cyrilzakka/clinical-trials huggingface dataset:
Helping Poor Smokers Quit

Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri to compare the relative and combined effects of these two strategies for augmenting an existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will receive standard Missouri quitline services and half will receive new Specialized Quitline services targeted to this group. In each of these groups, half also will receive calls from a trained navigator to help them address unmet Basic Needs and the accompanying psychological distress that act as barriers to smoking cessation.

2-1-1 information specialists will deliver standard service, then ask a random number of callers per day if they would be willing to answer a few health questions as part of a new 2-1-1 service. Callers eligible to receive the invitation to screen for study eligibility will be: Missouri residents, calling for themselves, English-speaking, and not in acute crisis. Eligible smokers will then be asked if they are willing to share their contact information with a research team conducting a study to help smokers quit. Smokers who agree to share their contact information will be considered "enrolled". Trained 2-1-1 operators will record all recruitment screening data in a secure electronic database that is shared with research staff. Research staff will attempt to reach enrolled smokers by phone by the next business day.

Alere, through the Missouri Tobacco Quitline, will provide quitline services to smokers in all study conditions. Contact information and study group assignment for smokers will be provided to Alere via secure data transfer.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Missouri resident
* English speaking
* Not in crisis
* Smoke cigarettes every day of the week
* Planning to quit smoking in the next 30 days
* Comfortable receiving calls from smoking expert and project team
* Willing to provide phone numbers to be reached

Exclusion Criteria:

* Pregnant or planning to become pregnant in the next 3 months
* Currently breastfeeding
* Insurance through employer
* Currently enrolled in smoking quitline
Effects of a Red/Gold/IR LED Combination Light on Reduction of Fat

An open-label evaluation of the effects of a red/gold/IR LED combination light on reduction of fat. The results shall be compared to previous results from a comparator device utilizing only red LED monotherapy for the non-invasive reduction in fat layer for body contouring.

The combination of gold/red/IR light is theorized to enhance the effect of the deeper penetrating red/IR light with the photomodulated effects of gold light. The light is positioned alongside the patient as they lay, or sit on a treatment table. A light panel is mounted to an articulating arm for positioning the light at the correct treatment position above the patient (non-contact). The effects of a red/gold/IR combination LED light therapy device on circumferential reduction of fat will be measured, and the overall health of the patients will be monitored using blood tests.

Eligibility Criteria:
Inclusion Criteria:

* Study participant is 18 years of age or older.
* Diagnosed with adult-onset (type 2) diabetes.
* Obesity

Exclusion Criteria:

* Photosensitive condition or medication.
* Active chemotherapy treatment or other cancer treatment.
* Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation.
* Developmental disability or cognitive impairment that, in the opinion of the investigator, would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
* Chronic stomach conditions (IBS, Crohn's, Ulcerative Colitis, etc.)
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients

The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.

A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim (G-CSF)is better than filgrastim (G-CSF) alone in helping multiple myeloma patients collect at least 6 million stem cells in two or less apheresis sessions.

This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple myeloma in first or second complete or partial remission
* \>= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade were not considered prior chemotherapy for the purpose of this study)
* Recovered from all acute toxic effects of prior chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* White Blood Cell count (WBC) \> 2.5\*10\^9/L
* Absolute polymorphonuclear leukocytes (PMN) count \> 1.5\*10\^9/L
* Platelet (PLT) \> 100\*10\^9/L
* Serum creatinine \<=2.2 mg/dL
* Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
* Negative for HIV

Exclusion Criteria):

* Failed previous stem cell collection
* Previous stem cell transplantation
* Brain metastases or myelomatous meningitis
* Radiation to ≥ 50% of the pelvis
* Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality
* Received bone-seeking radionuclides (e.g. holmium)
* A residual acute medical condition resulting from prior chemotherapy
Evaluation of Health Costs and Resource Utilization

Utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response to infliximab or adalimumab.

The purpose of this study is to evaluate the utilization of health resources in a testing based strategy versus an empiric dose escalation strategy to manage Crohn's disease and Ulcerative Colitis in subjects with loss of response to infliximab or adalimumab.

