cyrilzakka/clinical-trials huggingface dataset:
Occupational Exposure to Dust and the Relationship With the Respiratory Symptoms, Lung Function Among Construction Workers of the University of Malaysia Sabah (UMS)

Background The respiratory tract often becomes the site of injury from occupational exposure. All construction sites generate high levels of dust, typically from concrete, silica, asbestos, cement, wood, stone, sand and therefore, the workers are exposed to this airborne dust and increased their risk of developing respiratory disorders. Limited studies have been conducted to assess the relationship between respiratory symptoms, lung function and occupational dust exposure among construction workers in Sabah. The objectives of this study are to determine the occupational exposure to dust and the relationship with the respiratory symptoms as well as lung function among construction workers in UMS Teaching Hospital.

Materials and methods This cross-sectional study consisted of construction workers working in all sections in the development of UMS Teaching Hospital. A standard respiratory questionnaire was distributed to construction workers and lung function measurement was performed using Spirometry and the results of their respiratory status were compared between workers who were exposed and unexposed to dust. Occupational dust exposure was determined by the gravimetric method using an air sampler. The total duration of the collection was 8 hours and the filters with the dust samples were analyzed in the laboratory.


Eligibility Criteria:
Inclusion Criteria:

* all construction worker

Exclusion Criteria:

* has chronic lung impairment
Maintenance Capecitabine Plus Best Supportive Care Versus Best Supportive Care for Metastatic Nasopharyngeal Carcinoma

This multicenter, randomised, phase 3 study is to evaluate the survival benefit of maintenance capecitabine plus best supportive care versus best supportive care for metastatic nasopharyngeal carcinoma patients after disease controlled with TPC palliative chemotherapy.

Firstly diagnosed metastatic nasopharyngeal carcinoma patients will receive 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine. After disease controlled, they will be randomly assigned to maintenance capecitabine plus best supportive care(BSC) or BSC alone. The primary end point is progression-free survival, the secondary end points are overall survival, duration of response, objective response rate, adverse effects and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Firstly diagnosed metastatic nasopharyngeal carcinoma patients
* Disease controlled after 4-6 cycles of palliative chemotherapy with taxol,cisplatin and capecitabine
* Eastern Cooperative Oncology Group (ECOG) 0-2
* Life expectation at least 12 weeks
* No systemic chemotherapy within 6 months, except for induction chemotherapy or concurrent chemotherapy
* With at least one measurable lesion
* Enough blood test
* Signed informed consent

Exclusion Criteria:

* Sever heart disease
* HIV infection
* Sever infection
* Brain metastasis, except received radical therapy 6 months ago and stable in 4 weeks
* Allogeneic organ transplantation
* Malignancy other than nasopharyngeal carcinoma, except:cervical carcinoma in situ, cured basal cell carcinoma,bladder cancer of Ta,Tis or T1, or any cured cancer for at least 3 years
* Pregnancy or breast feeding
* Difficulty in swallowing
* Received other test drugs
Standardization of 6 Minute Walk Test

The 6 minute walk (6MW) gives information about the exercise capacity and it is an important tool for clinical decisions and for the prognostic evaluation of PH patients. The test is technically simple to perform, inexpensive and reproducible. During the 6MW O2 saturation, heart rate, walking distance (in this study after every minute) and the level of dyspnea (BORG-dyspnea scale) may be recorded; however, at present, mainly the walking distance is evaluated. The test is sometimes criticized, because of the dependence on the patient's motivation.

The purpose of the present study is to standardize the test by the incorporation of objective factors. The investigators are correlating the change of heart rate and dyspnea (BORG scale) with the achieved walking distance during subsequent examinations performed with different effort.

On two different days the patients have to absolve four 6MW on different levels of effort - on both days a traditional test will be performed and additionally a test with more effort or with less effort. The order of the tests will be randomized. These two days of the examinations should be within a maximum of three months, provided that there is no sign of relevant clinical changes. After every minute the walking distance is determined. Heart rate and the O2 saturation are measured by pulsoxymetry during the whole test. Every two minutes the patients are asked about their dyspnea (Borg scale).

