cyrilzakka/clinical-trials huggingface dataset:
Psychological Symptoms in Patients With Behcet's Disease by SCL90-R

To find the overall psychological profile of patients with Behcet's Disease (BD) and compare it with Non-BD patients.patients were checked for psychological symptoms by Symptom Check List 90 Revised (SCL90-R)

200 BD and 200 Non-BD patients were checked for psychological symptoms by Symptom Check List 90 Revised (SCL90-R). BD diagnosis was based on the new International Criteria for Behcet's Disease (ICBD). Non-BD patients were patients mimicking BD. All patients were asked to complete the SCL90-R when they attended the clinic for their routine follow-up. The demographic information and disease manifestations including ocular and neurological involvement were registered. For those with visual impairment, SCL90-R was applied by an interviewer. Frequencies and descriptive analysis were measured in both BD and Non-BD groups. Means and standard deviations (SD) of visual acuity were calculated. Data collected from SCL90-R did not have normal distribution in any dimension. The mean values of raw numbers, global severity index (GSI), the positive symptoms total (PST) and the positive symptom distress index (PSDI), were compared by Mann-Whitney U (M-W U) test.).To detect any bias in results due to data collection method, self reported data and reviewer collected data were compared.

Eligibility Criteria:
Inclusion Criteria:

* Behcet's disease patients that their diagnosis was based on the new International Criteria for Behcet's Disease (ICBD).
* Non-Behcet's disease patients were patients mimicking BD.

Exclusion Criteria:

* Probable Behcet's Disease
Visualization Versus Neuromonitoring of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy.

Injury to the external branch of the superior laryngeal nerve (EBSLN) during thyroidectomy results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. It remains unclear if use of intraoperative nerve monitoring (IONM) can improve clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.

Phonation changes following thyroidectomy have been reported in many investigations. They are considered to be multifactorial in origin and can be a consequence of laryngeal nerve injury or other events during thyroidectomy including arytenoids trauma after endotracheal intubation, cricothyroid dysfunction, strap muscle malfunction or lesion of the perithyroidal neural plexus, laryngotracheal fixation with impairment of vertical movement and psychological reaction to the operation. Injury to the external branch of the superior laryngeal nerve (EBSLN) can occur during the dissection and clamping of the superior thyroid vessels and the prevalence of this complication has been reported from 0.5% to 58%. This injury causes a complete paralysis of the cricothyroid muscle which results in lowered fundamental frequency of the voice and worsened voice performance in producing high-frequency sounds. Intraoperative nerve monitoring (IONM) has gained widespread acceptance as an adjunct to the gold standard of visual nerve identification and this technique can be used to identify both the recurrent laryngeal nerve (RLN) and the EBSLN. However, it remains unclear if there is any IONM added-value to the clinical outcome of thyroidectomy in terms of preserved individual voice performance. This study was designed to test that hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* thyroid pathology qualified for first-time bilateral neck surgery in a female patient with small to moderate sized goiter (below 100 ml in volume).

Exclusion Criteria:

* male gender,
* previous neck surgery,
* unilateral thyroid pathology eligible for unilateral lobectomy,
* goiter volume above 100 ml,
* preoperatively diagnosed RLN palsy,
* abnormal preoperative voice assessment on GRBAS scale,
* pregnancy or lactation,
* age below 18 years,
* high-risk patients ASA 4 grade (American Society of Anesthesiology),
* inability to comply with the scheduled follow-up protocol.
An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia

This pilot project was developed to investigate subjective and objective data related to the patterns of physical activity participation among hemophilia patients (FVIII or FIX) between the ages of 5 and 18 years. Physical activity participation among different levels of disease severity will be compared using accelerometers to calculate the amount of time spent in moderate to vigorous physical activity (MVPA) and the number of bouts of MVPA; additionally, data will be collected from two validated questionnaires (PedHAL and 3 day physical activity recall). Current literature that relates level of physical activity to disease severity in the pediatric hemophilia population is limited. The information gained about the type and quantity of physical activity participation in children with varying levels of hemophilia will assist in the development of education and interventions to promote good physical activity and potentially examine the role of tailored prophylaxis.

