cyrilzakka/clinical-trials huggingface dataset:
The Value of Botox-A for Management of Low Anterior Resection Syndrome

Low anterior resection syndrome (LARS) is frequent after treatment for low rectal cancer. Increased bowel frequency and urgency with rectal spasms and incontinence have deleterious impacts on quality of life in a third of the cases.

One possible physiopathology hypothesis suggests an ongoing spastic process; different mechanisms have been postulated. These include alteration of normal anorectal sensation with loss of the recto-anal inhibitory reflex (RAIR), decreased rectal compliance and reduced rectal capacity as well as sphincter damage secondary to preoperative chemoradiation therapy or during surgery.

Current available treatments are often ineffective, highlighting the need for more successful management. Botulinum toxin A (BTX-A) is a neurotoxin inhibiting acetylcholine release at the neuromuscular junction. It is currently used for the treatment of various smooth muscle spastic diseases.

The hypothesis of this study is that intra-rectal BTX-A injections could represent a medical treatment alternative for LARS. The goal of this study is to document the effects of intra-rectal BTX-A injections on sphincter function and quality of life of patients with LARS.

No more information desired

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Aptitude to sign informed consent
* Diagnosis of low anterior resection syndrome (LARS) : More than 12 months after sphincter-preserving surgery for treatment of locally advanced rectal cancer, Mild to moderate underwear soiling, Baseline Wexner score ranging from 0-16 (moderate symptoms, and Patient-reported imperious defecation or Patient-reported incomplete stool evacuation
* Digital rectal exam (by surgeon) demonstrating satisfying anorectal tonus considering prior radical rectal surgery.
* Willingness to complete questionnaires and manometric studies before and after Botox-A administration
* Prior failed medical treatment, at least one attempt (narcotics, loperamide, cholestyramine, fibers)

Exclusion Criteria:

* Inability to sign informed consent
* Counter-indication to Botox-A administration : Allergy to Botox-A or its ingredients (Clostridium botulinum type A neurotoxin complex, human albumin and sodium chloride, Allergy to other forms of botulinum toxin (Dysport, Xeomin or Myobloc, Myasthenia gravis, Eaton-Lambert syndrome, lateral amyotrophic sclerosis or any other neurological disease which might interfere with neuromuscular function
* Prior use of any form of botulinum toxin A, for any indication
* Infection at proposed Botox-A injection site
* Personal or family history of bleeding diathesis
* Pregnancy or breastfeeding
* Severe incontinence (Wexner score ≥ 17 or daily use of diapers)
* Patient taking anticoagulant. ASA ( acetylsalicylic acid) allowed
Surgical Correction of Astigmatism

Laser correction for myopia and astigmatism using an excimer laser has been performed with success for several years.

During the last 2 years, a new method for correction of refractive errors has emerged. In the method (ReLex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is subsequently removed. For simple myopia this method has proved effective and on par with excimer baser LASIK. However, it remains to be determined if ReLEx is as effective in the treatment of astigmatism.

In the study, patients with high astigmatism are treated with conventional LASIK for astigmatism in one eye and with ReLEx for astigmatism in the other.


Eligibility Criteria:
Inclusion Criteria:

* Myopic astigmatism between -2.0 and -5.0 diopters
* Maximal difference in spherical equivalent refraction of 2 D between eyes
* No ocular or systemic disease
* Not pregnant or breastfeeding
* Minimum BSCVA of 0.8 (decimal)
* Normal corneal topography
* Sufficient corneal thickness to allow the treatment

Exclusion Criteria:

* Subjects not fulfilling the above criteria
Impact of Self-Management Strategies in Self-Reported Bruxism

This study aim to evaluate the effects of a 6-week self-management program on pain, muscle stiffness, and temporomandibular joint (TMJ) functions in sedentary individuals aged 18-40 with bruxism. Thirty-five individuals will be evaluated. Bruxism will be assessed using the Bruxism Assessment Questionnaire, while temporomandibular joint dysfunction (TMJD) will be evaluated using the Helkimo Clinical Dysfunction Index and the Fonseca Questionnaire. Masseter muscle pain threshold will be measured with a digital algometer, muscle stiffness with a Shore Durometer, mandibular depression range of motion with a bicondylar caliper, and TMJ proprioception with TMJ position sense. Assessments will be conducted pre-intervention and at the end of the fourth week.

