cyrilzakka/clinical-trials huggingface dataset:
The Role of Attention in Modulating the Placebo Effect

This project aims to examine whether these forms of attention to sensory information can modulate the mind-body interaction. This will be demonstrated through a study focused on the placebo effect with attention manipulation. Specifically, the project will focus on the construct of mindful attention to increase the precision of the likelihood and reduce the effects of priors, and on directed attention to modify the position and precision of the likelihood, hypothetically modulating the placebo effect.

The study involves recruiting 128 healthy individuals, who will be asked to cycle on an ergometer for approximately 60 minutes, with alternating phases in which attention will be manipulated. After an initial warm-up phase, they will receive a placebo drink, presented as "highly stimulating." An additional group of 32 participants will not receive either the placebo drink or the attentional stimuli, but will undergo the same training cycles. All participants will receive a pre-intervention assessment, and heart rate, emotions, and perceived fatigue will be monitored.


Eligibility Criteria:
Inclusion Criteria:

* Persons (18+) in good health, verified by presenting a medical certificate (sporting, competitive or non-competitive, or of good health).
* Be available to go to a gym. If not enrolled, the cost of admission is borne by the project.

Exclusion Criteria:

* known cardiovascular diseases, gastrointestinal diseases, musculoskeletal injuries, upper respiratory tract infections;
* allergy and/or intolerance to caffeine.
Pomegranate Extract Biomarker Study in Osteopenic Women

Treatment of post-menopausal subjects (with decreased bone mineral density) with pomegranate extract capsules will produce statistically significant changes in biomarkers for bone resorption and formation when compared to subjects receiving placebo.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (having had their last menstrual period within the past 15 years and an appropriate serum FSH value) 45-65 years of age;
* The subject must have a T score of -1 to -2.5 at the lumbar spine or proximal femur;
* All clinical safety laboratory values at screening and randomization must be either within the reference range or be determined by the investigator and the sponsor to be abnormal, but not clinically significant;
* The patient must have provided written informed consent.

Exclusion Criteria:

* The subject has any of the following conditions: connective tissue disease, history of clinically significant renal, hepatic pulmonary, cardiovascular, cerebrovascular, gastrointestinal, metabolic, hematological, endocrinological, urological, immunological, neurologic or psychiatric disorders, unless approved by the sponsor on a case by case basis;
* The subject has a positive test result for Hepatitis B surface antigen or antibody to hepatitis C virus at Screening;
* The subject has a known history of infection with the human immunodeficiency virus (HIV); -
* The subject has used bisphosphonate or fluoride therapy within the past 12 or 24 months, respectively;
* The subject has used denosumab within the past 24 months;
* The subject has used tibolone, parathyroid hormone (or any of its derivatives), systemic glucocorticoids or inhaled glucocorticoids, anabolic steroids or testosterone within the past 6 months;
* The subject has used estrogens, selective estrogen receptor modulators, calcitonin or calcitriol within the past 3 months;
* The subject has hyperparathyroidism, hypoparathyroidsim, hyperthyroidism, hypothyroidism, hypocalcemia, rheumatoid arthritis, paget's disease of bone, osteomalacia;
* The subject has had a bone fracture within the past year;
* The subject has acute or chronic disease requiring frequent changes in medications or dosages of chronic therapy;
* A history of alcoholism within the last 2 years or a current history of imbibing 3 or more units of alcohol per day. (1 unit is equivalent to 1 glass of wine, 1 pint of beer, or 1 shot of hard liquor);
* The subject has participated in another study with an investigational drug or device during the 30 days prior to study entry;
* The subject has a condition interfering with his ability to provide informed consent or comply with study instructions, or the patient has a condition, which might confound the interpretation of the study result;
* The subject has a condition endangering herself if she were to participate in this trial
An Open Label Study to Evaluate the Safety and Efficacy of BOR15001L7 for the Treatment of Cold Sores in Patients With Recurrent Herpes Labialis

BOR15001L7 is a natural product. The primary objective of this study is to demonstrate its non-inferiority to docosanol 10% based on the healing time of cold sores in patients with recurrent herpes labialis.

