cyrilzakka/clinical-trials huggingface dataset:
Meridian Yoga on Chemotherapy-induced Peripheral Neuropathy in Breast Cancer Patients

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in breast cancer patients with completion of chemotherapy, and that is characterized by associated clinical symptoms such as pain, tingling, numbness, and paresthesia etc. CIPN also interferes with patients' functions of daily living and leads to chronic functional decline and a reduced quality of life. Meridian yoga is beneficial to the treatment of patients with peripheral neuropathy and the improvement of their quality of life.

Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect in breast cancer patients with completion of chemotherapy, and that is characterized by associated clinical symptoms such as pain, tingling, numbness, and paresthesia etc. CIPN also interferes with patients' functions of daily living and leads to chronic functional decline and a reduced quality of life. Meridian yoga is beneficial to the treatment of patients with peripheral neuropathy and the improvement of their quality of life.

Therefore, the aim of this study was to evaluate the efficacy of meridian yoga for CIPN in breast cancer patients. The investigators designed a clinical randomized controlled trial in which 80 patients with CIPN were equally divided into a control group (8 weeks of general care) and a treatment group (general care plus 16 times yoga interventions for 8 weeks). The assessment time was before (vision 1) and at the completion of 8 weeks of Meridian yoga treatment (vision 2). The primary outcome was the change in scores of the neuropathic pain scale (Chinese version). The secondary outcome was to the changes of meridian energy \[Meridian Energy Analyzer (M.E.A.D.)\], Perfusion Index (PI) value of peripheral blood flow, and the changes of cortisol and IL-6 level in salivary fluid.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese or Taiwanese-proficient men and women aged ≥18 years.
2. Patients with stage I-III breast cancer.
3. Suffering from peripheral neuropathy caused by chemotherapy (professional judgment by a physician).
4. Willing to adhere to requirement that no new pain medication be taken throughout the study period.
5. Willing to adhere to all study-related procedures, including randomization to one of the two arms.
6. Patient answers "Yes" to at least one factor in the question: "Do participants think your balance, gait, posture, alignment, or flexibility has been affected by your experience of CIPN?"

Exclusion Criteria:

1. Metastatic disease.
2. Drugs abuse such as amphetamines, morphine, etc.
3. Pregnant
4. Those with severe mental illness or mental instability who cannot cooperate with the trial.
5. People who are severely hearing impaired, visually impaired, or demented and unable to perform yoga.
6. Severe heart disease or chronic obstructive lung disease, liver or kidney failure,and edema or severe skin damage.
7. Severe spinal disease, affecting actors.
8. Those who have participated in yoga practice in the past month.
9. Those who do not sign the informed consent.
A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).


Eligibility Criteria:
Inclusion Criteria:

* In the opinion of the Investigator, the subject is expected to benefit from participation in this Open-Label Extension study
* Subject completed PA0010 \[NCT03895203\] or PA0011 \[NCT03896581\] without meeting any withdrawal criteria
* Female subjects must be postmenopausal, permanently sterilized or willing to use a highly effective method of contraception

Exclusion Criteria:

* Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of investigational medicinal product (IMP)
* Subjects who meet any withdrawal criteria in PA0010 or PA0011. For any subject with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder studies, the Medical Monitor must be consulted prior to the subject's entry into PA0012, although the decision to enroll the subject remains with the Investigator
* Subject has a positive or 2 indeterminate interferon gamma release assays (IGRAs) in one of the feeder studies, unless appropriately evaluated and treated
Exploring Volunteers' Experiences in Health TAPESTRY

This study is meant to evaluate the Health TAPESTRY volunteer program. The objective of this study is to explore volunteer experiences in Health TAPESTRY in terms of implementation and to understand how participation in Health TAPESTRY as a volunteer is related to compassion, self-reported physical activity, quality of life, and attitudes toward older adults.

Health TAPESTRY aims to help people stay healthier for longer in the places where they live. As a person-focused, proactive approach, Health TAPESTRY incorporates trained community volunteers into the primary care team in a way that is seamless and complementary to the essential work that clinicians are undertaking each day. In the program, volunteers conduct home visits with older adult clients, complete questionnaires, and connect their clients to primary care and community resources. This study offers the opportunity to fill a major gap in the literature by investigating the experiences of volunteers within Health TAPESTRY and the effect on them of participation as an intervention in its own right.

Specifically, the study seeks to understand volunteers' experiences in the program and evaluate any effects that volunteering with the program has on the volunteers including with the volunteers health and wellness (specifically physical activity and quality of life), empathy, and attitudes toward older adults. The investigators will also look at how the volunteers patterns of compassion fatigue and compassion satisfaction might change throughout involvement in the program, and how that connects to volunteer demographic characteristics like age and gender, as well as other characteristics like empathy, how many home visits are conducted, and the initial motivation to volunteer with the program.

