cyrilzakka/clinical-trials huggingface dataset:
Guided IMagery and Patient Satisfaction (GIMPS) Following Urogynecological Surgery

We hypothesize that women who use GIM pre-operatively will feel more prepared for surgery, have less anxiety on the day of surgery and have higher satisfaction scores 6 weeks after surgery compared to women who undergo our routine pre-operative care.

Guided imagery (GIM) is a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state. In clinical settings, it was originally found effective in treating patients suffering primarily from emotional or psychological issues by using descriptive language and the five senses to help the patient visualize their desired change or outcome (1, 2). More recently, GIM has been incorporated into chemotherapy and surgical settings. While it has not been conclusively found to improve outcomes, patients who received GIM reported feeling less anxious, less nausea following chemotherapy, slightly shorter surgical recovery times and a higher quality of life (3-8). While these studies suggest exciting prospects for the incorporation of GIM into the normal pre-op routine, we believe that they have left out one integral piece of the puzzle. We have previously found that patients who feel "unprepared" for surgery have less post-operative satisfaction (9). We propose that the stress and anxiety of the unknown during a patient's surgical experience can make them feel unprepared for surgery. Therefore, the same techniques that have been previously shown to decrease these symptoms in chemotherapy treatment and surgery should help patients feel more prepared, and therefore more satisfied with their surgical experience. This key finding would give sufficient support for the incorporation of GIM into the pre-op routine of any surgical patient, and may prove to be a successful vehicle for increasing the overall satisfaction of any hospital's patient population.

Eligibility Criteria:
Inclusion Criteria:

* routine vaginal or laparoscopic surgery for pelvic organ prolapse planned ≥ 1 week from enrollment
* a planned overnight hospital stay
* commitment to listen to a 15 minute audio Compact Disc daily
* proficiency in English.

Exclusion Criteria:

* Not having routine vaginal or laparoscopic surgery for pelvic organ prolapse planned ≥ 1 week from enrollment
* Not a planned overnight hospital stay
* Unable to commitment to listen to a 15 minute audio Compact Disc daily
* Not proficiency in English.
Effect of an Education Programme for Patients With Osteoarthritis in Primary Care - a Randomized Controlled Trial

Osteoarthritis is a common disease. The core treatment is often patient education. The aim of this study is therefore to study the effect of a patient education programme for patients with osteoarthritis in primary health care.

Osteoarthritis (OA) is a degenerative disease, considered to be one of the major national diseases that cause suffering for affected patients and costs for society.The predominant symptoms are pain, stiffness and impaired quality of life, often together with psychological distress. Treatment often consists of medication. Later in the disease, when the joint is destroyed, joint replacement surgery commonly occurs. Physical exercises aimed to increase muscle strength, endurance, proprioception and stability have proved to influence cartilage as well as function, symptoms and quality of life positively. Physical exercise may also reduce the need for hospital care after knee joint replacement.

Research suggests that patient education is feasible and valuable in terms of improvements in quality of life, in function, in well-being and improved coping . Accordingly, guidelines recommend education as a core treatment for osteoarthritis.

Patient education programmes are often defined as a planned learning experience to influence a patient's knowledge and health behaviour \[13\]. There are various types of patient education. It can be given by a physician as part of consultation, in small groups or delivered by a multi-disciplinary team \[13, 14\] Since 1994, Primary Health Care in Malmö has used a patient education programme directed towards OA. The programme has been developed by physiotherapists and occupational therapists in primary health care and has been implemented in the ordinary work.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of osteoarthritis

Exclusion Criteria:

* Must be able to speak and understand swedish
Mechanistic Study of Ocrevus

The purpose of this study is to investigate the immune cell and other factor changes with Ocrevus in Multiple Sclerosis (MS) patients. Researchers will recruit 35 participants for this study. Patients will be enrolled from the Multiple Sclerosis Center at the University of Michigan Health System in Ann Arbor. The goal of the study is to understand the role of regulatory B cell, T cell and other factors in mediating the therapeutic effects of Ocrevus.


Eligibility Criteria:
Inclusion Criteria:

Patients with MS either with relapsing or primary progressive course; who are newly starting on ocrelizumab (Ocrevus) at the time of enrollment

OR

Healthy controls who do not have a significant medical conditions such as cancer, chronic infection, or autoimmune disease, have not taken steroids in the past 2 months, and who are not on an immune suppressant medication.

