cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the New Orleans Intervention for Infant Mental Health

Early intervention for maltreated infants can improve mental and physical health throughout life and benefit families and society as a whole. The New Orleans Model provides intensive assessment and treatment for families of maltreated preschool children in foster care, with recommendations to court about adoption, or permanent return to birth families. The New Orleans Model appears to have led to better informed decisions about permanent placement and to better child mental health in Louisiana. The investigators propose an exploratory randomised controlled trial investigating the effectiveness of the New Orleans Model in the Scottish context, informing the development of an economic model to explore the potential cost-effectiveness. Families with a maltreated child under 5 years of age will be offered the New Orleans Model or "case management" i.e. quality assured services as usual, using random allocation. The investigators will measure outcome using well validated measures of parent-child interaction, cognition and attachment.

The first 5 months of this trial - from December 2011 to April 2012 - is an internal pilot or "implementation period". During this time we have fewer research staff, both services will just have started and we will only be collecting selected outcome measures. These will be the Principle Outcome Measure, the Infant-Toddler Social-Emotional Assessment (ITSEA), plus the Disturbance of Attachment Interview (DAI) and Parent-Infant Global Assessment of Functioning (PIR-GAS). We hope to include data from implementation period in our trial analysis, but if results are very different due to services "bedding in", we may not do so

Eligibility Criteria:
Inclusion Criteria:

* All maltreated children placed in foster care, aged between 6 and 60 months, whose parents give informed opt-in consent

Exclusion Criteria:

* Children with profound learning disability
A Study Comparing the Safety, Tolerance, and Efficacy of Various Doses of SK-0403 Versus Placebo and Sitagliptin 100 mg in Patients Not Well-Controlled on Metformin Therapy

The purpose of this study is to evaluate the safety and efficacy of a range of doses of SK-0403 in subjects with type 2 diabetes that are not adequately controlled on metformin alone.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with type 2 diabetes between 18 and 75 years of age, inclusive
* Screening HbA1c between 7.0% to 10.0% for metformin stable subjects, 6.5% to 9.0% for subjects on metformin and 1 other antidiabetic agent (excluding thiazolidinediones, insulin, or incretin therapies \[DPP-4 inhibitors and GLP-1 analogues\]), or 7.5% to 11.0% for subjects on no antidiabetic medication or, if taking metformin, not on a stable dose of 1500 mg/day or maximum tolerated dose.
* No antidiabetic medication other than metformin for 3 months prior to randomization.
* Fasting plasma glucose less than 270 mg/dL (15 mmol/L) at screening.
* Body mass index between 20 kg/m2 and 45 kg/m2 inclusive at screening.

Exclusion Criteria:

* History of type 1 diabetes.
* Received treatment with insulin within 30 days of the screening visit or for more than 1 week within 3 months of the screening visit.
* Use of 3 or more oral antidiabetic medications at the time of the screening visit.
Dry Needling Versus Stretching for Muscle Extensibility

Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Currently several authors have shown the presence of active myofascial trigger points (MTrP) in the muscles surrounding the hip joint that reproduce the symptoms of the patients with hip OA.

Despite of the beneficial effects that have shown may conservative non-pharmacological treatments, there is a lack of studies evaluating the effects of the conservative treatments on muscle extensibility.

According to the new paradigm about the presence of MTrPs, the investigators decided to conduct a randomized clinical trial to compare the effects of DN intervention and stretching protocol on muscle extensibility in patients with hip OA.


