cyrilzakka/clinical-trials huggingface dataset:
Treatment of Chronic Pelvic Pain Due to Endometriosis by Transcutaneous Auricular Vagus Nerve Stimulation

6-10% of women of childbearing age suffer from endometriosis, which is mainly manifested by dysmenorrhea, non-menstrual pelvic pain and dyspareunia. Several treatment strategies, including surgical ones, are proposed but they are sometimes insufficient because endometriosis-related pain is frequently accompanied by sensitization. Endometriosis surgery, when indicated, is therefore changeably effective, even though the lesions have been completely resected. Patients therefore consult Pain Units seeking for the effective treatment as the pain persist even after surgical management of endometriosis.

Vagus nerve stimulation is a non-invasive technique that includes an anti-inflammatory effect and a modulation of neurotransmitter production (adrenaline, norepinephrine; serotonin, acetylcholine). Yuan and Silberstein published a general review on the technique. Migraine and depression are one of the selected indications. In addition, Napadow et al. published favourable results in a short series of patients with chronic pelvic pain. The Investigators of this study have treated some patients with this technique with a result deemed satisfactory which leads to propose a randomized study to confirm this impression.


Eligibility Criteria:
Inclusion Criteria:

* Women aged \>= 15 years
* With chronic pelvic pain and/ or dysmenorrhoea and/ or dyspareunia
* Who has been cared for by a gynecologist in one of the institutions participating in the study
* Diagnosed with endometriosis
* Having signed an informed written consent
* Affiliated to a health insurance scheme

Exclusion Criteria:

* contraindication to the use of transcutaneous auricular vagus nerve stimulation (cardiac pathology, asthmatic patient)
* pregnant or breastfeeding women
* patient undergoing in vitro fertilization
* associated pathology requiring long-term analgesic treatment
* patient with atria trans vagal neurostimulation in the 12 months prior to inclusion
* patient deprived of liberty or under guardianship
Effect of Melatonin on Reduction of Pelvic Pain

In two double blinded randomized controlled trials (RCT) we will study the effect of pain reduction of melatonin vs placebo in women with severe dysmenorrhea and women with endometriosis.The aim is to find an effective method for pelvic pain caused by dysmenorrhea and endometriosis.The primary outcome is reduction of pain in patients with dysmenorrhea and endometriosis respectively when treated with melatonin vs placebo. Secondary outcomes include the effect on daily life, quality of life and cognition. Sleep will also be assessed to evaluate its potential relation to quality of life and cognition.

Two substudies will be performed. Forty women with severe dysmenorrhea will be randomized to treatment with 10 mg melatonin daily or placebo during the menstruation for 2 menstrual cycles. Another 40 women with endometriosis will be randomized to treatment with 20 mg or placebo daily during 8 weeks. Participants will report drug intake, bleeding details (duration and amount) and pain as well as possible side effects. They will also perform a test for sleep quality and cognition before and after completion of the study.

See protocol for more details

Eligibility Criteria:
Dysmenorrhea group

Inclusion Criteria:

* Regular menstrual cycles,
* Severe dysmenorrhea (NRS\>6)
* Speaks and understands Swedish
* If other medication, those should be un-altered for the last 3 months

Exclusion Criteria:

* Smoker
* Prior or ongoing liver or kidney disease
* Endometriosis
* Pregnancy

Endometriosis group:

Criteria for inclusion:

* Endometriosis (endometriomas or diagnosis by laparoscopy)
* Moderate to severe pain (NRS \>/= 4)
* Good general health
* Understands and speaks Swedish
* If any other treatment, unchanged regimen for the last 3 months
* Signed informed consent

Criteria for exclusion:

* Prior or ongoing disease in kidney or liver
* Use of opioid analgesics
* Smoker
* Pregnant
A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease

The purpose of this study is to assess the safety and tolerability of E5555 in Japanese subjects with coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

1. 45 - 80 years old (at time of informed consent).
2. Male or female (females of childbearing potential must use contraception).
3. Confirmed coronary artery disease.
4. All subjects must be receiving aspirin (75 - 325 mg).

