cyrilzakka/clinical-trials huggingface dataset:
Nutritional Markers in Normal and Hyperemesis Pregnancies

This study evaluate the rate of nausea and nutritional status in patients with hyperemesis gravidarum (severe nausea and vomiting in pregnancy) and healthy pregnant women using a questionnaire (PUQE-score), self-reported food/drink intake form and blood test. The Investigators aim for developing normal range of prealbumin measurements (reference values) during first trimester of pregnancy.

Women affected with hyperemesis gravidarum are at severe nutritional risk. Reference values for biochemical parameters evaluating nutritional status during early pregnancy needs to be determined.

The investigators will compare clinical nutritional parameters (weight gain/weight loss) with rate of nausea (PUQE-questionnaire), self-reported nutritional intake form and biochemical measurements (prealbumin) in women admitted to hospital with hyperemesis gravidarum and healthy pregnant women.

For hyperemesis patients measurements will be repeated at discharge.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women \< 16 weeks of gestation
* Admitted to hospital for hyperemesis gravidarum (HG group) with nausea and vomiting in pregnancy with at least two of following criteria; weight loss, dehydration, fluid-/electrolyte disturbances, ketonuria

Exclusion Criteria:

* Non-viable pregnancy diagnosed at time of inclusion
* Unable to understand Norwegian
* PUQE-score \>= 13 (control group)
* Nausea an vomiting in pregnancy caused by other conditions than Hyperemesis gravidarum
Oral Diclofenac Sodium Versus Oral Hyoscine Butyl Bromide During Intrauterine Device Insertion

The aim of our study is to compare the analgesic effect of oral diclofenac sodium versus oral hyoscine butyl bromide during intrauterine device insertion.


Eligibility Criteria:
Inclusion Criteria:

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion
* Women not taken misoprostol prior to intrauterine device insertion
* Women who will accept to participate in the study

Exclusion Criteria:

* Any contraindication to intrauterine device placement
A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain

The main goal of this ethnographic study is to learn a holistic and enriched view of the behaviors, actions, and views of a group of people with advanced breast cancer (ABC) cancer living in Spain. The primary objective of this study is to collect data on the psychosocial needs of (ABC) patients to identify spaces and strategies to improve these needs.


Eligibility Criteria:
Key Inclusion Criteria:

1. Informed consent to individual in the qualitative study and to allow the recording of the interview for analyses purposes (individual and/or caregiver).
2. Women or men (individual and/or caregiver) over 18 years of age.
3. Confirmed diagnosis of triple-negative breast cancer (TNBC), hormone receptor (HR)+/ human epidermal growth factor receptor 2 (HER2)-, HER2+ unresectable locally advanced breast cancer (ULABC) or metastatic breast cancer (mBC) (individual).
4. Individuals must have initiated at least the firstline treatment.
5. Functional status according to the Eastern Cooperative Oncology Group (ECOG) scale 0-2 (individual).
6. Ability to conduct interviews from home (individual and/or caregiver) or remotely (ie, with technology available for an online interview).

Key Exclusion Criteria:

1. Individual unable to collaborate in the collection of necessary information (alteration in mental status, noncollaboration, limited language comprehension).
2. Individual unable or unwilling to provide informed consent.

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Transplantation of Autologous Oral Mucosal Epithelial Sheets for Limbal Stem-cell Deficiency

The study purpose is to evaluate the efficacy and safety of cultivated oral mucosal epithelial sheet transplantation as a novel therapy for limbal stem cell deficiency, for which no effective approaches has thus far been available, for the purpose of establishing this therapy as an effective strategy for this disease with an aim of improving visual acuity and corneal transparency.

The efficacy and safety of cultivated oral mucosal epithelial sheet transplantation as a novel therapy for limbal stem-cell deficiency, for which no effective approaches have thus far been available, will be evaluated for the purpose of establishing this therapy as an effective strategy for this disease with an aim of improving visual acuity and corneal transparency. The primary endpoint will be an area of no conjunctivalization and no corneal epithelial defect at one year, which will be evaluated according to a 6-grade rating scale. The secondary endpoints will be corrected visual acuity, severity of corneal opacification, extent of corneal neovascularization, expected ocular complications, and all adverse events including abnormal laboratory findings. The purpose of this research is to evaluate the efficacy of the investigational therapy so as to provide rationales for making this strategy approved as an advanced medical care in the future.

Eligibility Criteria:
Inclusion Criteria:

* Among patients with bilateral limbal stem-cell deficiency, those who meet all the criteria listed below when they give their informed consent to participate in this research will be included.

  1. Patients in whom the eye(s) (subject to the interventional therapy) show(s) loss or dysfunction of corneal epithelial stem cells throughout the total\* circumference of the cornea
  2. Patients in whom the corneal surface of the eye(s) (subject to the investigational therapy) is(are) entirely enveloped by conjunctival tissue
  3. Patients of both genders aged ≥20 years when they give their informed consent
  4. Patients who have given their own written consent to participate in this clinical research (The target disease is bilateral limbal stem-cell deficiency, although it is not always necessary that the both eyes of the patient meet the inclusion criteria.)

Exclusion Criteria:

1. Patients who are or may be pregnant, and patients who are breast feeding
2. Patients with infections (HBV, HCV, HIV, HTLV-1)
3. Patients with extreme hypolacrimation resistant to therapy
4. Patients from whom oral mucosal specimens cannot be collected because clear scar formation or inflammatory findings are noted in a cell-collection site of the mucosal membrane
5. Patients whose score of Performance Status (PS\*) is 3 or more
6. Any others who are judged by the chief subinvestigator to be ineligible for this clinical research, due to the presence of complications, etc.
A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations

The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).


Eligibility Criteria:
Inclusion Criteria:

* The patient is willing and able to provide written informed consent and has the ability to comply with the study protocol
* Men or women, age ≥ 18 years at the time of signing informed consent.
* Histologically or cytologically confirmed surgically unresectable, locally advanced, metastatic solid tumor.
* ECOG score is 0 or 1.
* An expected survival of ≥ 12 weeks.
* Evaluable or measurable disease per RECIST v1.1.
* Adequate organ function, as measured by laboratory values.

Exclusion Criteria:

* Active brain metastases.
* Have other malignancies within the past 3 years.
* The toxicity from previous anti-tumor treatment has not recovered to ≤ grade 1.
* Clinically significant corneal or retinal disease/keratopathy.
* Clinically significant cardiovascular disorders.
* Failure to swallow, chronic diarrhea, or presence of other factors affecting drug absorption.
* Known to be allergic to any study drug or any of its excipients.
* Any other diseases or clinical laboratory, etc that may affect the interpretation of the results, or renders the patients at high risk from treatment complications.
Effect of Ketamine in Depressive Symptoms of Elderly Patients With Visual Impairment.

the prevalence of depression in elderly is from 4 to 30% and is associated with a lower quality of life mayor medical comorbidity, and increased mortality. Although there are various treatments for depression in the elderly, the study of interventions in resistant depression is limited and there are few reports of the efficacy and safety profile of alternative interventions such as ketamine in the elderly. The final objective of the present study is to report the effects of a single infusion of ketamine on the depressive symptoms in patients undergoing ophthalmologic surgery

The final objective of the present study is to report the effects of a single infusion of 0.5 mg / kg ketamine in infusion on depressive symptoms assessed using the scale Yesavage's abbreviated Geriatric Depression Scale.

This is a randomized double-blind follow-up study in patients over 60 years of age with ocular pathology who required ophthalmological surgery with retrobulbar block and conscious sedation with ketamine. The sample consisted of two groups: a control group and an experimental group with ketamine. The dose used for the study was 0.5mg / kg in slow infusion for two hours. In both groups the Yesavage's questionnaire was applied at three different times; Basally, at the end of the recovery and at 24 hours after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 60 years or older who due to the severity of visual disability required to be operated on for eye surgery using retrobulbar block
* Intraocular pressure \<20 mm Hg and
* ASA functional capacity from I to III

Exclusion Criteria:

* Previous antidepressants medications
* Cognitive impairment was found according to the Short Portable Mental Status Questionnaire (SPMSQ) assessment
* In case of a history of psychosis, schizophrenia, nephropathy
* They had a history of difficulties to control arterial blood pressure, uncontrolled hepatic disorders or had a history of adverse response to ketamine according clinical records
1 Week Crossover Dispensing Study Between Two Soft Contact Lenses

The objective of this investigation is to compare the visual clinical performance of a silicone hydrogel daily disposable investigational contact lenses to a hydrogel daily disposable commercially available contact lenses.

This is a prospective, bilateral, double masked (participant and investigator), randomized, cross-over dispensing study with 1 week wearing period in each arm by comparing visual acuity and subjective vision quality.

Eligibility Criteria:
Inclusion Criteria:

1. Are 8 to 18 years of age inclusive and have full legal capacity to volunteer;
2. Have read and signed and dated the Parental Permission Form (for those aged 16 and younger); participant has read, signed and dated the study Information Consent Letter (if aged 17 or 18 years) or Assent (aged 16 and younger);
3. Are willing and able to follow instructions and maintain the appointment schedule;
4. Are habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye;
5. Currently wears spherical soft contact lenses or myopia control soft lenses;
6. Have a pair of wearable back-up spectacles;
7. Are willing and able to wear contact lenses for at least 10 hours a day, 6 days a week while in the study;
8. Are myopic with subjective refraction: -0.75D to -7.00D spherical, with an astigmatism ≤ -0.75D in each eye with maximum spherical equivalent anisometropia of 1.00D
9. Are correctable to a visual acuity of +0.10 logMAR or better (in each eye) with sphero-cylindrical subjective refraction;
10. Have clear corneas with no corneal scars or any active ocular disease;
11. Can be fit with the study contact lenses with a power between -0.75 and -7.00 DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -0.75 and -7.00 (inclusive) at screening visit.
12. Demonstrate an acceptable fit with the study lenses.
13. Demonstrate that they can safely and independently insert and remove contact lenses at the screening/fitting visit;

Exclusion Criteria:

1. Have taken part in another clinical research study within the last 14 days;
2. Are currently habitual wearers of toric lenses.
3. Have worn any rigid contact lenses or ortho-keratology lenses in the past 30 days
4. Are an extended lens wearer (i.e., sleeping with their lenses)
5. Are on ongoing atropine treatment for myopia control
6. Have a difference of \> 1.0 D in best vision sphere subjective refraction between eyes;
7. Have amblyopia and/or strabismus/binocular vision problem
8. Have any known active ocular disease, allergies and/or infection;
9. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
10. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
11. Have a known sensitivity to the diagnostic pharmaceuticals to be used in the study;
12. Have undergone refractive error surgery or intraocular surgery;
13. Are a member of CORE directly involved in the study.
Long-term Mortality Post Liver Transplantation in the Era of Modern Immunosuppression.

Liver transplantation is the primary intervention for decompensated chronic liver diseases and some cases of hepatocellular carcinoma. This study aims to examine long-term mortality after liver transplantation and identify related risk factors in the modern immunosuppression era, using a French multicenter cohort. This study does not interfere with patients' medical care. The study method involves collecting and analyzing only the essential data from patient records.

Liver transplantation stands as the gold standard for treating decompensated chronic liver diseases and select cases of hepatocellular carcinoma. Over time, post-transplant survival rates have shown consistent improvement, attributed to advancements in surgical techniques, refined immunosuppressive protocols, and enhanced comprehension of post-transplant complications. These developments have significantly mitigated the incidence of infectious, immunological, and neoplastic complications following transplantation.

Research indicates post-liver transplant survival rates of approximately 85% at one year, 68% at five years, and 50% at ten years. It is important to note that these statistics are based on patients transplanted in the 1990s, whose immunosuppression relied on a combination of cyclosporine, azathioprine, and corticosteroids.

The field of immunosuppression has undergone substantial evolution, with an expansion in therapeutic options. These include the gradual replacement of Cyclosporine A with Tacrolimus, and the introduction of interleukin-2 receptor inhibitors, mycophenolate mofetil, and mTOR inhibitors. These innovations facilitate more adaptable protocols, offering improved preservation of renal function and allowing for earlier discontinuation of corticosteroids. As a result, these new therapeutic options offer immunosuppression that is more tailored to each patient, with reduced long-term toxicity.

The primary objective of this study is to investigate long-term mortality rates following liver transplantation and to identify the various risk factors contributing to mortality in these patients, with a particular focus on the current era of immunosuppression techniques. This investigation will be conducted within the framework of a French multicentric cohort study.

The results of this study have the potential to enhance our understanding of long-term post-transplant mortality and to more accurately identify risk factors. This knowledge could inform the refinement of immunosuppressive treatments and post-transplant patient care protocols. The overarching aim of this research is to optimize the management of liver transplant recipients and ultimately prolong their survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients with liver transplant between 2008 and 2013 and follow up during 2008-2023

Exclusion Criteria:

-
A Study of Whole Brain Radiation Therapy and Capecitabine in Breast Cancer Participants With Newly Diagnosed Brain Metastasis

This open-label, randomized, parallel arm study will evaluate the effect of capecitabine administered concurrently with WBRT and as maintenance therapy in participants with breast cancer and newly diagnosed brain metastases. Participants will be randomized to receive either capecitabine with 10 days standard WBRT, or WBRT alone. Maintenance therapy will follow with capecitabine or another systemic therapy in the WBRT only group.


Eligibility Criteria:
Inclusion Criteria:

* Women with histologically confirmed breast cancer with known human epidermal receptor-2 (HER2) and hormone status
* Newly diagnosed CNS metastasis with at least one brain lesion measuring greater than or equal to (\>/=) 1 centimeter (cm) or two lesions measuring \>/= 0.5 to less than (\<) 1 cm in longest dimension
* Participant not eligible for or refusing surgery or stereotactic radiosurgery
* Eastern cooperative oncology group (EOCG) performance status 0 to 2

Exclusion Criteria:

* Prior treatment of brain metastases
* Leptomeningeal disease
* Known contra-indication to radiotherapy or magnetic resonance imaging (MRI) or capecitabine
Switching to Low Oxidant Content Cigarettes in Adult Smokers

The overall objective of this clinical study is to determine if smokers who switch from their usual high reactive oxygen and nitrous oxide species (ROS/NOS) products to a low ROS/NOS product exhibit increased or decreased levels of oxidative stress/damage, respectively.

Researchers at Penn State Hershey are seeking healthy adult cigarette smokers between the ages of 21-65 who smoke at least 10 cigarettes a day for at least one year.

The aim of this study is to evaluate the effect of reduced oxidative/ nitrogen species (ROS/RNS) cigarettes compared to high ROS/RNS cigarettes.

Study participation lasts 8 weeks, with 5 study visits at the Hershey Medical Center. All eligible participants will be given Spectrum research cigarettes, provided free of charge, and will be asked to only smoke those cigarettes for the first four weeks of the study. Following that four-week period of time all participants will be given low ROS content cigarettes (American Spirit Dark Green or Pall Mall Red). Participants will be asked to smoke only these cigarettes for the final four weeks of the study, these cigarettes will also be provided to you free of charge.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-65
* Smoke 10 cigarettes per day or more for at least one year
* Read and write in English
* Menthol and nonmenthol smokers
* Able to understand and provide consent to study procedures
* Plan to live in the local area for the next 3 months
* Women not pregnant or nursing and taking steps to avoid pregnancy
* No quit attempt in the last one months and not planning to quit in the next 3 months (ensuring stability of smoking)

Exclusion Criteria:

* Currently pregnant or nursing
* Unstable or significant medical conditions that affect oxidative stress, such as COPD, kidney failure, heart disease, stroke, cancer, tumors, lung or respiratory disease, diabetes, liver disease, autoimmune disorder, rheumatoid arthritis, infectious disease or fibromyalgia.
* Use of non-cigarette nicotine delivery
* History of difficulties providing blood samples: fainting, poor veins, anxiety, etc.
* Current or recent history of substance or alcohol abuse
* No more than seven alcoholic drinks a week, and/ or \>two drinks a day
* Use of a high dose antioxidant supplement prior to 1 month
* Currently smoking cigarettes that will be used for the study (Pall Mall Red or American Spirit Dark Green)
Tension Versus Tension- Free Foley Balloon for Cervical Ripening

Foley balloons are commonly used as a mechanical method of cervical ripening for induction of labor. Foley balloons may be placed either under tension or without tension (tension-free). The purpose of our study is to examine time to delivery in nulliparous women undergoing induction of labor who have a Foley balloon placed as a mechanical cervical dilator, assigned to either tension or without tension. The goal is to determine if there is a potential added benefit to placing the Foley balloon on tension as compared to no tension. Our hypothesis is that Foley balloon under tension for cervical ripening results in shorter time to vaginal delivery compared to Foley balloon placed without tension.

This is a pragmatic cluster randomized clinical trial. The target population is nulliparous women who present for induction of labor at term. If there is a decision by the obstetric team to place a transcervical Foley dilator for cervical ripening in a prospective subject meeting inclusion criteria for the study, the obstetric provider will follow the weekly randomization sequence for study group (No Tension) or the control group (Tension) based on the assigned cluster for the entire unit for that week. Both study groups will receive standardized labor management as Foley balloon placed with tension and without tension are both considered standard of care at our institution.

The Tension standard of care (control group) will undergo induction of labor by placement of a transcervical Foley balloon, which is standard of care at our institution. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh.

The No Tension standard of care (study group) will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely.

Subjects in the control and study group will then undergo standard intrapartum care. The total participation time in the study will be considered terminated following delivery.

Eligibility Criteria:
Inclusion Criteria:

* Term induction of labor
* Nulliparous
* Vertex
* Singleton
* Plan for Foley balloon placement by the managing obstetrics team
* Cervical exam less than 3 cm dilated and less than or equal to 60% effaced

Exclusion Criteria:

* Patient unwilling or unable to provide verbal consent
* Fetal demise or major congenital anomaly
* Preterm (\<37 0/7weeks)
* Multiple gestation
* Previous uterine surgery
* Abnormal placentation
* Malpresentation
* Magnesium infusion for preeclampsia with severe features
* Prelabor rupture of membranes
* Fetal growth restriction
* Non-reassuring fetal heart rate tracing prior to inclusion