Eligibility Criteria:
Inclusion Criteria:

* Males 18 years of age or older who are not receiving azathioprine or 6 mercaptopurine.
* Non-pregnant, non-lactating females, 18 years of age or older.
* Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. \[defined as a minimum of one year since the last menstrual period\]).
* Documented diagnosis of CD or UC.
* Active disease symptoms at visit 1 defined by: a. CD subjects: HBS \~ 6 UC subjects: PMCS \~ 4.
* Current infliximab therapy (naive to adalimumab) or current adalimumab therapy (naive to infliximab ).
* A minimum of 13 weeks of infliximab or adalimumab treatment prior to visit 1 at the following dose:
* Stable dose of azathioprine, 6 mercaptopurine, methotrexate, and/or 5-aminosalicylates in the 4 weeks prior to visit 1.

Exclusion Criteria:

* Contraindication to the use of either infliximab or adalimumab.
* Current infliximab treatment but not naive to adalimumab or
* Current adalimumab treatment but not naive to infliximab.
* Infliximab dosing prior to visit 1 was not 5 mg/kg at weeks 0, 2 and 6 and then q8w.
* Adalimumab dosing prior to visit 1 was not 160 mg at week 0, 80 mg at week 2, and then 40 mg q2w.
* Received any investigational drug within 30 days prior to visit 1.
* Serious underlying disease other than CD or UC which in the opinion of the investigator may interfere with the subject's ability to participate fully in the study.
* History of alcohol or drug abuse which in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
* Stools positive for clostridium difficile.
* Pregnant or lactating women.
* Change in dose of azathioprine, 6 mercaptopurine, methotrexate, and/or 5-aminosalicylates in the 4 weeks prior to visit 1.
* Males 22 years of age or less who are receiving azathioprine or 6 mercaptopurine.
Development, Implementation, and Evaluation of School-based Smoking Prevention Education Program Among Non-smoking Adolescents

Preventing smoking among adolescents is critical to end the epidemic of smoking in Malaysia. Despite the implementation of several smoking prevention programs, the prevalence of adolescent smoking and experimenting with tobacco in Malaysia is still increasing. Therefore, the purpose of this quasi-experimental study was to evaluate the effectiveness of Smoking Prevention Education Programs (SPEP) in preventing the smoking initiation among non-smoker adolescents based on their smoking status on follow-up and smoking intention, which includes; attitude, subjective norms, and perceived behavioural control as described by the Theory of Planned Behaviour. A total of 140 Primary five students (non- smokers) were involved in this study. Four schools in Kuantan district were randomly assigned to intervention and control groups. The intervention schools received a lecture on the hazards of smoking and SPEP intervention whereas the control schools received just a lecture on the hazards of smoking. The questionnaires and exhale carbon monoxide levels were first assessed at baseline and then again after three months.


Eligibility Criteria:
Inclusion Criteria:

* Primary school students (standard 5)
* 11years' old
* Non- smoker (CO level less than 4ppm) to maintain baseline never- smoker
* Both genders
* Consented by parent

Exclusion Criteria:

* Ex-smoker (self- reporting) and smoker (CO level more than 4ppm)
* Students unable to understand and read the national language (Bahasa Malaysia)
* Children with special needs
Weight Loss and Exercise in Obese, Physically Limited, Older Women and Men

The purpose of this study is to determine the effect of weight loss and exercise on physical function, body fat and muscle mass, bone strength, and quality of life.

Obesity causes serious medical complications and impairs quality of life. Moreover, in elderly persons, obesity can lead to frailty by exacerbating the decline in strength, endurance, balance and mobility associated with aging and physical inactivity. The primary objectives of the proposed research are to evaluate the independent and combined effects of weight loss and exercise on physical function, body composition, bone and muscle metabolism, and quality of life in frail, obese elderly men and women. The central hypothesis is that in frail obese elderly subjects, weight loss will improve physical function and quality of life, while the addition of exercise will not only augment improvement in these outcomes, but also attenuate the adverse effects of weight loss on bone and muscle masses. To test this hypothesis, 110 elderly (65-85 years old) obese men and women (body mass index \[BMI\] \> 30 kg/m2) with physical frailty will be randomized to 4 treatment groups: 1) control, 2) 10% weight loss, 3) exercise training, and 4) 10% weight loss plus exercise training.