Exclusion Criteria:

1. Unwilling or unable to provide informed consent.
2. History of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder.
3. Recent trauma or major surgery.
4. Evidence of active pathological bleeding or history of bleeding such as gastrointestinal or genitourinary, unless the cause has been definitely corrected.
5. History of intracranial bleeding or history of hemorrhagic retinopathy.
6. New York Heart Association class III or IV congestive heart failure.
7. Pregnant or lactating women.
Fish Oil in PREgnancY for Personalized Prevention of Early Childhood Asthma

The overall aim of the study is to develop a nutritional preventive fish oil supplementation strategy in pregnancy for early childhood asthma/persistent wheeze during the first three years of life as we hypothesize that both supplementations in higher doses than recommended could reduce the risk of disease development.

Randomization of 2000 pregnant women to fish oil of 2.4 g/day (55% EPA and 37% DHA) in triacylglycerol form vs placebo. Supplementation begins in gestational week 24 (22-26) until 1 week after delivery. Allocation to the trial will be determined based on the pre-interventional maternal blood levels of EPA+DHA with a dried blood screening test. Women with low levels (below 4.7% of total fatty acids) will be assigned to the fish oil RCT. Maternal blood will be used for genetic, metabolomic and proteomic profiling. A 3-year follow-up of the children with longitudinal registration of parent reported symptoms, diagnoses, medication use, and hospitalizations will be performed. The primary outcome is persistent wheeze or asthma until age 3 years, with predefined analyses of effect modification by maternal genotypes. Secondary outcomes are lower respiratory tract infections, gastrointestinal infections, croup, troublesome lung symptoms, eczema, allergy, bone fractures, developmental milestones, mental health, cognition, and growth until age 3 years. A follow-up on both primary and secondary outcomes is planned after unblinding, from age 3 to 6 years.

Eligibility Criteria:
* Pregnant Danish women before week 26 with blood levels of EPA+DHA below 4.7% of total fatty acids
* No planned use of fish oil supplementations
* No endocrine-, heart-, kidney- or auto-immune disorders
The Effect on Decreasing Chemotherapeutic Toxicity and Increasing Anti-tumor Effect of Chinese Herbs Based on Syndrome Differentiation

To study the effect on decreasing chemotherapeutic toxicity and increasing anti-tumor treatment of Chinese Herbs based on syndrome differentiation


Eligibility Criteria:
Inclusion Criteria:

* Histology and cytology diagnosed IIIB or IV non-small-cell lung cancer (NSCLC) and untreated; Age \> 18 ages
* Sex unlimited; ECOG (Eastern Cooperative Oncology Group) fitness score (Performance status, PS)≤2.
* White blood cell count ≥ 3 x 10E9 / L, neutrophils ≥1 x 109 p/L, hemoglobin≥80 g/L , platelet ≥100 x 10E9 / L
* ALT, AST, normal or less than 2 times, bilirubin is normal
* Serum level in the normal range;Thr ecg is normal
* Expected survival time≥ 3 months or more;
* Agreed to the treatment combined traditional Chinese medicine with western medicine

Exclusion Criteria:

* Engaged in other clinical subjects
* Pregnant or lactating women, women in childbearing age refuse contraceptives during the trail
* Severe pneumonia, tuberculosis, lung abscess, myocarditis and other malignant tumor
* Severe damage of heart, liver and kidney (cardiac function grade 3 \~ 4, ALT and/or AST 2 times more than normal , Cr more the normal limit)
* Mental illness, Refused to partner; Cannot obtain informed consent
Effect Mode of Delivery and Feeding on Body Composition and Nutritional Status of Children

* Feeding and growth during infancy have been associated with later life body mass index.
* Breastfeeding seems to have a small but consistent protective effect against obesity in children.
* The Cholesterol content of human milk is 6-fold greater than that of the standard infant formulas.
* Infants delivered by caesarean section may be at increased risk of childhood obesity and adulthood obesity.