Objectives:

1. To determine if the amount of time spent performing moderate to vigorous physical activity (MVPA) and the number of bouts of MVPA engaged in on a weekly basis differs by the level of disease severity in the pediatric hemophilia population.
2. To determine if recorded physical activities and intensity of activities from self-report questionnaires (PedHAL and 3 day physical activity recall - 3DPAR) differ according to the severity of hemophilia.
3. To determine if, among patients with hemophilia, there is a relationship between physical activity level and patient age, weight, and body mass index (BMI).

Specific Aims:

•Aim # 1: The primary aim of the study is to determine if there are differences in the amount of time spent in MVPA by level of disease severity of children with hemophilia.

Secondary Aims:

* Aim # 2: To determine if there are meaningful differences in the accumulation of MVPA (bouts of exercise) by disease severity of children with hemophilia.
* Aim # 3: The compare the findings from Aim #1 and #2 to the NHANES (National Health and Nutrition Examination Survey) data, recognizing that this survey provides a comparative healthy normal cohort.
* Aim # 4: To investigate MVPA with these data collected from the PedHAL (11) and the 3DPAR (12) by disease severity of children with hemophilia.
* Aim # 5: The review and determine the relationship between physical activity participation and timing of prophylaxis factor replacement and whether participation is limited to days of factor infusion.
* Aim #6: To investigate the amount of physical activity and how it relates to age, weight, and patient body mass index (BMI).

Eligibility Criteria:
Inclusion Criteria:

* 5-17 years of age, has a diagnosis of Hemophilia A or B.

Exclusion Criteria:

* Muscle or joint bleed within 4 weeks of study.
* Pre-existing co-morbidities that would affect physical activity participation.
* Unable to cooperate with study protocol.
* Unable to speak, read, or understand English.
Sensory Evaluation of Chinese Specialty Foods

This project aims at college student consumers, recruiting a certain number of college student volunteers as sensory evaluators, and requiring them to evaluate samples of Babao Congee and deep-fried dough sticks.

The specific evaluation methods are as follows: the samples are randomly numbered and distributed to college student volunteers. Scale method is used to quantify the appearance score, texture score and taste score of Babao Congee and deep-fried dough sticks. Basic information, general physical conditions and sensory characteristics of Babao Congee and deep-fried dough sticks are collected through questionnaires or interviews.

Eligibility Criteria:
Inclusion Criteria:

* University students at school

Exclusion Criteria:

* Smoking (≥1 cigarette/week);
* heavy alcohol consumption (\>224 g/week for men and \>168 g/week for women);
Identification of New Biological Markers for the Progression of Mycobacterium Abscessus-induced Lung Disease in Cystic Fibrosis

In this project the investigators aim to identify new biological markers by characterizing the response/inflammation associated with the development and progression of M. abscessus lung disease in patients suffering from cystic fibrosis with the aim of increasing current knowledge available on the development and progression of lung disease.

Main objective:

Evaluate the correlation between early alterations in the profile of specific cell populations or expression markers or soluble immunity activation proteins, considering in particular the development and progression of M. abscessus lung disease in patients with cystic fibrosis.

Secondary objectives

* Identify cellular expression profiles associated with the development and progression of M. abscessus lung disease in cystic fibrosis patients and evaluate its ability to predict clinical outcome
* Identify biomarkers or molecular profiles associated with the development and progression of M. abscessus lung disease in cystic fibrosis patients and evaluate its ability to predict clinical outcome
* Expand pathogenetic knowledge to support disease progression pulmonary disease from M. abscessus in patients with cystic fibrosis and evaluate their ability to predict clinical outcome.
* Describe the reciprocal interactions between cellular and humoral components of the response inflammatory disease during M. abscessus infection with/without M. abscessus lung disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a certain diagnosis of cystic fibrosis and visited during normal clinical practice, in accordance with the standard operating procedures in force at the Centres.
* Both sexes
* Age \>18 years
* Obtaining informed consent for patients (based on the procedures established by the protocol).