Eligibility Criteria:
Inclusion Criteria:

* unilateral hip OA diagnosed medically with a X-Ray tess and following the American College of Rheumatology Criteria

Exclusion Criteria:

* Secondary osteoarthritis by a traumatism, Paget disease, inflammatory or metabolic disease, congenital diseases etc.
* Vascular or neurological disease.
* Musculoskeletal pathologies in lumbar spine, pelvis or lower limbs
* DN contraindications or fear of needles
Waveform Analysis of the Doppler Curve of Ophthalmic Arteries in Glaucoma Patients

Color Doppler Imaging (CDI) has been providing information about ocular blood flow over the past decades. This non-invasive procedure based on ultrasound technique has identified increased resistance and decreased systolic blood velocities to exist in the ophthalmic arteries of glaucoma patients. However, existing data has provided very little information regarding the analysis of the Doppler waveform in itself and to whether variables such as early systolic acceleration or systolic/diastolic velocity ratios are of any significance in glaucoma disease. In other medical specialties using CDI technology, such as nephrology or cardiology for instance, this analysis has been part of the normal routine. This information has been used in screening patients for disturbed circulation such as arterial stenosis or providing information regarding prognosis of renal and hepatic transplants have been used for decades now.

What is the normal characteristics of the waveform Doppler analysis? To answer this, the investigators will create a normative database using healthy controls.

Are there signs of altered stiffness or compliance in the ophthalmic arteries of glaucoma patients? To answer this, the analysis of early acceleration acceleration and detection of an early peak systolic will be done on the Doppler curves of glaucoma patients and compared to the healthy normative database.

Are there any difference between the two types of glaucoma \[primary open-angle glaucoma (POAG) and normal-tension glaucoma (NTG)\]? The investigators will compare the variables of the ophthalmic artery waveform in these two groups.

Do any of these Doppler waveform variables have any clinical significance? To answer this, the investigators will search for the existence of any correlation between the waveform data and both functional (visual field testing) and structural (Confocal scanning laser ophthalmoscopy - CSLO) variables of the glaucoma groups.

1. Color Doppler imaging of the ophthalmic artery will be performed 2. Visual field testing will be done 2. CSLO will be done

Eligibility Criteria:
Inclusion Criteria:

* • individuals over 18 years old

  * willing to sign an informed consent and able to comply with the requirements of the study
  * having no other ocular diseases besides glaucoma

Exclusion Criteria:

* • history of ocular trauma

  * intraocular surgery (except for cataract surgery)
  * eye disease (except glaucoma)
  * systemic diseases with ocular involvement like diabetes
Pilot Randomized Controlled Trial of a Collaborative Agenda-setting Intervention (CASI) for Patients With Ovarian Cancer

This research is being done to test a new communication tool for people with ovarian cancer, caregivers, and clinicians.

The name of the intervention in this research study is:

-Collaborative Agenda-Setting Intervention (CASI)

This two-arm, parallel group-randomized research study is to test a new communication tool (CASI) for people with ovarian cancer, caregivers, and clinicians. This is a pilot feasibility study, which means this is the first time researchers are studying CASI. Clinicians will be randomized into one of the two study groups, Arm 1 or Arm 2, and patients and caregivers will be enrolled in the study arm to which their clinician has been randomized.

The research study procedures include screening for eligibility, audio recorded clinic visits, and questionnaires.

Participation in this research study is expected to last for up to 12 weeks for patients and caregivers, and for up to 52 weeks for clinicians.

It is expected that up to 112 people will take part in this research study, including up to 50 patients, 50 caregivers, and 12 clinicians (six dyads).

The National Institute for Nursing Research is supporting this research by providing funding.

Eligibility Criteria:
Participant Inclusion Criteria:

* At least 18 years old
* Able to speak, understand, and respond to questions written in English
* Willing to be audio recorded
* Have a diagnosis of advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease)
* Be under the care of a participating clinician dyad
* Be scheduled for chemotherapy during the recruitment period
* Be signed up or willing to sign up for Patient Gateway

Caregiver Inclusion Criteria:

* At least 18 years old
* Able to speak, understand, and respond to questions written in English
* Willing to be audio recorded
* Be a family member, partner, or friend of a patient participant with whom the patient participant discusses their cancer care

Clinician Inclusion Criteria:

* Be employed at DFCI as an oncologist, nurse practitioner, or physician assistant
* Take care of at least 4 patients per month with advanced ovarian cancer (defined as stage III, stage IV, or recurrent disease) in the outpatient setting

Participant Exclusion Criteria:

* Age of \<18 years
* Unable to consent
Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia

This study investigated the short term effects of repeated administrations of repetitive-transcranial magnetic stimulation (rTMS) on clinical changes and investigate neurophysiologic responses to rTMS of the activated motor system in patients with FHD.