This program evaluation study will employ qualitative and quantitative data collection strategies including surveys, narratives written by volunteers, and volunteer focus groups.

Eligibility Criteria:
Must be a Health TAPESTRY Volunteer or Volunteer Coordinator. There are no further inclusion or exclusion criteria.
Anti-Helicobacter Pylori Antibodies (IgG) in Serum of Women With Unexplained Infertility

Prevalence of anti-H.pylori IgG in serum of women with unexplained infertility and comparing that with it's prevalence in fertile women.

Unexplained infertility was diagnosed according to standard World Health Organization (WHO) criteria. All women in the study had hormonal assessment to evaluate their ovulatory cycles, thyroid function, circulating prolactin and androgen levels. The ovarian reserve was checked by measurement of serum FSH and an antral follicle count on the third day of the menstrual cycle. Screening for infertility also included transvaginal ultrasound and hysterosalpingography, to exclude possible uterine malformations or pathologies, and to assess the patency of the fallopian tubes. Male factor infertility was excluded in all couples, according to standard WHO semen analysis.

Following admission, all patients underwent complete clinical examination and detailed medical history was obtained.

A venous sample was collected to test serum for HP IgG seropositivity by enzyme linked immunoassay for HELICOBACTOR PYLORI IgG (ENZYME IMMUNOASSAY TEST KIT).

Eligibility Criteria:
Inclusion Criteria:

1. regular cycles.
2. normal thyroid function, prolactin and androgen levels.
3. normal semen analysis of the partner.
4. normal hysterosalpingography.
5. normal transvaginal ultrasound examination.

Exclusion Criteria:

1. possible uterine malformations or pathologies.
2. presence of infections, including hepatitis, human immunodeﬁciency virus (HIV), TORCH, Chlamydia trachomatis and Mycoplasma.
3. presence of anti-sperm antibodies in serum.
4. Male factor infertility.
Intraoperative TAP Block After Repeat Cesarean

The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.

Transversus abdominis plane (TAP) block is a well-described technique to provide a field block for analgesia. It has been shown to be effective in postoperative analgesia after cesarean delivery. TAP blocks are commonly performed post-operatively by anesthesiologists using liposomal bupivacaine with ultrasound guidance. Liposomal bupivacaine is an FDA approved medication for post-surgical analgesia and available at UMass-Memorial Medical Center. Liposomal bupivacaine provides sustained release of medication for up to 120 hours. A recent multicenter randomized controlled trial demonstrated the efficacy of anesthesiologist administered TAP blocks using liposomal bupivacaine after cesarean delivery. Infiltration of the skin and fascia with liposomal bupivacaine after cesarean did not have an effect and this can be explained by the path that the pain fibers take through the TAP which makes them amenable to a TAP block while a superficial infiltration is ineffective.The aim of this study is to perform a randomized trial to investigate if intraoperative surgeon administered TAP block reduces pain and use of oral and parenteral pain medications after repeat cesarean delivery. The investigators aim to compare surgeon administered TAP block with liposomal bupivacaine compared to standard treatment (i.e. no TAP block) with regard to the primary outcome of post-operative narcotic use.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women presenting for elective repeat cesarean delivery at 37-42 weeks gestational age.
* Pregnancy and delivery care obtained at UMass Memorial Medical Center
* Patients able to provide written informed consent
* English, Spanish, or Portuguese-speaking patients

Exclusion Criteria:

* Participants who are under the age of 18 years
* Active labor.
* Baseline pain score \> 6.
* Unable to provide informed consent.
* Prisoners will be excluded from this research.
* Narcotic use in the 2 weeks prior to delivery.
* Active substance abuse.
* Inability to take narcotic analgesia.
Evaluation of the Immunogenicity and Safety of VARIVAX™ in Healthy Russians (V210-058)

The purpose of this study was to evaluate the immunogenicity and safety of VARIVAX™ vaccine in healthy Russian children, adolescents, and adults. No formal hypothesis was tested.