The purpose of the present study is to standardize the test by the incorporation of objective factors and to detect the correlation between the walking distance and the level of effort during exercise. The investigators expect that the reliability and objectivity of 6MW may increase by the standardization.

The additionally performed cardiopulmonary exercise testing helps to evaluate and stratify patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of pulmonary hypertension or exercise-induced pulmonary hypertension by right heart catheterisation
* informed consent

Exclusion Criteria:

* Myocardiac Infarct within the last 12 months
* Uncontrolled ventricular arrhythmia
* Uncontrolled bradycardic or tachycardic supraventricular arrhythmia
* relevant operations within the last 12 weeks
* change of the hemodynamic therapy within the last 6 weeks
* joint diseases or diseases of peripheral vessels and nerves which may make the results of the six minute walk test unreliable
Cell-Free DNA Chromatin Immunoprecipitation (ChIP) for Diagnosing Cancer

The goal of this research is to use chromatin immunoprecipitation, a method used to study protein-DNA interaction, as a tool to diagnose and prognose pancreatic ductal adenocarcinoma in human samples.

This is a Non-Human Subject Research study. All participants are de-identified.

Pancreatic ductal adenocarcinoma (PDAC) is a neoplastic disease which accounts for "90% of pancreatic malignancies," and has a 5-year survival rate of only 9%. The dismal nature of the PDAC diagnosis, which has a median survival time of about one year, can be attributed in part to late detection. In fact, the Cancer of Pancreas Screening-5 study demonstrated a 73.3% survival rate in participants whose PDAC was found early through surveillance via MRI and endoscopic ultrasound. This eightfold increase in survival rate suggests the inherent efficacy of PDAC screening, however, with the median cost of a full MRI being about $2,000, there is a significant barrier to entry for PDAC screening. As a result, finding a cost-effective alternative to PDAC screening could improve survival rates and lower costs, both directly and indirectly. Liquid biopsy could prove to be a valuable tool in the early diagnosis of PDAC, as it provides a non-invasive way to detect the presence of a disease state such as PDAC. Chromatin immunoprecipitation (ChIP), a type of liquid biopsy used to study protein-DNA interaction, is a promising method at the forefront of cancer research, and has been proven to be capable of detecting tumor-specific transcriptional activity. Additionally, the assay has shown promise in diagnosis and prognosis of disease state. Currently, few (if any) modalities of liquid biopsy in pancreatic cancer use ChIP, and other forms of liquid biopsy have proven to lack sensitivity and specificity. Thus, the aim of this research is to utilize the ChIP assay as a diagnostic and prognostic tool in PDAC by detecting and quantifying tumoral gene expression.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Pancreatic cancer patients

Exclusion Criteria:

* Children may not register
* Persons who are unable to consent may not register
Non Invasive Ventilation During Physical Training in Cystic Fibrosis

Patients with cystic fibrosis older than 18 years will performance a Bruce test with non invasive ventilation (once) after 30 minutes they perform the same test with oxygen supplementation.

Measurements: Transcutaneous level off carbon dioxide, saturation, puls and dyspnea scale.

measurements before and after the test: transcutaneous level off carbon dioxide, saturation, respiratory rate, dyspnea scale.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with Cystic Fibrosis at Stockholm Cystic Fibrosis center
* \> 18 years of age
* Forced expiratory volume in one second (FEV1) between 20 and 69% of predicted value
* Developed alveolar hypoventilation at the physical performance test
* Use oxygen supplementation during aerobic training

Exclusion Criteria:

* Symptomatic upper airway infection characterized by fever less than 1 month before entering the study
* Cognitive dysfunction
* Cardio-respiratory instability
* Infection with Burkholderia cepacia complex
* Gastroesophageal reflux
* History of pneumothorax
* Massive hemoptysis.
Intervention With Legume Kernel Fibre in Healthy Subjects

The objective of the conducted study was to determine the efficacy of the native legume kernel fibres of Lupinus angustifolius Boregine (Boregine), Lupinus albus Typ Top (TypTop) and Glycine max Hefeng (Soy fibre) on prevention of risk factors for gastrointestinal or cardiovascular diseases.

