cyrilzakka/clinical-trials huggingface dataset:
Biopsychosocial Predictors of Nicotine Relapse

This study aims to investigate the associations between emotion regulation ability, stress-induced neural activity changes, and susceptibility to relapse in smokers attempting to quit. Participants will undergo assessments of emotion regulation, neural activity via quantitative electroencephalography (qEEG), and stress responses before and during a 24-hour nicotine abstinence period. They will then participate in a computerized smoking cessation intervention, and their abstinence status will be monitored for 6 months.

The study will examine the unique and interactive effects of emotion regulation ability (a trait-like vulnerability factor) and biomarkers of stress responses (emotion regulation and neural activation changes) prior to smoking cessation, on cravings, abstinence adherence, and response to a smoking cessation intervention.

The study will be divided into three main phases:

* Ad libitum nicotine use (Day 1): Participants will smoke as usual. Baseline assessments of emotion regulation (heart rate variability), neural activity (qEEG), stress responses (salivary cortisol), and nicotine craving will be conducted before and after exposure to a stress task.
* Acute 24-hour abstinence (Day 2): Participants will abstain from smoking for 24 hours. Emotion regulation, neural activity, withdrawal symptoms, and cue-induced cravings will be assessed.
* Smoking cessation intervention (Days 3 to 180): Participants will engage in a computerized smoking cessation program. Abstinence will be biochemically verified at 3 and 6 months post-quit. Smoking lapses and time to relapse will also be monitored.

The primary outcomes are maintenance of abstinence, smoking lapses, and time to relapse. Secondary outcomes include changes in emotion regulation, neural activity, stress responses, withdrawal symptoms, and cue-induced cravings.

The study hypothesizes that smokers who fail to maintain long-term abstinence will exhibit enhanced stress-induced high-frequency qEEG oscillations, disrupted connectivity in emotion regulation brain regions, and emotion regulation deficits. It is also hypothesized that the interplay between these measures will predict smoking cessation outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years
* Smoking at least 10 cigarettes daily for at least 2 years
* Intention to quit smoking
* Medication-free

Exclusion Criteria:

* Presence of psychiatric or medical treatment
* Pregnancy
* Current unstable medical illness
* Recent (prior 6 months) drug or alcohol use disorder
* Major Depression
* Diagnosis of psychotic disorder
Chronic Endometritis and Benefits of Antibiotics in Women With Recurrent Miscarriage

The aim of the study is to estimate the incidence of CE, evaluate the endometrial microorganism of CE, and investigate the therapeutic benefits of antibiotics for women with unexplained recurrent miscarriage and CE.

Eligible women, based on the inclusion and exclusion criteria, will be recruited from the miscarriage clinic in the Prince of Wales Hospital. Endometrial sampling (ES) will alternatively be conducted during mid-luteal phase. In natural cycles, all the subjects will have a daily urine test from day 9 of the menstrual cycle to identify the Luteinizing Hormone (LH) surge. The ES will be obtained precisely 7 days after LH surge. Endometrial samples will be obtained using a Pipelle sampler as an outpatient procedure. The endometrium will be divided into three aliquots. One will be fixed in 4% formalin for 24 hours, routinely processed and embedded in paraffin wax. One will be investigated by microbial culture for infectious agents and one will be sequenced to reveal the endometrial microbiota.

CE will be diagnosed either by the presence of plasma cells and changes in endometrial stromal cells identified using HE and IHC, or by the finding of infectious agents using microbial culture. The selection of antibiotics will be based on the type of infectious agents or empirical, doxycycline 100mg BD po. for 14 days, for women with negative microbial culture. Endometrial biopsy will be repeated at the same time point after antibiotic treatment for women with CE. For persistent subjects with negative culturing, ciprofloxacin 500mg, BD po., and metronidazole 400mg TDS po. for 14 days will be used. The treatment will be repeated for three courses at maximum for women with persistent CE according to their willingness.

