cyrilzakka/clinical-trials huggingface dataset:
Chinese Herbal Medicine for Gynecologic Patients

This is a prospective randomized-controlled trial looking at the safety and acceptability of using Chinese herbal medicine in patients with primary dysmenorrhea. The research team hopes to enroll 100 patients, 50 of whom will be randomized to receive the herbal tincture and 50 who will receive a placebo tincture. Patients will be enrolled and using the assigned tincture for twelve weeks. The research team will assess safety as a primary outcome by the presence or absence of adverse events related to study protocol during the period of participation.


Eligibility Criteria:
Inclusion Criteria:

* Female aged 18-36 are met:
* Self-reported pain or discomfort during menstruation, as indicated by Grade 1 or higher on the verbal multidimensional scoring system
* May experience regular menstrual cycle and period must be \<7 days in duration
* May be on birth control
* Must know or can estimate the date of the next cycle/period
* May find blood clots in menstrual blood
* Must be in good health (doesn't report any medical conditions asked in the screening questionnaire)
* Following a stable, consistent diet regimen
* Follow a stable, consistent exercise regimen and are willing, for the duration of the study, to not decrease or increase the amount of exercise in their regimen
* Agree to refrain from any lifestyle changes that may affect their menstrual cycle for the duration of the study (for example, getting on or off hormonal birth control, reducing the amount of exercise)
* Follow a stable consistent regimen when using any other interventions, such as massage, chiropractic medicine, or acupuncture; agree not to increase or decrease the number of their other interventions
* Willingness to adhere to the dietary supplement regimen
* Willingness to refrain from any other dietary supplements targeting the menstrual cycle during the study period
* Is able to communicate in English
* Is willing and able to share feedback via REDCap
* Must provide written informed consent (ICF)

Exclusion Criteria:

* Do not experience a menstrual cycle
* Cannot estimate the onset of their next menstrual cycle
* Do not experience menstrual pain or cramping
* Follow an extreme diet intervention
* Experienced severe weight loss in the past 3 months prior to study participation
* If currently taking allowed supplements, the dosage needs to remain the same throughout the entirety of the study
* Food intolerances/allergies that require an EpiPen
* Known allergic reaction to any of the test product ingredients
* Currently pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
* Previous users of Elix Cycle Balance
* Having more than 3 alcoholic drinks a day
* Have been diagnosed with the following conditions: PCOS, endometriosis, PMDD, adenomyosis, Hashimoto's, anorexia, bulimia, orthorexia, binge eating, any other eating disorder
* Smokers
* Not been on a stable dose of birth control for the past 6 months
Butyrate-enriched Triglyceride and Diabetes Prevention

A body of animal studies as well as observational studies in humans demonstrated that butyrate is one SCFA that has pronounced positive effects on body weight control, inflammation, and insulin resistance. Even though the SCFA hexanoate is less researched, it has been shown to be involved in anti-inflammatory processes. Of note, acute human studies showed that fibre-induced metabolic improvements are linked to higher SCFA levels in the systemic circulation. It has been shown that a butyrate/hexanoate-enriched triglyceride oil enhanced systemic butyrate and hexanoate concentrations for a prolonged time. Yet, it remains to be determined whether a chronic increase in circulating butyrate and hexanoate concentrations translate into long-term benefits. In this study it is hypothesized that a chronic increase of butyrate/hexanoate in the circulation may improve host metabolism and metabolic health by improving adipose tissue function, reducing systemic lipid overflow and inflammation thereby increasing peripheral insulin sensitivity in individual with overweight/obesity and prediabetes.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Age 20-70 years
* BMI ≥ 28 and \< 40 kg/m2
* Weight stable for at least 3 months
* Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
* One or more of the following criteria to determine disturbed glucose/insulin homeostasis

  * Fasting glucose 5.6-6.9 mmol/L
  * Two-hour glucose of 7.8-11.1 mmol/L
  * HOMA-IR ≥ 2.2
  * HbA1c (5.7-6.4%)

