cyrilzakka/clinical-trials huggingface dataset:
High Altitude (HA) Residents With High Altitude Pulmonary Hypertension (HAPH), Pulmonary Artery Pressure (PAP) Assessed at HA (3200 m) vs LA (760 m)

To study the effect of relocation from 3200 m (Aksay) to 760 m (Bishkek) in patients with high altitude pulmonary hypertension (HAPH) who permanently live \>2500 m on pulmonary artery pressure (PAP)

This research in highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA \>30 mmHg who permanently live at HA \>2500 m will have pulmonary arterial pressure (PAP) assessed by echocardiography near their living altitude in Aksay at 3200 m and at 760 m in Bishkek the day after the first and the seventh night after relocation.

Eligibility Criteria:
Inclusion Criteria:

* Permanently living \>2500 m
* HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
* Written informed consent

Exclusion Criteria:

* Highlanders who cannot follow the study investigations,
* Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, heavy smoking \>20 cigarettes/day or \>20 pack-years.
* Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
* Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)
Study of the Intervention Effect of Outdoor Activity Period Patterns in Promoting Myopia Among Preschool Children

This study is a randomized controlled trial based on outdoor activity interventions at specific time periods, involving preschool children aged 4 to 5 years. It compared the axial length and myopia incidence between the intervention group and the control group at the 6th and 12th months of the intervention to determine the effect of outdoor activities at specific time periods on the prevention of myopia in preschool children. Additionally, the study investigated the association between outdoor activities at specific time periods and axial length and myopia in preschool children.

Preschool children with insufficient outdoor activity during specific time periods from one kindergarten were assigned to the intervention group, while those from another kindergarten with insufficient outdoor activity during specific time periods were assigned to the control group. The intervention group received an additional 1 hour of outdoor activity during a specific time period on each school day, while the control group did not receive any intervention and continued their regular routine. The intervention lasted for one year.

Participants underwent multiple assessments after joining the study. These assessments took place at baseline, at the 6th month of the intervention, and at the 12th month.

Eligibility Criteria:
Inclusion Criteria:

* Students and their families were informed and voluntarily participated in the study, with parents signing the informed consent form.
* Able to cooperate with eye examinations and questionnaires.

Exclusion Criteria:

* Communication barriers, unable to cooperate.
* Strabismus, amblyopia, or any other ocular or systemic diseases that may affect refractive development.
* Children currently using orthokeratology lenses or rigid contact lenses.
* Using other interventions (such as acupuncture, massage, medication, ear acupuncture, etc.) to control myopia, apart from school eye exercises.
Intermittent Oro-esophageal Tube Feeding in Late Dysphagia for Nasopharyngeal Carcinoma

This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oro-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared.

Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma continues to be a challenge. This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oro-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* With the history of Nasopharyngeal Carcinoma and radiation therapy.
* With dysphagia occurred at least three years after radiotherapy (confirmed by videofluoroscopic swallowing study), in need of and feasible for enteral nutrition support.
* Conscious and with stable vital signs;
* Willing to participate and sign the written informed consent form either personally or by a family member.

Exclusion Criteria:

* Presence of other diseases that might cause dysphagia.
* With distant metastasis of tumors, or complicated with severe systemic disorders or malignancies.
* Concurrent participation in other treatments that could interfere with the trial.
* Inability to cooperate with treatment due to aphasia, mental health issues, etc.
* Received tube feeding for enteral nutrition support within the past three years.
PhaseII,Open-label,Pilot Study Evaluating the Safety+Efficacy of Certican ® in the Prevention of Chronic Graft-versus-host Disease+Late Pulmonary Complications After Allogeneic Hematopoietic Cell Transplantation Blood

In this prospective study is to examine whether the use of everolimus in patients after allogeneic SCT as part of GVHD prophylaxis for a further review in clinical studies is appropriate.


Eligibility Criteria:
Inclusion Criteria:

* Patients after allogeneic stem cell transplantation aged ≥ 18 years
* Prophylaxes of GvHD with calcineurin inhibitors (Ciclosporine A, Tacrolimus) and MTX or MMF (previous therapy of acute GvHD with additional prednisone is permitted)
* Increased risk of chronic GvHD, defined by
* Male with female donor
* HLA mismatch class I- or II towards GvHD
* Persistant active acute GvHD on day +50 after stem cell transplantation despite of high-dose steroids and cyclosporine
* Reduction of baseline FEV1 or DLCO (examined 0 - 50 days before transplantation) of ≥ 25%
* New occurrence of acute GvHD between day +50 and +100 after stem cell transplantation
* Informed concent