The 4-week self-management program significantly increased the masseter pain threshold (p\<0.001) and reduced muscle stiffness at rest and during contraction (p\<0.001). TMJD severity, as measured by the Helkimo Index (p=0.010) and Fonseca Questionnaire (p\<0.001), was significantly reduced. Additionally, TMJ position sense and mandibular depression range of motion improved significantly (p\<0.001). Self-management strategies positively impact bruxism symptoms, including pain, muscle stiffness, and TMJ functions. These strategies should be considered an integral part of TMJD and bruxism management.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 40 years
* Sedentary lifestyle
* Clinical diagnosis of sleep and/or awake bruxism

Exclusion Criteria:

* Significant musculoskeletal disorders of the cervical or thoracic spine
* Chronic illnesses
* Neurological conditions affecting balance and postural control
* Pregnancy
* The presence of dental prostheses
* Participants who missed more than 15 sessions
A Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women

To determine the efficacy of escitalopram in treating depression in HIV seropositive women.

To determine the efficacy of escitalopram in treating depression in HIV seropositive women.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depression based on DSM-IV criteria;
* age 18-70 years;
* Greater than 15 on MADRS for severity of depression;
* HIV seropositive;
* no new antiviral medications over the past 2 months;
* involved in active treatment for HIV disease,
* negative serum pregnancy test
* Those subjects who are actively being treated for depression but show no improvement as defined by self-reported failure to improve with current treatment or residual depression as demonstrated by a MADRS of 15 or greater will be asked to participate in the study as well.

Exclusion Criteria:

* The presence of an active and significant psychiatric disease other than Major Depressive Disorder as diagnosed on MINI in the last 3 months;
* meeting DSM-IV criteria for an Axis I disorder within the last three months, or meeting criteria for substance abuse within the last 12 months;
* current pregnancy or lactation if breast feeding;
* history of hypersensitivity, intolerance, or contraindication to LEX;
* baseline creatinine of 2.5 or greater;
* patients taking anticoagulants;
* history of diagnosed gastric or duodenal ulcer;
* history within past year of bleeding or clotting diathesis;
* lifetime history of myocardial infarction or cerebrovascular accident;
* history of surgery within the past 3 months;
* inability to follow study procedures or complete the study;
* the use of any antidepressant medications within 5 half-lives of randomization;
* women of child-bearing potential who will not agree to use approved means of birth control during the trial;
* other reason that the primary investigator believes that the subject will be unable to complete trial or has medical/psychiatric contraindications to the trial.
* Individuals who are currently being treated for depression and show significant improvements in their depression such that discontinuing their current antidepressant therapy would likely have negative clinical consequences will be excluded from participating in this study.
* Individuals who are or become suicidal will be excluded from this study.
Comparative Analysis of Filmed Sequences for the Assessment of Discomfort in Atopic Dermatitis of Infants Under 6 Months of Age

Atopic dermatitis (AD) is an frequent chronic and itchy inflammatory dermatitis which concern about 20% of pediatric population with a revelation usually toward 3-6 months of live. However, there are very few data about the prevalence of pruritus of young infants and about the discomfort linked with it. While the skin and the nervous system of young infants (Under 6 month) are competent in pruritus experiment, the acquisition of conscious and deliberate motor ability allowing specific scratching of the body parts which are affected is possible only from 6 month. Thus, the diagnosis of AD intensity and the assesment of the potential associated discomfort are hard. At the present time, the diagnosis and the assesment of pruritus of children are based on a hetero-assesment via scales which are not applicable for infants under 6 month. The visual scale "Numeric Rating Scale" validated in adult population seems to be the most specific to assess AD severity. In pediatric population, the use of "Eppendorf Itch Questionnaire" and the american version of "Childhood Atopic Dermatitis Impact Scale" are recommended. Alternatives to clinic and subjective scoring of pruritus severity are described via actigraphy. Thus, a strong statistic correlation have been demonstrated between a nocturne measure of motor activity of wrist, as a reflect of the intensity of pruritus, and infra-red video analysis. But, once again, the technic is not adapted to young infants because of the absence of conscious and oriented motor ability and as a result of less organised sleep/wake cycle.

In order to improve young infants' (Under 6 month) care, the analysis of their behaviours with AD seems to be necessary to better identify a discomfort of these patients.


Eligibility Criteria:
Atopic dermatitis patients :

Inclusion Criteria:

* Young infant Under 6 month
* Patient with AD (SCORAD between 25 and 50 for moderate AD and \> 50 for severe AD)
* Informed consent of the patient's parents

Healthy patients :

Inclusion Criteria:

* Young infant under 6 month
* Free of any pathology
* Informed consent of the patient's parents

Exclusion Criteria (for every patients) :

* Acute intercurrent disease
* Severe malformation
* Underage parents or parent unable to give their consent
Retraining of the Amygdala and Insula for the Treatment of Persistent Covid

Prolonged COVID, also known as post-COVID or Sar-CoV-2 infection with post-acute sequelae, refers to a set of multi-organ symptoms that persist in patients who have suffered SARS-CoV-2 infection, even after of the acute phase of the disease. Approximately 10% of people experience this set of symptoms after their acute COVID has resolved. Such symptoms may include respiratory problems, myalgia, extreme fatigue, moodiness, cognitive impairment, and difficulty sleeping.