Exclusion Criteria:

* Diabetes mellitus (type 1 or 2)

  * Cardiovascular disease: including no history or myocardial infarction, heart failure, arrhythmias
  * Pulmonary disease: no history of chronic obstructive pulmonary disease, emphysema, bronchitis, asthma
  * Kidney (e.g. kidney failure) or liver (e.g. cirrhosis, non-alcoholic fatty acid) malfunction
  * Gastrointestinal disease (no inflammatory bowel disease, irritable bowel syndrome or digestive disorders) or a history of abdominal surgery (except appendectomy and cholecystectomy)
  * Autoimmune disease
  * Any other diseases affecting glucose and/or lipid metabolism or use of any medication that influence glucose or fat metabolism and inflammation
  * Ongoing disease or any disease with a life expectancy ≤ 5 years
  * Abuse of products; alcohol (\>15 units per week) and drugs, excessive nicotine use defined as \>20 cigarettes per week
  * Regular supplementation of pre- or probiotic products, use of pre- or probiotics, antibiotics and laxatives 3 months prior to the start of the study
  * Intensive exercise training more than three hours a week
  * Plan to lose weight or to follow a hypocaloric diet or vegetarian diet
  * Pregnancy
Efficacy of Adding Low Dose Ketamine or Fentanyl to Propofol-dexmedetomidine as Total Intravenous Anesthesia

Efficacy of adding low dose ketamine or fentanyl to propofol-dexmedetomidine as total intravenous anesthesia for patients undergoing craniotomy in supra tentorial brain tumor

Efficacy of adding low dose ketamine or fentanyl to propofol-dexmedetomidine as total intravenous anesthesia for patients undergoing craniotomy in supra tentorial brain tumor surgery on brain relaxation score, hemodynamics, surgeon satisfaction score , total requirement of intra operative propofol and post operative analgesia

Eligibility Criteria:
Inclusion Criteria:

- Patients aged 18-70 years old ASA I - III with GCS 14-15 and BMI\<35 scheduled for elective craniotomy for resection of supratentorial masses

Exclusion Criteria:

* Patients will be excluded if they will refuse to give a written consent. Also patients with GCS \< 14 or having endocrine or blood diseases or sever cardiac disease or sever liver disease or renal failure and patients with uncontrolled hypertension or uncontrolled diabetes mellitus and patients have allergy to any of the study drugs.
MicroPulse Transscleral Laser Therapy and Its Short-term Impact on Ocular Surface

MicroPulse transscleral laser therapy (TLT) is proven to be effective in reducing intraocular pressure with minimal complications in either primary or secondary glaucoma. However, its impact on the human ocular surface remains unexplored. This study aims to bridge this gap by examining the clinical and histopathological effects of MicroPulse TLT on the ocular surface.

This prospective study, conducted at Mohamed Taher Maamouri University Hospital in Nabeul, Tunisia, investigates the clinical and histopathological short-term effects of MicroPulse transscleral laser therapy (TLT) on the ocular surface. The study involves 16 eyes from 15 adult patients. Participants underwent MicroPulse TLT, followed by conjunctival biopsies for the analysis of inflammation and fibrosis. Participants also benefited from ophthalmological examination and responded to the Ocular Surface Disease Index (OSDI) questionnaire before and after MicroPulse TLT.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Non-controlled open-angle glaucoma despite undergoing maximal medical therapy
* Poor therapeutic adherence
* Local or general intolerance to topical treatments.

Exclusion Criteria:

* Ophthalmic or general diseases that could potentially impact the conjunctiva such as symblepharon, ocular injury, or prior eye surgery
* Pevious transscleral laser therapy applied to the same eye
* angle-closure glaucoma
* active ocular inflammation
* a non-functional eye (absence of light perception)
* scleral thinning
Trial of Non-invasive Ventilation for Stable COPD

The use of domiciliary non-invasive positive pressure ventilation (NPPV) in stable chronic obstructive pulmonary disease (COPD) with chronic hypercapnic respiratory failure has yielded variable effects on survival, quality of life and dyspnea. The investigators hypothesized that use of NPPV in stable COPD might result in improvement in quality of life and dyspnea.