Dietary fibre is suspected to effect the faecal concentration and excretion of bile acids by binding the bile acids and by increasing the faecal mass. Bile acids, especially the secondary bile acids, are potential risk factors for colorectal cancer. A high bile acid-binding ability of fibre could lead to lower serum cholesterol concentrations by interrupting the enterohepatic circulation. There is evidence that the consumption of legume kernel fibre, containing both soluble and insoluble fibre fractions, may beneficially modify bowel health.

Seventy-eight healthy volunteers were enrolled. Seventy-six subjects (mean age of 24 years, 55 women and 21 men) completed the double-blind, randomized crossover trial. After two weeks run-in period, half of the volunteers consumed 25 g of legume fibres (Boregine, TypTop or Soy fibre) every day, and the other half received a reference fibre product (citrus fibre, Herbacel AQ Plus) for a period of two weeks. After two weeks wash-out the intervention changed between the groups.

At the end of each period a quantitative stool and urine collection took place and fasting blood samples were drawn.

Eligibility Criteria:
Inclusion Criteria:

* age 20-45 years
* healthy subjects

Exclusion Criteria:

* intake of pharmaceuticals and nutritional supplements
* allergy against legumes
* intolerance against milk protein
* pregnancy, lactation
* chronic diseases
Assessment of Functional Capacity in Long-COVID

A paucity of prognostic studies in patients with post-COVID-19 syndrome (long-COVID) shows the need to identify the main effects on functional capacity in the short and medium term. In this regard, the evaluation of lung function, lung structure and functional capacity in long-COVID patients is essential to estimate the impact of the disease. This retrospective observational study aims to compare functional capacity, lung function, and lung ultrasound findings in patients who underwent physical therapy to those who did not.

Introduction: The pandemic caused by the Severe acute respiratory syndrome by coronavirus 2 (SARS-CoV-2) has been presented as a one of the greatest health challenges on a global scale at the beginning of this millennium. Many patients need physical therapy in their recovery process. A paucity of prognostic studies in patients with long-COVID shows the need to identify the main repercussions on functional capacity in the short and medium term. In this regard, the evaluation of lung function, lung structure and functional capacity in long-COVID patients is essential to estimate the impact of the disease.

Objective: The present study aims to compare functional capacity, lung function, and lung ultrasound findings between patients diagnosed with long-COVID who underwent physical therapy to those who did not.

Methods: This is a retrospective observational study with quantitative data analysis. The study will be carried out at the Pulmonary Function Laboratory of the Policlínica Universitária Piquet Carneiro, from the State University of Rio de Janeiro. First, a clinical evaluation will be performed. In the survey, it will be asked whether the patient had undergone physical therapy treatment, so they can be allocated in the control or intervention group. After that, they will answer to the Post-COVID-19 Functional Status Scale (PCFS), a tool to measure functional status over time after COVID-19. Then, patients will have their lung function evaluated through spirometry and impulse oscillometry (IOS). In addition, lung ultrasound (LUS) images will be analyzed. And their functional capacity will be assessed using the six-minute walk test (6MWT) coupled to pulmonary ventilation measurement using Spiropalm® (Spiropalm 6MWT, Cosmed, Rome, Italy).

It is expected that understanding the consequences of long-COVID on pulmonary ventilation can help to design therapeutic strategies in rehabilitation services.

Eligibility Criteria:
Inclusion Criteria:

Individuals with an established diagnosis of COVID-19 (RT-PCR) who required hospitalization or not, regardless of whether or not they were treated in the ICU.

Exclusion Criteria:

Patients unable to perform the tests. Patients with musculoskeletal disorders not associated with COVID-19. Patients with lung, heart or cerebrovascular diseases not associated with COVID-19.
The Efficacy and Safety of PEG-rhG-CSF（Pegylated Recombinant Human Granulocyte Colony Stimulating Factor)in Patients With Breast Cancer Who Were Treated With Intensive Chemotherapy

The purpose of the study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer who were treated with intensive chemotherapy for prevention of neutrophil reduction.


