cyrilzakka/clinical-trials huggingface dataset:
Developing a Psychosexual Educational Partners Program: PEPP A Feasibility Study

This is a single arm study to evaluate the feasibility, adherence, and usefulness of a psychosexual education partner program (PEPP) to improve partner communication and sexual function. This study is intended to get initial input from a small group of up to 10 women and their partners about the appropriateness, usefulness, and critical nature of the content as well as the feasibility and appeal of the method of delivery.

The overall objective of this program of research is to improve sexual health outcomes for women diagnosed with breast or gynecologic cancer. The investigators are developing a multi-component intervention for the four key predictors of sexual health in female cancer survivors: self-image, vaginal symptoms, desire/energy, and relationship-partner concerns. This proposal addresses the evaluation of this last component, relationship-partner concerns. The planned intervention to address these concerns is a psychosexual education partner program (PEPP) delivered by workbook and three follow up phone calls (to coincide with the end of each module) to women and their partners who have experienced a negative change in their relationship since their cancer diagnosis. Ten women with breast or gynecological cancer and their stable partners (ten dyads) will evaluate the content and delivery method of the intervention through self-report questionnaires and a qualitative interview.

Eligibility Criteria:
Eligibility Criteria below apply only to the patient. (The patient's partner must be 18 years of age or older.)

Patient Inclusion Criteria:

1. Age ≥18 female with a history of any stage breast and/or gynecological cancer.
2. Completed primary treatment (chemotherapy, radiation and/or surgery) ≥ 3 months and ≤ 5 years prior to registration.
3. May use concurrent adjuvant endocrine therapy or HER2-targeted therapy while on study.
4. Responds yes to the question "Has there been change in communication and/or intimacy with your partner since your cancer diagnosis?"
5. Ability to read and write English.
6. A stable partner, defined as anyone with whom the woman has had an intimate relationship with for at least 3 months prior to her cancer diagnosis.
7. Both partner and woman must agree to participate in the study and sign informed consent to the study.

Patient Exclusion Criteria:

1. Antidepressants are allowed if a person has been on them for 30 days prior to registration, and dose or treatment is not expected to change.
2. Past history of sexual abuse.
3. Psychiatric disorder such as major depressive disorder, bipolar disorder, obsessive compulsive disorder or schizophrenia. (Defined per medical history and/or patient self-report.)
4. Currently enrolled in another study that addresses sexual health (enrollment in other clinical trials will be allowed).
Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity

This study is a prospective cohort clinical research that analyzes the changes in CMR parameters before and after immune checkpoint inhibitors (ICIs) therapy in patients with gynecologic malignancies. It also evaluates the value of CMR parameters in predicting long-term outcomes. The baseline assessment will be conducted prior to ICIs treatment, followed by multiple assessments during the medication process including within one week prior to cycle 3 , within the week prior to cycle 5 , 1 year after the first dose, and 2 years after the first dose. Assessment will also be conducted after discontinuation of ICIs medication. The assessment includes clinical assessment, CMR imaging, echocardiography, serum cardiac injury biomarkers, etc. Cancer therapy-related cardiac dysfunction (CTRCD), survival, and major adverse cardiac events (MACE) will be followed up.


Eligibility Criteria:
Inclusion Criteria:

* 1. Female patients aged 18 to 75 years, diagnosed with gynecological malignancies through histology or cytology.
* 2. Patients who are preparing for monotherapy or combination therapy with ICIs.
* 3. Voluntary signing of informed consent form.
* 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* 5. Expected survival of at least 6 months.

Exclusion Criteria:

* 1. Previously received ICIs treatment.
* 2. With allergies or contraindications to ICIs.
* 3. Confirmed to be brain metastasis.
* 4. Patients who have major surgery within 4 weeks prior to or following the screening period.
* 5. Patients who have received systemic corticosteroids (at a dose equivalent to \>10 mg prednisone per day) or other immunosuppressive medications within 14 days prior to enrollment or during the study period; however, the following situations are allowed for inclusion:

  1. the use of topical or inhaled corticosteroids is permitted;
  2. short-term (≤7 days) use of corticosteroids for prevention or treatment of non-autoimmune diseases is allowed.
* 6. Left ventricular ejection fraction (LVEF) ≤50%, or New York Heart Association functional classification (NYHA) ≥III.
* 7. Coronary heart disease, cardiomyopathy, congenital heart disease, valvular heart disease and pericardial diseases with confirmed diagnosis.
* 8. Lack of autonomous capacity, or a documented history of mental disease.
* 9. MRI contraindications: Pacemakers, neurostimulators, artificial metal heart valves, arterial aneurysm clips, intraocular metallic foreign bodies, inner ear implants, metal prostheses, metal limbs, metal joints, and any other metallic implants or foreign objects; severe hyperthermia patients; claustrophobia; severe respiratory conditions that prevent breath-holding.
Is Kinesio Taping More Effective Than Medical Adhesive Tape in Patients With Chronic Non-specific Low Back Pain?