* Previous guidelines recommended that infants who are exclusively breast fed for the first 6 months of life, with particular solid foods gradually introduced from 6 months associated with lower childhood fat mass.
* The stated reason for discouraging introduction of solids to infant before 4 months include the risk of excessive weight gain, vulnerability of the gut to infection and increased susceptibility to the development of allergic disease.
* Infants whose dietary pattern was most similar to feeding guidelines, with high frequencies of fresh fruit and vegetables, home prepared foods and breast milk, gained weight and skin fold thickness more rapidly from 6 to12 months than other infants, independent of milk feeding, age of introduction of solids and maternal factors.
* Exclusively breastfed infants had significantly higher Total Cholesterol (TC) level and Low density Lipoprotein level (LDL) and lower High density lipoprotein level (HDL) as compared to mixed-fed infants in the first 6 months of life.
* Exclusive breast feeding seems to have a protective effect against some risk factors for cardiovascular disease in later life, as those who exclusively breastfed had lower level of plasma low density lipoprotein (LDL) cholesterol conc., higher level of high density lipoprotein (HDL) and lower LDL/HDL ratio than those bottle fed.
* Early weaning is related to rapid weight gain in infancy, and this may have implication for childhood obesity.
* Vaginally delivered children are colonised with bacterial strains from the mothers' vagina during delivery in contrast to children delivered by CS, and these differences seem to persist throughout infancy.
* The gut microbiota may have a role in energy harvesting, hence inoculation with maternal microbiota through vaginal delivery may be protective for childhood overweight compared with delivery by CS.

Eligibility Criteria:
Inclusion Criteria:

* Infants of both sexes
* Infants from 2 to 3 years
* Breast fed or formula fed or mixed fed infants

Exclusion Criteria:

* Children less than 2 and more than 3 years ago.
* Children having family history of chronic illness
* Children having family history of metabolic
* Children fed cow milk or buffalo milk.
* Infants delivered preterm.
Safety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

The purpose of this study is to 1) provide continued pregabalin treatment for 6 additional months to patients who have taken part in the placebo controlled study A0081060; and 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day)


Eligibility Criteria:
Inclusion Criteria:

* Adults with Type 1 or 2 diabetes
* Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months

Exclusion Criteria:

* Patients must not be in poor or unstable health.
Resilience Mobile App for Teens and Young Adults With Cancer

The goal of this pilot trial is to examine whether a mobile app version of the Promoting Resilience in Stress Management (PRISM) intervention is acceptable, easy to use, and helps improve quality of life and mental health symptoms.

Adolescents and Young Adults (AYAs) with cancer are at risk of distress, anxiety, depression, and poor quality of life. The use of mobile applications for psychosocial symptom self-management is appealing to this demographic population but this has not yet been developed and tested.

PRISM is a novel, brief, evidence-based 1:1 intervention that teaches stress management, goal-setting, meaning making, cognitive-behavioral, and mindfulness strategies. Here, we propose to test a mobile health (mHealth) version of PRISM, mPRISM. In a pilot randomized controlled trial, we will evaluate the feasibility, acceptability, and exploratory efficacy of mPRISM using a waitlist control design.

Eligibility Criteria:
Inclusion Criteria:

* Age 12-25 years
* Diagnosis of new malignancy within 12 months of enrollment treated with chemotherapy and/or radiation therapy at Seattle Children's Hospital (SCH)
* Patient able to speak/read/write English or Spanish language
* Cognitively able to participate in mHealth psychosocial intervention and interactive interviews

Exclusion Criteria:

* Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age
* Patients with diagnosis of malignancy \>12 months
* Patients with relapsed, recurrent, or refractory disease
* Patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible)
* Cognitively or physically unable to participate in mHealth psychosocial intervention and surveys
Low Dose Primaquine for Clearance of Gametocytes

Primaquine (PQ) is currently the only available drug that can clear mature transmission stages of P. falciparum parasites. PQ was previously shown to clear gametocytes that persist after artemisinin-combination therapy. However, there are safety concerns about the use of PQ at the currently recommended dose of 0.75mg/kg in individuals who are glucose-6-phosphate dehydrogenase (G6PD) deficient. PQ causes transient but significant haemolysis in G6PD deficient individuals; this side-effect is dose dependent. There are indications that a lower dosing of PQ may effectively reduce gametocyte carriage but the lowest efficacious dose for gametocyte clearance is currently unknown. Recently, the World Health Organization changed their recommendation to a low dose of primaquine, 0.25mg/kg. However, there is no direct evidence on the extent to which (low dose) PQ prevents malaria transmission to mosquitoes and what the lowest efficacious dose is.

