cyrilzakka/clinical-trials huggingface dataset:
A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis

Symptomatic osteoarthritis (OA) is the most common joint disease and the leading cause of disability in industrialized countries. Therapeutic approaches to prevent the development and progression of osteoarthritis are disappointing and very limited. New therapeutic alternatives seem essential to better manage his daily life. Non-drug approaches, including psycho-corporal approaches are increasingly used in the management of chronic pain.

Mindfulness is a technique of attention training, which is to focus one's attention on the present moment and to examine the sensations that come to mind, how they appear, how they last time, and how they disappear.

Regarding rheumatological pathologies, a Mindfulness Program (MBSR) has shown its effectiveness in chronic pain; and in particular in osteo-articular localization, such as chronic low back pain. A recent study found a correlation between a pre-disposition to mindfulness and less pain and / or better quality of life in patients with knee osteoarthritis. However, to the knowledge of investigator, no study has evaluated the effectiveness of an intervention based on a mindfulness training program as a therapeutic alternative in osteoarthritis of the knee or hip.

The goal of investigator is to evaluate, using a randomized, controlled study, the effect of a mindfulness program (according to the MBSR protocol) on pain, function, psychological state and quality of life patients with knee or hip osteoarthritis


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee or hip (Kellgren and Lawrence X-ray stage ≥ 2)
* Mean pain VAS on at least one reference joint (knee or hip)\> 40 mm during the last week
* Stable treatment with analgesics for at least a week

Exclusion Criteria:

* Corticosteroids (oral or injectable) in the month prior to inclusion
* Intra-articular injection of hyaluronic acid in the last 3 months prior to inclusion
* Inflammatory rheumatic disease (rheumatoid arthritis, spondyloarthritis, CCPD)
* Current depressive episode
* Psychotic disorders
* Usual practice of a relaxation method (mindfulness, yoga, sophrology ...)
* Major protected by law (guardianship, curatorship or under the safeguard of justice)
* Subject in a period of exclusion relative to another protocol or for which the annual amount maximum compensation of € 4500 has been reached.
* Subject participating in another research protocol
* Subject not affiliated to a social security
* Pregnant woman, parturient or nursing, patient unable to give her major consent protected, vulnerable persons (Articles L.1121-6, L.1121-7, L.1211-8, L.1211-9)
* Subject deprived of liberty by judicial or administrative decision
Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have chronic peripheral neuropathic pain present for than 6 months after a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.
* Subjects must be literate and have the ability (unaided) to understand and use the interactive voice response system (IVRS), have daily access to a telephone in order to complete the IVRS assessments each day, perform telephone visits and complete all required assessments/forms.
* Subjects must have sufficient post-traumatic neuropathic pain at screening and baseline.

Exclusion Criteria:

* Subjects with neuropathic pain due to diabetic peripheral neuropathy (DPN), post herpetic neuralgia (PHN), HIV, trigeminal neuralgia (TGN), carpal tunnel syndrome (CTS) or with central neuropathic pain (for example, due to spinal cord injury) or with Complex Regional Pain Syndrome (CRPS, Type I or Type II).
* Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain.
* Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate course of therapy at doses greater than or equal to 150 mg/day, who have previously participated in a pregabalin clinical trial or who have been treated with pregabalin at any time during the 6 month period prior to screening.
* Subjects with epilepsy; pernicious anemia; hematological illnesses; known HIV infection; any clinically unstable cardiovascular (including a myocardial infarction \[heart attack\] in the 3 months prior to screening), hematological, autoimmune, endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the 3 months prior to screening) respiratory, or gastrointestinal disease; symptomatic peripheral vascular disease including intermittent claudication; uncontrolled diabetes mellitus; untreated hypothyroidism.
* Subjects with a diagnosis of DSM-IV TR Axis I disorder (including, for example, schizophrenia, bipolar disorder) with the exceptions of Generalized Anxiety Disorder (GAD) or major depression that is clinically stable.
* Subjects considered at risk of suicide or self-harm based on investigator judgment and/or details of a risk assessment.
* Use of prohibited medications in the absence of appropriate washout periods.
Observational Evaluation of the Peristomal Skin Condition in Ostomates

The purpose of this study is to estimate the incidence and severity of peristomal skin lesions and evaluate the progression of the peristomal skin condition at 8-15 days following application of the barrier.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are 18 years old and older.
* Subjects who agree to participate in the evaluation and who have signed the informed consent form.
* Subjects presenting with a stoma (ileostomy, colostomy or urostomy).
* Subjects for whom a ConvaTec Moldable Technology™ Skin Barrier per package insert is used as the first long-term (within 7 days of ostomy surgery) system following surgery and have intact peristomal skin.

