Brief Intervention for Alcohol Problems

The objective of this project was to test whether screening and brief intervention for unhealthy alcohol use leads to improved alcohol-related outcomes (such as alcohol consumption and linkage to alcohol assistance) and is cost-effective.

In this study the effectiveness and cost-effectiveness of brief intervention for unhealthy alcohol use in a diverse group of hospitalized medical patients was tested.

We conducted a randomized trial of medical inpatients with the whole spectrum of alcohol problems from risky use through dependence. Subjects in one group received standard care; subjects in the second group received a brief motivational intervention tailored to the severity of his or her alcohol problem. Primary outcomes are alcohol consumption and linkage to alcohol treatment. Additional outcomes include health-related quality of life, health care utilization, alcohol problems, and readiness to change. Costs, and clinical outcomes measured in quality-adjusted life years, a standard metric that allows comparison to other chronic illnesses, will be compared in a cost-effectiveness analysis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Fluent in English or Spanish
* Consume risky amounts of alcohol
* Provide 2 contacts to assist with follow-up
* Have no plans to move from the local area within a year of screening
* Score \>21 on Mini-Mental State Examination (no serious cognitive impairment)
Radiofrequency Ablation of Lung Tumors

Radiofrequency ablation has achieved impressive results in the treatment of unresectable primary and metastatic liver cancer. Animal studies have demonstrated that radiofrequency can fully ablate lung tumors in animal models. We set up a prospective study to evaluate the local efficacy of radiofrequency ablation of lung neoplasms. The aim of the study is to prospectively evaluate local efficacy with a minimal follow-up of one year, tolerance, lung disease-free survival and survival after radiofrequency ablation of lung tumors (primary lung cancer or lung metastases).

Radiofrequency (RF) ablation has achieved impressive results in the treatment of unresectable primary and metastatic liver cancer. Animal studies have demonstrated that RF can fully ablate lung tumors in animal models. We set up a prospective study to evaluate the local efficacy of radiofrequency ablation of lung neoplasms with a minimal follow-up of one year. The primary endpoint was to determine the rate of incomplete local treatment at 1 year. The secondary endpoints were to evaluate tolerance, survival, disease-free survival and lung tumor-free survival. Patients are followed-up by CT scan examination at day 1 or 2 before discharge from the hospital, then at 2, 4, 6, 9 and 12 months and then at 2 years

Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral unresectable primary or metastatic lung tumors \<= 40 mm and a number of tumor \<=5
* Tumors located more than 1 cm from the hilum, and not involving soft tissues or mediastinum.
* Malignancy histologically proven for pulmonary nodules in patients with no history of cancer outside the lung.
* Lung tumors in patients with a known distant cancer history, has to be either histologically proven or a demonstrated change in size of at least 25% in their largest diameter is required on CT during the previous year
* Pretreatment imaging work-up within 4 weeks of scheduled RF ablation (at least a chest CT and an abdomino-pelvic CT)
* If a tumor is found outside the lung, it has to be amenable to complete eradication with RF or RF plus surgery
* Lung spirometry within 4 weeks of treatment with a FEV1 \>= 1 liter
* Written informed consent.

Exclusion Criteria:

* Uncorrectable coagulopathy with a prothrombin time greater than 1.5 and a platelet count below 106/mm3
Quality of Life and Quality of Sleep Studies in Children with Home Care Ventilation in the West of France

Home ventilation in children, invasive or non invasiv,e is an interesting treatment for different disease which cause chronic respiratory impairement. The aim of this treatment is to support alveolar hypoventilation. Concerned diseases are : neuro-muscular disease, upper airways pathologies, whest wall or lung pathologies, central control ventilation disease. Prevalence of home children ventilation is in augmentation in France. The last national study in 2021 about infants show a prevalence of 9.3/100 000. Advantages with home children ventilation in addition of improvement of survey, it can observe improvement of quality of life and improvement of the quality of their sleep. Quality of life is a thematic less studying. Last studies show an impairment of quality of life in all thematics compare to children with no disease but also with infants whith chronic diseases. This study were about few numbers of patients. The aim of this study is to evaluate the quality of life and the quality of sleep in children with home ventilation to complete the actual littérature to improve the respiratory care of this population.