Eligibility Criteria:
Inclusion Criteria:

1.18-65 years old, gender no limited.

2.Breast cancer diagnosed by pathology.

3.Did not receive chemotherapy previously and plans to receive 4 cycles intensive EC (epirubicin, cyclophosphamide) treatment.

4.No obvious blood system disease, ANC(absolute neutrophil count)≥ 1.5 × 10\^9/L, PLT（Platelet）≥80×10\^9 /L, Hb（hemoglobin）≥75g/L, WBC（White blood cell ）≥3×109/L, and no bleeding tendency.

5.KPS (Karnofsky performance status) score≥70.

6.Expected survival≥3 months.

7.Written informed consent are acquired.

Exclusion Criteria:

1. Severe or uncontrolled infection.
2. Sensitive to the product or other genetically engineered biological products from Escherichia coli strains.
3. Mental or nervous system disorders.
4. Severe heart, lung and central nervous system disorders.
5. Pregnant or lactating women.
6. TBIL(total bilirubin ), ALT（alanine aminotransferase）,AST（glutamic-oxalacetic transaminase） \> 2.5×ULN（upper limit of normal）; if it were caused by liver metastases, TBIL, ALT,AST \>5×ULN.
7. Cr（creatinine） \>1.5×ULN.
Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania

The proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial comparing two treatment strategies in adolescents with mania and prominent psychotic features. One group will receive a second generation antipsychotic (SGA) and placebo and the other will receive a SGA and lithium.

The primary double-blind phase of the study will last 8 weeks, followed by a 24-week extension-phase.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 12-18 years old, inpatients or outpatients
* meet DSM-IV criteria for Bipolar I disorder - manic or mixed episode
* psychotic symptoms present

Exclusion criteria:

* current serious homicidal/suicidal ideation
* prior non-response or intolerance to an adequate trial of lithium
* prior non-response or intolerance to adequate trials of both aripiprazole and risperidone
* any unstable medical condition or medical contraindication to treatment with lithium, aripiprazole or risperidone
* inability or unwillingness to discontinue concomitant medication that interferes with the pharmacokinetics of either lithium, aripiprazole, or risperidone
* seizure disorder
* pregnant or, if sexually active, not using birth control, such as oral contraceptives, two barrier methods, long-acting depot preparations or an intra-uterine device
* Full Scale IQ less than 70
* meets criteria for a DSM-IV diagnosis of substance-induced mood disorder or mood disorder due to a general medical condition.
Impact of Protein Supplementation to Mother Milk on Resting Energy Expenditure (REE) in Growing Healthy Preterm Infants.

Resting Energy Expenditure is the amount of energy, usually expressed in Kcal required for a 24 hour period by the body during resting conditions. It is closely related to, but not identical to, basal metabolic rate.

According to the ESPGHAN committee guidelines on enteral nutrient supply for preterm infants, which were published in 2010, the daily protein intake of extremely low birth weight infants shall be 4.5 g/kg/day, and for those above 1000g, 4 g/kg/day. In order to meet these recommendations, the human milk for all premature infants is enriched with human milk fortifier, and supplemental liquid protein according to our NICU protocol.

Little is known on the effect of this enrichment on the basal metabolic rate of premature infants.

One way of determining the basal metabolic rate is by measuring the resting energy expenditure. In order to do that the investigators use an indirect calorimety by using the Deltatrac II metabolic monitor (Datex-Ohmeda). This instrument uses the principle of the open-circuit system that allows continuous measurements of oxygen consumption and carbon dioxide production using a constant flow generator.

Infants will be enrolled when tolerating full feeds (150-160 ml/kg/d) of human breast milk fortified with standard fortifier for 2 days and before protein supplementation.