Eligibility Criteria:
Inclusion Criteria:

* Women with a history of 2 or more consecutive miscarriages before 24 weeks of gestation
* Women aged 20-45 years old

Exclusion Criteria:

* Uncorrected uterine anomalies, such as the septate or bicornuate uterus, fibroids (submucous/intramural)
* Untreated hydrosalpinx
* Antiphospholipid syndrome
* Known clinical autoimmune disease
* Undergoing immunotherapy
* Abnormal thyroid function
* Abnormal karyotyping of couples
* Known immunodeficiency pathologies such as diabetes or HIV
* Currently taking other antibiotics or other trial medications or TCM;
* Currently or previously involved in other clinical trials with medication intake;
* Those with active pelvic inflammatory disease or suspicion of infection etc.
Role of Metabolic Enzymes in Non-Melanoma Skin Cancer

The researcher can proved that certain compounds play an important role in the prevention of skin cancer. Researcher can use specific compounds, which classified as metabolic enzymes, and lower concentrations and complete absent in skin cancer cells. Researcher can biopsies of normal skin and precancerous or cancerous lesions, and can compare the concentrations of these compounds to determine the difference between the two areas. The result can lead to further understanding of skin cancers and pre-cancers. Because skin cancers and pre-cancers are so common, any knowledge would be very useful for many people in the future and may be used for development of future treatments or prevention strategies.

Biopsy procedure will be done at the Beckman Laser Institute or at the Dermatology Clinic Gottschalk Medical Plaza, of University of California, Irvine. Standard procedure of punch biopsy will be done in the areas determined by the physician researchers. The normal skin biopsy will be obtained from an area of skin without any suspicious lesions located on an area of the body. Biopsy specimens will be stored frozen at Beckman Laser Institute chemistry-lab for research and will be assigned with subject ID number, there will be no personnel health information attach to the skin specimens. There will be no cost to the subject or their insurer for participation in this study, except in the specific scenario of a suspected skin cancer that would undergo biopsy regardless of participation in this study. The time commitment for each subject is approximately 1 hour for each set of biopsies.

Researchers can test the hypothesis that expression of key metabolic enzymes is reduced and/or lost during skin cancer progression. Total ribonucleic acid, a single-stranded biologic molecule involved in gene transcription, regulation, and translation, can be isolated from biopsied skin specimens. Quantitative Real-Time can be performed to determine the expression levels of several key metabolic enzymes.

Metabolic enzymes regulate several vital signaling pathways in the human body. Some examples include hormone and bioactive lipid regulation. Aberrant regulation of these signaling pathways can lead to human diseases including cancer.

Recent evidence has shown that metabolic enzyme call UGT in the genes call UDP-glucuronosyltransferases were shown to have significantly reduced expression in breast tumors compared with normal breast tissue from the same patients This observed loss of expression is hypothesized to be causal as these two enzymes are responsible for estrogen metabolism.

However, relatively little is known about metabolic enzymes and skin cancer. We have preliminary data that UGT enzyme expression is lost during melanoma progression which allows deregulated lipoxygenase signaling.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female are age18 years and older
* Have normal skin and a skin lesion of interest
* Willing to have skin biopsies on those areas

Exclusion Criteria:

* Male or Female are under 18 years of age
* Pregnant women
A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).


Eligibility Criteria:
Inclusion Criteria:

* male or female subjects 65 years of age or older
* OAB symptoms for at least 3 months
* score 3 or greater on Vulnerable Elderly Survey (VES-13)
* adequate mobility for independent toileting
* mean number of at least 2 UUI episodes per 24 hours
* mean urinary frequency of 8 or more micturitions per 24 hours
* able to independently complete the bladder diaries

Exclusion Criteria:

* PVR urinary volume greater than 200 ml
* MMSE score less than 20
* greater than 15 UUI episodes per 24 hours
* creatinine clearance less than 30 ml/min
* an average resting heart rate of greater than or equal to 90 beats per minute
Castrate Resistant Prostate Cancer Enhertu Therapy

Use of Enhertu as a Subsequent Line of Therapy in HER2-Positive Metastatic Castration-Resistant Prostate Adenocarcinoma.