Exclusion Criteria:

* Use (prophylactic or therapeutic) of mTor inhibitors after SCT
* Overlap of acute and chronic GvHD
* Total cholesterol ≥ 3-fold of upper limit (UL) or triglycerides ≥ 3-fold UL
* GOT, GPT, Bilirubin ≥ 3-fold UL (if not related to GvHD)
* Creatinine ≥ 3-fold UL
* Confirmed active hepatitis B or C
* All circumstances where impaired wound healing might be a risk factor, esp. surgical interventions in the last weeks, ulcers of skin or mucosa
* Known intolerance to Everolimus, Sirolimus or other compoments of Certican®
* Lactose intolerance
* Pregnancy or lactation
* Women in reproductive age, except of women with the following criteria:
* Postmenopausal (12 month natural amenorrhea)
* Postoperativ (≥ 6 months after bilateral ovariectomy with / without hysterectomy)
* During therapy and at least 6 months after the last application of Everolimus: regular and correct high-effective contraception (Pearl-Index \< 1; e. g. oral contraception, intrauterine device, implantate, contraceptive patch, combination of barrier methods (condom and cervical cap/diaphragm), abstinence
* Men, not using one of the following methods of contraception during therapy and at least 6 month after the last application of Everolimus:
* Sexual abstinence
* Vasectomy
* Condom
* Impairments or diseases reducing the ability of informed consent
* Participation of another study (e.g. for prophylactic immunsuppression in the stem cell transplantation procedure) within the last 60 day before recruitment
A Trial for Subjects With Systemic Lupus Erythematosus Who Have Completed Protocol AN-SLE3321

The purpose of this study is to evaluate the long-term safety of A-623 in subjects with SLE.


Eligibility Criteria:
Inclusion Criteria:

* Completed the treatment period specified in study AN-SLE3321 or were enrolled in study AN-SLE3321 prior to November 30, 2010

Exclusion Criteria:

* Developed a new medical disease or condition that has made the subject unsuitable for this study in the opinion of the Investigator, including interference with written informed consent, study evaluation, completion, and/or procedures
* Pregnant or nursing
* Any prior administration of a B-cell modulating therapy other than A-623
* Received cyclophosphamide, cyclosporine, anti-TNF alpha therapies, transfusion, plasmapheresis or plasma exchange, IV immunoglobulin, or live vaccines according to listed wash-out periods
Web-Based Tailored Educational Program in Improving Nurse Communication With Patients About Clinical Trials

This pilot, randomized clinical trial studies a web-based tailored educational program in improving nurse communication with patients about clinical trial treatment options. A web-based tailored educational program may empower and prepare nurses to discuss clinical trial treatment options with patients and may also increase patient participation in clinical trials.

PRIMARY OBJECTIVES:

I. To develop and pilot test a theory-driven, web-based, tailored, interactive educational program (Oncology Nurse IMPACT: Improving Communication with Patients about Clinical Trials) for oncology nurses to address barriers to discussing clinical trials with patients.

II. To implement Oncology Nurse IMPACT on a national level and conduct a formal program evaluation.

III. To evaluate the mediators and moderators of education program effect on intentions to discuss clinical trials with patients.

OUTLINE: Participants are assigned to 1 of 2 intervention arms.

ARM I: Oncology nurses watch web-based informational video clips addressing knowledge, attitudes, subjective norms, and perceived behavioral control (barriers of discussing clinical trials with patients). They also watch role-play video clips to help improve perceived behavioral control and address attitudinal barriers.

ARM II: Oncology nurses view online clinical trials educational materials developed based upon National Cancer Institute (NCI) clinical trials educational materials for health care providers. The educational materials contain text and tables as presented on the NCI Website.

After completion of study intervention, participants are followed for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Currently practicing nurse
* Involved in direct patient care
* Self-identify in one of the following primary practice roles--case managers, clinical nurse specialists, nurse practitioners, managers/coordinators, nurse navigators, patient educators, and staff nurses
* Available email address

Exclusion Criteria:

* Research nurses, nurses without direct patient care, and nurse managers/directors (i.e. not involved in direct patient care)
* Lack of email address
The Women's Health Initiative Memory Study (The WHIMS Study)

Excessive memory decline or dementia affects an increasing number of women as they become older. The frequency of dementia doubles every 5 years beginning at age 60, making the discovery of ways to prevent or slow the disease imperative. Previous studies have indicated that changes in memory may be associated with the female hormonal decline that occurs after menopause, but more research is needed to establish the link between menopause and poorer memory function. It is believed that taking the female hormones estrogen and/or progesterone may help improve women's health by protecting against memory decline. This study will evaluate the effects of female hormone replacement therapy (HRT) on the development and progression of memory loss in older women enrolled in the Women's Health Initiative (WHI) study.

