cyrilzakka/clinical-trials huggingface dataset:
Impact of Health Literacy and Other Factors on Glaucoma Patient Adherence in South India

The purpose of this study is to determine how health literacy impacts glaucoma patient adherence (as measured by following up with the doctor) in Tamil Nadu, India. We hypothesize that individuals with better health literacy will have higher rates of follow-up with their ophthalmologist.

Many studies have shown the importance of health literacy on patient adherence in the United States (Juzych, M, et al., 2008; Muir, KW, et al., 2006). Low adherence in glaucoma patients leads to increased intraocular pressure, optic nerve damage, and blindness. To date, no research has been done with health literacy and patient adherence in the developing world.

We will use TOFHLA and REALM to assess the health literacy of glaucoma patients in Tamil Nadu, India. We will also survey other demographic information and patient knowledge of glaucoma. This information will be compared with follow-up rates to identify barriers to patient adherence.

Eligibility Criteria:
Inclusion Criteria:

* Better than 20/100 corrected vision in better eye
* Must live within 50 miles of Aravind Eye Hospital
* Clinical diagnosis of primary glaucoma
* Paying patient
RIOTC: Reducing the Impact of Ovarian Stimulation. Novel Approaches to Luteal Support in IVF-Study 2

The goal of the randomised controlled study (RCT) is to identify novel strategies that can improve the luteal phase endocrinology after ovarian stimulation, with the aim of using less or no luteal support in IVF while making the endometrium thinner and more receptive to embryo implantation.

The high estradiol levels generated in IVF by multiple dominant follicles at the follicular-luteal phase transition generate powerful negative feedback at the pituitary gland, effectively switching off gonadotropin production. Without stimulation by endogenous luteinizing hormone (LH), the corpora lutea undergo involution and menstruation follows, preventing the establishment of pregnancy.

To address these detrimental effects of ovarian stimulation, the investigators will do a RCT with the use of aromatase inhibitors, which suppress the conversion of androgens to estrogens to ameliorate the unwanted effects of high estrogens.

This study is designed to test the hypothesis that preventing supra-physiological estrogen levels during ovarian stimulation restricts pituitary suppression sufficiently to allow LH levels to rise and support the corpora lutea, leading to a normal post-ovulatory luteal phase, evidenced by a normal duration and luteal phase endocrine profile. To test this, consenting oocyte donors will be randomized to receive co-treatment with aromatase inhibitors or no co-treatment during ovarian stimulation. Following oocyte retrieval, no luteal support will be provided to donors in both Groups.

Eligibility Criteria:
Inclusion Criteria:

* Meet the clinical criteria for acceptance as oocyte donors (healthy women who volunteers to donate oocytes to other women).
* Regular ovulatory cycle of 26-32 days.
* Age: 18-35 years old.
* Written consent.

Exclusion Criteria:

* Contraindications for ovarian stimulation or aspiration of oocytes according to local guidelines
* Polycystic Ovary Syndrome (PCOS)
* Allergy towards study drug
* Women who have had a hormone or copper intra-uterine device (IUD) within 3 months

Exclusion of patients after earlier inclusion in the study in case of

* Patient withdrawal of consent
* Lack of compliance with medication
* Medical complication arising from IVF treatment that requires the cycle to be terminated
* Serious adverse events (SAE) or serious adverse reactions (SAR) including severe allergy to study drug.
* Specific ARs to study drug: severe degree of hot flushed, severe degree of nausea/vomiting, severe diarrhea, severe degree of muscle and joint pain.

In case of exclusion of a patient after earlier inclusion in the study, a new patient will be included.
Music and Local Anesthesia During Dermatologic Procedures

The goal of the study is to determine the effect of classical music on participants pain and anxiety associated with lidocaine administration during routine standard of care dermatologic procedures.

The study is a randomized, unblinded, prospective, single center clinical trial. The purpose of the study is to determine the effect of a music intervention in reducing anxiety and pain from local anesthesia administration in subjects undergoing a routine, standard of care dermatologic procedure. The study population will consist of 100 adult subjects undergoing a dermatologic procedure on the head and neck. Subjects will be randomized 1:1 into either the placebo or music intervention group.

Individuals randomized into the placebo (P) group will undergo a set of standardized steps prior to local anesthesia injection. Other factors such as skin preparation technique, needle size, anesthesia temperature, use of unbuffered solution, needle angle and approximate depth of injection will remain standardized. Individuals randomized into the music intervention (MI) group will undergo the same set of standardized steps and then be played Frederic Chopin's piano sonatas through a headphone device prior to injection. After local anesthesia administration, subjects in both treatment arms will be asked to fill out a demographics, pain and anxiety questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing dermatologic procedures on the head and neck
* Ages 18-89 years old
* English speaking
* Willingness and the ability to understand and provide informed consent

Exclusion Criteria:

* Subjects who are allergic to lidocaine
* History of bleeding tendency or coagulopathy
* Pregnant or lactating
* Active skin infection in the treatment area
* Active cancer diagnosis
* Unable to understand the protocol or give informed consent
* Any other condition, in the professional opinion of the investigator, that would potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject
Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis

Treatment period 1:To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) ≥ 10 g/dL and ≤ 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb \> 11 g/dL.