Eligibility Criteria:
Inclusion Criteria:

* Obese (BMI 30 or greater)
* Elderly (age 65 years or older)
* Frailty

Exclusion Criteria:

* Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results.
* Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 years, or current use of bone acting drugs.
Brainstem Dysfunction Involvement in the Pathogenesis of Pierre Robin Sequence

Introduction Pierre Robin Sequence, PRS, incidence is about one hundred births per year in France. The main neonatal clinical manifestations are secondary to airway obstruction and food difficulties related to swallowing disorders. Despite recent progress, the pathogenesis of PRS is not fully understood.

The hypothesis is that brainstem dysfunction, BSD, plays a central role in the pathogenesis of PRS.

The purpose of the study is to achieve a complete evaluation of BSD to specify its role in the pathogenesis of PRS.

The primary objective is to compare central apnea index (CAI) of infants with PRS with those of infants with isolated airway obstruction (AWO) and those of healthy infants in order to clarify the direct role of BSD.

Material and Methods This prospective interventional study will be carried out in Lyon at the Hôpital Femme-Mère-Enfant and in Paris at the Hôpital Necker-Enfants Malades for 2 years. 3 groups of patients will be studied: PRS, 50 patients, AWO, 50 patients and healthy, 30 patients, included before 2 months of life. Infants will be followed for a maximum of 10 months. The evaluations will be carried out for 48 hours between birth and 2 months of life and then for 24 hours between 6 and 10 months of life for PRS and AWO group. Concerning the healthy group, the evaluation will be carried out during 48h during a single hospitalization before 2 months. Polysomnography, holter-ECG, 24h gas exchange, impedance-pH monitoring and mental region EEG will be performed. The central apnea index (mean number per hour), obstructive apnea index, non-nutritive swallowing index (NNS), gastroesophageal reflux and NNS-respiration coordination will be assessed for each stage of sleep and compared between the three groups of patients.


Eligibility Criteria:
Inclusion Criteria for the group 1

- infants with PRS

Inclusion Criteria for the group 2 - infant with isolated airway obstruction

Inclusion Criteria for the group 3

- healthy infant : siblings of sudden unexpected death of the infant or with any known pathology

Inclusion Criteria for the 3 groups

* During one hospitalization or program for one hospitalization
* Parental consent
* Social safety affiliation

Exclusion Criteria:

* Birth before 37 SA
* Neonatal complication
* Group 2 only: AWO with neurological disease including brainstem dysfunction
* Group 3 only : AWO, ENT disease or syndromic disease, neurological disease including brainstem dysfunction, Intra uterine growth retardation
A Randomised Controlled Trial of Family Mediated Exercises (FAME) Following Stroke

The aim of the study is to evaluate the functional recovery in two groups of primary stroke patients presenting with moderate/severe disability over a six month period through the implementation of a randomised controlled trial. The first group or the experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The second group or the control group will receive routine therapy with no additional formal input from their family members. A secondary aim of the project is to evaluate the impact of the FAME programme on the person with stroke and the individual (s) assisting in the delivery of exercises.

Participants with primary stroke eligible for inclusion to the study at 2 weeks post stroke will be randomised into either a 'control' group that will receive routine therapy or an 'experimental' group that will receive routine therapy AND additional 'family mediated exercise therapy.

Training will be provided to the nominated family member (s)/friends of participants in the 'intervention' group on a weekly basis by the research physiotherapist (R1). Family members/friends will be requested to keep an exercise diary on a daily basis to document completion of exercises. The trial will continue for eight weeks with an expectation that at least 1200 additional minutes of FAME therapy will be delivered over this time period. Each FAME session is expected to last 35-40 minutes.

Exercises will include repetitive sit to stand exercises with an emphasis on improving symmetry, weight bearing exercises during standing, bridging, straight leg raises, quadriceps strengthening exercises, active/active assisted range of movement exercises for the lower limb and walking. Outcome will be assessed by a blinded outcome assessor (R2) on entry to the study, at eight weeks (post-intervention) and again three months post-intervention (follow-up)

In addition, a semi-structured interview will be carried out with a random sample of the participants and their family member (s)/friends to gain a more qualitative insight into the impact of the programme on those involved. This interview will be completed by a person unknown to the participant. (R3)

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of first unilateral stroke
* Patients who score between 3.2 and 5.2 on the Orpington Prognostic Scale
* Patients participating in a physiotherapy programme
* Patients willing to give informed written consent
* Patients with family willing to participate in their assigned physiotherapy intervention programme