Exclusion Criteria:

* Patients unable to understand the instructions and information provided and be able to adequately accept the study methods.
The Stress Management Training Provided to Obese Women

Introduction: Obesity, which is an important public healthcare issue, can affect women's physical, mental, social health, stress level, and coping negatively.

Aim: The present study was conducted to determine the effects of stress management training provided to obese women on eating attitudes, stress, and coping with stress.

Methods: The sampling of the randomized controlled experimental study based on the pre-test and post-test model consisted of 70 women (experimental = 35; control = 35) with a Body Mass Index ≥30, who applied to a Community Healthcare Center Obesity Unit in primary care in Turkey. The data were collected by using Personal Information Form, Perceived Stress Scale, Stress Coping Styles Scale, Dutch Eating Behavior Questionnaire, and height-weight measurements.

Eligibility Criteria:
Inclusion Criteria:

* Women who lived in the city center,
* Body Mass Index ≥30,
* Having no perception and communication problems and being able to answer questions,
* Women who volunteered to participate in the study

Exclusion Criteria:

* Being a man
* Non-obese women and those with a body mass index below 30
* Those with communication problems
* Those who do not live in the city center
Comparison of Remifentanil With Dexmedetomidine or Midazolam in Regards of Sedation Effectivity and Postoperative Cognitive Functions in Cystoscopies

The aim of the study was to compare the effects of remifentanil-dexmedetomidine and remifentanil-midazolam with mini-mental state examination (MMSE) in monitored anesthesia care (MAC) patients undergoing cystoscopy.

Forty patients undergoing cystoscopy receiving remifentanil infusion of 0.05 microgram per kg-1 min-1 were randomized into two groups: Either dexmedetomidine 1 microgram per kg -1 (GroupD) or midazolam 0.2 mg kg-1h-1 (GroupM) were administered intravenously for the first 10 minutes. Subsequently anesthesia was maintained by using the bispectral index(BIS) as a continuous infusion of dexmedetomidine 0.2-0.7 microgram per kg-1h-1 or midazolam 0.05-0.15 mgkg-1h-1. Heart rate, mean arterial pressure, MMSE, sedation and the patient's and surgeon's satisfaction were determined.

Eligibility Criteria:
Inclusion Criteria:

* patients with indication of cystoscopy must be able to have sedation

Exclusion Criteria:

* hypersensitivity to drugs used
* morbid obesity
* coronary disease
* diabetes mellitus and other endocrinologic diseases
* pregnancy
* psychomotor diseases
A Study to Evaluate the Safety and Tolerability of QR-1123 in Subjects With Autosomal Dominant Retinitis Pigmentosa Due to the P23H Mutation in the RHO Gene

This study evaluates the safety, tolerability and efficacy of QR-1123 injection in the eye (intravitreal; IVT) injections (one eye/unilateral) in subjects receiving a single dose or repeat doses. Single injections will be assessed in an open label way, and repeat injections will be assessed in a double-masked, randomized, sham-controlled fashion.

QR-1123 is an antisense oligonucleotide, designed to specifically target the mutant P23H messenger ribonucleic acid (mRNA) in order to reduce the expression of the P23H protein selectively, while preserving expression of the wild type (WT) rhodopsin (RHO) protein. It is hypothesized that the reduction of mutant P23H mRNA will reduce the deleterious effects of the dominant-negative protein and should result in increased function of WT rhodopsin protein in photoreceptors. Restoration of WT RHO function is expected to improve vision in patients with adRP due to the P23H mutation.

The study will comprise up to 8 single dose and repeat dose cohorts. Prior to initiating a higher single dose cohort and/or prior to initiating repeat dose cohort(s), available safety and efficacy data will be reviewed by the DMC.