* Ability to give informed consent
* Willing to have blood drawn as scheduled in the protocol
* Willing and able to complete all procedures and evaluations related to the study

Exclusion Criteria:

* Medical or psychiatric conditions that may affect the patient's ability to give informed consent
* Has received an experimental drug within 30 days of enrollment
* Concomitant other disease modifying medications (such as Rebif, Betaseron, Avonex, Copaxone, Gilenya, Tecfidera, Aubagio, Mayzent, Mavenclad, Alemtuzumab, methotrexate, azathioprine, Novantrone, cyclophosphamide, cyclosporine, Tysabri, Rituxan, Ocrevus, etc.)
* Has any contraindication to high-dose immunotherapy, including pregnancy, trying to become pregnant, or breast feeding during the study
* Active hepatitis B virus infection
* History of life-threatening infusion reaction to Rituxan or Ocrevus
* Chronic infection or any severe acute infection within 3 months prior to screening
Evaluation of Splenic Irradiation in Chronic Lymphatic Leukemia

Retrospective evaluation on the effect of splenic irradiation on clinical and hematological response and toxicity in patients with chronic lymphatic leukaemia (CLL).

The study will include patients with CLL treated with splenic irradiation in Maastro Clinic, Maastricht, The Netherlands, Maxima Medisch Centrum Veldhoven/Catharina hospital, Eindhoven, The Netherlands and Modena hospital, Modena, Italy. Data will be collected from patient records in an uniform database. Data will include demographic data, CLL stadium (RAI and Binet) at diagnosis and at the time of irradiation treatment, clinical data at diagnosis (haematology), splenic irradiation data, follow-up data such as date of progression or death

Eligibility Criteria:
Inclusion Criteria:

* patients with chronic lymphatic leukaemia.

Exclusion Criteria:

* none
Guatemala Biofortified Maize Study

Zinc (Zn) and iron (Fe) deficiencies are common in Guatemala, and maize is a staple food throughout the country. The primary aim of this study is to demonstrate if utilizing nixtamalized biofortified maize has the potential to increase dietary Zn and Fe intake and improve the amount of Zn and Fe absorbed when compared to diets incorporating traditional maize (control). This is a randomized, double blinded, comparison study of biofortified vs control maize prepared as tortillas from nixtamalized masa. This study will enroll up to 56 school aged children (10-14 yrs old) living in agricultural communities in the Western Highlands of Guatemala (28/group x 2 groups). Researchers will utilize Zn and Fe stable isotopes to measure total absorbed Zn and Fe. Participants will be active in the study for 27 days. During this time, they will have anthropometric measurements taken and collect 2 blood samples, 1 stool sample, and 9 urine samples.


Eligibility Criteria:
Inclusion criteria:

* 10-14 years old school children (male and female sex)
* BMI between10-85%tile
* Typically eat homemade tortillas at each meal every day

Exclusion criteria:

* Taking iron or zinc supplements
* Hemoglobin less than 12.9 g/dl for children 10-11 yrs old and less than13.4 g/dl for children 12-14 yrs old (Per the WHO's 2024 publication hemoglobin cut-offs for identifying anemia are 5-11 yrs: less than 11.5 g/dl; 12-14 yrs: less than 12.0 g/dl. To adjust for the elevation of Tecpán at 2254 m, 1.4 g/dl is added to the cut-off point.)
* Girls who are having a menstrual period during the metabolic studies
Intraoperative Use of an Optical Coherence Tomography (OCT) Imaging System to Guide Additional Margin Cavity Shaves in Breast Conserving Surgery (BCS)

Female patients undergoing a breast conserving procedure will be consented for the excised breast tissue to be imaged on an investigational OCT-based device. Additional tissue may be excised to obtain clear/negative margins based on routine standard of care tissue assessment techniques and intraoperative OCT image review.

Note: A retrospective review of the stated purpose and objectives of the PER-19-02 protocol has determined that this study better fits the definition of a medical device feasibility study, with regard to FDA guidance "Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies," issued October 2013. The primary objectives of the PER-19-02 study (NCT04314700) emphasize user factors, rather than health outcomes, as the focus is on collecting information related to usability and timing, with no change to the standard of care (pathology analysis and additional surgery when needed). PER-19-02 was not used as a pivotal study to support the substantial equivalence or safety and effectiveness evidence submitted as part of an FDA pre-market submission. The IDE-approved pivotal study for evaluating the effect of Perimeter's OCT technology on health-related outcomes in breast surgery is the randomized control trial registered on ClinicalTrials.gov under protocol PER-19-04 (NCT05113927). Perimeter has determined this trial does not meet the definition of an Applicable Clinical Trial per the "Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT) Under 42 CFR 11.22(b) for Clinical Trials Initiated on or After January 18, 2017."