Secondary objectives are to:

1. Evaluate the efficacy of BOR1500L7 on:

   * The reduction of ulcerative lesions rates following the prodromal stage;
   * The extension of the delay prior to first ulcerative lesions occurence following the prodromal stage;
   * The decrease of cumulative ulcerative lesions dimensions during papule, vesicles, ulcers/soft and hard crust stages;
   * The decrease of symptoms intensity (pain, tingling, itching, burning sensation) during prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages;
   * The reduction of symptoms duration (pain, tingling, itching, burning sensation) during the prodromal, erythema, papule, vesicles, ulcers/soft crust, hard crust, re-epithelialize stages in subjects with recurrent herpes labialis;
2. Evaluate the safety and tolerability of BOR15001L7 in subjects with recurrent herpes labialis

Eligibility Criteria:
Inclusion Criteria:

* Provide signed informed consent and willing to comply with study-related procedures;
* Males and females ≥18 years of age at screening;
* Diagnosed with recurrent herpes labialis, defined as showing at least 2 episodes of infections per year;
* Willing to avoid, during the treatment phase, the use of anti-inflammatory, anti-herpetic, antibiotic and antiviral agents as well as steroids or other natural products that would interfere with the immune system response (exception: only the use of valacyclovir will be permitted, if prescribed);
* Willing to avoid, during the treatment phase, the use of cosmetic products (ex. cream, make-up, etc.) at areas close to the infected region.

Exclusion Criteria:

* Patients with skin disease affecting the peribuccal region (eczema, psoriasis, dermatitis, etc.);
* Patients with herpes labialis occurring within 14 days prior to screening;
* Patients known for allergies or intolerance to drug and comparator ingredients, or any cream used to treat skin conditions;
* Treatment with an investigational product or biological agent or device within 30 days or five half˗lives, whichever is longer.
* Any other condition, which, in the opinion of the investigator or the sponsor would make the patient unsuitable for inclusion, or could interfere with the conduct of the study.
Phase II Study of Recombinant Relaxin for Progressive Systemic Sclerosis

OBJECTIVES: I. Determine whether parenteral relaxin improves skin tightness, Raynaud's phenomenon, digital morbidity, and digital ulcers in a patient with progressive systemic sclerosis (scleroderma).

II. Determine whether relaxin decreases collagen production by fibroblasts in vivo and cultured from skin biopsies.

PROTOCOL OUTLINE: This is a compassionate use study. The patient is treated with subcutaneous injections of recombinant relaxin for approximately 12 months. If clinically indicated, therapy may be extended.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Progressive systemic sclerosis (scleroderma)
* No pregnant or nursing women
Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

To determine the efficacy and safety of sildenafil citrate in the treatment of established pre-eclampsia


Eligibility Criteria:
Inclusion Criteria:

* Subjects with pre-eclampsia defined as new hypertension with a diastolic BP of \> or = 90 mmHg on two occasions separated by at least 4 hrs arising after 20 weeks of pregnancy, associated with \>500 mg/24 hr proteinuria. Subjects with pre-existing hypertension (on treatment) need only fulfill proteinuria requirement.
* Gestational age 24-34 w
* Singleton pregnancy

Exclusion Criteria:

* Where urgent delivery is indicated
* Where the fetus is suspected to have a structural or chromosomal abnormality
Comparative Study of Ketamine Added to Bupivacaine in PECS Block Versus Topical Wound Instillation on Post Operative Analgesia in Modified Radical Mastectomy Surgery

Comparative study of ketamine added to bupivacaine in PECS block versus topical wound instillation on post operative analgesia in modified radical mastectomy surgery


Eligibility Criteria:
Inclusion Criteria:

- 1) female patients aged 18 - 60 years, 2) American Society of Anesthesiologists (ASA) class \| , \|\| , \|\|\| 3) With body weight of 50 - 90 kg . 4) female patients diagnosed with cancer breast and scheduled for modified radical mastectomy .

5) patients not known to be allergic to any of the medications used in the study.

Exclusion Criteria:

- 1) patients with known allergy to the study drugs . 2) patients with significant cardiac, respiratory, renal or hepatic disease . 3) patients with drug or alcohol abuse . 4) patients with psychiatric illness that would interfere with perception and assessment of pain.

5) Patients with a history of bleeding diathesis; opioid dependence; sepsis; prior surgery in the supraclavicular, infraclavicular or axillary regions.
Performance of a New Glucose Meter System in Children and Young Adults

The purpose of this study is to evaluate the performance of a new blood glucose meter in the hands of children, teens, young adults.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or Type 2 diabetes
* Age 4 to 24 years
* Routinely performs blood glucose testing at home
* If age 18 or older at time informed consent is signed, subject must be able to speak, read, and understand English.
* If younger than age 18, subject's parent/guardian must be able to speak, read, and understand English, and is able to provide appropriate supervision.
* Is willing to complete all study procedures, with or without parent / guardian supervision, if appropriate

Exclusion Criteria:

* Currently pregnant
* Hemophilia or any other bleeding disorder
* Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded
* Infection with a blood borne pathogen (e.g., HIV, hepatitis)
* Subject or parent/guardian is employee of competitive medical device company
* Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
Patching or Gaming as Amblyopia Treatment?

Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. Standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular to improve visual acuity not only in children but also in adults. In this study we aim to compare the standard occlusion therapy with dichoptic video gaming.

Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. The standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular. The rationale behind these games is by using dichoptic stimulation, with the contrast of the stimuli presented to the good eye reduced to match the appearance of the same stimuli when shown to the amblyopic eye, suppression can be alleviated. The many studies now conducted, demonstrate improvement in visual acuity with the games, the effect however is limited, but the rate of improvement is higher. In these studies, prescribed patching-time was compared to realised game-time. We have demonstrated in multiple studies that electronically measured compliance is low: on average only 50%.

In this study we aim to compare the effect of patching therapy, using the ODM to objectively measure compliance, with the effect of a novel dichoptic action video game in children as well as in adults. In addition, the adult participants will undergo fMRI scans to document any changes in the visual cortex before and after either therapy.

Eligibility Criteria:
Inclusion Criteria:

* Amblyopia; an interocular difference in visual acuity of at least 2 logMAR lines.

Exclusion Criteria:

* A non-comitant or large angle constant strabismus \>30Prism Dioptres, a neurological disorder, nystagmus, other eye disorders and diminished acuity due to medication, brain damage or trauma.
Congestive Heart Failure Weight Study

Early morning weights to monitor CHF patient's fluid status is common practice but there is a lack of evidence that this is the best practice. The purpose of this study is to determine if there is a difference in net weight gain or loss for hospitalized patients with CHF who are weighed in the evening instead of early morning.

This is a quasi-experimental pilot study with prospective cohort design. Study subjects will be weighed in the early morning and then again in the evening for a minimum of three days. Analysis will be accomplished on data by analysis within-subjects data utilizing the paired t test. Other data to be collected includes dates of hospitalization, demographics, dose and timing of medications, lab results and documentation of comorbid conditions.

Eligibility Criteria:
Inclusion Criteria:

* 18-85 years old
* Admitted to hospital with a primary diagnosis of heart failure or fluid overload
* Ambulatory with a medical order to be out of bed
* Able to stand on a scale
* Have no problems with balance

Exclusion Criteria:

* Patients with a primary diagnosis other than heart failure or fluid overload
* Patients diagnosed with renal failure
* Non-English speaking
* Unable to follow directions or consent due to cognitive impairment
* Medical order for bed rest
* Involved in another study
A Single-Center, Epidemiological Study of the Survivorship of the DePuy Sigma HP Unicompartmental Knee Prosthesis

This study will be conducted to assess the survivorship of a particular prosthesis used in unicompartmental knee arthroplasties. Patients undergoing this procedure have been diagnosed with isolated medial or lateral compartmental arthritis and have failed conservative treatment. The patients received a unicompartmental knee replacement using the Sigma® HP Partial Knee System.

This study is an epidemiological Level IV-Case Series clinical study that will study the survivorship of the Sigma® HP Partial Knee System in a consecutive series of patients. All patients who received the Sigma® HP Partial Knee System between August 21, 2008 and October 31, 2009 will be available to include in the study. Data will be collected preoperatively, intra-operatively, and post-operatively at intervals of 6 weeks, 6 months, 1 year, 2 years, and 5 years. Data will be analyzed for survivorship status at the 2- and 5-year follow-up visits. Other data, including functional outcomes, radiographic outcomes, and wear will be analyzed at the 5-year follow-up visit. Subjects will participate in the study for five years after their surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient over the age of 18
* Diagnosis of isolated medial or lateral compartmental osteoarthritis of the knee joint
* Must have failed conservative treatment and received a unicompartmental knee arthroplasty between August 21, 2008 and October 31, 2009.
* Must have received the Sigma® HP Partial Knee System.
* Must have received the surgery from Dr. Almand, Dr. Johnson, or Dr. Pickering at Mississippi Sports Medicine and Orthopaedic Center.
* Must be willing to provide written consent to participate in the study.
* Subjects who do not have the legal capacity to consent may be enrolled in the study by a Legally Authorized Representative (LAR). The LAR must provide verification that they have the legal authority to represent the subject.

Exclusion Criteria:

* Did not receive a unicompartmental knee arthroplasty between August 21, 2008 and October 31, 2009.
* Did not receive a unicompartmental knee arthroplasty using the Sigma® HP Partial Knee.
* Did not receive their unicompartmental knee replacement from Dr. Almand, Dr. Johnson, or Dr. Pickering at Mississippi Sports Medicine and Orthopaedic Center.
* Subjects lost to follow-up for any reason including, but not limited to: refusal to consent, death, or geographic isolation will also be excluded from the study.
Phase II Study in Patients With Recurrent Non-Small-Cell Lung Cancer

Determine tumor response rate and time to disease progression, survival and safety in total populations.