This Phase II clinical trial aims to evaluate the efficacy and safety of Enhertu in HER-2 positive mCRPC who have progressed on prior androgen deprivation therapy and novel hormonal agents, who are either not candidates for or have refused taxane based chemotherapy. Led by Dr. Maneesh Jain at the Washington DC VA, the open label multi center study will include 60 participants treated with Enhertu. Primary endpoints focus on objective response rates, while secondary measures include safety, progression-free survival, overall survival, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed adenocarcinoma of the prostate
* Diagnosis of mCRPC
* Documented progression on androgen deprivation and novel hormonal agents, with or without progression on taxane containing regimen
* Ongoing ADT to maintain serum testosterone levels below 50 ng/dL
* Formalin fixed paraffin embedded tumor tissue for HER2 immunohistochemistry
* Life expectancy 6 months
* ECOG 0 or 1
* LVEF at least 50%
* Adequate Blood Clotting function
* Adequate Organ and Bone Marrow function
* Adequate Renal function
* Adequate Hepatic function

Exclusion Criteria:

* History of interstitial lung disease or pneumonitis requiring steroids
* Significant coronary vascular disease
* Previous exposure to HER2 targeted therapy
Zinc With Chloroquine/Hydroxychloroquine in Treatment of COVID-19

we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19.

we want to investigate if zinc supplementation enhance the clinical efficacy of chloroquine in treatment of COVID-19. As, zinc may be of value in these cases and may be of value in enhancing chloroquine effect.

Eligibility Criteria:
Inclusion Criteria:

* Patients with positive COVID-19.

Exclusion Criteria:

* Contraindications or hypersensitivity to chloroquine.
Immunosuppression During Penetrating Keratoplasty, Using a Subconjunctival Implant Releasing Dexamethasone : Tolerance and Safety Pilot Study

Immune rejection episodes after penetrating keratoplasty occur in 30% of patients and constitute one of the main factors reducing graft survival. They mainly occur during the first 18 months. Prevention usually relies on a topical treatment with dexamethasone or prednisolone for standard risk patients. Eye drops are instilled three times a day during at least 3 months then tapered.

OZURDEX is an absorbable small implant that releases a total of 700 micrograms dexamethasone during several months. It is indicated for intravitreal injection to treat macular edema.

The investigators hypothesized that this implant could be used after subconjunctival injection during corneal graft, to prevent immune rejection and avoid repeated eyedrop instillations.


Eligibility Criteria:
Inclusion Criteria:

* Keratoconus
* Fuch's dystrophy
* Hereditary stromal dystrophy
* Age 18 years old and more
* Signed informed consent
* Affiliated to the French Social Security

Exclusion Criteria:

* Hypersensitivity to Dexamethasone or the excipients (polylactic and glycolic acid)
* Active ocular or periocular infection
* Advanced glaucoma
* History of herpetic or zoster keratitis
* Retinal disease for which an intravitreal injection of Ozurdex is planed for the next 3-4 months
Add-on Effectiveness of EA or TENS in Early Postpartum Breast Engorgement

A total of 36 volunteers of postpartum women within 7 days with significant breast engorgement, will be recruited in China Medical University Hospital, Taichung, Taiwan. The participants will be randomly assigned into 3 groups, each of 12 people, namely, routine care group, routine care plus electrical-acupuncture experiment group, and routine care plus transcutaneous electrical nerve stimulation group.

Participants will receive once a day, three consecutive days of interventions in each group, including identical routine care. On each visit, severity index (SI) subject to the extent of erythema, tension and pain over breast will be assessed. Questionnaires of Breastfeeding Self-Efficacy Scale (BSES-SF) and of Edinburgh postnatal depression scale (EPDS) will be performed. Heart-rate variability was evaluated and recorded via a real-time handheld HRV device. Oxycontin, Cortisol, sodium and potassium levels in breastmilk will be tested . A telephone follow-up will be performed in 30 days after completion of treatment, and the data will be collected and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \> 37 wk
* Delivery of singleton, healthy newborn baby
* Within 7 days postpartum
* Within 24 hours from initial painful breast engorgement
* Difficulty on lactation due to plugged ducts, SI index ≧ 5 (0-19)

Exclusion Criteria:

* Fever\>37.5∘C
* Mastitis or breast abscess
* Signs of sepsis or other infection
* Perinatal mother and infant diseases (Gestational hypertension、Gestational Diabetes Mellitus、Pre-eclampsia 、Gestational thyroid diseases or Intrauterine growth retardation)
* Psychological diseases
* Bleeding tendency
* Artificial valves
* Pacemaker
* Epilepsy
* Consciousness disturbance
* Skin infections
* Hepatitis B carrier
* Acquired Immune Deficiency Syndrome
* Breast tumors
* Breast Surgeries
CT Perfusion Imaging in Predicting Treatment Response in Patients With Non-small Cell Lung Cancer or Lung Metastases Treated With Stereotactic Ablative Radiation Therapy

This study assesses computed tomography (CT) perfusion imaging in predicting treatment response in patients with non-small cell lung cancer or tumors that have spread from the primary site (place where it started) to the lungs (metastases) treated with stereotactic ablative radiation therapy. CT perfusion imaging is a special type of CT that uses an injected dye in order to see how blood flow through tissues, including lung tissue. CT perfusion imaging of the lungs may help doctors learn whether perfusion characteristics of lung tumors may be predictive of response to treatment and whether lung perfusion characteristics can be used to follow response to treatment.

PRIMARY OBJECTIVES:

I. To assess the feasibility of performing computed tomography (CT) perfusion imaging (CT perfusion imaging) at baseline, within 48 hours post-stereotactic ablative radiation therapy (SABR), and at 2-4 months SABR in patients undergoing SABR for treatment of a lung tumor per standard of care.

SECONDARY OBJECTIVES:

1. To determine the range (variability) of perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
2. To assess the change in perfusion parameters at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
3. To correlate any change in perfusion parameters with circulating-tumor deoxyribonucleic acid (DNA) levels at baseline, within 48 hours post-SABR, and at 2-4 months post-SABR
4. To correlate perfusion parameters with tumor response 1 year post-SABR

OUTLINE:

Patients receive an infusion of Isovue-200 and undergo CT perfusion imaging of the lungs at baseline, within 48 hours of first SABR, and at 2-4 months after completion of SABR. Cancer Personalized Profiling by Deep Sequencing (CAPP-Seq) will be conducted evaluate circulating-tumor DNA levels.

Perfusion parameters will be correlated with tumor control at 1 year post-SABR, with tumor control defined as no evidence of disease seen at the site of SABR by surveillance imaging at 1 year post-SABR.

After completion of treatment, patients are followed up at 2-4 months and then at 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing SABR for the treatment of a lung tumor, inclusive of non-small cell lung cancer or lung metastases

Exclusion Criteria:

* Patients who are pregnant or are trying to become pregnant are excluded from this study
* Patients with renal failure, defined as glomerular filtration rate (GFR) \< 60 at the time of the radiation treatment-planning (RTP) scan, will be excluded
Effect of Rosuvastatin Response in Healthy Subjects: Potential Mechanisms of Anti-inflammatory Effects

The purpose of this study is to see whether Statin drugs will act as anti-inflammatories. The investigators will study this potential anti-inflammatory activity in healthy subjects.

After providing consent healthy subjects (N=20) completed a health and drug inventory questionnaire and had blood samples drawn to measure baseline electrolytes, kidney function, liver function, and creatine kinase to determine study eligibility. Blood samples were also collected to analyze baseline inflammatory markers (tlr-4 monocyte expression and cytokine production). Patients received 20 mg daily of rosuvastatin for 3 weeks followed by blood collection, and the measurement of inflammatory markers repeated. Whole blood samples were analyzed by flow-cytometry to determine percent expression of tlr-4 on monocytes which was the primary inflammatory marker for the study. Secondary inflammatory markers tumor necrosis factor (TNF), interleukin-6 (IL-6), and interleukin-8 (IL-8) were measured after blood was incubated ex-vivo with lipopolysaccharide (LPS) for 3 hours. LPS induction experiments were performed on blood from pre and post rosuvastatin treatment. Finally, blood lipid profiles (cholesterol, low density lipoprotein (LDL), very low-density lipoprotein (VLDL), and high density lipo protein (HDL), were assessed both pre and post rosuvastatin treatment. End of study (after 3 weeks of rosuvastatin treatment) electrolytes, kidney function, liver function, and creatine kinase (CK) were measured to determine any changes as a result of rosuvastatin treatment. In addition to pre and post safety assessment a phone call was made to evaluate rosuvastatin side effects at the midpoint of the three-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male non-asian subjects

Exclusion Criteria:

* Patients with increased liver function tests, elevated serum creatine, patients on anti-inflammatory or immunomodulating drugs
A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes Mellitus

20 eligible subjects will be enrolled into the treatment phase of the trial.