Eligibility Criteria:
Inclusion Criteria:

* Female age 18 or older
* Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal or lobular breast carcinoma and/or ductal carcinoma in situ
* May include subjects treated with neo-adjuvant endocrine therapy
* May include subjects treated with neo-adjuvant chemotherapy with confirmed complete clinical response
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Male
* Stage IV breast cancer
* Participation in another study that prolongs time to pathologic processing (greater than 1 hour)
* Neo-adjuvant treated patients with any chemotherapeutic who have not achieved a complete clinical response
* A surgeon makes an intraoperative decision to conduct a frozen section analysis (Any subject-specific data collected from an enrolled subject until the surgeon's intraoperative decision will not be used in the data analysis of this study. These subjects will be replaced in the study and the surgeon's intraoperative decision to conduct a frozen section analysis will be recorded).
* Use of cryosurgery
* Currently lactating
* Current pregnancy
* Previous ipsilateral breast surgery for benign or malignant disease in the same quadrant as currently planned surgery
One Month Daily Wear Clinical Evaluation of New Prototype Contact Lenses in Habitual and Neophyte Contact Lens Wearers

There will be four study lenses tested; one marketed lens, and three prototype study lenses. Subjects will be randomized to one of the four study lenses which will be worn in a daily wear modality, with a two week replacement.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be between 18 and 39 years of age.
2. The subject must be able to read and understand English.
3. The subject read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
4. The subject must not have been a participant in a contact lens or contact lens solution study/investigation in the previous seven days.
5. The subject must be willing to wearthe study lenses for at least 6 hours per day, 7 days per week (e.g. does not regularly swim).
6. The subject must appear able and willing and able to the adhere to the instructions set forth in this clinical protocol.
7. The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -4.00D in each eye.
8. The subject's refractive astigamatism must be less than or equal to -1.00D in both eyes.
9. The subjet must have best corrected visual acuity of 20/30 (6/9 or +0.20 logMAR) or better in each eye.
10. The subject must require a visual correction in both eyes (no monofit or monovision allowed).
11. The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

    * No amblyopia
    * No evidence of lid abnormality or infection (including blepharitis/meibomitis)
    * No conjunctival abnormality or infection.
    * No clinically significant slit lamp findings (i.e. stromal edema, vascularization, corneal scaring, infiltrates or abnormal opacities).
    * No other active ocular diseases.

Exclusion Criteria:

1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
2. Any systemic diseases, autoimmune disease, or use of medication, which may interfere with contact lens wear.
3. Clinically significant (Grade 3 or 4) corneal edeam, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
4. Any ocular infection.
5. Any corneal distortion resulting from previous hard or rigid permeable contact lens wear.
6. Pregnancy or lactation (subjects who become pregnant during the study will be discontinued).
7. No extended wear in the last 3 months.
8. Diabetes.
9. Infectious diseases (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).
10. Has had refractive surgery.
11. Employee of VRF with direct involvement in the study or a family member of the clinic.
Pharmacological Preparation of the Cervix for Hysteroscopy

Pain accompanying office hysteroscopy is the most common reason for its discontinuation. Urogenital atrophy may cause technical difficulties in passage through the cervical canal, further increasing the pain. The aim was to evaluate the effectiveness of vaginal estradiol and hyaluronic acid to facilitate diagnostic hysteroscopy in peri- and postmenopausal women.

A prospective cohort tertiary-center study includes women over 45 years of age subjected to office hysteroscopy in 2021-2022. Women who consent are assigned to three study arms: i) estradiol 0.5 mg in vaginal cream twice daily for 10 days pre-procedure, ii) hyaluronic acid 5 mg in vaginal gel twice daily for 10 days pre-procedure, iii) no treatment (control). The following endpoints are compared: need for cervical dilation, incidence of severe urogenital atrophy and vaso-vagal reaction, time of cervical passage, cervical canal diameter, pain during and after the procedure in the Numeric Rating Scale (NRS).

Eligibility Criteria:
Inclusion Criteria:

* age 45-90 years
* uterine cavity focal lesion, abnormal uterine bleeding

Exclusion Criteria:

* drug allergy
* no consent to the procedure or participation in the study
Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection

A phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 administered in subjects with non-cystic fibrosis bronchiectasis and chronic pulmonary Pseudomonas aeruginosa infection.

This study will be conducted in two cohorts running in parallel: Cohort A will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have not received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Cohort B will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Subjects in both Cohorts A and B will be followed for approximately 4 weeks after last dose of study drug and evaluated for safety, tolerability, and efficacy.