In the current study we aim to identify the lowest efficacious dose of PQ in individuals with normal G6PD function. Children with asymptomatic malaria and normal G6PD enzyme function will be randomized to treatment with artemether-lumefantrine alone or in combination with low doses of PQ. All enrolled individuals will receive a full three-day course of AL, and will be randomized to receive a dose of primaquine or placebo with their fifth dose of AL. Efficacy will be determined based on gametocyte carriage during follow-up, measured by molecular methods. For a subset of participants with patent gametocytes, primaquine effect on infectivity to mosquitoes will be assessed by membrane feeding assays


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 2 years and \<15 years
2. Weight over 10kg
3. P. falciparum parasitaemia \>1,000 parasites and \<200,000 parasites/µl
4. P. falciparum gametocytes detected by microscopy
5. Normal G6PD enzyme function
6. Informed consent by legally acceptable representative

Exclusion Criteria:

1. Enrolled in another study
2. Fever or history of fever in the last 24 hours
3. Evidence of severe illness/ danger signs
4. Known allergy to study medications
5. Hb \< 8g/dL
6. Started menstruation
7. Pregnancy or breastfeeding
8. Antimalarials taken within the last 2 days
9. Primaquine taken within the last 4 weeks
10. Blood transfusion within the last 90 days
11. Non-falciparum malaria co-infection
ClearWay™ RX Registry Trial

The primary goal of this registry is to collect data regarding the use of the ClearWay RX Local Therapeutic Infusion Catheter for all indications.

The registry will collect de-identified data regarding the indication for use, ease of use, drug perfusion, catheterization procedure details, success for intended use, and overall operator performance evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Subject required the use of the ClearWay Rx Local Therapeutic Infusion Catheter.

Exclusion Criteria:

* Subject not meeting the above inclusion criterion
Interventions to Increase HBV Vaccinations in Sexually Transmitted Disease (STD) Clinics

The goal of this study is to evaluate two sets of interventions to increase acceptance of hepatitis B virus (HBV) vaccination in patients attending sexually transmitted disease (STD) clinics. The 1st set of interventions, with 3 levels, is based on message framing. The 3 levels are: 1. information only; 2. gain-framed message; and 3. loss-framed message. The 2nd set of interventions, with 2 levels, involves how the vaccine is recommended by the health care provider. The 2 levels are: 1. HBV vaccine offered; and 2. HBV vaccine recommended. The outcome of interest is1st dose acceptance.

The goal of this study is to evaluate two sets of interventions to increase acceptance of hepatitis B virus (HBV) vaccination in patients attending sexually transmitted disease (STD) clinics. The 1st specific aim is to assess the effect of message-framing on vaccine acceptance. Framing theory suggests that positively framed messages (i.e., benefits of getting vaccine) are more effective than negatively framed messages (i.e., dangers of not getting vaccine) in stimulating preventive health behaviors. Research on Framing Theory and engagement in health behaviors suggests also that the effects may be moderated by other attitudinal factors, including perceived risk of the behavior and degree of involvement in the message. The 2nd aim is to evaluate the effect of provider-based interventions. Prior research suggests that recommendations by health providers are very important in patients' decisions regarding acceptance of health care procedures. Patients (18 years and older) will be recruited and followed from Chicago and Indianapolis STD clinics during routine medical visits. An audio computer-assisted self-interview (A-CASI) will cover demographics, risk behaviors, and perceived risk associated with vaccination. Subjects then will be randomized to receive a gain-framed, loss-framed, or information only message regarding HBV immunization (also delivered by A-CASI). Upon completion of the message-framing intervention, subjects will complete additional attitude questions via A-CASI. Upon completion of the A-CASI subjects will be randomly assigned to one of two provider intervention conditions: 1. vaccine offered or 2. vaccine recommended. For both conditions free HBV immunization will be provided by a nurse practitioner. Subsequently, postcard reminders will be sent and phone call reminders made for follow-up appointments for those receiving the first and second doses of vaccine. The primary outcome measure is HBV vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older males and females
* No prior self-reported history of HBV immunization or infection
* Fluent in English
* Not known to be HIV positive.

