cyrilzakka/clinical-trials huggingface dataset:
Contingency Management for Smoking in Substance Abusers

The aim of this study is to determine whether contingent reinforcement for smoking abstinence, compared to noncontingent reinforcement, increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment.

Substance abusers have a high prevalence and rate of smoking with little success in quitting, so stronger approaches are needed to encourage attempts to quit smoking.

The aim of this study is to determine whether contingent reinforcement for smoking abstinence (CM), compared to noncontingent reinforcement (NR), increases the effectiveness of brief counseling and nicotine replacement on smoking abstinence of substance abusers in residential treatment. The proposed study will be a 2-group design in which up to 274 substance abusers who smoke 10 or more cigarettes per day receive brief advice (4 sessions) and nicotine replacement (NRT) (8 weeks), and are randomized to 19 days of CM for smoking vs. a matched NR condition. The brief advice is adapted slightly for sobriety settings. Point-prevalence abstinence will be assessed at 1, 3, 6 and 12 months after starting treatment. Secondary aims evaluate effects of CM on substance use outcomes and potential mediators of effects on outcome, including within-treatment abstinence, motivation level and tolerance for smoking discomfort.

The significance is to add knowledge about the most effective ways to maximize smoking cessation among substance abusers, important given that no methods are known to work with this population.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of substance abuse or dependence by DSM-IV criteria
* in residential treatment at one particular agency
* currently smoking at least 10 cigarettes per day for the past 6 months

Exclusion Criteria:

* hallucinating or delusional or marked organic impairment (to the point of impairing ability to understand informed consent) according to medical records
* current use of nicotine replacement therapy, Zyban, or any other smoking cessation treatment
* medical exclusions for NRT: pregnant or nursing; treatment in the last 3 months for unstable angina, severe congestive heart failure, uncontrolled hypertension; lung cancer; supplemental oxygen; history of adverse reactions to NRT; allergies to adhesive; or any severe skin disease that requires treatment (e.g., psoriasis or eczema).
Desmopressin Response in the Young

The purpose of this study is to determine whether desmopressin administered as a melt tablet is effective in reducing the number of wet nights in children and adolescents who suffer from bedwetting.

Primary nocturnal enuresis (PNE), or bedwetting, is a common childhood urological disease. Factors contributing to nocturnal enuresis include nocturnal polyuria due to, at least in part, a relative deficiency of antidiuretic hormone arginine vasopressin (AVP) which has been supported by the finding that some enuretic children lack a nocturnal increase in endogenous AVP secretion. Desmopressin, a synthetic, structural analogue of AVP, selective for V2-receptors and with a longer half life than the natural hormone, has been found to be especially beneficial in PNE subjects with nocturnal polyuria and normal functional bladder capacity.

A melt tablet formulation offers benefits compared to regular tablets and nasal spray. Regular tablets are more difficult to swallow for some patients and require fluid intake for swallowing. Nasal spray absorption may be altered by seasonal allergies, upper respiratory infections or improper administration.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents (age 5-16 years) with diagnosed primary monosymptomatic nocturnal enuresis.
* A minimum of 3 wet nights per week in the 2-week screening period without treatment.

Exclusion Criteria:

* Presence or a history of organic urological disease, diurnal urinary incontinence, polydipsia, diabetes insipidus, ongoing urinary tract infection, clinically significant renal, hepatic, gastrointestinal, pulmonary, cardiovascular, endocrinological or neurological disease that would interfere with evaluation.
* Ongoing systemic antibiotic use, use of diuretics or any drugs affecting urinary concentration, or medical treatment for hyperactivity.
* Usage of any experimental drug or device during 30 days before study entry.
Mindfulness for Older Adults With Cognitive Concerns

The current study will examine the effects of a brief mindfulness based intervention (BMBI) on mood, memory and attention in comparison to a wait-list control (WLC) group. Participants for the study will be 90 adults aged 50 years and above who have presented at a memory clinic within SLaM NHS Trust with subjective cognitive concerns and/or those who have received a diagnosis of mild cognitive impairment (MCI) from their memory clinic.

Participants will be randomly assigned to either the BMBI group or the WLC group. Those assigned to the BMBI group will complete a number of cognitive assessments and questionnaires at Time 1. They will then receive a 45 minute mindfulness intervention. Following this, they will be asked to practice mindfulness for 30 minutes per day for 7 days a week in their own homes. After 7 days, participants in the BMBI group will be invited to complete a paired set of cognitive assessments and questionnaires (Time 2). Participants in the WLC group will complete the same number of cognitive assessments and questionnaires as the BMBI group at Time 1. However, they will not receive the 45 minute mindfulness intervention nor will they be asked to practice it at home for 7 days. After 7 days, participants in the WLC group will be invited to complete a paired set of cognitive assessments and questionnaires (Time 2). After completion of the measures at Time 2, the WLC participants will then receive the 45 minute mindfulness intervention. All assessments, questionnaires and the intervention will be carried out either in a SLaM memory clinic or at participants own homes depending on level of mobility.