Purpose: The ability of low-frequency repetitive transcranial magnetic stimulation (rTMS) to enhance intracortical inhibition has motivated its use as a potential therapeutic intervention in focal hand dystonia (FHD). In this preliminary investigation, we assessed the physiologic and behavioral effects of multiple sessions of rTMS in FHD. Methods: 12 patients with FHD underwent five daily-sessions of 1 Hz rTMS to contralateral dorsal premotor cortex (dPMC). Patients held a pencil and made movements that did not elicit dystonic symptoms during rTMS. We hypothesized that an active but non-dystonic motor state would increase beneficial effects of rTMS. Five additional patients received sham-rTMS protocol. The area under curve (AUC) of the motor evoked potentials and the cortical silent period (CSP) were measured to assess changes in corticospinal excitability and intracortical inhibition, respectively. Behavioral measures included pen force and velocity during handwriting and subjective report.

Eligibility Criteria:
Inclusion Criteria:

* Task specific Focal Hand Dystonia

Exclusion Criteria:

* any neurologic condition other than FHD
* medication for dystonia
* botulinum toxin within the past three months
* seizure history
* pregnancy
* implanted medical devices
A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease

A Randomized, Double-Masked, Vehicle-Controlled Parallel Group Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Dry eye chamber challenge trial

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age (either gender and any race)
* Ability to provide written informed consent and sign the Health Information Portability and Accountability Act form
* Reported history of ocular discomfort associated with dry eye disease for at least 6 months prior to Visit 1
* Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion Criteria:

* Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
* Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
* Contact lens use within 7 days of Visit 1 or anticipated use of contact lenses during the trial
* Previous laser-assisted in situ keratomileusis surgery within the last 12 months
* Systemic corticosteroid or other immunomodulator therapy (not including inhaled corticosteroids) within 14 days of Visit 1, or any planned immunomodulatory therapy throughout the clinical trial
* Use of and unwillingness to discontinue topical ophthalmic prescriptions (including medications for glaucoma) or over-the-counter solutions (not including artificial tears), gels, or scrubs for the duration of the trial (excluding medications allowed for the conduct of the trial)
Study and Monitoring of Multiple Endocrine Neoplasia Type 1

Multiple Endocrine Neoplasia Type I (MEN1) is a rare autosomal dominant disorder, predisposing sufferers to the development of endocrine tumors. The three most commont endocrine disorders of MEN1 are the secretory tumours of the parathyroid, pituitary gland and pancreas, in addition to which other tumours may be observed.

The diagnosis of MEN1 is essential for 1) appropriate therapeutic management of proven endocrine disorders, 2) screening for other endocrine and non-endocrine tumours, 3) family screening of affected relatives and 4) monitoring of patients who have been diagnosed. Undiagnosed MEN1 is one of the reasons for therapeutic failure in the management of endocrine damage. Detection is therefore of major importance, and any improvement in early diagnosis can improve management.

The natural history of the disease in all its clinical forms remains poorly understood, with published studies of selected or small populations. There are still clinical forms that are difficult to link to the syndrome. These clinical forms need to be specified in order to ensure optimal management. Only a large cohort will lead to the identification of the various forms of this condition and clarify its prognosis.