In the single dose cohorts subjects will receive a single, unilateral IVT injection of QR-1123 in an open label fashion. In the repeat dose cohorts subjects will be randomized to receive either a unilateral IVT injection of QR-1123 every 3 months or a unilateral sham procedure every 3 months, in a double masked fashion. Subjects will be followed for safety, tolerability and efficacy for a total period of 12 months.

Eligibility Criteria:
Main Inclusion Criteria:

1. Male or female, ≥ 18 years of age.
2. Clinical presentation consistent with adRP, based on ophthalmic examinations.
3. Impairment on VF in the opinion of the Investigator, as determined by perimetry.
4. A molecular diagnosis of autosomal dominant form of RP with the P23H mutation in the RHO gene, based on genetic analysis.
5. A clear ocular media and adequate pupillary dilation to permit good quality fundus imaging, as assessed by the Investigator.

Main Exclusion Criteria:

1. Presence of additional pathogenic mutations in genes (other than the P23H mutation in the RHO gene) associated with inherited retinal degenerative diseases or syndromes, based on genetic analysis (eg, Usher syndrome, Leber congenital amaurosis, etc).
2. Presence of any significant ocular or non-ocular disease/disorder (including medication and laboratory test abnormalities) which, in the opinion of the Investigator and with concurrence of the Medical Monitor, may either put the subject at risk because of participation in the study, may influence the results of the study, or the subject's ability to participate in the study.
Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT

The purposes of the study are to determine the maximum tolerated dose (MTD) and effectiveness of Artificial Antigen Presenting Cell (AAPC)-expanded donor T-cells administered as a single infusion after an allogeneic hematopoietic cell transplant (alloHCT) to treat patients with Acute Myeloid Leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged between 18 and 75 years of age undergoing allogeneic hematopoietic stem cell transplantation (alloHCT) or the treatment ELN 2017 adverse risk AML
* Have \< 5% blasts in bone marrow by morphology at the time of transplantation. Patients with pre-alloHCT or post-alloHCT flow cytometric or molecular evidence of MRD are allowed
* Karnofsky performance status (KPS) ≥ 70% during the study screening.
* Free of symptomatic congestive heart failure or uncontrolled arrhythmia
* Adequate organ function as defined per protocol
* Negative serum pregnancy test
* Note: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for at least 30 days following study treatment (T-cell infusion); should a woman subject or female partner of a male subject become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study.
* Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

* Current use of concomitant systemic glucocorticoid at the time of γδ T-cell infusion for any reason will not be allowed in order to avoid their immunosuppressive effects on γδ T-cell function.
* Active grade II-IV acute GVHD (patients with prior GVHD should be off prednisone for at least 14 days prior to infusion of the study cell product).
* Uncontrolled serious infection.
* Morphologic relapse of leukemia at any timepoint after HCT.
* Active central nervous system malignancy.
* Pregnancy or lactation.
* Treatment with another investigational drug or other intervention within 14 days of T-cell infusion
Hypercapnia and Its Association With Long-term Respiratory Morbidities in Premature Infants With Chronic Lung Disease

This is a prospective, longitudinal observational study to provide data regarding the natural course of hypercapnia in premature infants with bronchopulmonary dysplasia using both available blood pCO2 and measured capnography, as well as relate the degree and trend of hypercapnia to later respiratory outcomes.

Data collection will begin once an infant no longer requires mechanical ventilation, CPAP, and HFNC, up to twice per week while in the NICU. Investigators will obtain up to twenty minutes of end-tidal capnography data, using Masimo ISA modules with continuous CO2 display. Five minutes of good quality data, at approximately 30 breaths per minutes, should provide approximately 150 data points. After filtering for artifact, the mean and range of end tidal CO2 will be recorded during this interval. These recordings will be started after a feed for infants receiving enteral feeds. The capnography cannula will be placed by the bedside nurse or respiratory therapist at the conclusion of a feed and removed no later than the next feed. If data is unable to be obtained, investigators will attempt to collect it at the next regularly scheduled interval.

Available blood gases with pCO2 will also be recorded during the NICU hospitalization.