OR

* Subjects presenting with peristomal skin lesions using a traditional barrier and for whom a decision to replace the traditional barrier with ConvaTec Moldable Technology™ Skin Barrier per package insert is made in the context of routine clinical care.

Exclusion Criteria:

* Subjects who, according to the investigator, have cognitive problems that prevent them from answering a questionnaire or for whom the evaluation could be a problem.
* Subjects who are in a simultaneous clinical evaluation.
Irritable Bowel Syndrome and Low FODMAP Diet

The patients having a syndrome SII would be more intolerant in the fructose than the healthy subjects and would benefit from a fructose diet but also from the fructans which contain some fructose. The intolerance in the fructose is diagnosed thanks to a respiratory test after absorption of fructose. However, the eviction of the fructose is sometimes recommended to the patients without having realized beforehand the test of intolerance.

The main objective is to evaluate the efficacy of the FODMAPS diet on IBS symptoms and to correlate the results with the respiratory test

Eligibility Criteria:
Inclusion Criteria:

* older than 18, patients with IBS, patients with no organic disorders, patients informed and agreed to participate

Exclusion Criteria:

* patients with sclerodermia, diabetes, obesity, anorexia, colo-rectal surgery, patients with small intestinal bacterial overgrowth, pregnancy
Exercise With Music for ICU Survivors

This project will test whether the individualized music-enhanced exercise playlist (Exercise with Music intervention) can prevent further physical and psychological deterioration and motivate ICU survivors to more actively participate in their rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old
* length of ICU stay \>5 days (excludes patients with less comorbidity)
* within 72 hours of ICU discharge (standardizes time to begin intervention)
* ability to independently move upper and lower extremities (required to participate in intervention)
* ability to speak English or Spanish

Exclusion Criteria:

* documented mental incompetence
* dependent status pre-ICU admission (KATZ, activity daily living scale)
* evidence of delirium using the Confusion Assessment Method (CAM)
* hearing impairment
* documented "comfort measures only" in the electronic medical record
* prior residence in a long-term care facility
* unstable hemodynamics
Nutritional Risk Factors and Colorectal Surgery

This observational study aims to learn about the relationship between the nutritional status of patients with colorectal cancer and clinical outcome after colorectal surgery.

The main question\[s\] it aims to answer are:

* which anthropometric, laboratory and specific parameters best define that patient is at nutritional risk
* will patients that are at nutritional risk stay longer in the hospital after surgery than those who are not at nutritional risk Patients will be preoperatively examined anthropometrically, radiologically and laboratoryally. Postoperatively, the course of their treatment will be monitored, as well as the monitoring of postoperative complications. A group of patients with and without malnutrition will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer
* First operation of this type

Exclusion Criteria:

* Urgent surgery
* Peritoneal carcinomatosis
Restless Leg Syndrome: Is There a Response to Buddhist Walking Meditation in Hemodialysis

the restless leg syndrome is a common complaint in person who undergo hemodialysis. Buddhist walking meditation efficacy was not investigated in those population

the total participants will be 40. all patients will be on hemodialyis. they complain restless leg syndrome. the participants will be divided to group I which received Buddhist walking meditation. this program of meditation will be 30 minutes thrice weekly. before and after buddhist meditation walking, there will be 5 minutes stretching exercises working as warm up or cooling down respectively. the other group will serve as control one .. the number of patient in every group will be 20. the total duration of Buddhist walking meditation will be 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* hemodialysis patient (40)
* complain of restless leg syndrome
* non obese patients

Exclusion Criteria:

* cardiac patients
* chest diseases
* mental diseases
* hepatic diseases
* lower limb orthopedic hurting
Predicting Response to Interventional Pain Management Techniques in Chronic Low Back Pain in a Prospective Cohort.

The main aim of this study is to identify factors that may be associated with a better or worse response to interventional pain management therapies for the treatment of chronic lumbar pain in adult patients. If several predictive factors are to be identified, a predictive model will be developed.

Chronic lumbar pain is a common affection in the adult population, and an important source of chronic incapacity and impaired quality of life. There is a wide range of therapeutic options for the treatment of chronic lumbar pain. This study will analyze the response to several interventional pain management techniques and will search for factors that may be associated to a better or worse response to the techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old with chronic lumbar pain to whom one of the following interventional pain management techniques has been indicated:
* Radiofrequency lumbar facet joint injection
* Radiofrequency lumbar facet joint denervation
* Lumbar epidural corticosteroid injection
* Caudal epidural corticosteroid injection
* Pulsed radiofrequency of the lumbar dorsal root ganglion
* Dorsal root ganglion injection

Exclusion Criteria:

* Patients that have not undergone the interventional pain management technique. The interventional pain management technique is considered not performed if it is not done after a twelve month period after recruitment.
* Patients who are not willing to participate.
* Patients of whom it is impossible to obtain data of response.
* Patients who undergo low back surgery while they are in the study.
* Patients who suffer from an intercurrent disease that may interfere with the evaluation of chronic lumbar pain.
* Patients who suffer from myofascial pain syndromes.
* Patients who undergo pulsed radiofrequency denervation for the treatment of sacroiliac joint syndrome.
Clomiphene Stair-Step Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome

The objective of our study is to evaluate the efficacy of the clomiphene stair-step protocol to induce ovulation in women with polycystic ovarian syndrome (PCOS) compared to traditional protocol.