Diseases of the memory, including dementia and Alzheimer's disease, are a primary health concern of the aging population. In just the last 30 years, the number of Americans diagnosed with memory diseases has doubled. The beginning signs and symptoms of Alzheimer's and dementia include mild forgetfulness, confusion, and disorientation with time and place. As the diseases advance, people often experience difficulty in carrying out normal activities, recognizing family and friends, and eventually speaking and comprehending. Early identification and treatment for dementia and Alzheimer's may help prevent and slow the progression of symptoms, but the most beneficial means of treatment is still unknown. Previous studies have suggested a link between menopause and reduced memory function in women, possibly attributed to the dramatic decline in the levels of the female hormones estrogen and progesterone. HRT in postmenopausal women may help to curb memory loss and reduce risk of developing memory-related diseases. This study will evaluate the effects of female HRT on the development and progression of memory loss in older women enrolled in the WHI study.

Participants in this study will be drawn from the WHI study and will have previously been assigned to HRT with estrogen, HRT with estrogen plus progesterone, or placebo. During this study, participants will continue to take their assigned treatments from the WHI study.

Participation will last up to 6 years. All participants will undergo baseline memory and thinking tests, including a mood assessment and tasks measuring memory and other brain functions. Study staff will conduct a telephone interview with a close family member or friend. Some participants may additionally undergo a 45-minute interview with a clinician, a blood draw, and a computerized tomography (CT) scan. All participants will repeat the baseline memory and thinking tests once annually for 6 years, and some participants will repeat the interview, blood draw, and CT scan at these annual visits as well.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the Women's Health Initiative - Hormone Therapy Trial
* Aged 65 - 79 years of age at time of enrollment
A Post-Market Clinical Evaluation of the Treatment of Tibia Fractures With the T2 Alpha Tibia Nailing System

This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of 80 subjects will be enrolled. Neither subjects nor investigators are blinded to treatment and the clinical investigation includes a historical control which will be compared to the T2 Alpha Tibia Nailing System.

Total duration of enrollment, 12 month follow-up and analysis is expected to take 31 months. The clinical investigation has been designed to follow the surgeon's standard of care for tibia fractured subjects, in addition to a 12 month follow-up visit.

The primary endpoint of this clinical investigation is to confirm efficacy/performance at 12 months, as measured by the SF-36 Physical Component Summary (PCS). Confirmation of efficacy/performance at 12 months will be based on an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) result of the T2 Alpha Tibia Nailing System compared to the benchmark literature.

The objective of this clinical investigation is to demonstrate the safety and efficacy/performance of the T2 Alpha Tibia Nailing System. Efficacy/performance of the procedure will be measured by an equal or higher (non-inferior) SF-36 Physical Component Summary (PCS) score result of the T2 Alpha Tibia Nailing System compared to the T2 Tibia benchmark literature at 12 months.

In addition, demonstration of bone consolidation in correct alignment will be measured by Investigator assessment by 12 months. Safety of the T2 Alpha Tibia Nailing System will be demonstrated through reporting of device related intra-operative and post-operative Adverse Events/incidents by 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or non-pregnant female age 18 years or older at the time of surgery;
* Subject is willing and able to give written informed consent and comply with the requirements of this Clinical Investigation Plan;
* Subject is intended to be, treated with the Tibial Nail of the T2 Alpha Tibia Nailing System in accordance with the following legally cleared/ approved Indications for Use:

Indications for Use approved In United States and Canada include:

* Open and closed tibial fractures
* Pseudoarthrosis and correction osteotomy
* Pathologic fractures, impending pathologic fractures and tumor resections
* Fractures involving osteopenic and osteoporotic bone
* Nonunions and malunions

Exclusion Criteria:

* Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device clinical investigation that, in the opinion of the Investigator, may confound results;
* Per the Investigator, the subject is in poor general health or undergoing any concurrent disease that would place the subject in excessive risk to surgery (i.e. significant circulatory problems, cardiac disease).
Evaluating the Impact of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics

Participants diagnosed with Type 2 diabetes receive personal coaching from a Certified Diabetic Educator (CDE) over a six-month period. The coaching program is enhanced using an mobile application and care management platform.