Treatment Period 2:To demonstrate that switching subjects with a Hb \> 11 g/dL and ≤ 13 g/dL from once weekly IV darbepoetin alfa to once every 2 weeks (Q2W) maintains the mean Hb at \> 11 g/dL.


Eligibility Criteria:
Inclusion Criteria: -at least 18 years old - Diagnosis of chronic kidney disease (CKD) and receiving dialysis for at least 3 months prior to screening - Baseline Hb level greater than or equal to 10.0 g/dL and less than or equal to 13.0 g/dL - Adequate iron stores (defined as serum ferritin greater than or equal to 100 µg/L or transferrin saturation \[TSAT\] greater than or equal to 20%) - Stable IV (epoetin alfa or beta) or SC rHuEPO (epoetin beta) therapy 2 or 3 times per week for at least 8 weeks before screening (stable is defined as less than 25% change in weekly dose and no change in frequency or route) - All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial. Exclusion Criteria: - Received SC epoetin alfa in the 12 months before screening - Uncontrolled hypertension (diastolic blood pressure greater than 100 mmHg or systolic blood pressure greater than 180 mmHg on 2 separate occasions during screening) - Prior history (within 12 weeks before enrolment) of cardiovascular events including:

* acute myocardial ischemia;
* hospitalization for congestive heart failure;
* myocardial infarction. - Pregnant or breast-feeding women - Treatment with an investigational agent or device within 30 days before screening or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study - Known sensitivity to any of the products to be administered during dosing - Disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Epirubicin or Not in Patients With TOP2A (Topoisomerase (DNA) II Alpha (170kD)) Normal Early Breast Cancer

The Danish Breast Cancer Cooperative Group (DBCG) wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.

In DBCG trial 89D we in more than 1,200 patients showed that substitution in CMF chemotherapy of methotrexate with epirubicin improves survival for patients with primary and operable breast cancer. In a retrospective evaluation we have also shown that approximately 20% of all patients in 89D have tumors with numerical changes of the TOP2A gene, and that only patients with abnormal TOP2A benefit from epirubicin. In the current trial the DBCG wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.

Eligibility Criteria:
Trial Population:

1. Younger than 35, but at least 18 years of age
2. Hormone receptor-negative tumor (ER- and PgR-negative) and 35 to 75 years of age.
3. Hormone receptor-positive tumor, 35 to 59 years of age and presenting at least one of the following characteristics: spread to lymph nodes, tumor \> 2 cm, degree of malignancy II-III or HER2-positive.

Inclusion Criteria:

1. Signed informed consent
2. Histologically confirmed invasive breast carcinoma which has been micro-radical removed by breast preserving surgery or mastectomy according to DBCG's guideline
3. TOP2A normal tumor (score of 0.8 - 2.0)

Exclusion Criteria:

1. Pregnancy or breast-feeding
2. Earlier medical cancer treatment, including docetaxel, epirubicin or cyclophosphamide.
3. Distant metastases or bilateral breast cancer (excluded after checking by means of chest radiography, bilateral mammography and normal blood samples as a minimum).
4. Other active, malign disease in the latest 5 years, except for adequately treated and cured carcinoma in situ cervices uteri or non-melanoma skin cancer.
5. Comorbidity score \> 3 (patients with a score of 1-2 start at dose level -1).
6. Treatment with a non-approved product or test product in the latest 30 days.
7. Known severe hypersensitivity to docetaxel, epirubicin or cyclophosphamide or auxiliary agents in these products.
Impact of Behavioral Economic Strategies on Low-Income Older Adults' Food Choices in Online Retail Settings

The specific aims of this proposal are to 1) develop the components of a behavioral economics strategy (i.e., healthy bundle defaults) to influence diet behaviors; 2) characterize the online grocery shopping behaviors and attitudes of low-income adults nationally; and 3) examine the extent to which "healthy bundles defaults" and other behavioral economic strategies increase fruit and vegetable purchases among low-income adults in an online randomized controlled experiment.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-99 years
* ability to read and speak English
* have ever received SNAP benefits
* live with fewer than 5 people
* access to a personal computer, laptop, tablet, or mobile phone.