Eligibility Criteria:
Inclusion Criteria:

SYMPTOMATIC PATIENTS

* person (adult or minor) who has not opposed participation
* if the patient is a minor, the parents must not oppose their child's participation,
* at least two of the three main types of lesions (parathyroid, pancreas, pituitary gland)
* OR a known isolated tumor, main type or not, associated with the gene mutation of the NEM1 locus on chromosome 11q13
* OR an isolated tumor, main type or not, in an individual with a confirmed family history of NEM1

ASYMPTOMATIC PATIENTS WITH A MUTATION

- Presence of a characteristic mutation of NEM1

Exclusion Criteria: NA
Sub-chronic Effects of 5-hydroxytryptophan on Mood and Emotional Processing in Healthy Volunteers

5-hydroxytryptophan (5-HTP) is a nutritional supplement sold in many health food stores, and is taken in order to raise levels of serotonin in the brain. Serotonin is a neurotransmitter that is involved in the regulation of mood.

Previous research has assessed the effects of raising serotonin levels using tryptophan (the precursor of 5-HTP) and serotonergic antidepressants on emotional processing in healthy volunteers. However, to date there has been no human trial investigating the effects of 5-HTP on emotional processing in healthy volunteers.

Thus, the current study aims to assess the effects of 5-HTP, on emotional processing and mood in healthy volunteers.

The serotonin precursor 5-HTP is sold as a nutritional supplement and has been used to offset low mood for over 30 years due to its ability to raise levels of neural serotonin. However, evidence for the efficiency of 5-HTP is limited and the mechanism of action of 5-HTP in offsetting low mood has not been well-characterised.

The current study assessed the ability of 5-HTP to induce biases for positive emotional material in healthy volunteers, similar to those induced by serotonergic antidepressants and the nutritional supplement tryptophan. The effects of 5-HTP on subjective mood and depressive symptoms were also assessed.

Participants were randomised to receive either 150mg of 5-HTP or placebo daily for 14 days. Depressive symptoms and subjective mood were assessed pre- and post-intervention. Emotional processing was assessed on the 15th day using a battery of emotionally valenced cognitive tasks.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female
* Healthy
* Aged 18-65
* Not taking any herbal or prescription medications (excluding contraceptive pill)
* Free from depressive illness or mood disorder for the last 6 months
* Free of physical illness

Exclusion Criteria:

* Physically ill
* History of medical illness
* Current or previous (6 month) history of psychiatric disorder
* Pregnant/breastfeeding
* Allergy or hypersensitivity to any of the ingredients contained in the investigational product
* Taking any medication (excluding contraceptive pill)
Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication

The study aimed to compare the efficacy and safety of dual and quadruple regimens with different durations (7-day, 10-day, 14-day) for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-70 years old
2. Patients with H.pylori infection (13C/14C-urea breath test)
3. Patients without previous treatment for H. pylori eradication

Exclusion Criteria:

1. Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%
2. Patients with active gastrointestinal bleeding
3. Patients with a history of upper gastrointestinal surgery
4. Patients allergic to treatment drugs
5. Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks
6. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial
7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
8. Patients who are unwilling or incapable to provide informed consents
Biomarkers in Native American Women With Breast Cancer

RATIONALE: Studying samples of tumor tissue in the laboratory from Native American women with breast cancer may help doctors identify and learn more about biomarkers related to breast cancer in these patients. It may also help doctors learn more about the prognosis of these patients.

PURPOSE: This laboratory study is looking at biomarkers in Native American women with breast cancer.

OBJECTIVES:

* Evaluate a selected panel of molecular markers in tissue specimens from Native American women with breast cancer.
* Determine which molecular markers provide independent prognostic information with respect to traditional prognostic factors in these patients.
* Compare and contrast the prevalence of positivity in Native American women with breast cancer with an age- and stage-matched cohort of Caucasian women with breast cancer enrolled on clinical trial NCCTG-77-30-51 or the Mayo Breast Cancer Registry.