Eligibility Criteria:
Inclusion Criteria:People aged 50 years and older with subjective memory concerns (SMC) and/or those who meet criteria for amnestic mild cognitive impairment (MCI) who have been seen by one of the three SLAM memory services (i.e. Croydon Memory Service; Southwark and Lambeth Memory Service; and Lewisham Memory Service) in the past three months. Participants must be able to give informed consent to participate.

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Exclusion Criteria: Diagnosis of dementia or multi-domain mild cognitive impairment, intellectual disability, current substance misuse, a current diagnosis of epilepsy or another neurodegenerative disorder (such as Parkinson's), a history of brain injury or stroke, a severe and enduring mental health disorder (e.g. severe depression or anxiety, personality disorder, schizophrenia, schizoaffective disorder, bipolar affective disorder), active suicidal ideation, severe sensory impairment that would significantly impair a person's ability to engage in the intervention.

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Renal Denervation in Patients With Uncontrolled Hypertension in Chinese

The purpose of this study is to determine whether renal denervation is safe and effective in the treatment of Chinese patients with uncontrolled hypertension.

Prevalence of hypertension is increasing in China.While actually,the controlled rate of hypertension is relatively low,though numerous safe and effective pharmacological therapies are used in clinical practice.Studies confirmed that renal sympathetic nerves contributed to development and perpetuation of hypertension. Previous study has stated that renal denervation was effective and safe in patients with resistant hypertension, while little data is known in Chinese patients. We hypothesis that renal denervation is effective and safe in treatment of Chinese patients with uncontrolled hypertension. This trial plan to recruit 100 patients(Ablation group VS Control group = 1:1) with a follow up duration of 3 years.Patients in ablation group will receive percutaneous renal denervation combined with necessary antihypertension drugs and patients in control group will receive appropriate antihypertension drugs. We aim to explore the long term safety and validity of renal denervation in Chinese patients with uncontrolled hypertension.

Eligibility Criteria:
Inclusion Criteria:

* \>= 18 years of age
* a systolic blood pressure of 160mmHg or more and/or a diastolic blood pressure of 90mmHg or more
* receiving and adhering to at least three full doses of appropriate antihypertensive drug regimen
* estimated glomerular filtration rate (eGFR) of ≥45mL/min
* agrees to have the study procedure(s) performed and additional procedures and evaluations
* is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria:

* secondary hypertension
* renal arterial abnormalities
* has experienced MI, unstable angina pectoris, or CVA within 6 months
* has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
* requires respiratory support
* patients with sick sinus syndrome
* pregnant woman
* others
Parent and Family Oriented Support Interventions for the Facilitation of Weight Loss in African American Families

This study tests the effectiveness of parent and family oriented support interventions that are designed to help with weight loss among African American families. Obesity tends to run in families, thus family based interventions, with parents as main change agents have been strongly recommended. The parent and family oriented support Interventions may help facilitate weight loss among African American families.

PRIMARY OBJECTIVES:

I. Determine whether a parent/caregiver intervention or a family intervention can produce greater weight loss among obese African American (AA) parents at 12 months compared to a cancer prevention group (control).

II. Use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model, to evaluate individual and church-level barriers and facilitators on program reach, effectiveness, adoption, implementation, maintenance and dissemination.

SECONDARY OBJECTIVES:

I. Explore whether a parent/caregiver intervention and a family intervention can produce weight maintenance or weight loss, as determined by change in body mass index (BMI) z-score, among AA children at risk for obesity at 12 months compared to the control group.

II. Determine the extent to which the proposed interventions improve fruit and vegetable (FV) consumption, physical activity, blood pressure, body fat percentage, muscle mass and waist circumference.

OUTLINE: Churches are randomized to 1 of 3 groups.

GROUP I: Parents/caregivers whose churches are randomized to Group I, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.

GROUP II: Families whose churches are randomized to Group II, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.

GROUP III: Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.