Exclusion Criteria:

* Under age 18
* Received any prior HBV vaccination
* Prior infection of Hepatitis B
* Unable to read or comprehend the English language
* HIV positive
Impact of IVF Hormonal Therapy on Endometrial Receptivity and Endometrial Senescent Cell Pathological Accumulation

Both controlled ovarian stimulation (COS) and frozen embryo transfer has become an integral part of in vitro fertilization (IVF) treatment. Fresh embryo transfer is usually performed by providing Luteal Phase Support (LPS) with progesterone after COS. Frozen embryo transfer (FET) is usually performed in artificial cycles with hormone replacement treatment (HRT), in which exogenous progesterone is administered, although it can also be performed in a Natural Cycle (without hormone supplementation) (NC). There is evidence that the supraphysiologic levels of estradiol and progesterone during COS+LPS and HRT could lead to morphologic and biochemical endometrial modifications, altering endometrial receptivity and lowering implantation and pregnancy rates.

We hypothesize that the supraphysiologic hormone levels required for both COS+LPS, and HRT may be inducing alterations in endometrial composition and function, specifically the chronic accumulation of senescent cells; either due to an excessive hormonal induction, a lack of clearance due to a deficit of uNKs, or a combination of both, ultimately affecting both endometrial receptivity and decidualization, worsening IVF outcomes.

The in vitro clearance of endometrial senescent cells by selective induction of apoptosis has been found to enhance the decidualization capacity of the rest of Endometrial Stromal Cells (EnSC), which could represent in a future adjuvant strategy to reduce the potentially deleterious effects of supraphysiologic hormone levels and improve reproductive outcomes in IVF patients.

The results derived from this project would have a direct impact on clinical practice. First, the results would allow us to evaluate, based on experimental data, potential endometrial side effects of stimulation protocols commonly used in IVF treatments. In addition, in the case of finding a pathological accumulation of senescent cells affecting endometrial receptivity, we will be able to in vitro evaluate the effectiveness of adjuvant senolytic (drugs designed to specifically remove senescent cells) compounds to in vitro improve the expression of endometrial receptivity markers, as a first step to demonstrate the effectiveness of their use in improving the reproductive outcomes of IVF patients.


Eligibility Criteria:
Study group (subfertile IVF patients).

* Inclusion Criteria: Women aged 18-45 years, BMI ≥ 18.5- 30.
* Exclusion criteria: Women presenting any uterine disease that affects the endometrial cavity, or with a thin or irregular endometrium, altered karyotypes, thrombophilias, or uncorrected systemic or endocrine diseases will be excluded.

Endometrial receptivity reference group (oocyte donors).

* Inclusion criteria: women aged between 18 and 35 years, BMI ≥ 18.5- 25.
* Exclusion criteria: Any cases of DIU presence, hormonal contraceptives at least during the last three months, altered karyotypes, thrombophilias, or uncorrected systemic or endocrine diseases will be excluded.
Combined Hormone Therapy, C-reactive Protein(CRP) Levels and Life Quality in Natural Menopause Women

This study aims to assess the effect of low dose combined estradiol and norethindrone acetate hormone therapy on serum CRP levels and life quality in natural menopause women. 45 natural menopause women who admitted to Karadeniz Technical University, Faculty of Medicine, Department of Obstetrics and Gynaecology for 1 year and diagnosed as menopause and planned to have hormone therapy for menopausal symptoms involved in this study. The serum CRP levels and vasomotor symptoms scores graded according to Blatt-Kupperman Index and life quality scores according to Menopause-Specific Quality of Life Questionnaire (MENQOL) in Turkish were recorded before and after (3 months later) low dose hormone treatment (1 mg Estradiol and 0.5 mg Norethindrone acetate).


Eligibility Criteria:
Inclusion Criteria:

* Accepting consent to participate in the research and signing the form;
* Postmenopausal women 45-55 years old
* not having had menstruation for the past 6 months;
* Hormone results compatible with menopause (FSH\> 20 milli-International unit(mIU) / mL, E2 \<20 mIU / mL) and presence of vasomotor and/or menopausal symptoms (moderate to severe);
* no systemic disease (Diabetes, hypertension, hyperlipidemia, ischemic heart disease), or no infectious disease in the past 2 weeks;
* not taking any hormone therapy or medication for at least 2 months;
* no contraindications for hormone therapy in routine menopause evaluation;
* Willingness to take hormone therapy
* No smoking.

Exclusion Criteria:

* Any systemic disease (DM, HT, hyperlipidemia, ischemic heart disease) presence
* Smoking
* Contraindications for hormone therapy
* Failure to follow-up
* Inability to complete three months of hormone therapy
* Stopping hormone therapy due to vaginal bleeding during hormone therapy