Participants diagnosed with Type 2 diabetes receive personal coaching from a Certified Diabetic Educator (CDE) over a six-month period. The coaching program is enhanced by integrating a participant-facing mobile application with the coaching platform. Blood glucose test results automatically populate the coaching platform, providing the CDE with information that may better support their coaching efforts.

The participants complete Diabetes Self Management Education (DSME) learning modules for the first 7-12 weeks. Following completion of the modules, the coach continues to provide support to the participant until 24 weeks after the participant's enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Lives in the United States
* Speaks and understands English
* Has a Type 2 diabetes mellitus diagnosis
* Has a LifeScan Verio Flex blood glucose meter, which is connected to OneTouch Reveal ® app
* Has a verified A1c ≥ 8%
* Willing to participate in coaching program

Exclusion Criteria:

* Uses a continuous glucose monitoring device
* Currently pregnant
* Unable to make lifestyle behavioral changes due to a cognitive or physical disability
* Has end stage renal disease (ESRD) diagnosis
* Is not able to read or understand English
Chamas for Change: Impact of the COVID-19 Pandemic

In Kenya, the chamas strategy (a peer support approach aimed at improving MNCH and reducing gender and social inequalities) has been shown to significantly improve maternal and child health outcomes while also providing social and financial support to participating women. However, the COVID-19 pandemic caused significant disruptions in women's work and MNCH services around the world due to reallocation of health care resources, COVID-19 fears, transportation restrictions, and lockdowns. These consequences appeared to disproportionately affect the poor, particularly poor women. The purpose of this participatory action design study is to determine how Chamas participation intersected with other factors to mitigate the effects of the COVID-19 pandemic on the health and economic well-being of women and children.

The study objectives are:

To evaluate the effect of Chama participation on mitigating the effects of the pandemic on social and gender equity.

* Impact on economic status (assessed using the changes in the Poverty Probability index scores)
* Impact on health service utilization and behaviours (assessed using enrollment in the national health insurance scheme, number of ANC visits attended, facility delivery, maternal death, newborn death, infant death, exclusive breastfeeding, number of children fully immunized at age 1)
* Social attitudes and well-being (assessed using, attitude towards harsh punishment of children, level of parental stress)
* COVID-19 related information (assessed using COVID-19 infection, COVID-19 vaccination, and effects of COVID restrictions)

To use an equity-centered design process and narrative approach to share research findings.

The research team intends to evaluate women's experiences during the pandemic using a mixed method approach and a participatory action design method. The focus will be on 3 study cohorts: (1) women who participated in Chamas throughout the pandemic, (2) women who left Chamas during the pandemic, (3) women whose communities were randomized to not receive the Chamas intervention. To better understand the effects of Chama participation on study outcomes, we will conduct an interviewer-administered survey among the described cohorts of women. This will be followed by qualitative studies to contextualize the study findings and investigate gender dynamics as social processes. Focus group discussions (FGDs) and key informant interviews (KIIs) will be conducted to further investigate our study cohort's experiences during the pandemic and identify strategies used by participants to mitigate the negative effects of the pandemic and its associated restrictions.

Eligibility Criteria:
Inclusion Criteria:

* Women who participated in the 2021 Chamas study in Western Kenya

Exclusion Criteria:

* Women who did not participate in the 2021 study.
Neomycin and Rifaximin Plus Neomycin in Treating Methane Positive Constipation Predominant Irritable Bowel Syndrome

In this study the investigators aim to compare the efficacy of neomycin to a combination of rifaximin and neomycin in the treatment of C-IBS subjects with methane on their breath test. This study will be conducted in collaboration with Dr. John DiBaise at the Mayo Clinic in Scottsdale, AZ and Dr. Satish Rao in Georgia Regents University in Augusta, GA.


Eligibility Criteria:
Inclusion Criteria:

* Rome III positive IBS subjects (18-75 years of age)
* Meet criteria for constipation predominant IBS symptoms including ≤ 3 complete spontaneous bowel movements per week with hard or lumpy stools.
* Presence of detectable methane on single breath sample (≥ 3ppm).
* If subjects are ≥ 50 years old, a colonoscopy had to have been completed within the past 5 years.

Exclusion Criteria:

* Subjects with history of intestinal surgery (except appendectomy or cholecystectomy)
* Recent antibiotic use (within the last 30 days)
* Subjects with known pelvic floor dysfunction
* Pregnancy
* Creatinine level \> 1.4
* Poorly controlled/uncontrolled significant medical condition that would interfere with study procedures
* Subjects with hearing loss and/or tinnitus
* History of bowel obstruction
* History of celiac disease
* History of inflammatory bowel disease
* Cirrhosis
* Diabetes