Psychological therapies, such as mindfulness, have already demonstrated their effectiveness in pathologies of this type, improving mental health and physical function, as well as reinforcing acceptance and reducing symptoms. Specifically, amygdala-insula training was originally designed for patients with chronic fatigue syndrome as a method of reducing chronic over-sensitization and heightened fear response of the amygdala, which may be behind some of the symptoms related to both with this pathology as with fibromyalgia.

A lot of research is currently being done on different types of treatments such as pharmaceutical, biological, dietary, homeopathic and rehabilitation for the treatment of persistent COVID; however, an effective treatment has not yet been found. Therefore, this study aims to evaluate the impact of a retraining intervention of the amygdala and insula for the improvement of the quality of life of patients with persistent COVID.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-30 years old.
* Grant informed consent.
* Diagnosis of persistent COVID by primary care physicians.

Exclusion Criteria:

* Age: \<18 years old
* Serious medical or psychiatric illnesses
Neoadjuvant FDC With Melatonin or Metformin for Locally Advanced Breast Cancer.

This study evaluates the addition melatonin and metformin to conventional chemotherapy FDC (Fluoruracil, Doxorubicin, cyclophosphamide) in the treatment of locally advanced breast cancer. Third of patients will receive FDCх6 cycles, other third will receive combination of melatonin and FDCх6 cycles and other patients will receive combination of metformin and FDCх6 cycles.

The treatment of locally advanced breast cancer is a complicated issue. For neoadjuvant treatment is often needed to downstage locally advanced BC tumors prior to surgery, however many patients do not achieved objective response during treatment. The ability of melatonin and metformin to decrease side effects of chemotherapy had been investigated, moreover several studies confirm, that this drugs in combination with conventional treatment may increase objective response. But, this data is still controversial. We hypothesized that combinations of melatonin and conventional chemotherapy regimen such as FDC could be more effective than FDC alone in terms of response rate.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18. Obtained Inform Consent Morphologically confirmed breast cancer stage IIB, IIIA,IIIB,IIIC. ( triple negative, luminal B) Eastern Collaborative Oncology Group Performance Status Scale 0 - 2. Expected survival \>6 month Adequate liver and bone marrow function

Exclusion Criteria:

* Systemic treatment for breast cancer IV stage disease Evidence of liver and bone marrow clinically meaningful disfunction Severe uncontrolled concomitant conditions and diseases Pregnancy or lactation Second malignancy Diabetes mellitus requiring drug therapy Any condition preventing study participation by investigator opinion
Characterizing a 5P-Linked BHR Susceptibility Locus

To identify the predisposing genes responsible for asthma and bronchial hyperresponsiveness (BHR) at region 5p13.3 in an inbred Hutterite community.

BACKGROUND:

Asthma is the most common chronic disease in industrialized nations, affecting more than10 million people in the U.S. alone. Familial aggregation and concordance rates in monozygotic twins have suggested a genetic component to asthma. Dr. Ober and colleagues have been conducting studies on the genetics of asthma and atopy in the Hutterites, an inbred population of European origins that practices a communal lifestyle. A genome-wide screen with 564 markers (average spacing 6 cM) was completed in an extended pedigree of 717 Hutterites who were well characterized with respect to asthma, atopy, and related phenotypes. These individuals are descendants of only 64 ancestors who lived in the early 1700's to the early 1800's. Evidence for linkage with bronchial hyperresponsiveness (BHR) by the likelihood ratio test extended over 30 centimorgans (cM) on chromosome 5p, with P-values as small as 0.001. Additional evidence for linkage at this same location was evident by the transmission disequilibrium test (P=0.0061). Typing additional markers in this region identified a critical region of 2.4 cM, corresponding to 1.5 Mb of DNA, and a high risk haplotype that is over transmitted to affected individuals.

The study was conducted in response to a Request for Applications, "Positional Candidate Approaches in Asthma Gene Discovery" released in Ocatober, 1999.

DESIGN NARRATIVE:

Dr. Ober and colleagues characterized the 5p-linked BHR susceptibility locus in the inbred Hutterites by positional cloning and replicating these findings in outbred, ethnically diverse populations. They examined single nucleotide polymorphisms (SNPs) spaced about 10 kb apart in each gene, and assessed the evidence for over transmission to affected offspring with each SNP and SNP haplotypes. Associations in the Hutterites were replicated in two outbred samples (a Caucasian sample from Germany, and an African American sample from Chicago). The functional effects of associated variants were assessed by in vitro assays as well as by genotype-phenotype studies in outbred samples that had been evaluated for asthma and atopy phenotypes. Identifying asthma or BHR susceptibility loci may identify novel pathways in asthma pathogenesis, thereby allowing for the development of new therapies and intervention strategies for these common diseases.