Chronic obstructive pulmonary disease (COPD) is associated with progressive decline in lung function with resultant chronic respiratory failure. This leads to significant rates of hospitalization, disability, and death. COPD is also associated with sleep disordered breathing and nocturnal hypoventilation, resulting in nocturnal and daytime hypoxemia and hypercapnia. These, in turn, can contribute to fatigue, dyspnea and impaired quality of life. Presence of hypercapnia is associated with a 33% 5-year survival. Nocturnal NPPV can theoretically rest overloaded respiratory muscles, prevent nocturnal hypoventilation, and reset central respiratory drive in patients with hypercapnia. The use of non-invasive positive pressure ventilation (NPPV) in late stage COPD appears logical to change this inexorable course, to alleviate symptoms and to improve quality of life. While NPPV has a definite role in the management of acute hypercapnic respiratory failure, its role in the management of late stage stable COPD is controversial. Multiple studies have shown no survival benefit for nocturnal NPPV in chronic hypercapnic stable COPD patients. The effects on quality of life and dyspnea scores in such patients have been inconsistent. The variable efficacy might have been due to late administration of the intervention in the course of disease, in the presence of advanced hypercapnic respiratory failure. We sought to assess the effect of applying NPPV on indices of health-related quality of life in patients with relative normocapnia. We hypothesized that patients with stable severe COPD have improved quality of life and reduced dyspnea with the use of NPPV.

Eligibility Criteria:
Inclusion Criteria:

* stable chronic obstructive pulmonary disease (COPD) defined as forced expiratory volume in the first second (FEV1)/forced vital capacity (FVC) ratio of \<0.70, with at least 10 pack-years smoking history

Exclusion Criteria:

* congestive heart failure, obstructive sleep apnea, chronic respiratory conditions other than COPD, age \< 35 years, any disease limiting life expectancy to less than two years, active malignancy other than non-melanotic skin cancer in the previous two years, and with any anatomic variation or disease process that precluded wearing a nasal mask
Impact of Plastic and Aesthetic Surgery on Self-esteem

The primary objective of QUALIPLAST is to evaluate the impact of plastic and aesthetic surgery interventions on patients' self-esteem. While the demand for these procedures is steadily increasing worldwide, patients' motivations often extend beyond purely aesthetic concerns, encompassing significant psychological and emotional expectations. However, despite the growing popularity of these interventions, scientific literature remains limited when it comes to the systematic and long-term evaluation of their effects on patients' self-esteem and overall well-being.

The majority of existing studies focus on short-term outcomes or functional and physical aspects, often overlooking the psychological and emotional dimensions that play a crucial role in post-operative satisfaction. Furthermore, much research is limited to specific procedures, without adopting a comprehensive approach to plastic and aesthetic surgery. This lack of robust and generalisable data hinders a full understanding of how these interventions influence self-esteem across different types of surgeries and patient profiles.

QUALIPLAST stands out due to its multicentric, prospective, and large-scale nature, involving a wide range of procedures and collecting longitudinal data before the intervention, as well as at 3 and 12 months post-operatively. It will allow for the observation of self-esteem changes over time, providing a more complete and nuanced understanding of the effects of surgery.

This project relies on standardized and validated measurement tools, such as the Rosenberg Self-Esteem Scale, to ensure the reliability and comparability of the results. By addressing the current gaps in the literature, QUALIPLAST aims not only to enrich scientific knowledge in this field but also to provide valuable insights for healthcare professionals to improve patient care and tailor clinical practices based on the identified psychological needs.