Eligibility Criteria:
Inclusion Criteria:

* Child aged 6 months to 17 years treated with non-invasive ventilation at home for at least 1 month
* Follow-up in one of the five centers participating in the study (Angers, Nantes, Le Mans, Rennes and Brest)
* Informed consent form signed by both parents, or holder of parental authority, for the participation of their child
* To be affiliated or beneficiary of social security

Exclusion Criteria:

* Parents with poor command of the French language, implying not being able to complete the various questionnaires
* Refusal of the child to participate in the study
Cyproheptadine and Chlorpromazine Effects on Spasticity

The main goal of this research is to understand the neuronal mechanisms that mediate the development of spasticity and motor dysfunction after spinal cord injury. The investigators examine how neurons and neuronal circuits in an injured nervous system adapt to produce the uncontrolled and unwanted muscle contractions that affect the majority (80%) of patients with spinal cord injury. One of the neurons that the investigators study is the motoneuron that excites the muscles of the limbs to produce movement. Previously, the investigators have shown that after spinal cord injury, the excessive and uncontrolled activity of motoneurons during muscle spasms is mediated, in large part, by the activation of calcium currents in the human motoneuron. In human patients the investigators have used recordings from single muscle fibres to estimate the contribution of these calcium currents in activating the motoneuron during muscle spasms. In this proposal, the investigators study why motoneurons recover these calcium currents and self-sustained activity after chronic spinal cord injury. Because the calcium currents require the presence of the monoamine serotonin (5HT) to activate, and this monoamine is greatly reduced after injury, the investigators examine if the calcium currents recover because the 5HT receptors become spontaneously active without the need for 5HT to bind to the receptor, which the investigators hypothesize to be one of the causes of spasticity after spinal cord injury. This research will pave the way to develop new pharmacological and rehabilitative therapies to both control spasticity after spinal cord injury and augment residual motor movements.


Eligibility Criteria:
Inclusion Criteria:

Patients must have suffered a trauma to the spinal cord at least 6 months ago or longer. In addition, subjects must exhibit some degree of spasticity as determined by having an Ashworth Spasticity Score, as assessed by a physical therapist, greater than 1.

Exclusion Criteria:

* If patients have damage to the nervous system other than to the spinal cord
* Pregnant women
* Elderly Patients and debilitated patients
* Alcoholic Patients
* Patients with:

  * Known or suspected allergy to the medication or its ingredients
  * Cardiovascular disease
  * Hypotension
  * Coronary artery disease
  * Reduced liver or kidney function
  * Comatose or depressed states due to CNS depressants
  * Blood dyscrasias
  * Bone marrow depression
  * History of seizures
  * Respiratory problems
  * Hypocalcemia
  * Monoamine oxidase inhibitor therapy
  * Angle-closure glaucoma
  * Stenosing peptic ulcer
  * Symptomatic prostatic hypertrophy
  * Bladder neck obstruction
  * Pyloroduodenal obstruction
  * History of bronchial asthma
  * Increased intraocular pressure
  * Hyperthyroidism
  * Cardiovascular disease
  * Hypertension
* Patients taking:

  * Amphetamines
  * Antihistamines-second generation
  * Anticonvulsants
  * Anticholinergics
  * CNS depressants
  * Antidepressants
  * Hypotensive agents
  * Levodopa
  * Lithium
The Effectiveness and Mechanism Study of Auricular Needling in Treating Cancer Induced Anorexia

Controlling of cancer induced anorexia is highly demanded by advanced cancer patients. It plays an important role in improving the quality of life among advanced cancer patients. Through a randomized controlled single blinded clinical research, we will observe the differences of appetite, food intake amount, weight and KPS between the auricular needling treating group and control group before and after the treatment. Based on the results of the research, we can prove the clinical effectiveness of auricular needling in treating cancer induced anorexia and possible mechanism of the method.

Patients will be recruited from Xiyuan Hospital. In this study, eligible participants will be randomly assigned to two groups. In the auricular needling treating group, patients will receive needling treating for 4 weeks(auricular needles are given to one ear every time for 2-3days,then switch to the other). Conventional nutrition support and symptomatic treatment are given at the same time. In the control group, patient just receive conventional nutrition support and symptomatic treatment.