To determine the tumor response rate and time to disease progression, survival and safety in the EGFR-positive, EGFR-negative and total populations.

Eligibility Criteria:
Inclusion Criteria

1. Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC
2. Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination
3. Unidimensionally measurable NSCLC
4. Subjects with tumor tissue available for EGFR assessment
5. ECOG performance status of 0 or 1
6. Subjects with asymptomatic brain metastasis were eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and have been off steroids

Exclusion Criteria

1. Women of childbearing potential who were unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Male subjects must also have agreed to use effective contraception
2. Women of childbearing potential using a prohibited contraceptive method
3. Women who were pregnant or breastfeeding
4. Women with a positive pregnancy test on enrollment or prior to study drug administration.
A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence

A short presentation of a randomized clinical trial of biofeedback and anal injections as a first treatment option of faecal incontinence.

Background: Faecal incontinence affects mainly women who have suffered sphincter disruption from vaginal delivery, but individuals of all ages can be affected. The treatment of this debility is not uniform between institutions or internationally. Often is surgical reconstruction of the anal sphincter performed, or other invasive, costly treatment options.

The study: We intend to conduct a randomized, controlled, clinical trial where we compare the effect of two less invasive, less costly treatment options as a first alternative: biofeedback and anal injections. Our hypothesis is that anal injections will give a better and more lasting effect than biofeedback. The primary endpoint will be change in faecal incontinence assessed by the St. Marks incontinence score. Secondary endpoints will include change in quality of life and several physiological parameters. We intend to include 62 patients in both groups, 124 all together, from 2 centres in Norway. The observation time is 2 years. We plan to include the first patient April 2006, and conclude the study by December 2010. This study can contribute to a more appropriate treatment-algorithm for these patients.

Study group:

* Barthold Vonen MD PhD, Department of gastroenterological surgery, University Hospital of North Norway
* Rolv-Ole Lindsetmo MD PhD, Department of gastroenterological surgery, University Hospital of North Norway
* Arvid Stordahl MD PhD., Department of Surgery, Østfold Hospital Fredrikstad
* Ylva Sahlin MD PhD, Department of Surgery, Innlandet Hospital Hamar
* Trond Dehli, MD, Department of gastroenterological surgery, University Hospital of North Norway
* Kjersti Mevik, Stud. Med, University of Tromso

Project manager: Trond Dehli

Funding, approvals, publication: This study is funded from Northern Norway Regional Health Authority and The Institution of Norwegian Health- and rehabilitation-organizations. It has been approved by the Regional Committee for Medical Research Ethics and Norwegian Social Science Data Services. The results will be published in an international peer-reviewed journal after the Vancouver-convention's guidelines. The results will also be presented at national and international conferences.

Contact:

Trond Dehli, Department of gastroenterological surgery, University hospital North Norway, Breivika, 9038 Tromsø trond.dehli@unn.no tlf: +47 776 26 000


Eligibility Criteria:
Inclusion Criteria:

* Fecal incontinence lasting more than 6 months
* St. Marks score of 4 or more
* No known local or general neurological disease
* 18 years or older
* No constipation

Exclusion Criteria:

* Total rupture of the sphincter of more than 120 degrees
* Diabetes mellitus with late complications (neurological og cardiovascular)
* Ulcus simplex/rectal ulcus
* Anal/rectal prolapse
* ileo-anal anastomosis
* Cancer recti or cancer ani last 2 years
* Pregnancy
Validation of the O3 Regional Somatic Tissue Oxygenation Monitor

Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 45 years, inclusive
* Willing and able to provide written informed consent
* Healthy subjects

Exclusion Criteria:

* Pregnant women
* Presence of any cardiovascular or pulmonary disease
* Exposure to high altitude(s) (\>2000 m) within 30 days prior to the study
* Known allergy to intravenous contrast medium or heparin
* Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study
* Patients deemed not suitable for the study at the discretion of the Investigator
A Low Glycemic Load Diet During Pregnancy in Overweight Women

This study will compare the effects of a low glycemic load versus standard diet for pregnancy on outcomes related to risk for obesity, diabetes, and heart disease in both mother and infant.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with prepregnant or first trimester BMI equal to or greater than 25 kg/m2 and less than 45 kg/m2
* Singleton pregnancy
* Willing to consume the diets for duration of pregnancy
* Participant to be at week 28 or less of pregnancy at baseline visit

Exclusion Criteria:

* Smoking during pregnancy
* Major medical illness (e.g., diabetes mellitus, hypertension, thyroid disease)
* Patients taking prescription medication known to affect body weight
* Alcohol consumption during pregnancy
* Patients who declare their intention to deliver infants in the environment outside of Beth Israel Deaconess Medical Center, Boston
* High level of physical activity