Eligibility Criteria:
Inclusion Criteria:

Patients consulting a plastic surgeon for one of the following operations:

* Breast augmentation
* Breast reduction
* Breast lift
* Facelift
* Otoplasty
* Rhinoplasty
* Blepharoplasty
* Abdominoplasty
* Brachioplasty
* Cruroplasty
* Liposuction
* Gender affirmation: breast augmentation
* Gender affirmation: Facial feminisation
* Gender affirmation: Thoracoplasty
* Botox / Hyaluronic acid

Patients who agreed to take part in the study

Exclusion Criteria:

* Pregnant, parturient or breastfeeding women
* Minors
* Persons deprived of their liberty by a judicial or administrative decision
* Persons receiving psychiatric care
* Persons admitted to a healthcare or social institution for purposes other than research
* Adults under a legal protection measure (guardianship, curators)
A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer

This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients, or patients with ECOG performance status of 2, with advanced non-small cell lung cancer.Patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on days 1 and 8 + Tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=70 years of age or with ECOG PS of 2;
* advanced (stage IIIB or IV)non-small cell lung cancer;
* no prior systemic chemotherapy for advanced NSCLC or prior treatment with HER-axis targeted drugs.

Exclusion Criteria:

* active brain metastasis or spinal cord suppression;
* unstable systemic disease.
The Efficacy of a Novel, Non-contact EKG in the NICU

We will be comparing a novel, non-contact EKG waveform and heart rate to the standard of care, contact-based EKG waveform and heart rate in neonates, who have sensitive skin.


Eligibility Criteria:
Inclusion Criteria:

* Apgar at 5 min \>/= 7
* Admitted to the NICU
* Indication for standard EKG monitoring

Exclusion Criteria:

* Apgar \< 7 at 5 min
* Not in the NICU
* Not being monitored with standard EKG monitors
Sustaining Physical Activity Following Cardiac Rehabilitation Completion

Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use.

Cardiac rehabilitation participants will be enrolled during cardiac rehabilitation and provided an activity tracker to use. Each week they will be provided a summary report of their steps and physical activity, that will continue to 6 weeks post discharge from cardiac rehabilitation.

Eligibility Criteria:
Inclusion criteria:

* coronary heart disease
* currently attending cardiac rehabilitation with at least 4 weeks left
* \>=18 years of age
* own a smart phone and able to participate in mobile health program
* able to understand and write English
* adequate clinical stability
* understand and sign informed consent

Exclusion criteria:

* currently using a digital physical activity tracker
* past use of a digital activity tracker
* planning to relocate in 12 weeks
* acute coronary artery disease symptoms
* decompensated heart failure
* New York Heart Association class IV heart failure
* severe valvular heart disease
* severe pulmonary hypertension
* cardiac transplantation
* visually impaired, severe
* end stage renal disease
* impairment from stroke, injury, or other medical disorder that precludes participation
* dementia that precludes ability to participate and follow protocol
* inability or unwillingness to comply with study requirements
LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser vs AMO Visx Wavefront-Guided Excimer Laser

The purpose of the study is to compare the results of LASIK surgery when using Alcon Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom wavefront-guided excimer laser system in patients with nearsightedness with and without astigmatism.

The patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. if there is any pathology noted that would exclude the patient from the study, then we will inform the patient and make an appropriate referral. If the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is treated with a wavefront-guided excimer laser and which eye is treated with wavefront-optimized will be randomized so there is a 50% chance for either eye to receive one treatment. The patients will be seen on the day of surgery, post op day one, post op day 4-7, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. LASIK treated eyes will receive pred forte 1% ophthalmic drops for one week after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing lasik surgery.

The research procedures are the least risky that can be performed consistent with sound research design.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 21 and older with healthy eyes.
* Nearsightedness between -0.50 diopters and -7.00 diopters with or without astigmatism of up to 3.50 diopters.