The simple appetite questionnaire, a symptom based Anorexia assessment questionnaire and fatigue symptom inventory questionnaire are used to assess the condition of patients. Other observation index include weight, KPS, appetite and the expectation of patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of malignant cancer of stage III or IV
* Meet the diagnosis criteria of cancer induced anorexia
* Karnofsky performance status(KPS) score≥ 60
* Expected survival time≥3 months
* Willing to give informed consent
* Able to comply with trial protocol

Exclusion Criteria:

* have blood routine, hepatic and renal disfunction,which is over 2 times of the normal value
* obvious eating disorder, intestinal obstruction, poor controlled heart disease and diabetes
* who are receiving progesterone, glucocorticoid or other hormone Therapy
* those who are participating in other trials.
* pregnant women, nursing mother or psychotic patients
Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children

Glucomannan (GNN), a water-soluble dietary fiber derived from the plant Amorphophallus konjac, is marketed for weight reduction. The exact mechanisms by which GNN might exert its actions are unclear. Nonetheless, it has been shown that GNN slows gastric emptying by forming a viscous gel of large volume, which increases the feeling of satiety. Current evidence on the effectiveness of GNN for weight reduction is sparse, and well-designed trials performed in children are needed to assess the efficacy of this modality. We aim to systematically evaluate the efficacy of GNN consumption for the management of overweight and obesity in children.

Methods and analysis

Children aged 6 to 17 years with overweight and obesity (based on the WHO growth criteria) will be randomly assigned to receive GNN or placebo (maltodextrin) (both at a dose of 3 g/day) for 3 months and will be followed up for 3 months. Prior to the intervention, all children will receive dietetic advice, and they will be encouraged to engage in physical activity. The primary outcome measure will be the BMI-for-age z-score difference between the groups at the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* age 6-17 years;
* overweight or obesity based on the WHO (World Health Organization) growth charts/references (\>+1 standard deviation \[SD\] or \>+2 SD, respectively)

Exclusion Criteria:

* drug therapy for a chronic disease (including drugs that influence appetite or body weight);
* type 1 or 2 diabetes;
* history of surgical treatment of obesity;
* participation in another program for treating obesity during the project and/or 3 months prior to recruitment;
* secondary causes of obesity;
* pregnancy.
The Effect of Nursing Care With Peri-Natal Loss

This study was planned to evaluate the effect of standardised nursing care given to women with perinatal loss using the nursing process on perinatal grief, posttraumatic stress and postpartum depression.

H01: There is no difference between pre-test, post-test and follow-up tests in terms of perinatal grief scale mean scores in the intervention group.

H02: There is no difference between pre-test, post-test and follow-up tests in terms of IES-R mean scores in the intervention group.

H03: There is no difference between pre-test, post-test and follow-up tests in terms of EPDS mean scores in the intervention group.

H04: There is no difference between the pre-test post-test and follow-up tests in terms of the mean scores of the Complicated Grief Scale in the intervention group.

* At the first encounter with women, the mean scores of PMI, IESR and EPDS will be evaluated.
* The mean EPDS score will be evaluated on the 10th postpartum day, 1st, 3rd and 6th month.
* The mean I-ESR scale score will be evaluated at postpartum 1st, 3rd and 6th month.
* At postpartum 1st and 3rd month, the mean score of PMS will be evaluated.
* At the postpartum 6th month, the mean score of the PBI scale will be evaluated.


Eligibility Criteria:
Inclusion Criteria:- To be over 18 years old

* Being married (according to the woman's declaration)
* Not having an existing psychiatric illness (according to the woman's declaration)
* Not having communication problems (knowing Turkish, being literate, not having vision, speech or hearing problems, etc.)
* Spontaneous conception
* Singleton pregnancy
* No substance addiction

Exclusion Criteria:Women who agreed to participate in the study but did not want to receive post-discharge care, who were hospitalised for any reason, who became pregnant again, who did not want to complete the last tests or who wanted to leave the study at any stage of the study will be excluded from the sample.
Improving Adherence to ACS Guidelines on Nutrition and Physical Activity in Latinas With Cancer and Their Informal Caregivers

This research study is testing the feasibility and acceptability of a 12-week intervention that integrates telephone coaching and printed materials about the ACS guidelines and healthy lifestyle behaviors in order to manage symptoms after treatment for cancer. We will recruit 57 dyads (the survivor plus one identified informal caregiver) from the community.

This research study is testing the feasibility and acceptability of a 12-week intervention that integrates telephone coaching and printed materials about the ACS guidelines and healthy lifestyle behaviors in order to manage symptoms after treatment for cancer. The study population is 36 Latinas who have recently completed treatment for solid tumor cancers and their informal caregiver (36 dyads). Research suggests that family members can be facilitators to behavior change more specifically, Latinos rely on family support more than non-Hispanic Whites.

Fewer than 20% of Latina cancer survivors meet the American Cancer Society's (ACS) Guidelines on Nutrition and Physical Activity. Healthier lifestyle behaviors (such as diet and physical activity) would result in an immediate benefit of reduced symptoms and long-term benefit of improved health while lowering cancer risk. This pilot study tests an intervention that will help in lessening survivors' symptoms to improve adherence to the ACS guidelines for cancer prevention ultimately improving overall health. A telephone-based intervention does not require any in-person meetings (outside of initial recruitment) and lessens participant burden.