Exclusion Criteria:

* hemiplegia of a non-vascular origin
* discharged from hospital less than two weeks following stroke
* pre-existing neurological disorder
* any lower limb orthopaedic condition that may limit exercise capacity
* aphasia
* cognitive impairment
* not willing to give written consent
MicroFluO: FLUorescence-guided Surgery for Ovarian Cancer

Epithelial ovarian cancers (EOC) are discovered in 75% of cases at an advanced stage, marked by the presence of peritoneal carcinomatosis. It has been shown that one of the main prognostic factors is the achievement of a macroscopically complete cytoreductive surgery, i.e. without visible peritoneal metastasis at the end of the procedure. The prognosis of patients is inversely correlated to the tumor residue at the end of the procedure, and 60% of patients present a peritoneal recurrence within two years after the initial management. This suggests that microscopic peritoneal metastases may be present that are not eradicated by surgery and not controlled by systemic chemotherapy. Their presence could be involved in the mechanisms leading to the occurrence of peritoneal recurrence.

The MicroPCI protocol (NCT03754569), showed that microscopic peritoneal metastases were present at the end of macroscopically complete surgery of advanced-stage EOC in 98.14% of cases.This naturally lead to the question of the impact of microscopic cytoreduction on the prognosis of patients. Fluorescence detection of peritoneal metastases after intravenous injection of indocyanine green (ICG) and their resection have already been evaluated with promising results in digestive and ovarian carcinomas.

The objective of the MicroFluO protocol is to propose on the one hand a diagnostic time by fluorescence during the laparoscopic evaluation performed to define the resectability of the peritoneal carcinomatosis and also at the end of the macroscopically complete cytoreductive surgery to perform the biopsy of the fluorescent areas suspected of presenting residual microscopic peritoneal metastases.

Patients diagnosed with peritoneal carcinomatosis undergo exploratory laparoscopy, during which lesion mapping is performed to assess the resectability of the lesions. A biopsy is performed during this procedure to confirm the histological diagnosis. An initial fluorescence mapping will be performed at this diagnostic time.

Once cytoreductive surgery has been performed, intravenous injection of ICG is performed according to the manufacturer's recommendations. Peritoneal lesions emitting a fluorescent signal will be sampled. These samples will be studied in anatomopathology under the same conditions as the other surgical parts.

No increase in morbidity is expected in relation to this study. The number of specimens taken is dependent on the peritoneal tumor burden.


Eligibility Criteria:
Inclusion Criteria:

* Patient at least 18 years of age.
* Presenting with an epithelial ovarian cancer
* Affiliated to a social security system
* Having received full information on the organization of the research and having given written consent.

Exclusion Criteria:

* Borderline ovarian tumor.
* Non French speaking patient.
* Patient under a legal protection measure (guardianship, curatorship, safeguard of justice).
A Comparison of the VBM Intubating Laryngeal Tube and the I-Gel

A study comparing two second generation supraglottic Airway devices, the VBM intubating laryngeal tube and the I-Gel.

This is a study comparing the use of a newer generation laryngeal mask to the 2nd generation widely used at present. The company responsible for the manufacture of this product is VBM Medizintechnik GmBH, Germany. The recent difficult airway society guidelines recommend the use of these newer generation devices and this has been the incentive to conduct this project. These newer generation supraglottic devices have an additional feature which is an extension of the mask with a balloon that sits in the oesophagus. The trial is investigating ease of placement of these devices, ventilatory pressures, leak pressure and ease of intubation through the VBM device compared to I-Gel. The position of the supraglottic device on insertion and the position of the endotracheal tube will be confirmed with a fibrescope. A follow up will take place on the same day and after 24 hours for symptoms of a sore throat postoperatively.

Eligibility Criteria:
Inclusion Criteria:

1. Any patient between the age of 18 - 70
2. Any patient having the capacity to consent
3. Any patient requiring general anaesthesia but not endotracheal intubation immediately after induction of anaesthesia.

Exclusion Criteria:

1. Patient refusal
2. Patients involved in another research project
3. Patients who require endotracheal intubation immediately after induction of anaesthesia
4. Patients who are systemically unwell/unstable
5. Patients at risk of aspiration