Metabolic studies will be conducted while the infants are prone and asleep and at the same time of the day (noon time) for all infants, starting 1 hour after the completion of the last feed. Measurements will be stopped during body movements.

Each measure, once a day, will last for 30 min. A total of 4 REE measurements will be performed for all participants: before starting with protein supplementation, on day 0 (D0), and at days 2, 3 and 4 of protein supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born with birth weight \< 1500 g gestation
* Full enteral feeds (150-160 ml/kg/d) of breast milk fortified with standard HM fortifier will be well tolerated for 2 days, without significantly gastric residuals (less than 5%)
* Clinically and thermally stable.

Exclusion Criteria:

* Ventilated infant (invasive or non-invasive)
* Necrotizing enterocolitis (NEC)
* IVH grade 3-4
* BPD
* PDA
* Active infection.
* Congenital or genetic disorder ( trisomy, heart defect.)
Oxytocin Modulates Eye Gaze Behavior During Social Processing

The main aim of the study is to examine whether the effects of intranasal oxytocin on eye-gaze behavior towards social stimuli are modulated via individual differences in trait autism

In this double-blind, within subject, placebo controlled design a total of n = 40 healthy male subjects will receive either 24 IU of oxytocin or placebo (interval between administration \> two weeks). 45 minutes after treatment subjects will undergo a total of 7 eye-tracking paradigms examining eye-gaze behavior during social processing: (1) dynamic social-nonsocial visual preference task during which movies of dynamic geometric images (DGI) and dynamic social images (DSI) will be presented; (2) non-biological versus biological motion task; (3) social attention and motivation of sharing enjoyment; (4) preference for emotional faces versus schematic faces (emoticons); (5) shared social attention - shared gaze direction with an actor shifting his attention to different objects; (6) preferred visual scanning of face regions in emotional faces; and, (7) eye gaze in response to empathy eliciting visual stimuli. Autistic and associated traits will be assessed using the Autism Spectrum Quotient (ASQ), Social Responsibilities Scale (SRS) and the Interpersonal Reactivity Index (IRI). Within-subject differences in the effects of oxytocin on social eye gazing behaviour will be related to individual differences in autistic traits.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without any past or present psychiatric or neurological disorders

Exclusion Criteria:

* History of brain injury
* Visual impairments
* Use of medication
* Contraindications for oxytocin administration
Quality of Life in Children With Cancer

Childhood cancers cover a wide range of diseases; leukemia, central nervous system cancers and lymphomas are the most common ones among them. During medical treatment children with cancer are at risk of neuromuscular and musculoskeletal complications such as reduced muscle strength, gross and fine motor performance impairment, decreased energy consumption. These neuromuscular and musculoskeletal complications can affect dynamic balance, endurance and quality of life of the children. Childhood cancers have negative effects on sleep. The aim of this study is to identify the status of sleep, fatigue, and quality of life in children with various types of cancer and to examine the relationship between these conditions.The general situation of children will be determined according to findings from this study.

Childhood cancers cover a wide range of diseases; leukemia, central nervous system cancers and lymphomas are the most common ones among them. Acute lymphoblastic lymphoma (ALL) is the most common childhood cancer and 78% of leukemia's reported to be ALL. During medical treatment children with leukemia are at risk of neuromuscular and musculoskeletal complications such as reduced ankle range of motion, reduced muscle strength, gross and fine motor performance impairment, decreased energy consumption, osteonecrosis and osteoporosis. These conditions can develop as a result of cancer or its treatment. These neuromuscular and musculoskeletal complications can affect dynamic balance, endurance and quality of life of the children. Childhood cancers have negative effects on sleep; sleep complaints can develop with the diagnosis and continue even after recovery period.The aim of this study is to identify the status of sleep, fatigue, and quality of life in children with various types of cancer and to examine the relationship between these conditions. In addition, families will be assessed about their children's conditions and satisfaction with the health care they receive.The general situation of children will be determined according to findings from this study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of childhood cancer and having medical treatment at the hospital

Exclusion Criteria:

* Having any other health condition (neurologic, developmental or metabolic disorders)