Sixty patients will be randomized into three groups to receive the Kinesio taping, placebo Kinesio taping (medical adhesive tape) and control group. The group Kinesio taping receive the correct application of the method described. The placebo group will receive a medical adhesive tape. The control group will not receive any form of intervention.

The group Kinesio taping receive the correct application of the method described with tension paper off (10-15%). The placebo group will receive a medical adhesive tape. The control group will not receive any form of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-specific low back pain longer than 3 months
* Seeking care for low back pain

Exclusion Criteria:

* Contra indications to any bandage
* Serious sinal pathologies (e.g. tumors, fractures and inflammatory diseases)
* Nerve roto compromise
* Pregnancy
Innovative Family Prevention With Latino Siblings in Disadvantaged Settings

The current study is a randomized intervention trial that tests the efficacy of a family-focused sibling relationship promotion program. The study includes a treatment group and a contact-equivalent attention control condition with 288 sibling dyads and data collection with target parents, target sibling dyads, and teachers at three time points (pre-test, post-test, and 18-month follow-up). Data will be collected using a three-cohort design with 96 families in each of the three cohorts.

The proposed project tests the efficacy of a family-focused program. This innovative program is focused on sibling relationships and parenting of siblings as synergistic targets of change to promote positive interpersonal family dynamics and parent and youth psychosocial and behavioral health and well-being. This translational effort builds on strong theoretical and empirical premises including a successful pilot study (ASU SIBS Program). Using a rigorous design and measurement, aims are to: (a) test the efficacy of SIBS, delivered via 12 weekly afterschool sibling sessions and 3 family nights in the familiar elementary school setting, versus a contact-equivalent attention control condition. Mexican-origin sibling dyads (5th graders and younger siblings; N = 288 dyads) and their parents will be recruited from economically disadvantaged elementary schools and randomly assigned within school to intervention or contact-equivalent attention control conditions. Assessments will be conducted at pre-test, post-test, and 18-month follow-up. Program effects will be tested on primary and secondary outcomes, including sibling relationship quality (i.e., warmth and negativity), sibling relationship skills, children's efficacy (social, emotional), children's internalizing symptoms, parents' stress and depressive symptoms, parent-child warmth and conflict, and family cohesion. Findings will advance prevention science by identifying an efficacious program that capitalizes on cultural assets to promote positive family dynamics and psychosocial well-being among Latinos, including by incorporating daily measurements of intervention targets (sibling relationship skills) to identify mechanisms underlying program effects.

Eligibility Criteria:
Inclusion Criteria:

* Target child has to be a 5th grader
* Target child has to be of Latino/Hispanic heritage
* Target child has to have a younger sibling enrolled in the same school in the 1st through 4th grade
* Target child and younger sibling have to be enrolled students in a participating elementary school.

Exclusion Criteria:

- Enrollment in a self-contained special education setting
A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322

To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Those judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.
* Those who can sign and date a written, informed consent form prior to the initiation of any study procedures.

Exclusion Criteria:

* Those with concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease etc.
* Others who are assessed to be ineligible for the study by the investigator or subinvestigator.
Efficacy and Safety of Different Hyaluronic Acid Tear Substitutes Formulations in Evaporative Dry Eye

The objective of the study is to compare the efficacy and safety of different hyaluronic acid tear substitutes formulations in patients with evaporative dry eye. For this purpose, a randomized, single-blind clinical trial has been designed.


Eligibility Criteria:
Inclusion Criteria:

1. Self-reported history DED.
2. Ocular surface disease index (OSDI) \> 13 points.
3. Non-invasive tear film break-up time (NIBUT) \< 10 s.
4. Schirmer test (ST) without anesthesia ≥ 5 mm.
5. MGD grade \> 1. For MGD, the Sirius device (CSO, Florence, Italy) was used, which determines MGD grade based on loss area of meibomian glands (LAMG). MGD grade was scored from 0 to 4 (MGD grade 1 = LAMG \< 25%; MGD grade 2 = LAMG ≥ 25% and \< 50%; MGD grade 3 = LAMG ≥ 50% and \< 75%; MGD grade 4 = LAMG ≥ 75%).