The Specific Aims of this project are to evaluate this intervention among 36 survivors who have recently completed treatment for solid tumor cancers and their informal caregivers to 1) Determine the feasibility and acceptability of the intervention 2) Establish the preliminary efficacy for improvement in diet, physical activity, and quality of life for the dyads, and symptom burden for survivors through surveys given at baseline and study completion as well as a weekly symptom distress survey.

Eligibility Criteria:
Inclusion Criteria:

Patients

* Female
* at least 18 years of age
* diagnosis of cancer
* speak and understand English or Spanish
* are finishing (or have finished) curative intent cancer treatment and do not have any subsequent cancer treatments planned, except for hormonal therapy or trastuzumab for breast cancer.
* Patients must also have at least 1 of the 5 most common cancer-related symptoms (pain, sleep disturbance, anxiety, depression and/or fatigue) with a severity score of 4 or higher (2 or higher for depression) on a 0-10 rating scale which is based on the National Comprehensive Cancer Network guidelines for symptom monitoring.

Caregivers

* must be 18 years or older
* able to speak and understand English or Spanish
* not currently treated for cancer preserving the distinction between survivor and caregiver.
Effect of Calcium and Vitamin D on Bone Loss From the Hip

The primary aim of this study is to determine the effects of supplementation with both calcium and vitamin D on changes in bone density of the hip in men and women age 65 and older.

In this study 445 men and women age 65 and older were enrolled for three years each. Subjects were randomized to treatment with 500 mg of calcium s calcium citrate malate plus 700 IU of vitamin D daily or placebo. Subjects came to the research center every six months for biochemical and bone mineral density measurements. Changes in these measures over the three years were determined in each group and compared.

Eligibility Criteria:
Inclusion Criteria:

\>65 years calcium intake \< 1500 mg/day Willing to discontinue calcium and vitamin D pills for 2 months prior to enrollment

Exclusion Criteria:

Mentally incompetent, femoral neck BMD greater than 2 SD above/below age/sex-matched reference mean, 24-hr urine calcium/creatinine \> 300 mg/d women or \>350 mg/d men terminal illness, renal disease requiring treatment, kidney stone in the past 10 years, current hyperparathyroidism, treated with glucocorticoids, estrogen or androgen, fluoride, calcitonin, bisphosphonate, or any other treatment for osteoporosis.
Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result

The objective of this multi-center clinical study is to determine the association of the PCA3 Score with prostate biopsy outcome and validate the assay's performance characteristics in men with previous negative prostate biopsies. An elevated PCA3 Score is thought to be associated with an increased likelihood of positive biopsy. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test.

PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that can be quantified in urine specimens following a digital rectal examination. Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen (PSA) testing. Gen-Probe's PROGENSA(R) PCA3 assay is the first urine-based molecular diagnostic assay for prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Men 40+ years of age who have had at least 1 previous negative prostate biopsy, who have never had a positive prostate biopsy, and who have been recommended for a repeat biopsy by their clinician.
* The subject must be able to comprehend and sign an approved informed consent form and other applicable study enrollment documents

Exclusion Criteria:

* Use of medications or hormones that are known to affect serum PSA levels within 3 - 6 months of study enrollment
* Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment
* History of prostate cancer
* History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary tract symptoms within 6 months of study enrollment
* Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
* Participation in pharmaceutical or treatment related clinical study within 6 months of study enrollment. Exception: Trials for non-prostate conditions may be acceptable, with approval by the investigator and Sponsor
Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are receiving background non-biologic disease-modifying anti-rheumatic drug therapy.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of RA prior to the Screening Visit.
* Active disease despite ongoing therapy with up to two non-biologic disease-modifying anti-rheumatic drugs, including methotrexate at both the Screening and Baseline Visits.
* Screening hs-CRP ≥1.2 x upper limit of normal (ULN).

Exclusion Criteria:

* Prior/current exposure to biologic and/or kinase inhibitor therapy.
* Known history or presence of polyneuropathy of any cause and no presence of clinically active compression neuropathy, radiculopathy or plexopathy at the Screening Visit.
* Positive test results for human immunodeficiency (HIV) virus, hepatitis B virus or hepatitis C (HCV) virus at the Screening Visit.
* Positive drug of abuse and alcohol test results.
* History of a clinically-significant infection that required oral antimicrobial or antiviral therapy within 8 weeks prior to Day 1.