Eligibility Criteria:
Inclusion Criteria:

* has a negative clinical history for varicella and herpes zoster
* females of reproductive potential have a negative pregnancy test prior to each study vaccination
* females of reproductive potential remain abstinent or use 2 acceptable methods of birth control during study until 3 months following last study vaccination
* females not of reproductive potential do not require a pregnancy test or use of contraceptives
* legal representative of adult or parent of children understands risks involved with, consent to participate in, and comply with the study procedures

Exclusion Criteria:

* has a history of allergy or anaphylactic reaction to neomycin, gelatin, or any component of VARIVAX\^TM
* has received any form of varicella or herpes zoster vaccine at any time prior to study, or anticipates receiving any during study
* has received immune globulin, a blood transfusion or blood derived products within prior 5 months or plans to do so during study
* has received aspirin or any aspirin-containing products within prior 14 days
* has been exposed to varicella or herpes zoster in the prior 4 weeks involving playmate, hospital or continuous household contact, or had contact with a newborn whose mother had chickenpox 5 days before or 2 days after delivery
* has, or lives with a person who has, any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity including those resulting from corticosteroid use or other immunosuppressive therapy
* has received glucocorticosteroids for more than 5 consecutive days within prior 3 months, or any dose of glucocorticoids within prior 7 days, or expects to use glucocorticosteroids during the study
* was vaccinated with licensed non-live or live vaccine within prior 30 days or expects vaccination during 42 day follow-up postvaccination period
* had a fever within 72 hours prior to study vaccination
* has participated in another trial within prior 30 days, is currently participating in another trial, or plans to participate in another trial during the planned study period for this trial
* is pregnant or nursing
The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome

This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome.

This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome(PNS). The study will be Planned at 1500 participants, and subjects will be on study for up to one year. Data will be collected by authorized physicians for 48 weeks. all of the data included demographic characteristics, information about PNS, laboratory tests and adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. In accordance with Pediatric Branch , the Chinese Medical Association in 2009: guidelines for diagnosis and treatment of common kidney diseases in children (for trial)Ⅰ. Hormone-sensitive, relapsed/dependent nephrotic syndrome diagnostic and evidence-based guidelines; Ⅲ.Diagnostic criteria for the diagnostic and evidence-based guidelines for hormone-resistant nephrotic syndrome, which means children who are diagnosed with primary nephrotic syndrome should be included;
2. Age from 1 to18;
3. ALT and AST levels do not exceed twice the upper limit of the normal range;;
4. Provision of written informed consent by legal guardians.

Exclusion Criteria:

1. a variety of secondary nephrotic syndromes are caused by infectious diseases such as lupus nephritis, hepatitis b associated nephritis, purpura nephritis, and EB virus, cytomegalovirus (CMV), etc;
2. with combined diseases of cardiovascular, liver, hematopoietic system, mental disorders and other serious diseases;
3. History of diabetes or examinations showed elevated blood glucose levels;
4. Participation in other ongoing clinical trials or during their observation period within the last three months prior to visit 1;
5. Previous/concomitant treatment with any other immunomodulators within the last three months prior to visit 1 ;
6. Patients who are unlikely to adhere to the protocol.
Natural History and Functional Status Study of Patients With Lafora Disease

A natural history and functional status study to characterize the clinical disease course in Lafora disease patients using standardized, quantitative evaluations and to identify useful biomarkers and clinical outcome measures for use in future Lafora treatment studies.


Eligibility Criteria:
Inclusion Criteria:

1. Documented genetic diagnosis of Lafora disease based on mutations in both alleles of either the EPM2A or the EPM2B gene and a sibling with a known mutation in EPM2A or EPM2B.
2. Able and willing to comply with the study protocol, including travel to Study Center, procedures, measurements and visits, including:

   1. Adequately supportive psychosocial circumstances, in the opinion of the Investigator
   2. Caregiver/trial partner committed to facilitate patient's involvement in the study who is reliable, competent, at least 18 years of age.
   3. Adequate visual and auditory acuity for neuropsychological testing

Exclusion Criteria:

1. Any known genetic abnormality, including chromosomal aberrations that confound the clinical phenotype
2. Subjects with:

   1. complete absence of speech OR
   2. inability to perform any activities of daily living OR
   3. who are completely bedridden.
3. Current participation in an interventional or therapeutic study
4. Receiving an investigational drug within 90 days of the Baseline Visit
5. Prior or current treatment with gene or stem cell therapy
6. Any other diseases which may significantly interfere with the assessment of Lafora disease.
7. Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study.
Effect of PDA Closure on the Left Ventricular Remodeling

failure of closure of the ductus arteriosus after birth results in a congenital anomaly known as patent ductus arteriosus. The large ductus can induce left side heart remodeling changes which could interfere with the normal cardiac function.