Eligibility Criteria:
Inclusion Criteria:

* DYAD: Be parent/caregiver (legal parent or custodial grandparent; male or female) and child willing to participate
* DYAD: Live together in the same household
* PARENT/CAREGIVER: Self-identify as a racial ethic minority (i.e., black or African American or Hispanic)
* PARENT/CAREGIVER: Parent or caregiver age 18 through 65 years old
* PARENT/CAREGIVER: Are overweight (BMI greater than or equal to 25);
* PARENT/CAREGIVER: Are not currently participating in a physical activity (PA), diet, or weight management program
* PARENT/CAREGIVER: Have a valid home address, telephone number, and internet access
* PARENT/CAREGIVER: Enroll with a child aged 8-17 years
* PARENT/CAREGIVER: Are able to speak English

Exclusion Criteria:

* PARENT/CAREGIVER: They are currently pregnant or thinking about becoming pregnant during the study period
* PARENT/CAREGIVER: They present any contraindications for exercise based on responses to the PA Readiness Questionnaire plus (PAR-Q +)

Exclusion criteria for child:

1) None.
Preoperative Fluoroscopy Guided Hip Articular Branch Blocks and Analgesic Outcomes Following Hip Arthroscopy

Arthroscopic hip surgeries are increasingly being performed as both diagnostic and therapeutic interventions. These procedures are considerably painful, thus requiring the proper pain management techniques in order to provide patient satisfaction and sufficient pain control. Articular branch blocks have not been evaluated for their use in hip arthroscopy, but have potential advantages of blocking the sensory innervation of the entire hip joint, with minimal impact on motor innervation compared to alternative blocks.

This current study aims to evaluate the efficacy of using preoperative fluoroscopic-guided blockade of articular branches of the femoral and obturator nerves for analgesic management of patients undergoing arthroscopy compared to a saline sham block.

The utility of pre-operative hip articular branch block (ABB) prior to hip arthroscopy will provide superior pain management postoperatively compared to a saline sham block. We hypothesize that the ABB (Articular Branch Block) will reduce the area under the NRS pain scores by time curve (AUC) and decreased oral opioid milligram equivalent use in the first 24 hours post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* Presenting for Hip Arthroscopy (Diagnostic or Therapeutic)
* Pre-operative Numeric Rating Score (NRS) for pain \<8 on a 0 to 10 scale where 0 is no pain and 10 is worst pain imaginable.

Exclusion Criteria:

* Allergies to any of the study medications
* Anti-coagulation status (INR \> 1.1, PT or APTT \> 1.5 control)
* History of Hip Arthroplasty
* Infection of Hip
* Evidence of tumor
* Pregnancy
* History of diabetes with HbA1c \> 10%
* Prior history of Hip Articular Branch Blockade or Hip Articular Branch PRF Ablation
Clinical Safety Study on an Eyelid Warming Device to Evaluate the Eyelid and Cornea Temperature in Healthy Volunteers

The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in the eyelids.

Prospective, non comparative, open, monocentre study.

The objectives are:

* To verify and establish the temperature of the eyelids and cornea for each eye before and after 10 minutes device application
* To evaluate the ocular surface, NIBUT and IOP before and after device application
* To determine the acceptability of healthy volunteers on the practical use of this device

The subjects will attend 2 visits.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged from 18 to 80 years old.
* Healthy volunteers.
* For any contact lens wearers, they must be wearing hydrogel contact lenses (worn at least 3 times per week)
* Normal ocular examination in both eyes.
The Maintenance Treatment of UFT in Advanced Gastric Cancer

The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of tegafur-uracil (UFT) after the standard first-line chemotherapy in advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
* ECOG PS 0-2
* At least one measurable or evaluable lesion in the first-line chemotherapy (5-FU based regimen: ECF/EOF/EOX/FOLFOX/XELOX) with the efficacy evaluation of non-PD
* Adequate hepatic,renal,heart, and hematologic functions (platelets ≥75×109/L, neutrophil≥1.5×109/L, hemoglobin≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase≤2.5×the ULN)

Exclusion Criteria:

* Receiving more or more than 2 regimens of chemotherapy
* Pregnant or lactating women
* Concurrent cancer
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Neuropathy, brain, or leptomeningeal involvement
* Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
* Uncontrolled significant comorbid conditions and previous radiotherapy
Is There A LIfe for Drug Eluting Stent (DES) After Discontinuation of Clopidogrel

The ITALIC PLUS Trial was designed with the objective of extending to other countries the enrollment of patients into the ITALIC trial initially conducted in France, in order to achieve statistical significance by pooling the data of both trials.

The use of drug-eluting stents has resulted in a significant reduction in the restenosis rate and in the need for repeat angioplasty of the stented lesion. However, the occurrence of late stent thrombosis has resulted in an increase in the duration of dual antiplatelet treatment.

According to the guidelines of the ESC, the current recommended duration of dual antiplatelet treatment is 12 months.

A relationship has been demonstrated between the occurrence of late stent thrombosis and aspirin resistance.

Furthermore, dual anti-platelet treatment is associated with an increase in bleeding, the severity of which has been well documented. In addition, the patients involved, and especially those over 70, have significant co-morbidities often requiring extra-cardiac surgery which cannot easily be carried out in patients on dual antiplatelet treatment or clopidogrel.

The objective of this study is to determine whether, after a period of 6 months following Drug eluting stent (DES) implantation in patients regarded as sensitive to aspirin, dual antiplatelet therapy may be replaced by aspirin alone.