Exclusion Criteria:

1. Abnormal lid anatomy, including active blepharitis, and active lid margin.
2. All corneal disorders that affect diagnostic test, such as active corneal infection and corneal dystrophies.
3. Active ocular allergies.
4. Vectored thermal pulsation (VTP) intense pulse light (IPL), quantum molecular resonance (QMR), or other procedure to treat DED within the previous 6 months.
5. Intraocular surgery or laser ocular surgery within the previous 6 months.
6. Use of topical antibiotics and anti-inflammatory treatments, including steroids and non-steroidal anti-inflammatory drugs.
7. Systemic autoimmune diseases.
8. Contact lens wearers.
9. Pregnant or lactating women.
10. Patients who did not understand or comprehend the informed consent.
A Study to Evaluate Continuous Glucose Monitor in Hospitalized, Post-operative Patients With Diabetes Mellitus

The purposes of this study is to study if CGMs worn in the postoperative ICU or non-ICU hospital setting have adequate accuracy for blood glucose monitoring when compared to point-of-care (POC) capillary glucometers.

Eligible patients will be approached by research staff either preoperatively or on the first 5 days post-surgery and offered to be enrolled. If agreed to participate, they will be fitted with a blinded CGM monitor (Dexcom G6 PRO) as soon as they are awake and alert after the surgery. They will continue to have their blood glucose check as usual in the ICU and on surgical floors with POC glucometers. On discharge, or at the end of the first CGM sensor life, the sensor will be removed and sensor data will be analyzed. CGM data will be compared with Point-of-Care blood glucose monitoring obtained in the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 1 or 2 Diabetes Mellitus.
* Patients 18 years of age or older.
* Admitted for deceased donor renal transplant surgery, pancreas transplant surgery, heart transplant surgery, liver transplant surgery and lung transplant surgery.
* Anticipated minimum of 72h hospital stay.
* Patients on insulin therapy (IV, SQ) post-surgery.

Exclusion Criteria:

* Active COVID-19 infection.
* Pregnant or lactating female.
* Altered Mental Status at the time of sensor placement (sensor will be placed once mental status will improve).
* Inability to provide informed consent.
* Patients taking more than 4 g of acetaminophen in 24 hours or more than 1 gm every 6 hours.

Patients with skin lesions at the application site that may interfere with placement of the sensor.

Patients with known allergy to medical grade adhesive.
Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study

The purpose of this study is to demonstrate decrease in cardiovascular mortality and morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with those with Calcium carbonate.

Elevated serum phosphate and calcium in dialysis patients are independently associated with increased risk of arterial calcification and mortality. Calcium-based phosphate binders can induce hypercalcaemia and are associated with progression of vascular calcification. A recent randomized study demonstrated that sevelamer, a non-calcium-based phosphate binders, reduced mortality in elderly hemodialysis patients compared with calcium-based phosphate binders. Lanthanum carbonate is another efficacious and well-tolerated non-calcium phosphate binder. A post-hoc survival analysis of lanthanum carbonate versus standard therapy suggested a survival benefit of lanthanum carbonate treatment for elderly patients.

Eligibility Criteria:
Inclusion Criteria:

* hemodialysis patients with hyperphosphatemia who require phosphate binders
* hemodialysis for more than 3 months
* patients who have at least one calcification risk factor (elderly \> 65 years, postmenopausal woman, type 2 diabetes mellitus)
* intact-PTH \< or = 240pg/mL
* life expectancy \> 1 year
* with written informed consent

Exclusion Criteria:

* contraindications to lanthanum carbonate and calcium carbonate
* swallowing disorders
* severe GI disorders
* history of obstructed bowels
* history of IHD/stroke within 6 months before randomization
* NYHA classification Ⅲ-Ⅳ
* severe liver dysfunction (AST or ALT greater than 3 times the upper limit of institution
* require treatment of arrhythmia
* severe malnutrition
* malignancy of any type within the last five years
* peritoneal dialysis patients
* pregnant or possibly pregnant women or women on lactation and planned to get pregnant within study term
* ineligible patients according to the investigator's judgment
Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children

The primary aim of this study is to compare eyeball elongation in existing ortho-k subjects who stop the treatment with subjects who continue ortho-k lens wear and control subjects wearing single-vision glasses.

Children wearing ortho-k have been shown to have slower rate of myopic progression than those wearing single-vision spectacles (Cho et al. 2005) or soft lenses (Walline et al. 2009). Both studies showed that the effect of myopic control was most significant during the first six months of the treatment. It is unknown whether the myopic control effect would dissipate upon the discontinuation of the treatment or whether the myopic control effect only happened in the first six month of lens wear and was maintained thereafter. The current study aims at evaluating the effect of discontinuation of ortho-k treatment on myopic control in children who are currently on the treatment. This knowledge is necessary and important as patients/parents have concerns about the permanent dependency on ortho-k once they enrolled in the treatment.

