cyrilzakka/clinical-trials huggingface dataset:
Concerns of Children Whose Parents Have Cystic Fibrosis

As more and more patients with cystic fibrosis (CF) become parents, we have studied parenting concerns in this serious chronic disease in a first study (MucoPar) which is ongoing.

The current study (MucoKids) is an extension of the previous MucoPar study and aims to explore and collect the perceptions, expectations and needs of children whose one parent has CF.

This will be done in the context of individual interviews or in several small groups of children led by a psychologist who will encourage them to develop what constitutes to be the child of somebody with CF.

The collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations.

Life expectancy has improved significantly in cystic fibrosis in recent years. From pediatric disease, it has become a disease of the adult, with the emergence of new issues, such as becoming a parent. Parent patients still face the risk of complications and death while their child is still young. However, there is very little data in the literature on parenting in cystic fibrosis. In a first study which is ongoing (43 patients out of the 50 planned have been included), we intended to study parenting, considering the sick parent's point of view.

However, this question does not only concern parents and their spouses. It is also fundamental to take into account the experience of the children, to understand their experiences and their own needs in this context of serious illness of a parent with limited life expectancy.

Therefore, the purpose of this study is to explore and collect the perceptions, expectations and needs of children whose one parent has CF. Children are eligible from the age of 6 if their parents agree.

Children will have semi-structured individual interviews or will participate in focus groups with the study psychologist in order to express their feelings, difficulties, expectations and needs in living with a parent who has CF.

Thematic analysis of the content will first be done separately for individual interviews and focus groups, and a global synthesis will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Have a parent with CF cared at one of the 2 adult CF centres participating into the study
* Have the authorization of the parent with CF if the child is an adult and of both parents for subjects less than 18 years old
* Be ay least 6 years old
* Have a good level of French and good speaking skills for adolescents and adults
* Have a level of French and oral expression skills adapted to their age group for the youngest

Exclusion Criteria:

* Psychiatric pathology (borderline state, bipolarity and other psychotic disorders) in their parents or themselves
* Serious somatic disease not related to cystic fibrosis in their parents or themselves
Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation

Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants. There are multiple options for fortifying human milk, which vary depending on whether the fortifier is derived from bovine sources (B-HMF) or human sources (H-HMF). Fortifying human milk has been proven to enhance growth in preterm infants without raising the risk of necrotizing enterocolitis (NEC), though it could potentially affect feeding tolerance. Changes in blood flow and oxygen levels in the intestines are commonly observed in infants experiencing feeding intolerance. Research indicates that feeding a mother's own milk (MOM) doesn't affect splanchnic (intestinal) oxygenation, whereas it decreases when feeding bovine-derived human milk fortifiers (B-HMF) or preterm formula, indicating greater oxygen requirements in the intestines of preterm infants fed these alternatives.

The goal of this clinical trial is to compare the effect of H-HMF and B-HMF on splanchnic oxygenation in infants less than 30 weeks.

The fortification of human milk has been proven to enhance growth without raising the risk of necrotizing enterocolitis, although it may affect feeding tolerance.

Non-invasive techniques like Doppler ultrasonography of the superior mesenteric artery (SMA) and near-infrared spectroscopy (NIRS) have been utilized to evaluate mesenteric blood flow and intestinal oxygenation in preterm infants. Numerous studies have investigated the relationship between SMA flow and feeding intolerance. Findings indicate a significant correlation between increased mean Superior Mesenteric Artery blood flow velocity and early tolerance of enteral feeding. Moreover, research suggests a higher incidence of necrotizing enterocolitis (NEC) in preterm infants exhibiting increased resistance patterns of SMA blood flow velocity on the first day.

Non-invasive monitoring methods offer the ability to assess the impact of various fortification products on intestinal perfusion and oxygenation. This could aid in determining the most suitable fortification product to minimize episodes of feeding intolerance.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm infants born \<30 weeks' gestation age and less than 1500g of weight.
2. Admitted in Neonatal Intensive Care Unit at Foothills Medical Center
3. Reached full fortified enteral feed and at least 21 days of chronological age.

Exclusion Criteria:

1. Chromosomal or major congenital anomalies
2. Infants diagnosed with NEC.
Education Given on Their Attitudes Towards Violence Against Women and Their Conflict

Introduction: Violence against women is the violation of human rights faced by women of all ages, cultures and education levels everywhere. It can be experienced in many different ways, either individually or socially.

Aim: The study was conducted to investigate the effects of education given to university students on their attitudes towards violence against women, and their conflict and awareness levels.

Methods: The sample of this randomized controlled experimental study comprised 87 (experimental group=45; control group=42) university students studying in health-related fields. The students in the experimental group received in one session education on violence against women and conflict, whereas the students in the control group did not receive any education. The study data were collected with the Personal Information Form, Attitudes towards Violence Scale among University Students, and Conflict and Violent Awareness Scale.

Eligibility Criteria:
Inclusion Criteria:

* Women who lived in the city center,
* University students
* Studying in health-related fields
* Women who volunteered to participate in the study

Exclusion Criteria:

* Being a man
* Training other than health-related fields
* Those who do not live in the city center
* Involuntary
A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors

The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4.

The main questions it aims to answer are:

What is the the safe and effective dose of CRB-701 when used alone? What cancers can be treated effectively with CRB-701?

Participants will be asked to attend clinic and be given a intravenous infusion of CRB-701 on its own. They will have blood tests and other assessments to measure whether CRB-701 will have CT or MRI scans to measure the effect on tumors.

This is a three-part open-label, Phase 1/2 clinical trial designed to evaluate the safety, PK, and efficacy of CRB-701 in participants with advanced solid tumors expressing nectin-4.

Part A will include solid tumor types known to express nectin-4. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design to determine the MTD of CRB-701. Four (4) dose groups are pre-determined. Dose escalation/de-escalation decisions are made based on the occurrence of DLT.

Part B will determine the RP2D of CRB-701 by evaluating two dose levels of CRB-701 by using a time-to-event Bayesian optimal Phase 2 (TOP) study design to optimize the dose of CRB-701 in one or more separate cohorts of participants with nectin-4-positive tumors.

During Part C, the RP2D dose of CRB-701 will be evaluated in five planned expansion cohorts using Simon's optimal two-stage design.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed following at least one line of therapy or have no other standard therapy with proven clinical benefit.

Exclusion Criteria:

* Active of uncontrolled CNS metastases
* History of solid tumors other than the diseases under study
* History of and/or current cardiovascular events or conditions in the previous 6 months
* Pre-existing \>/= Grade 2 neuropathy
* Hemoglobin A1C (HbA1C) \>/= 8%, uncontrolled diabetes mellitus or know diabetic neuropathy
* Active ocular disease at baseline
* Chronic severe liver disease or live cirrhosis
* Interstitial lung disease or pneumonitis within 6 months on initiating treatment on study
* Other significant cormorbidities.
Conscious Sedation vs General Anesthesia in TAVR Patients

This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
2. Age over 18 years of age.
3. Women of child bearing age must have a negative urine or serum pregnancy test.
4. Clinical indication for a transfemoral aortic valve replacement.
5. English or Spanish speaking
6. No evidence of neurological impairment as defined by a NIHSS ≤ 1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization.

Exclusion Criteria:

1. BMI \> 40
2. Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) \>30 episodes/hr.
3. High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc).
4. Inability to lie supine for more than 30 minutes.
5. Marginal femoral vessels with concern for possible conversion to transapical or transaortic access.
6. Patient refusal
7. Patient involved in another research study
8. Psychiatric condition precluding ability to provide informed consent
9. History of clinical stroke within 3 months prior to randomization
Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

The objective is to evaluate the feasibility of using additional screening methods to optimize effectiveness outcomes with the LipiFlow System for application of heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia. The screening methods include diagnostic expression of the meibomian glands and interferometry assessment of the tear film.


Eligibility Criteria:
Inclusion Criteria:

* Meibomian gland dysfunction
* Dry Eye symptoms

Exclusion Criteria:

* Ocular surgery, ocular injury or ocular Herpes infection within past 3 months
* Active ocular infection
* Active ocular inflammation or recurrent inflammation within past 3 months
* Moderate to severe allergic conjunctivitis
* Severe eyelid inflammation
* Eyelid abnormalities that affect lid function
* Ocular surface abnormalities that may compromise corneal integrity
* Systemic disease conditions or medications that cause dry eye
* Use of other treatments for meibomian gland dysfunction or dry eye
* Pregnant or nursing women
* Participation in another ophthalmic clinical trial within past 30 days
Changes in Cerebral Blood Flow (CBF) in Prone and Sitting Position Before and After GSP-block and Before and After Epidural Blood-patch: A Substudy of NCT03652714

The purpose of this optional sub-study to GSPB-2018 (NCT03652714) is to evaluate the changes in cerebral blood flow (CBF) under different conditions to understand if postdural puncture headache is caused by changes in the cerebral blood flow and if treatment normalises that change.


Eligibility Criteria:
Study Population:

Subjects who have consented to participate in GSPB-2018 will be approached for participation in this sub-study. Subjects who have consented to participate in GSPB-2018 are not required to participate in this sub-study.

Inclusion Criteria:

* Age \> 18 years
* Patients with postdural puncture headache defined as moderate to severe postural headache (VAS \>= 30mm) after lumbar puncture or accidental dural puncture during epidural insertion with an onset within 3 days following the puncture.
* Lack of headache remission within 1 day after dural puncture and after treatment with fluids, caffeine and paracetamol
* Patients who have given their written informed consent for participation in the study and substudy after fully understanding the protocol content and limitations.

Exclusion Criteria:

* Patients who cannot cooperate to the study
* Patients who does not understand or speak Danish
* Allergy to the drugs used in the study
* Has taken opioids within 12 hours prior to intervention
* No possible transcranial window on transcranial doppler. If not possible to find a useable window to get measurement the patient will be excluded and replaced with another patient.
Efficacy of Cyclic DSG Compared With Cyclic MPA for the Treatment of Anovulatory DUB

The objectives of the present study is to determine the effectiveness of cyclic desogestrel (DSG) compared with cyclic medroxyprogesterone acetate for the treatment of anovulatory dysfunctional uterine bleeding (DUB) in the following aspects:

1. Endometrial histopathology changes
2. Menstrual cycle control.

Anovulatory dysfunctional uterine bleeding (DUB) is the most common cause of abnormal uterine bleeding especially in postmenarcheal adolescent, perimenopausal women, patient with polycystic ovary syndrome (PCOS) and in obese women. Aims of treatment in women with anovulatory DUB are to restore the natural control mechanism of endometrium (introduce normal synchronous growth, development, shedding of a structural stable endometrium) and to prevent endometrial hyperplasia. The two main treatment options are estrogen-progestin therapy and progestin therapy. Women who are sexually active and not immediately prepared to pursue pregnancy are best manage by estrogen-progestin treatment especially combined oral contraceptive pills (COCs) but in perimenopausal women, obese women or women who can't tolerate COCs or have contraindications in using COCs, cyclic progestin will be the treatment of choice. Common used progestin in anovulatory DUB is medroxyprogesterone acetate (MPA) 5-10 mg/day for 10-14 days each month. This progestin has strong progestogenic effect but has some undesirable effect such as glucocorticoid effect, mineralocorticoid effect and androgenic effect. Long term using this progestin especially in obese women or perimenopausal women who have risk for diabetes mellitus and dyslipidemia may be negative effect to glucose and lipid metabolism. DSG is the third generation progestin with no glucocorticoid, mineralocorticoid effect and low androgenic effect may be the better choice of treatment but the data of DSG in treatment of anovulatory DUB us scanty. So this study will evaluate the effect of cyclic DSG in endometrial histology changing and lipid, glucose metabolism in patient with anovulatory DUB.

Comparison : Women with anovulatory DUB are randomized into two groups, receiving a course of either cyclic DSG or cyclic MPA. The main outcome measured is to compare the effect of both interventions on endometrial histology changing.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women with anovular DUB (proved by endometrial histology)
* Age \> 18 yr.

Exclusion Criteria:

* Any uterine pathology that might cause abnormal uterine bleeding
* Contraindication to progestin treatment (such as breast cancer)
* Severe drug allergy towards a progestogen
* Intake of any hormonal treatment in the previous 3 months
Effect of Red Wine, White Wine and Beer on Contrast-Medium Induced Acute Kidney Injury

Patients with impaired renal function are at elevated risk for development of contrast-medium induced acute kidney injury (CI-AKI). CI-AKI is associated with increased risk for cardiovascular morbidity and mortality. Effective CI-AKI prevention strategies are needed.

The RenPro-II-WINE Trial was designed to test the hypothesis whether moderate red wine consumption prior to contrast-medium use is effective in CI-AKI prevention.

Consecutive patients with impaired renal function undergoing elective coronary angiography will be assigned in one of four treatment arms: a. control patients receiving standard care b. patients receiving standard care plus red wine c. patients receiving standard care plus white wine d. patients receiving standard care plus beer This study will give important answers on how to prevent CI-AKI in patients with impaired renal function undergoing contrast media exposure.


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18 years
* impaired renal function (baseline estimated glomerular filtration rate of \<60 ml/min)
* at least three of following comorbidities: hypertension, diabetes mellitus without insulin therapy, heart failure NYHA III and/or left ventricular ejection fraction \<35%, peripheral artery disease, coronary artery disease

Exclusion Criteria:

* known alcohol addiction
* severe renal impairment (estimated glomerular filtration rate \<15 ml/min and/or in chronic dialysis program
* Recent (\<=30 days) contrast media exposure
* insulin therapy
* Patients enrolled in concomitant studies
* fertile women
FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms

Constipated patients often have mental problems such as depression and anxiety due to difficult defecation. Our previous studies have proved the efficacy of FMT treating constipation. Meanwhile it is believed that mental diseases are correlated to gut microbiota. This trial is based on the theory of the gut-brain-microbiota axis. Patients with constipation, depression and/or anxiety are performed FMT, laboratory, imaging and microbiota examinations, and clinical follow-up, to observe the clinical efficiency of FMT and the potential role of gut microbiome in these gut-brain disorders.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as functional constipation (FC) according to Rome Ⅳ criteria were enrolled.
* Age ≥ 18 years
* Body mass index of 18-25 kg/m2.
* HAMA ≥ 14 and/or HAMD (17 items) ≥ 17

Exclusion Criteria:

* History of sever mental disorders such as schizophrenia and bipolar disorder
* History of organic intestinal disorders
* History of gastrointestinal surgery
* Pregnant or breast-feeding women
* Infection with enteric pathogen
* Usage of probiotics, prebiotics, antibiotics within the last month
* Uncontrolled hepatic, renal, cardiovascular, and respiratory, or any diseases that in the opinion of the investigator, could affect intestinal transit and the intestinal microbiota.
* Patients who could not complete the follow-up
Expectations and Needs of a Glioblastoma Caregiver

Cancers of the central nervous system have a poor prognosis. Glioblastoma is most common glial tumor of the central nervous system. The presence of a tumour in the brain determines the particular and specific nature of care for these patients and their families. Symptoms affect daily life and the balance of the family sphere.It's easy to imagine a difficult and disturbed family's daily routine.

Caregivers find themselves in great distress but can still benefit from support to lighten the domestic burden, and financial burden, thanks to the various recommendations of successive Cancer Plans. In fact, support for patients and their families during the illness and after is one of the key points of the programs in place. The aim of this research will be to provide food for thought in order to improve the support provided to family and friends.


Eligibility Criteria:
Inclusion Criteria:

* Caregivers of a person with glioblastoma glioblastoma undergoing oncology treatment
* Caregivers aged 18 and over

Exclusion Criteria:

- Patient's opposition to participating in the study
Parkinson's Research: The Organized Genetics Initiative

The purpose of this trial is to study genetic and other risk factors that may be important in the development of Parkinson's disease.

The The Parkinson's Research: The Organized Genetics Initiative, also known as PROGENI, is a multi-center study involving 2000 people throughout North America who are affected, or possibly affected, with Parkinson's disease (PD). The goal of the initiative is to study the genetic and other risk factors which may be important in the development of PD.

In order to better understand the genetic factors leading to PD, researchers will study families having 2 or more members diagnosed with PD. Using DNA samples from each participant, researchers hope to identify genes that may cause a person to be at higher risk for developing PD.

Each participant in the study will be asked to complete a family history questionnaire, providing information about the history of PD in the family. Participants also will be asked to discuss the symptoms they have experienced and their responses to PD medications. This information will be used by study personnel to determine further eligibility for the study. Those eligible for further participation will be asked to undergo a study visit at the site closest to their residence, during which they will be asked to complete questionnaires regarding PD symptoms, medical history, places of residence, occupations, mood, mental status, and activity level. A blood sample will be drawn for DNA extraction. The study visit will take about 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible to participate in this study participants must be diagnosed with or have symptoms of PD. In addition, they must also have a family history of PD in other relatives.

Exclusion Criteria:

* Subjects cannot have participated in any other genetic research project for Parkinson's disease.