The original Italic Trial is a multicenter, randomized study evaluating the non-inferiority of aspirin as a single treatment versus dual antiplatelet therapy with clopidogrel and aspirin 6 months after drug-eluting stent implantation, including a 12-, 24- and 36-month follow-up analysis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject ≥ 18 years of age eligible for PCI with at least one drug eluting stent (name: Xience) implanted in all clinical situations excluding primary PCI for acute MI and treatment of the left main artery.
* Male or female subject ≥ 18 years of age eligible for PCI with at least one DES Xience.
* Patient not pre-treated with protein IIb/IIIa inhibitors (name: abxicimab or eptifibatide) during hospitalization
* Patient pre-treated with aspirin and clopidogrel before PCI
* ASA check at least 24 hours after the interruption of tirofiban
* The subject has given written informed and dated consent to participate in this study.

Exclusion Criteria:

* Subjects not able to give informed consent
* Prior implantation of DES
* Known platelets \< 100 000/µl or known hemorrhagic diathesis
* Oral anticoagulation or treatment with abxicimab or eptifibatide during hospitalization
* ASA check less than 24 hours after the interruption of tirofiban
* Thrombolytic therapy within 4 days before ASA check
* Contra-indication to aspirin or clopidogrel
* Recent major surgery \< 6 weeks
* Evidence of an active gastrointestinal or urogenital bleeding
* Severe liver insufficiency
* Primary PCI for acute MI
* Left main PCI
* Any scheduled surgery during the year after enrollment
* Severe concomitant disease with life expectation \< two years
Evaluation of Deaf Men's Knowledge About Sexual Health

Evaluation of Deaf men's knowledge about sexual health in Nancy, France. The study consists of interviews with voluntary deaf men from Nancy, France, in order to assess their knowledge about sexual health, and determine if there is a lack of sexual health awareness.

If there is indeed a lack of information about sexual health, the study aims at finding ways of improving the situation, and see how the deaf men would like to have this information delivered to them.

Evaluation of Deaf men's knowledge about sexual health in Nancy, France. The study consists of interviews with voluntary deaf men from Nancy, France. The goal is to assess their knowledge about sexual health, and determine if there is a lack of sexual health awareness.

If there is indeed a lack of information about sexual health, the study aims at finding ways of improving the situation, and see how the deaf men would like to have sexual health information delivered to them.

Patients from Nancy's Regional Deaf Healthcare Service (URASSM) will be contacted and volunteers adult deaf men, using sign language as their main langage, will be recruited into the study.

The interviews will consist of a series of open questions aiming to evaluate the volunteers knowledge about sexual health, and evaluate their expectations about how sexual health care for deaf men should be dealt with.

A professional french sign language translator will be present during the interviews, and all the questions and answers will be delivered using french sign language.

Eligibility Criteria:
Inclusion Criteria:

* Deaf
* Over 18
* Using french sign language
* Whithout curatorship or tutelage

Exclusion Criteria:

* Female
* Under 18
* Non deaf
Middle Ear Pressure Disregulation in Cleft Palate Patients

The investigators know that middle-ear disease is very common in infants with cleft palate and causes hearing loss that can last into childhood. It is thought that a poor ability to keep the pressure in the middle ear at a similar level to that in the environment causes middle-ear disease and that this depends on the opening function of a natural tube that connects the back of the nose with the middle ear, called the Eustachian tube. The investigators believe that the middle-ear disease in cleft palate infants and children is caused by poor Eustachian tube function that in turn is caused by anatomical problems in the muscles that open the tube. The investigators plan to test these relationships by studying the changes between 5-24 months and 6 years in middle-ear health, the way the Eustachian tube works and Eustachian tube anatomy in cleft palate children.

Otitis media with effusion (OME) is recognized as nearly universal in the population of infants and children with cleft palate (CP) and is often associated with long-standing conductive and, perhaps, sensorineural hearing losses. Most evidence suggests that OME in CP patients is a complication of inefficient Eustachian tube function (ETF). The investigators plan to use our most complete tests to characterize ETF in CP infants tested at age 5-24 months and followed up through age 6 years by yearly collection of clinical data for the presence/absence of OME and repeat ETF testing. To obtain anatomical data, the investigators will obtain basal and lateral cephalograms at age 3 years in all subjects and perform MRI tests prepalatoplasty when possible and then at 3 and 5 years on a subset of the enrolled children. Functional-anatomical reconstructions based on the MRI data will be studied for the mechanical interactions underlying the phenomenon of ET constriction in CP patients and examined for the possibility of surgical interventions to correct identified abnormal interactions.

Eligibility Criteria:
Inclusion Criteria:

* birth-24 months
* unrepaired or recently repaired cleft palate

Exclusion Criteria:

* cleft palate associated with syndrome
* known immune deficiency