After discharge, consented subjects who are followed in the BCH outpatient pulmonary clinic will have capnography recorded at every clinic visit for a period of up to twenty minutes, and mean and range of end-tidal CO2 will be recorded after filtering for artifact. Available blood gases with pCO2 during pulmonary visits will be recorded; blood gases during sick encounters (i.e. emergency room) will be excluded. From available electronic medical record (EMR) and clinic note data, investigators will also record duration of time on respiratory support including positive pressure ventilation and nasal cannula oxygen.

Eligibility Criteria:
Inclusion Criteria:

* Potential eligible patients will be identified in the first 3-14 days of life at Beth Israel Deaconess Hospital (BIDMC) NICU who have a birth gestational age \<=32 0/7 weeks and current or previous requirement for positive pressure (ventilation or continuous positive airway pressure (CPAP).

Exclusion Criteria:

1. death prior to discharge from the NICU,
2. chronic lung disease secondary to pulmonary conditions other than bronchopulmonary dysplasia and
3. other underlying identified genetic syndromes.
A Phase II Trial Evaluating an Organ-conserving Strategy by Radiochemotherapy for Muscle-infiltrative Bladder Cancer

If radical cystectomy remains the standard of care for muscle invasive bladder cancer, consequences of this surgical procedure are often harsh. Over the past years, concurrent chemo-radiotherapy has imposed itself as an alternative treatment. Published data on concomitant radiochemotherapy (radiotherapy/cisplatin or radiotherapy/cisplatin/5-fluorouracil combinations) showed local control rates with bladder preservation at 5 years ranging from 40% to 65% according to the disease stage, and overall survival probabilities ranging from 40% to 50% at 5 years. In order to improve local and systemic prognosis, evaluation of other chemotherapy agents with higher radiosensitizing effect, such as gemcitabine, is justified. Gemcitabine possesses its own anti-cancer activities on urothelial diseases and has a synergetic activity with cisplatin. The investigators completed a monocenter phase I study combining radiotherapy, cisplatin, and twice-weekly gemcitabine, and determined a recommended dose of gemcitabine 25 mg/m². The objective of the present study is to evaluate the combination of radiotherapy + cisplatin + gemcitabine in terms of disease-free survival in non metastatic muscle invasive urothelial cancer patients.

The objective of the present study is to evaluate the combination of radiotherapy + cisplatin + gemcitabine in terms of disease-free survival in non metastatic muscle invasive urothelial cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Muscle invasive urothelial cancer (front line or following the progression of a superficial tumor), pT2-pT3 stage without lymphatic impairment (N0) and without detectable metastases (M0). An optimal macroscopic resection (TURB) have to be performed
* The proof of invasive tumor to the muscle should be brought by a transurethral resection under anaesthesia less than 8 weeks before or, in the absence, by superficial biopsies and formal imaging. Multiples biopsies in the bladder must also be performed.
* Age ≥ 18 years
* Life expectancy ≥ 6 months
* Kanorfsky index ≥ 70 % (WHO 0, 1, 2)
* Biological criteria: neutrophils ≥ 1500/mm3, Platelets ≥ 100 000/mm3, haemoglobin ≥ 10 g/dl, creatinine clearance \> 60 ml/mn
* No distant metastases (Thorax, abdomen, and pelvic CT-scan, bone scan)
* Efficient contraception for premenopausal women, maintained during the whole treatment and up to two months after the completion of radiotherapy.
* No radiotherapy or chemotherapy history except for in situ bladder lesions.
* No carcinological history except for non melanoma skin tumours, in situ uterine cervix cancer
* No contraindication to gemcitabine or cisplatin.
* No contraindication to radiotherapy
* Information letter and informed consent signed
* Patient covered by social security

Exclusion Criteria:

* Bladder tumors without any muscle infiltration
* Epidermoid carcinoma or adenocarcinoma
* Distance metastases or extrapelvic node positivity
* Severe digestive history (ulcerative colitis, complicated diverticulitis)
* Pregnancy and breast feeding