Methods:This was a randomized controlled clinical trial at the Fertility clinic of Al sadder teaching hospital at Al- Najaf city, Iraq . It included 140 women who met all of the inclusion criteria, they were divided into two groups; 65 patients for the stair step protocol and 75 patients for the traditional protocol.

Overall study design This was a randomized clinical trial using toss a coin as randomization technique carried out on subfertile women attending the Fertility Clinic of AL Sadder Teaching Hospital at Al- Najaf city, Iraq from May 2010 till May 2011. 170 infertile women were selected at that time for study participation after their written consent.

Participant, recruitment and randomization:

The diagnostic criteria adopted for PCOS was according to Rotterdam ESHRE/ASRM sponsored PCOS consensus workshop group, 2004 based on the presence of two of the following three criteria: i.e. Oligo- and/or anovulation, hyperandrogenism clinical and/or biochemical, Polycystic ovaries, an ovary with 12 or more follicles measuring 2-9 mm indiameter and increased ovarian volume (\>10 cm3) on transvaginal ultrasound(1) .

Eligibility Criteria:
Inclusion Criteria:Female in the reproductive age who is subfertile with the diagnosis of polycystic ovarian syndrome, serum FSH≤10 mIU/ml with spontaneous menses or positive bleeding response to progestagen withdrawal.

-

Exclusion Criteria:Male factor (moderate to severe) infertility, bilateral tubal blockage diagnosed by hystrosalpingographgy or laparoscopy and patients on metformin or other medication.

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Affective Responses in Mountain Hiking

Using a within-subject design, 42 healthy participants were randomly exposed to three different conditions: outdoor mountain hiking, indoor treadmill walking, and sedentary control situation (3.5 hours each). Measures included the Feeling Scale, Felt Arousal Scale and a Mood Survey Scale. Univariate ANOVAs were used to analyse differences between the conditions.


Eligibility Criteria:
Inclusion Criteria:

* voluntary participation

Exclusion Criteria:

* pregnancy
* breast-feeding
* chronic or acute diseases (already existing or diagnosed during the study)
* age below 18 and above 70 years
* unable to be physically active assessed by the Physical Activity Readiness Questionnaire (Shephard, Thomas, \& Weller, 1991)
Treatment of Local Gingival Recession With an Enamel Matrix Protein Coated Collagen Matrix

The clinical trial studies patients with gingival recession defects (receding gums).

The goal of the study is to test whether the additional use of enamel matrix derivatives (EMD), combined with the use of a coronally advance flap (CAF) and a CM (collagen matrix), shows a better outcome compared to a comparison group. The comparison group comprises patients receiving treatment with CAF and CM without the use of EMD.

The study aims to evaluate the influence of the additional use of EMD in treatment of gingival recession defects using a coronally advance flap (CAF) and a CM (collagen matrix) by means of digital and clinical assessment methods. The reference group comprises patients receiving treatment with CAF and CM without the application of EMD.

In this prospective, randomized, controlled study, recession height and area, width and thickness of keratinized gingiva, pocket probing depth, and the clinical attachment level were measured at baseline and followed-up for one year.

15 patients with 24 gingival recession defects (Recession Type 1 after Cairo/Miller Class I or II) were recruited and were randomly assigned into the two treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* able to achieve good oral hygiene (full mouth plaque score \< 20 %, full mouth bleeding score \< 20%),
* patients presenting with at least one gingival recession defect

Exclusion Criteria:

* general contraindications to dental surgery under local anaesthesia (e.g., severe systemic diseases, tumours, severe cardiovascular diseases, uncontrolled diabetes mellitus);
* ongoing or previous chemotherapy, radiotherapy, or bisphosphonate therapy;
* self-reported heavy smokers (more than 10 cigarettes/day);
* pregnancy and nursing mothers;
* disorders or treatments that impair wound healing;
* long-term treatment with high-dose steroids or anticoagulants;
* bone metabolism disorders;
* infections or vascular disorders in the region to be treated;
* known hypersensitivity to porcine collagen;
* patients with severe peripheral artery disease or autoimmune diseases;
* extruded or malpositioned teeth.
Sleep Health Education and Social Support Among Blacks With OSA

The primary purpose of this study is to ascertain the effectiveness of tailored, peer based sleep health education and social support in increasing adherence rates to recommended Obstructive Sleep Apnea (OSA) evaluation and treatment among blacks at risk of Obstructive Sleep Apnea.