Children who have been on the treatment for two years and have recently completed the myopic control studies at The Hong Kong Polytechnic University, i.e. the ROMIO, TO-SEE and HM-PRO studies, will be invited to participate in this 14-month study. Ortho-k subjects will be randomly assigned to study group or the ortho-k control group. The study group subjects will be required to stop lens wear for 7 months at the completion of the previous study (Phase I) and resume lens wear for next 7 months (Phase II). The ortho-k control group subjects will be required to continue the current treatment for another 14 months. Control subjects in the existing myopic control studies will be required to continue using the same treatment, i.e. single-vision glasses, for another 14 months. Rate of myopic progression among the 3 groups and at the two study phases will be determined and compared.

Eligibility Criteria:
Inclusion Criteria:

* Age 8-14 years old (inclusive)
* Subjects who have completed the ROMIO, TO-SEE or HM-PRO studies at The Hong Kong Polytechnic University
* Willingness to be randomized into groups (for ortho-k subjects)
* Availability for follow-up for at least 14 months

Exclusion Criteria:

* Non-compliance to the follow up schedule
* Non-compliance to the assigned optical correction (i.e. single-vision glasses or ortho-k lenses)
* Contraindication for contact lens wear and ortho-k (e.g. limbus to limbus corneal cylinder and dislocated corneal apex)
* Systemic or ocular) conditions which may affect contact lens wear (e.g. allergy and medication)
* Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)
The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics

The aim of the research is to evaluate the clinical outcome of short dental implants, characterized by a new macro-structural design and inserted in the upper or lower jaw in patients with reduced bone volume. The clinical outcomes will be compared for different surface treatments of implant neck and those of prosthetic components.


Eligibility Criteria:
Inclusion Criteria:

* healthy patients, with edentulous maxillary or mandibular ridge, requiring rehabilitation with two adjacent implants;
* at least 6 month after extraction;

Exclusion Criteria:

* post-extractive implants;
* sites requiring bone regeneration or maxillary sinus lift;
* general health problems that contraindicate implant treatment.
Respiratory Sarcopenia in Older Adults

The objectives of this study are to describe the prevalence of respiratory sarcopenia, evaluate its pattern of evolution over a one-year follow-up, and determine the response to a therapeutic exercise program in older adults in a geriatric nursing clinic.

A sample of approximately 115 older adults, of both sexes, from the geriatric nursing clinic of the Virgen de la Arrixaca Hospital, Murcia, will participate in the study. In the first stage, a prospective observational study will be carried out, with one year of follow-up, and subsequently a randomized controlled clinical trial, with patients who have been diagnosed with respiratory sarcopenia. In the clinical trial, patients will be divided into 3 groups: control, experimental 1 (diaphragmatic exercises) and experimental 2 (respiratory muscle training). Sociodemographic and clinical variables, physical function (palm grip, 5STS, 4MGS), respiratory function (respiratory muscle strength and diaphragmatic thickness) and health outcomes (respiratory infections, visit to the emergency department, hospitalization, falls, bedridden and/or death). Descriptive statistics, univariate and multivariate logistic regression models, Cox proportional hazards model and Kaplan-Meier curves will be used to analyze the data from the longitudinal study. To compare the differences between pre- and post-intervention of the clinical trial, a two-factor analysis of variance for repeated measures will be used. A P-value \<0.05 will be considered significant in all analyses. The recording and analysis of the data will be carried out with the IBM SPSS Statistics 24® program.


Eligibility Criteria:
Inclusion Criteria:

* have functional ambulation (even with technical aids)
* be able to obey simple commands, such as taking deep breaths
* have sufficient oral occlusion capacity to perform respiratory tes

Exclusion Criteria:

* presence of acute respiratory diseases
* serious orthopedic diseases that interfere with measurements
* diagnosis of severe dementia
* those who present any contraindication for performing respiratory pressure measurement tests, as established in the guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR).
Laryngeal Mask Airway (LMA) Complication in Children

Desflurane is known to be the most pungent of the currently used volatile anesthetics. The investigators tried to find out if desflurane increases the incidence of perioperative upper airway complications in infants and children undergoing general anesthesia using supraglottic airways compared to sevoflurane.

The investigators retrospectively reviewed and analyzed the electrical medical records of consecutive children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane or desflurane as maintenance agents.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane or desflurane as maintenance agents

Exclusion Criteria:

* Tracheal intubation