Patent ductus arteriosus (PDA) is a congenital heart disease that represents 6-11% of all congenital heart diseases and is due to failure of spontaneous closure of a normal foetal duct called ductus arteriosus, that is a duct connecting the left pulmonary artery to the aorta, and it may result in LV volume overload , pulmonary overflow that may end with development of Eisenmenger syndrome. LV volume overload of the big ductus induce left heart remodeling changes in form of LA and LV dilatation, and LV hypertrophy to compensate for the increased wall stress. Some patients compensate well and remain asymptomatic, while others can't and develop manifestations of LV systolic dysfunction .

Traditional echocardiography is the main diagnostic tool for the PDA and assessment of its hemodynamic effect on the heart. speckle tracking echocardiography ( STE) is a relatively novel tool that can assess the LV function by tracking the speckles of the grey scale 2D images. Recent studies revealed good correlation between the LVEF measured by traditional echocardiography and global longitudinal strain (GLS) measured by STE , in addition to detection of subtle myocardial dysfunction by STE in patients with heart failure with preserved LVEF before frank LV systolic dysfunction is apparent clinically .

PDA closure should induce reverse remodelling with improvement of the left heart dimensions and function . Many studies in pediatrics showed deterioration of LVEF early after PDA closure followed by rapid recovery , while fewer studies showed late improvement of the LVEF in the adults .

Eligibility Criteria:
Inclusion Criteria:

* all patients who are candidate for transcatheter PDA closure.

Exclusion Criteria:

1. Patients with PDA dependent pulmonary circulation.
2. Patients with small sized PDA which is silent by auscultation.
3. Patients with large sized PDA which is unsuitable for Trans-catheter closure .
4. Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).
5. Patients with active infection or active infective endarteritis.
6. Patients refusing the study.
7. Patients with DM, HTN and ischemic heart diseases.
8. Patients with associated congenital or acquired cardiac lesions that may interfere with LV mechanics.
Reducing Overdose After Release From Incarceration

The primary objective of the ROAR project is to evaluate an Oregon Department of Corrections (ODOC) pilot program that combines the use of extended-release naltrexone (XR-NTX) and Certified Recovery Mentors pre-release with linkage to community substance use disorder treatment to prevent fatal and non-fatal opioid overdoses among female adults released from prison.

ROAR examines implementation of a novel overdose prevention strategy for justice-involved women as they re-enter community treatment settings after incarceration. The ODOC pilot project offers initiation of opioid antagonist treatment prior to release (extended-release naltrexone \[XR-NTX\]), ongoing support from a Certified Recovery Mentor (CRM), and facilitated entry into community treatment for substance use disorders. Community treatment may include continuation of XR-NTX,or transition to agonist therapy including buprenorphine or methadone, or no medication for opioid use disorder.

Eligibility Criteria:
Inclusion Criteria:

* Be a woman (including transgender and non-binary adults assigned to women's housing at CCCF)
* 18 years of age or older with a known release date during the 18-month recruitment period
* Be released to Marion, Multnomah, Clackamas or Washington County, Oregon
* Be willing and able to provide informed consent and HIPAA authorization for medical record abstraction and linkage to state administrative data
* Meet DSM-V (Diagnostic and Statistical Manual) criteria for moderate or severe opioid use disorder
* Be willing to establish ongoing care at the community SUD (substance use disorder) treatment site in county of release
* Be willing to initiate XR-NTX prior to release from incarceration
* Not be currently pregnant and must be willing to take at least one evidence-based measure to avoid becoming pregnant during treatment with XR-NTX

Exclusion Criteria: A participant will be excluded if she

* Has a severe medical, psychiatric, or substance use disorder that, in the opinion of the CCCF Qualified Mental Health Professional (QMHP)or study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study due to imminent risk of death
* Has another medical condition leading XR-NTX to be contraindicated
* Has chronic pain requiring ongoing pain management with opioid analgesics
* Received methadone or buprenorphine maintenance therapy in the 4 weeks prior to consent
* Has a planned surgery or other procedure within the next 4 weeks that will require opioid analgesia
FOLLOW HEART TRANSPLANT FOR ACHIEVING THE HEART PRIMITIVE RELATED SCLERODERMA SYSTEMIC

Systemic sclerosis is a rare disease. The early cardiac disease affects 10% of patients sclérodemiques.

Heart transplantation in the early cardiac involvement in systemic sclerosis is exceptional.

we see patient data analysis with systemic sclerosis who used cardiac transplantation to understand the primitive cardiac damage associated with systemic sclerosis


Eligibility Criteria:
Inclusion criteria:

* Adult patients meet the criteria for classification of systemic sclerosis
* Adverse primitive heart that required a heart transplant
* Patients who have given their verbal agreement to use their data for research purposes.

Exclusion criteria:

* Localized Scleroderma or sclerodermiform syndrome
* Heart disease secondary to pulmonary or renal impairment
* Refusal to participate in the study