Eligibility Criteria:
No eligibility criteria
PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily

The primary objective of the study is to determine the effect of bismuth subsalicylate (Pepto-Bismol®) 524 mg versus placebo on gastrointestinal (GI)-related events reported in healthy volunteers receiving TECFIDERA™ (dimethyl fumarate \[DMF\]; also known as BG00012) twice daily (BID) The secondary objectives of this study in this study population are: To characterize the effect of bismuth subsalicylate (Pepto-Bismol®) 524 mg versus placebo on the frequency, severity, and duration of GI-related events and to evaluate GI-related events that lead to discontinuation of DMF.


Eligibility Criteria:
Key Inclusion Criteria:

* Must be in good health as determined by the Principal Investigator (PI) based on medical history and Screening evaluations (clinical laboratory evaluations, 12-lead electrocardiogram (ECG), and vital signs; see below for specific exclusion criteria).
* Must have a body mass index (BMI) of 18.0 to 34.0 kg/m2, inclusive.
* Subjects of reproductive potential (including males) must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study drug.
* Male subjects must agree to not donate sperm for 90 days after their last dose of study drug.
* Must be naïve to dimethyl fumarate (DMF) or fumaric acid esters.

Key Exclusion Criteria:

* History of or positive results at the Screening visit for HIV.
* History of or positive results at the Screening visit for hepatitis C virus antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\]).
* History of clinically significant gastrointestinal (GI) disease as determined by the PI (including Crohn's disease, peptic ulcer disease, ulcerative colitis, or confirmed diagnosis of irritable bowel syndrome) or active GI disease with ongoing symptoms.
* History of severe allergic or anaphylactic reactions, considered clinically relevant by the PI.
* Known allergy to Pepto-Bismol®, salicylates, or non-steroidal anti-inflammatory drugs, considered clinically relevant by the PI.
* Female subjects who are pregnant based on results of the serum pregnancy test at Screening or currently breastfeeding.
* Current enrollment in any other study treatment or disease study.
* Receipt of any investigational drug within 5 half-lives or 30 days, whichever is longer, prior to study entry.
* History of alcohol abuse or substance abuse (as determined by the PI) within the previous 5 years, a positive urine drug/alcohol test at Screening, or alcohol use prior to the screening visit.
* Regular use of any tobacco product, defined as smoke or smokeless product use equivalent to \>5 cigarettes/day for any consecutive week, within 3 months prior to Day 1.

Other unspecified reasons that, in the opinion of the PI or Biogen Idec, make the subject unsuitable for enrollment.

Other protocol-defined Inclusion/Exclusion criteria may apply
Wireless, Intermittent Monitoring of Right Heart Pressures in HF

The purpose of the trial is to evaluate the wireless monitoring of pulmonary artery pressure using the CardioMEMS HF Pressure Measurement System in adult subjects with NYHA Class III Heart Failure.

The trial is designed to demonstrate that the CardioMEMS Sensor can be positioned in the right or left pulmonary artery, and that Sensor pressure measurements correlate to standardized methods of intra-cardiac pressure measurements post-sensor implant and at the 60 day visit. Safety will be monitored by the occurrence of adverse events throughout the trial.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or female, at least 18 years of age
2. Subjects of childbearing age who have a negative serum pregnancy test, and at screening have agreed to use a reliable mechanical or hormonal form of conception during the study.
3. Subject has a diagnosis of New York Heart Association (NYHA) Class III HF at screening and at baseline.
4. Subject is able and willing to provide written informed consent or the subject guardian is able and willing to provide informed consent.
5. Subject has life expectancy of 1-2 years.

Exclusion Criteria:

1. Subject has unstable medical condition or impairment other than a medical condition associated with HF which would significantly increase the subject's morbidity or mortality risk.
2. Subject is unable to tolerate a right heart catheterization.
3. Subject is planned to undergo a heart transplantation or cardiac surgery within 2 months after enrollment.
4. Subject has permanent indwelling central venous catheter.
5. Subject has history of myocardial infarction (MI), unstable angina, stroke, transient ischemic attack, or intractable arrhythmias within last 2 months.
6. Subject has history of congenital heart disease or prosthetic valve on right side.
7. Subject has unstable hypertension.
8. Subject has a known coagulability disease state.
9. Subject has a known hypersensitivity and/or allergy to aspirin and clopidogrel.
10. Subject has active lung infection or acute pulmonary decompensation.
11. Subject has elevated white blood cell count and signs of infection are evident.
12. Subject has chronic renal insufficiency as defined by serum creatinine of greater than or equal to 2 mg/dl or requirement for dialysis.
13. Subject who is pregnant or lactating or might become pregnant during the duration of the study.
14. Subject who is participating in another therapeutic interventional trial.
15. Subject has other medical, psychological, or social circumstances that may affect the ability to comply with the study requirements or increase risk to the subject.