Obstructive sleep apnea (OSA), which disproportionately affects blacks (31% vs. 10%, whites), is a critical, preventable and/or treatable disease potentially causing increased cardiovascular disease (CVD) outcomes (e.g., obesity, diabetes, hypertension, stroke, arrhythmia, and chronic heart failure). Improving sleep may have direct effects in reducing CVD risk,2 enhancing brain functions, and increasing workplace productivity. Unfortunately, our focus groups suggest that most at-risk blacks are unaware of OSA symptoms or its related morbidity. Thus, it is imperative to address poor adherence among blacks with OSA, if we are to reduce health disparities associated with CVD outcomes between blacks and whites.

This is a randomized study with a total of 6 sites recruiting; 3 will serve as controls and 3 that will be intervention. Group A participants (Intervention group) will receive health education from a trained Peer Health Educator and Group B participants (Control group) will meet with a salon worker, barbershop worker, or church Health Ministry group leader. Participants will be asked to use a sleep diary and wear a home sleep test device to measure sleep for 7 days. They will be followed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* self-reported race/ethnic minority
* ages ≥18 years
* accessible by telephone
* consent to participate, which includes permission to release medical record information
* A positive screening for OSA is necessary to be enrolled in the intervention protocol.

Exclusion Criteria:

* are involved in another sleep study.
* are unable to understand and sign this informed consent form.
* know someone who is participating in this study.
* had a heart attack or stroke within the past 12 weeks.
* do not identify yourself as a racial/ethnic minority.
* are pregnant.
* Refuse to use the ARESTM home sleep test device.
* Refuse to use the WatchPATTM home sleep test device.
* are not at risk for sleep apnea.
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine


Eligibility Criteria:
Inclusion criteria:

* Informed consent
* Otherwise healthy outpatient with mountain cedar allergy
* Male or eligible female Females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control
* Age 12 years or older at Visit 2
* Diagnosis of seasonal allergic rhinitis (SAR) to mountain cedar
* Adequate exposure to mountain cedar pollen
* Ability to comply with study procedures
* Literate

Exclusion criteria:

* Significant concomitant medical conditions
* Use of intranasal corticosteroids within four weeks prior to Visit 1; use of inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1.
* Use of other allergy medications within specific timeframes relative to Visit 1
* Use of other medications that may affect allergic rhinitis or its symptoms
* Use of immunosuppressive medications eight weeks prior to screening and during the study
* Immunotherapy patients who are not stable on current dose
* Use of any medications that significantly alters the pharmacokinetics of fluticasone furoate or fexofenadine
* Allergy/Intolerance to corticosteroids, antihistamines, or any excipients in the two products
* Use of contact lenses
* Recent clinical trial/experimental medication experience within 30 days of Visit 1
* Subject previously failed the 21-day screen period or failed to complete the treatment period
* Positive or inconclusive pregnancy test or female who is breastfeeding
* Employee or relative affiliation with investigational site
* Current tobacco use
* Active chickenpox or measles or exposure in the last 3 weeks
Clinical Evaluation of Giomer Based Varnish Versus CPP-ACP Varnish in the Management of Dentin Hypersensitivity: a Randomized Clinical Trial

Dentin hypersensitivity is a drastic problem, which threaten many dental patients. According to the last published systematic review and meta analysis at 2019, the prevalence of dentin hypersensitivity is being 33.5% among the population. Moreover, it was determined that young adults with age range from 18 to 44 years exhibited high percentage (43.9%) of such problem

Several approaches to dentin hypersensitivity treatment were proposed to interfere, whether transiently or permanently, with the hydrodynamic theory. These approaches include root coverage and the use of lasers, ions, dentinal sealants, and occluding and nerve depolarization agents, chosen according to the primary cause. There are two major strategies in managing DH; the first is nerve desensitization, and the second is the physical occlusion of the patent tubule. The second approach can be carried out through a wide range of treatment modalities, including the use of proteins, salts or ions to plug the tubules. Many agents introduced are capable of sealing dentinal tubules, and can be used to reduce sensitivity. Of these agents are CPP-ACP varnish and the newly introduced giomer based varnish wilth S-PRG technology

Eligibility Criteria:
Inclusion Criteria:

* Participants of both genders aged 18 to 40 years with good oral hygiene, suffering from pain due to dentin hypersensitivity in at least one tooth

Exclusion Criteria:

* Taking desensitizing treatment in the last 6 months. (It affects the outcome)

  * Taking anti-inflammatory drugs. (It affects the hypersensitivity perception)
  * Pregnant females. ( They complain from nausea and repeated vomiting attacks)
  * Smokers. (Smoking will affect the oral hygiene and periodontal health)