Exclusion Criteria:

* Subjects under the age of 21.
* Patients with excessively thin corneas.
* Patients with topographic evidence of keratoconus.
* Patients with ectatic eye disorders.
* Patients with autoimmune diseases.
* Patients who are pregnant or nursing.
* Patients must have similar levels of nearsightedness with or without astigmatism in each eye.
* They can not be more than 1.5 diopters of difference between eyes.
* Patients must have similar levels of astigmatism in each eye.
* They can not have more than 1.5 diopters of difference in nearsightedness or astigmatism between their two eyes.
Multicenter Registry of Atrial Fibrillation Ablation With Radiofrequency Balloon Catheter

All consecutive patients with paroxysmal or persistent atrial fibrillation undergoing pulmonary vein isolation with the radiofrequency balloon catheter (RFB) "Heliostar" (Biosense Webster) will be included in a multicenter observational registry. The aim of the study is to assess the safety and arrhythmic outcome of atrial fibrillation ablation with the RFB in a real-world setting.

All consecutive atrial fibrillation patients undergoing pulmonary vein isolation (PVI) with the novel radiofrequency balloon catheter (RFB) "Heliostar" (Biosense Webster) will be prospectively included in a multicenter observational registry.

PVI with the RFB will be performed as previously described. Briefly, after optimal RFB positioning, confirmed through the correct alignment between the RFB and the pulmonary vein and sufficient electrode-tissue contact, ablation is performed in temperature-controlled mode with unipolar radiofrequency energy. Typically, \>2 posterior electrodes are identified on the RFB. The power setting is 15 W and the target electrode temperature is 55° C. The same energy is simultaneously delivered to all electrodes, with a duration of 15-20 s for the posterior and 45-60 s for the non-posterior electrodes. During ablation, pulmonary vein potentials are monitored on the circular diagnostic catheter to evaluate real-time isolation. In the case of pulmonary vein acute reconnection, additional applications are delivered to achieve durable PVI. An esophageal temperature probe will be used to monitor any increase in esophageal temperature.

Follow-up will be performed according to each standard institutional protocol.

Safety endpoints include any major periprocedural complications \[e.g. death, atrioesophageal fistula, stroke/transient ischaemic attack, pericardial effusion/tamponade with/without surgical treatment, myocardial infarction, and persistent phrenic palsy\] occurring within 7 days post-procedure (except for atrioesophageal fistula). Minor complications will also be reported, including vascular access complications requiring treatment, pericarditis, and transient phrenic palsy.

Efficacy outcome is defined as arrhythmia-free survival during the follow-up. Arrhythmia recurrence is defined as any atrial tachyarrhythmias ≥30 s after a 90-day post-ablation blanking period.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic atrial fibrillation with indication to catheter ablation

Exclusion Criteria:

* age \<18 years old
* pregnancy
* any contraindications to catheter ablation
A Systems-Level Intervention for Rural Adults With Depression

This study aims to test the effectiveness of a computer-assisted cognitive behavioral therapy for depression among rural adults. The intervention, called Raising Our Spirits Together (ROST), was developed via a community-based participatory approach and will be delivered in small groups, facilitated by local pastors. Groups will be held virtually, or in-person at two churches in rural Michigan. Eighty-four individuals will be recruited from Hillsdale, Michigan, to test the effect of ROST on depressive symptoms, compared to an Enhanced Control Condition (ECC).


Eligibility Criteria:
Inclusion Criteria:

* Must live in Hillsdale, Lenawee, Jackson, or Calhoun County, Michigan
* Positive screen for at least mild depressive symptoms based on the the Patient Health Questionnaire-9 (PHQ-9\>=5)

Exclusion Criteria:

* Non-English speaking
* Currently receiving cognitive behavioral therapy (CBT) for depression
* Ever completed a course of cognitive behavioral therapy (CBT; \>=8 sessions)
* Diagnosis of a psychotic disorder
* Current use of opiates or freebase cocaine
* Prominent suicidal/homicidal ideation with imminent risk.