Exclusion Criteria:

* aged \<18 years or \>99 years
* lack the ability to read and speak English
* have never received SNAP benefits
* live with 5 or more people
* do not have access to a personal computer, laptop, tablet, or mobile phone
Epsom Salt Compresses to Relieve Perineal for Postpartum Care: a Clinical Trial

The goal of this clinical trial is to determine if topical application of compresses soaked in 25% magnesium sulfate on painful perineum after birth is effective to alleviate pain.

Researchers will compare this treatment to a placebo, compresses soaked in water. Participants will be invited to use their compresses if needed, for 15 minutes, up to four times a day, during their stay at the hospital after giving birth. They will also have to keep a diary of their usage and of their pain.

Background: Despite the high frequency of perineal trauma in obstetrics, management of perineal care and pain is highly variable, relying on very few studies, if any. Treatment of the perineum with compresses soaked in a magnesium sulfate (Epsom salt) solution has not previously been studied but is routinely used in some hospitals in Quebec, Canada. Objectives: This study aims to determine whether compresses soaked in 25% magnesium sulfate in sterile water can alleviate perineal pain in women immediately after childbirth. Population and intervention: Women who have just given birth vaginally and report perineal or vulvar pain of 3/10 or more will be recruited and randomized into an intervention group receiving the treatment (compresses soaked in 25% magnesium sulfate) or a control group receiving a placebo (compresses soaked in water). Methods: This multi-centric, double-blinded randomized clinical trial will be conducted in four hospitals in the province of Quebec, Canada. The investigators plan to recruit a total of 104 participants. Participants will be instructed to apply the compresses on the vulva and perineum for 15 minutes, four times per day, if needed. They will be asked to score their pain before and after using the compresses for the length of their hospital stay, typically between 24 and 48 hours. Secondary outcomes include analgesic use, incidence of complications, participant satisfaction, opinions on feasibility, and any adverse effects caused by the compresses. Discussion: This randomized controlled trial will assess whether the treatment is more effective in relieving pain than the placebo. The study will also determine the safety and feasibility of this method for routine postnatal care. This study could contribute in the long term to the standardization of evidence-based practices for the management of postpartum perineal pain in Canadian hospitals

Eligibility Criteria:
Inclusion Criteria:

* Planned hospital stay at the mother-child unit of the Hôpital de Chicoutimi, Hôpital Charles-Le Moyne, or Hôpital Honoré-Mercier
* Vaginal delivery with or without perineal tear, any degree of tear, including episiotomies
* Obtaining consent for the study
* Languages spoken: French, English or both

Exclusion Criteria:

* Hemodynamic instability
* Surgical procedure such as a cesarean section
* Transfer to another hospital
* Transfer to another care unit
* Chronic use of narcotics
* Inability to complete the logbook
* Unsigned consent form
Efficacy and Safety of the Neodymium Laser in Treatment of Urogenital Tract Diseases in Women

Study objective: To evaluate the efficacy and safety of the Magic Max neodymium laser in the medical treatment of women with symptoms of genitourinary syndrome of menopausal, vulvar lichen sclerosus and pelvic floor muscle reduction.

Study objective: To evaluate the efficacy and safety of the Magic Max neodymium laser in the medical treatment of women with symptoms of genitourinary syndrome of menopausal, vulvar lichen sclerosus and pelvic floor muscle reduction.

Materials and methods: 60 patients with diseases of the urogenital tract were enrolled into the study; they were treated with a neodymium (ND) laser: three 20-minute sessions every 28 ± 2 days. Efficacy was assessed by means of the Female Sexual Function Index (FSFI), ICIQ-SF, PISQ-12, SF36 survey forms, and a questionnaire to identify urinary disorders at the following time points: before treatment, one month after each session and 6 months after the last procedure.

Eligibility Criteria:
Inclusion Criteria:

* diseases of the urogenital tract
* symptoms of genitourinary menopausal syndrome,
* vulvar lichen sclerosus
* pelvic floor muscle reduction

Exclusion criteria:

* pregnancy
* oncological diseases
A Single-cell Transcriptome Study in Patients With Non-Hodgkin's Lymphoma

Using single-cell RNA sequencing, this study will explore the heterogeneity of lymphoma inside and outside the lymph node, identify tumor specific molecular markers and cell subgroups, explore the differences in tumor microenvironment composition, and provide a basis for diagnosis and precision treatment.

In recent decades, the incidence of lymphoma has been increasing year by year in the world. Non-Hodgkin lymphoma accounts for about 90% of lymphoma, of which the classification is complex and the efficacy is poor compared to Hodgkin's lymphoma. Non-Hodgkin's lymphoma is often associated with the extra nodal involvement, and according to literature, extra nodal lymphoma accounts for 1/3 to 1/2 of all non-Hodgkin lymphomas. Compared with non-Hodgkin's lymphoma without extra nodal involvement, the prognosis of lymphoma with extra nodal involvement was relatively poor. The recurrence rate was higher, and its incidence, histology type, clinical staging and so on all had their own characteristics.