Trial objectives are to determine the safety \& pharmacological response of MKC253 Inhalation Powder.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking males and females between 18 and 70 years of age
* Body Mass Index (BMI) of \< 32 kg/m2
* Diabetes managed on a stable regimen of diet and exercise within the preceding 8 weeks and/or metformin and/or a sulfonylurea or meglitinide or alpha glucosidase inhibitors, without any dose adjustments within the preceding 8 weeks. For subjects taking both metformin and sulfonylurea or meglitinide or alpha glucosidase inhibitor, one or both oral agents must be less than 1/2 the maximal allowable dose as cited in the product label.
* HbA1c = 6.2 to = 8.5%. Fasting C-peptide = 0.5 ng/mL. On the last 3 days of the washout period (Day -3, -2, and -1) subjects should have a FBG (finger stick) = 13.5 mmol/L.
* Normal pulmonary function and performance on pulmonary function tests
* Written Informed Consent
* Treatment with any type of anti-diabetic therapy other than metformin, sulfonylurea, meglitinide and alpha glucosidase inhibitors within the preceding 12 weeks \[ie, thiazolidinediones (TZDs), dipeptyl peptidase inhibitors (DPP-IV), Symlin (pramlintide acetate) and or Byetta (exenatide)\].

Exclusion Criteria:

* Exposure to any investigational medications or devices within the previous 90 days prior to trial entry or participation in another clinical trial while participating in this trial.
* Use of any prescription medication within 90 days prior to screening, other than allowed anti-diabetic therapy, that has not been approved by the PI and Sponsor. The use of alpha blockers, antihypertensives, proton pump inhibitors and cholesterol medication as co-medications is allowed throughout the study.
* Significant improvement in pre- to post-bronchodilator spirometry (defined as an increase of 12% AND 200 mL in either FVC OR FEV1).
* Serum creatinine above Upper Limit of Normal (ULN) as defined by the laboratory
* Any other condition which, in the opinion of the PI, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent and/or impair the subject's ability to participate in the trial.
Integral Attention Program With or Without Palliative Chemotherapy in Advanced Cancer Patients

The purpose of this clinical trial is to compare a non-pharmaceutical intervention (Integral Attention Program or PAI) versus standard palliative chemotherapy treatment plus PAI in patients with advanced cancer who have already received at least a first course of chemotherapy but had proven therapeutic failure.

The study hypothesis is that palliative chemotherapy offers no clear benefits in relation to quality-of-life-adjusted survival compared to a comprehensive care program.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years of age.
* Patients potentially eligible to receive a new chemotherapy cycle and whose clinical condition, according to the oncologist, does not identify any therapeutic strategy clearly superior to another, in the light of scientific evidence.
* Patients with advanced cancers that have been treated with chemotherapy but who have not displayed complete response to treatment or who, after treatment response, are now in a situation of recurrence or disease progression
* Patients who have previously received at least one chemotherapy cycle of the following tumors:

  * Cancer of the digestive and gastrointestinal tract
  * Head and Neck Cancer
  * Lung cancer
  * Urologic cancers
  * Gynecologic cancers
  * Central nervous system cancer
  * Melanoma
* Patients who can potentially comply with study and/or monitoring procedures and to accept and sign the informed consent form.
* Patients whose home is located less than 10 km, approximately, of the hospitals participating in the study.

Exclusion Criteria:

* Patients who are currently receiving chemotherapy, although patient pursuing any other concomitant treatment are eligible (eg, hormone therapy or radiation therapy).
* Patients who have contraindications to chemotherapy.
* Patients who did not agree to participate in the clinical trial