Eligibility Criteria:
Key Inclusion Criteria:

* ≥ 18 years old
* Body mass index (BMI) of ≥ 18 kg/m2
* Evidence of bronchiectasis per CT
* Evidence of chronic pulmonary Pseudomonas aeruginosa infection
* Willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum samples at all other timepoints (for subjects who are able to expectorate)
* FEV1 ≥ 35% of predicted normal \[per Global Lung Function Initiative (GLI) standards\] at Screening
* For Cohort A: have not received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1
* For Cohort B: have received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1

Key Exclusion Criteria:

* Abnormal vital signs at Screening
* History of lung transplantation
* History of cystic fibrosis
* History of α1-antitrypsin deficiency
* History of primary or acquired immunodeficiency syndromes
* History of COPD
* History of pulmonary malignancy or any other malignancy requiring treatment
* History of prolonged QT syndrome
* History of hemoptysis
* Recent significant weight loss
* Recent use of supplemental oxygen during the day while at rest
* Recent use of cigarettes, cigars, or pipes, or used tobacco or other nicotine source by vaping
* Recent changes in either the treatment regimen or initiation of treatment with: oral macrolides, hypertonic saline, mucolytics, bronchodilator medications, or oral corticosteroids
* Currently receiving treatment for active infection at any site
* Female pregnant of breastfeeding
Limosilactobacillus Reuteri as an Adjuvant in the Treatment of Peri-implant Mucositis

Mechanical debridement is the traditional method for the treatment of peri-implant mucositis and its success depends on the patient's correct oral hygiene. It is believed that probiotics may help by their ability to modulate the oral biofilm, resulting in anti-inflammatory and anti-bacterial plaque action. The aim of this study is to evaluate the adjuvant effect of the probiotic Limosilactobacillus reuteri in the mechanical treatment of peri-implant mucositis. This study aims to include 32 subjects with implant-supported total rehabilitation and peri-implant mucositis, divided into test and control groups, equally subjected to professional mechanical debridement, with the administration of a daily GUM® PerioBalance® lozenge for 30 days added to the test group. Plaque Index, Bleeding Index and probing pocket depth are evaluated before the intervention (baseline) and at 6 and 10 weeks later.


Eligibility Criteria:
Inclusion Criteria:

(i) dental implants placed for at least 12 months according to the All-on-4® concept;

(ii) removal of the dental prosthesis as part of the conventional implant maintenance protocol;

(iii) modified Bleeding Index19 score \>0 in at least one implant in the studied rehabilitation;

(iv) implants connected to the prosthesis by means of transepithelial abutments;

(v) if there were natural teeth in opposing arch, they were periodontally healthy or had been treated for periodontitis and were on periodontal support with residual pockets ≤5mm;

(vi) demonstrated previous compliance with oral hygiene appointments; (vii) read and signed the informed consent.

Exclusion Criteria:

(i) Peri-implantitis proven clinically (implant mobility, suppuration and/or pocket depth (PD) ≥5mm) and/or radiographically (bone remodeling greater than 2mm in the first year of function20 and mean marginal bone loss greater than 0.2mm for each subsequent year21 in the rehabilitated arch that was intended to be studied);

(ii) clinically active peri-implantitis (mobility, suppuration and/or PD ≥5mm) in the opposing arch to the one intended to be studied;

(iii) presence of an extra-maxillary/zygomatic implant in the rehabilitated arch that was intended to be studied;

(iv) current probiotic supplementation;

(v) diabetes mellitus not controlled by medication;

(vi) current use of oral hygiene products containing chlorohexidine or essential oils;

(vii) special needs individuals who depended on others for their oral hygiene and medication uptake.
Do Patients With Early Post Operative Recurrence of Pelvic Organ Prolapse Have a Genetic Predisposition?

The objective is to explore the genetic predisposition to early pelvic organ prolapse after adequate surgical repair by exploring the association between pelvic organ prolapse recurrences and certain polymorphisms.

Pelvic organ prolapse develops as a result of a loss of support provided by the muscles and fascia that constitute the pelvic floor. Several recent population studies have estimated the prevalence of pelvic organ prolapse at between 10% and 30%. One in nine women will undergo surgery for these disorders in her lifetime and of these, one third will undergo repeated surgeries. The correction of pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patients quality of life. There are a few studies that have explored the genetic predisposition to developing pelvic organ prolapse but none so far looks at genetic factors involved in prolapse recurrence after adequate prolapse repair. There are two groups of women: women who underwent adequate repair of their prolapse and had an unexplained early recurrence. And a second control group of women who underwent the same prolapse repair procedure and had no further prolapse recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Cases: early, unexplained recurrence (within 6 months of procedure) after sacrocolpopexy), the recurrence required treatment (surgery or pessary) Controls: sacrocolpopexy during the same period, no recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery)

Exclusion Criteria:

* Obvious surgical technical failure
* Use of other graft material than polypropylene mesh
* Planned two staged operation
* Contraindications to surgery based on existing medical conditions
* Pregnancy
* Desire for pregnancy in the future