Tumor cells depend to some extent on the interaction with non-tumor cells and matrix components of the tumor microenvironment to maintain survival and proliferation. In addition, the non tumor cells and matrix components can mediate immunosuppressive action to promote tumor escape from immunosurveillance, resulting in disease progression. At the same time, more and more data show that the tumor microenvironment plays a key role in the development of tumor resistance. The cellular composition and spatial properties of the tumor microenvironment show significant heterogeneity, depending on a number of factors, including subtypes of lymphomas and extra nodal sites of lymphomas. Studying the tumor microenvironment will provide rationale for more precise target therapy. Through single-cell RNA sequencing, this study hopes to identify the heterogeneity of nodal and extra nodal lymphoma cells, to understand the differences in tumor microenvironment, and to provide a basis for diagnosis and precision treatment.

There are new target drugs for different antigen targets. But patients may not be sensitive to a certain drug, and the drug is often expensive, resulting in increased financial burden on patients without efficacy. Therefore, the research for biomarkers to predict patient efficacy and prognosis is particularly important.

The treatment efficacy of patients with relapsed lymphoma is often not good, so the prediction and treatment of patients with high-risk of relapsing is a clinical significant problem. On the basis of single-cell transcriptomics, this study hopes to find biomarkers for predicting the relapse of lymphoma and provide new ideas for clinical diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathological confirmed diagnosis of non-Hodgkin's lymphomas.
* Patients with both lymph node and extra nodal involvement, or patients at high risk of relapse, or patients receiving a novel target drug treatment.
Pragmatic Use of Next-generation Sequencing for Management of Drug-resistant Tuberculosis

TS ELiOT is a stepped-wedge, cluster randomized trial assessing the effect of a next-generation sequencing-based strategy on rifampin-resistant tuberculosis management and patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Active RR-TB diagnosed at a study facility during the study period
2. Positive Mtb culture, smear, or specimen derivative (e.g., GenoLyse remnant, Xpert cartridge extract)

Exclusion Criteria:

1. Patient expects to relocate/move residence outside of the study region
2. Patient does not agree to participate in the study

In addition, participants later found to have isolates with rifamycin susceptibility on at least two additional tests (e.g., phenotypic DST, LPA, or sequencing) will be considered late exclusions.
Pulsed Short Wave Therapy In Cesarean Section

This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following Cesarean section. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.

Pain is ranked highest among undesirable clinical outcomes associated with caesarean section therefore postoperative pain relief following a cesarean section is extremely important to optimize maternal and neonate well being. Multimodial analgesics are effective in reducing postoperative pain but analgesia is still not optimized. Opiate based analgesics are effective but having troubling side effects. Addition of non-drug pain therapies hold promise in improving postoperative recovery while potentially allowing for reduced use of drug based analgesics.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily
* Performed using spinal anesthesia
* ASA I (Normal healthy patients) and II (Patients with mild systemic disease) (as defined by the American Society of Anesthesiologists Physical Status Classification system)
* PARA 0000, 1, 2, 3 \[i.e. First, Second, or Third C-Section)
* At term pregnancy (\>38 weeks)
* BMI \<35
* Age between 18 - 50 years

Exclusion Criteria:

* Longitudinal surgical incision
* Placental abnormalities noted
* Time of extraction of the fetus \>10 min from cutaneous incision
* Blood loss during surgery of \>800 ml
* Any of the conditions not considered in inclusion criteria
TITAN™ Reverse Shoulder System

The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended the TRS will relieve pain and restore some functional joint motion to the affected shoulder. The purpose of this study is to assess the short, mid and long term outcomes of the TITAN™ Reverse Shoulder System.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with grossly deficient rotator cuff with severe arthropathy or Subjects with failed joint replacement with grossly deficient rotator cuff
* Subjects with a shoulder joint anatomically and structurally suited to receive the device
* Subjects at least 21 years of age and skeletally mature at the time of surgery
* Subject provided consent to participate in the clinical study (having signed the Informed Consent Form)

Exclusion Criteria:

* Subjects without a functional deltoid muscle
* Subjects with active local or systemic infection
* Subjects with inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
* Subjects with poor bone quality such as osteoporosis where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid
* Subjects with muscular, neurologic, or vascular deficiencies that compromise the affected extremity
* Subjects with known metal allergies
* Subjects are known to be at risk for lost to follow-up, or failure to return for scheduled visits
* Subjects who are prisoners
* Female subject who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods