cyrilzakka/clinical-trials huggingface dataset:
An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis

This study is designed to evaluate the risk of cataracts (lens opacities) and describe the best corrected distance vision (with glasses/contacts for those who wear them) of pediatric patients with Cystic Fibrosis who are 11 years of age or younger at the time of ivacaftor treatment initiation and are receiving or planning to receive commercially-available ivacaftor in the US.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be 11 years of age or younger at the time of treatment initiation with ivacaftor (as part of clinical trial) or commercially-available ivacaftor.
2. Subject must reside in the US and be receiving or planning to receive commercially-available ivacaftor.

Exclusion Criteria:

1. Subject is enrolled in an ivacaftor clinical study in which ivacaftor exposure is mandated by the protocol.
2. Subject has received surgery for cataracts
Comparative Study of Scalp Cooling System and Chemical Cold Cap (COHAIR Study)

This is a phase III, single-center, prospective, open-label, randomized,controlled study

To conduct a prospective randomized controlled study comparing the effect of scalp cooling system (DigniCap) and chemical cold cap on preventing chemotherapy-induced alopecia in a group of breast cancer patients receiving standard anthracycline followed paclitaxel regimens. To obtain the exact data on the role of different methods of preventing alopecia in Chinese women with breast cancer.

PASS 11 software was used to calculate the sample size. According to the results of previous studies, the hair retention rate of the cold cap group was 67.7%, the hair retention rate of the scalp cooling system group was 50.5%, α=0.05，Power=0.8. The sample size was calculated to be at least 128 cases in each group, 256 cases in total.

Eligibility Criteria:
Inclusion Criteria:

* Female patients, 18≦age ≦66 years
* Invasive breast cancer diagnosed with core needle needle biopsy
* Staging I-II
* Without chemotherapy contraindications, and planned to receive neoadjuvant chemotherapy with a standard regimen (containing 4-cycle dose-dense anthracycline followed 4-cycle paclitaxel)
* Attend the study voluntarily, sign the informed consent

Exclusion Criteria:

* History of malignant tumors
* With chemotherapy contraindications
* With severe dermatosis and severe sparsity
* History of chronic diseases such as cerebrovascular disease, migraine and hyperthyroidism
* Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
* Refuse to join the study
Post-Marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe

This study aims to observe the safety and efficacy of the Xyntha Solofuse prefilled syringe in the setting of routine practice. The primary objective is to detect medically significant events (factor VIII inhibitor). The secondary objective is to observe the overall efficacy and safety of the Xyntha Solofuse prefilled syringe including serious adverse events. In this open-label, non-comparative, observational, non-interventional, retrospective and multi-center study, post-marketing surveillance data will be collected retrospectively for up to 6 months from the initial administration day of the Xyntha Solofuse prefilled syringe injected into patients who have been administered the Xyntha Solofuse prefilled syringe.

As specified in the product approval issued by the Ministry of Food and Drug Safety, the study will be conducted for 4 years from the approval date. At least 600 study subjects will be enrolled in this study to meet the MFDS requirements. Although 600 is the assigned number of study subjects, the number of cases will be adjusted considering the actual number of enrolled subjects after the study start day.


Eligibility Criteria:
-. Inclusion criteria

To be eligible to enroll in this study, the study subjects will have to meet all the following inclusion criteria:

1. Hemophilia A (congenital factor VIII deficiency) patients who have been administered according to the indication of the product 1) Control and prevention of bleeding episodes and for routine and surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency) 2) This drug does not contain von Willebrand factor and, therefore, is not indicated in von Willebrand's disease
2. Those who have been administered the Xyntha Solofuse prefilled syringe at least once - Exclusion criteria

Patients who satisfy the following criteria are not included in the study according to the local labeling:

1. Patients who have a history of hypersensitivity to the Xyntha Solofuse prefilled syringe or the ingredients of this drug.
2. Patients who have a history of hypersensitivity to hamster proteins.
3. Patients who have bleeding disorders other than hemophilia A.
4. Patients who have a history of FVIII inhibitors, or currently have or are suspected of having FVIII inhibitors. In case inhibitor titers quantified in Bethesda Units in the laboratory test results are within the normal laboratory range or at least 0.6 BU/mL. If laboratory tests cannot be performed, the investigator will determine whether or not inhibitors exist based on the clinical assessment results that show a decrease in efficacy of the replacement of FVIII (e.g. bleeding at least once, if the replacement of anti-bleeding agents is needed to be administered, and if frequency or dosage of replacement FVIII therapy needs to be increased).
5. Use of immunomodulatory therapy. (e.g. intravenous injection of immunoglobulin, use of regular systemic corticosteroids, cyclosporine, and mediators of anti-TNF-α)
Real World Study of PEG-rhG-CSF in Prevention of Chemotherapy-induced Neutropenia

The aim of this study is to observe and evaluate the cost-effectiveness,efficacy and safety of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia(CIN) of cancer patients in the real world.1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.The primary outcome was cost-effectiveness and second outcome was febrile neutropenia,the incidence and duration of grade IV neutropenia,chemotherapy delay,incidence of reduced dose of chemotherapy and relative dose intensity of chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients' age≥18 years old, male or female
2. Diagnosis of non-myeloid malignant solid tumors
3. Patients are planned to perform chemotherapy and preventive use the PEG-rhG-CSF or preventive or therapeutic use of rhG-CSF after chemotherapy
4. Patients' mental status are well, could understand the study and willing to participate the study, sign the informed consent form
5. The investigator believes that patients can benefit from this study

Exclusion Criteria:

1. Patients who have been confirmed to be allergic to Jinyouli® or rhG-CSF or its excipients
2. Pregnant or lactating women and women who plan to be pregnant during clinical observation
3. Other patients that the doctor believe not suitable for inclusion
High-dose Chemotherapy With Hematopoietic Stem-cell Rescue for High-risk Breast Cancer: Long-term Follow-up

Collection of follow-up data from the original trial patient cohort.

Collection of follow-up data from the original trial patient cohort by means of structured patient file abstraction, a questionnaire to the general practitioner, and registry consultations.

Eligibility Criteria:
Inclusion Criteria:

* Enrolment in the original trial.

Exclusion Criteria:

* None.
Involvement of Nervous System in Muscle Weakness in COPD Patients

The purpose of this study is to determine whether nervous system alterations and motor drive failure can contribute to muscle weakness in COPD during voluntary movement. If necessary, we will look after the role of nocturnal hypoxia in these alterations.

COPD is a common disease that induces many systemic repercussions. Among these, peripheral muscle dysfunction is particularly deleterious because it leads to the decreases of the level of activity and the quality of life for patients. Movement involves activation of many structures, from the instructor, i.e. the brain, to the effector, i.e. the muscle. Netherless, the studies which have described peripheral muscle dysfunction have been focused on the muscle, so they have proposed a reducing vision of the phenomenon. Other studies have reported cerebral alterations in COPD, like cognitive disturbance, increase of the neuronal conduction time, and decrease of the white matter density, and were associated with chronic hypoxemia. Such alterations are consistent with the existence of a decrease of the central motor drive during voluntary movement in COPD patients. Therefore the study will aim to determine precisely which mechanisms are involved in peripheral muscle dysfunction in copd.

Eligibility Criteria:
Inclusion Criteria:

* COPD Patients at stage 2 and 3
* Healthy sedentary subjects

Exclusion Criteria:

* Epilepsy, pace-maker, nervous disorders
Motivational Interviews With Women Experiencing Sexual Dysfunction During Menopause Period

The aim of this study is to evaluate the effect of motivational interviews with women who experience sexual dysfunction during menopause on sexual quality of life and self-efficacy.The population of the study consisted of menopausal women who applied to the gynecology outpatient clinic of Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital. It was calculated as 164 women (82 experimental, 82 control).In data collection, 'Personal Information Form (EK- )', 'Arizona Sexual Experiences Scale (ACYÖ) (EK- )', 'Sexual Quality of Life Scale-Female (SIQQ-F) (EK-)' and 'Sexual Self-Efficacy Scale' (Annex- )' was used.

Aim: This study was conducted to determine the effect of motivational interviewing on sexual quality of life and sexual self-efficacy in menopausal women with sexual dysfunction.

Methods: This randomized controlled study was conducted with 164 menopausal women with sexual dysfunction who applied to the gynecology outpatient clinic of a university hospital in southern Turkey (82 experimental, 82 control). The data were collected using a personal information form, the Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F), the Sexual Quality of Life-Female Questionnaire (SQOL-F) and the Sexual Self-Efficacy Scale (SSES). Menopausal women with sexual dysfunction (with a score of 19 and above on the ASEX-F) who applied to the gynecology outpatient clinic of the relevant hospital were invited to the study.

Before starting the motivational interviews with menopausal women in the experimental group; the PIF, the SQOL-F and the SSES were applied and their pre-test data were obtained. After the pre-test data were obtained, 4 sessions of motivational interviews were conducted with the women, 1 session per week for four weeks. Motivational interviews were completed with face-to-face interviews lasting 20-30 minutes for each woman, and those in the control group did not receive any intervention.

Eligibility Criteria:
Inclusion Criteria:

* Being able to read and write,
* Ability to communicate
* Being sexually active,
* Having entered menopause in the last 3 years,
* Having entered menopause naturally,
* Diagnosis of sexual dysfunction according to the Arizona Sexual Experiences Scale (total score ≥19).

Exclusion Criteria:

* Having any diagnosed psychiatric illness,
* Having entered menopause surgically,
* Being on hormone replacement therapy
An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants

The primary objective of this study is to describe the incidence of RSV-associated LRI among infants \<1 year of age presenting to the ED during selected shoulder months.

* The primary objective of this study is to describe the incidence of RSV-associated LRI or apnea (% RSV positive) among infants \<1 year of age presenting to the ED during selected shoulder months. The total number of events will also be described.
* To characterize the clinical outcomes and demographic data of infants presenting to the ED with RSV-associated LRI or apnea
* To characterize the social burden (in the form of number of days lost from work by parent/ guardian) for these infants through 14 days after the index ED visit and through hospital discharge will also be described.
* Based on a sample of cases collected in a cohort of patients enrolled at or near the peak of RSV disease during the traditional season, a comparison of the rate of RSV between shoulder and peak periods will be described.
* To describe the overall rates of RSV-associated LRI or apnea based on the general ED statistics collected during the entire study period.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from parent/guardian to participate in this study
* Male and female infants \<1 year of age (child must be entered before his/her 1st birthday)
* Physician diagnosis of either a) acute LRI or b) apnea below:

A) Acute LRI, defined as:

1. Medical diagnosis of bronchiolitis or pneumonia, or
2. In the absence of either of these diagnoses, LRI will be determined by the investigator after review of the medical record and must include at least one of the following:

   * Retractions
   * Wheezing
   * Rales or crackles
   * The presence of a new infiltrate, if a chest X-ray is available, which must be diagnosed by the ED physician or radiologist

B) Apnea, defined as either:

1. Cessation of breathing for \>20 seconds by history or observation, or
2. Cessation of breathing for any length of time if accompanied by cyanosis or pallor, bradycardia as detected by a monitor, or
3. ED primary diagnosis of apnea

   * Parent/guardian has the ability and willingness to be available for a follow-up interview by telephone

Exclusion Criteria:

* Use of palivizumab or RSV-IGIV at any time prior to enrollment
* Participation in trials of investigational RSV prophylaxis or therapeutic agents
Daylight-controlled Lighting Adjusted for Geographical Orientation : Effects on Recovery, Energy Consumption and User Satisfaction

The trial takes place in 4 psychiatric closed wards at Ny Psykiatri Bispebjerg. The objective is to compare, retrospectively, over two consecutive winter periods (2022 and 2023) the effect of the lighting on the duration of stay of the patients. During the first winter, a standard lighting is used, and, during the second winter, the lighting will be modified to favor a greater light intensity in blue wave color light in the morning and a gradual decrease in light intensity in the evening adjusted for geographical orientation of the patients' rooms.

Light has benefits in many pathologies, especially in psychiatry and sleep disorders. It is the most powerful Zeitgeber, allowing a drive of the sleep-wake rhythm. But what are the "doses or quantities" of light necessary for humans to stimulate circadian regulation? And how is it possible to promote better people's exposure to this amount of light during winter (especially in Nordic countries where daily light exposure during winter is particularly reduced: 8 hours on average)? At the Bispebjerg Hospital, following the installation of LED lighting, a dynamic system favoring a greater light intensity in blue wave color light in the morning and a gradual decrease in light intensity in the evening adjusted for geographical orientation of the patients' rooms is evaluated. This device was effective on anxious and depressive symptoms for patients hospitalized after a stroke. Here, we'll study the effect the light may have on patients in psychiatric closed wards. Moreover, we'll assess the users' satisfaction and the energy consumption of the system.

If the described intervention is associated with a reduction in the duration of stay of the patients in the ward as well as with a general satisfaction of the users and that it consumes much less energy, one could think of the installation of this system on a large scale not only in hospitals but also in schools or other public buildings where it could be interesting to have this adapted lighting.

Eligibility Criteria:
Inclusion Criteria:

* patients being 18 years old or older
* patients having a duration of stay of at least 3 days in the wards

Exclusion Criteria:

* patients that have switched room during their stay
* patients that have been in rooms where the lighting wasn't working
Wheezing Diagnosis Using a Smartphone

Abnormal respiratory sounds (wheezing and/or crackles) are diagnosis criteria of acute bronchiolitis. One third of these infants will develop recurrent episodes, leading to the diagnosis of infant asthma. Nowadays, no available treatment shortens the course of bronchiolitis or hastens the resolution of symptoms, thus, therapy is supportive. Our hypothesis is that the diagnosis of wheezing during bronchiolitis (\~60% of infants) will help to select infants who will benefit from anti-asthma therapy. In this setting the diagnosis of wheezing is crucial, and an objective tool for recognition of wheezing is of clinical value. The investigators developed a wheezing recognition algorithm from recorded respiratory sounds with a Smartphone placed near the mouth (Bokov P, Comput Biol Med, 2016). The objectives of the present cross sectional, observational study are 1/ to further validate our approach in a larger sample of infants (1 to 24 months) admitted to hospital for a respiratory complaint during the period of viral bronchiolitis, and 2/ to use gold standard diagnosis of wheezing by respiratory sound recording (Littmann) and subsequent analysis by two experienced pediatricians.

Infants (1 to 24 months old) are recruited in two emergency departments (Robert Debré; Antoine Béclère hospitals of Assistance publique - Hôpitaux de Paris) based on a respiratory complaint. Six characteristics are recorded (age, sex, SpO2, presence or absence of wheezing, other respiratory sound, initial diagnosis). Two recordings of respiratory sounds are obtained almost simultaneously: one with a Smartphone at the mouth (5 cm) and one with an electronic stetoscope (Littmann). Two expert pediatricians listen the recordings giving thee groups: with wheezing (agreement), without wheezing (agreement) and non agreement diagnosis. The recordings made with the Smartphone are subjected to the wheezing recognition algorithm as previously described. The sensitivity, specificity, PPV, NPP are then evaluated. The algorithm will further be improved if necessary using the true negative and true positive recordings (those with expert agreement).

Eligibility Criteria:
Inclusion Criteria:

* infant 1 to 24 months old
* respiratory complaint in the emergency room

Exclusion Criteria:
Genetic Pathways Leading to Fatty Liver and Atherogenic Dyslipidemia

The aims of the study are:

1. To investigate if carriers of apolipoprotein (apo) CIII loss-of-function (LOF) mutations produce less apo-CIII that results in reduction of large very low-density lipoprotein (VLDL) particle secretion as compared to non-carriers of these variants and compare the results with carriers of apo-CIII gain-of-function (GOF) to elucidate the role of apo-CIII in hepatic lipid metabolism.
2. To study if carriers of the TM6SF2 E167K and PNLPLA3 I148M mutations produce less large VLDL particles to transport fat out of the liver as compared to non-carriers.
3. To test whether the specific mutations in the apo-CIII, TM6SF2 and PNLPLA3 genes are reflected in changes of liver de novo lipogenesis (DNL), liver fat, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), plasma lipid and apolipoprotein kinetics and fasting concentrations in carriers of the TM6SF2 E167K and PNLPLA3 I148M mutations as compared to non-carriers.
4. To study the effects of APOE, angiopoietin (ANGPTL3 and ANGPTL8) or endothelial lipase (LIPG) genotypes on liver fat metabolism, lipid and apolipoprotein metabolism and lipid phenotypes.


Eligibility Criteria:
Inclusion Criteria:

* persons who have provided written consent
* apo-CIII loss-of-function mutation (heterozygous) or apo-CIII gain-of-function mutations (heterozygous) or TM6SF2 E167K mutation (homozygous) or PNLPLA3 I148M or apoE or LIPG or ANGPTL3 or ANGPTL8 LOF and GOF variants. Control group without any of known risk variants in these genes.
* Hemoglobin A1c \< 6.5%
* Body mass index between 18.5 and 40 kg/m²
* Estimated glomerular filtration rate \> 60 ml/min/1.73 m² at inclusion

Exclusion Criteria:

* Patients with Type 1 and 2 diabetes, BMI \> 40 kg/m2,
* ApoE2/2 phenotype, thyrotropin concentration outside normal range,
* Lipid-lowering drugs
* Blood pressure \>160 mmHg systolic and/or \> 105 diastolic mmHg
* Liver failure or abnormal liver function tests \>3 x upper limit of normal
* Intestinal disease
* Pregnancy, breastfeeding
* Patients with volume depletion
Repeated Methotrexate for Proliferative Vitreoretinopathy Grade C

This multicenter randomized clinical trial evaluates the effect of multiple intra-silicone oil injections of methotrexate (MTX) on rhegmatogenous retinal detachment (RRD) with grade C proliferative vitreoretinopathy (PVR).

74 eyes with the diagnosis of RRD with PVR grade C will be randomized into two groups: the intervention group and the control group. All eyes undergo pars plana vitrectomy(PPV) and intraocular injection of silicone oil (SO). At the end of the surgical procedure, intra-SO injection of 250 µg MTX will be performed in the intervention group. No intra-SO injection will be done in the control group. In the intervention group, Intra-SO injection of MTX will be repeated at 3 and 6 weeks postoperatively. Silicone oil removal will be done 3 months after surgery.Spectral-domain optical coherence tomography (SD-OCT) image of the macula will be acquired at months 3 and 6. The retinal reattachment rate at months 6 will be assessed as the main outcome measure of the study. Best corrected visual acuity, retinal reproliferation rate and adverse events are the secondary outcome measures. Comprehensive ocular examination will be performed at weeks 1, 3, 6 and at months 3, 4 and 6.


Eligibility Criteria:
Inclusion Criteria:

* Rhegmatogenous retinal detachment with proliferative vitreoretinopathy grade C

Exclusion Criteria:

* Age of under 18 years old
* Pregnancy
* Glaucoma
* Macular disorders
* Diabetic retinopathy
* Retinal vascular occlusion
* History of penetrating ocular trauma
* Giant retinal tear
* Chronic uveitis
* History of intraocular steroid injection
Effects of Subanesthetic Concentrations of Nitrous Oxide - 1

The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To examine effects of subanesthetic concentrations of nitrous oxide on cold-pressor pain in humans.


Eligibility Criteria:
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