OUTLINE: Immunohistochemistry is performed on tumor samples to analyze the following molecular markers: estrogen receptor, progesterone receptor, c-erbB2, p53, Ki-67, Bcl-2, Bax, cyclin D-1, and insulin-like growth factor-1R.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of primary adenocarcinoma of the breast in Native American women
* Prior surgical treatment for breast cancer within the Aberdeen or Phoenix areas of the Indian Health Service or the Alaska area of the Native Health Service between 1990-2000

  * Paraffin-embedded tissue available
* Paraffin-embedded tissue available from Caucasian women with breast cancer enrolled on NCCTG-77-30-51 or the Mayo Breast Cancer Registry

PATIENT CHARACTERISTICS:

Age

* 18 and over

Sex

* Female
Study of ABT-263 When Administered in Combination With Either Fludarabine/Cyclophosphamide/Rituximab or Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia

This is a Phase 1 study evaluating the safety of ABT-263 administered in combination with either FCR or BR in subjects with relapsed or refractory chronic lymphocytic leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Must have relapsed or refractory Chronic Lymphocytic Leukemia (CLL), received no more than 5 prior myelosuppressive/chemotherapy regimens and must be a candidate for treatment with either Fludarabine/Cyclophosphamide/Rituximab (FCR) or Bendamustine/Rituximab (BR);
* Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of \</=1;
* Must have adequate bone marrow independent of growth factor support (with the exception of subjects with bone marrow heavily infiltrated with underlying disease \[80% or more\] who may use growth factor support to achieve Absolute Neutrophil Count (ANC) eligibility criteria), per local laboratory reference range at Screening as follows: ANC \>/=1000/mcL, Platelets\>/= 100,000/mm3 (entry platelet count must be independent of transfusion within 14 days of Screening),Hemoglobin \>/= 9.0 g/dL.

Exclusion Criteria:

* Subject has history or is clinically suspicious for cancer-related Central Nervous System disease;
* Has history of severe allergic or anaphylactic reactions to human, humanized, chimeric or murine monoclonal antibodies;
* Has undergone an allogeneic stem cell transplant; Exhibits evidence of other uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection, diagnosis of fever and neutropenia within 1 week prior to study drug administration;
* Has underlying, predisposing condition of bleeding or currently exhibits signs of bleeding; Has a recent history of non-chemotherapy induced thrombocytopenic associated bleeding;
* Currently receiving or requires anticoagulation therapy;
* Has active immune thrombocytopenic purpura (ITP) or a history of being refractory to platelet transfusions (within 1 year prior to 1st dose of study drug);
* Has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.
Effect of Transcranial Direct-current Stimulation Therapy on Primary Chronic Insomnia Patients

To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct current stimulation (tDCS) in the patients with primary chronic insomnia .

* visit 1

  * to fill in a questionnaire (Clinical Global Impression, CGI; Leeds Sleep Evaluation Questionnaire, LSEQ; Stanford Sleepiness Scale, SSS; Hospital Anxiety and Depression Scale, HADS; 36-Item Short Form Survey, SF-36)
  * EEG
* visit 2-6

  * tDCS stimulation (monday \~ friday)
  * anodal / cathodal / sham
  * to fill in a questionnaire (CGI, LSEQ, SSS, HADS)
  * analysis the results of sleep log and actigraphy
* visit 7 : 1 week after treatment

  * to fill in a questionnaire (CGI, LSEQ, SSS, HADS)
  * analysis the results of sleep log and actigraphy
  * EEG
* visit 8 : 1 month after treatment

  * to fill in a questionnaire (CGI, LSEQ, SSS, HADS, SF-36)
  * analysis the results of sleep log

Eligibility Criteria:
Inclusion Criteria:

* adult (older than 19 years)
* primary insomnia
* right handed
* agree with participation of this study

Exclusion Criteria:

* diagnosed with epilepsy or history of seizure
* change of antipsychotic drug within 1 month
* under suspicion of sleep apnea or periodic limb movement disorder
* mental retardation (IQ \< 70)
* pregnant woman