cyrilzakka/clinical-trials huggingface dataset:
Effect of Pilates on Balance and Spinal Curvature In Upper Crossed Syndrome

The study will be conducted to investigate the effect of Pilates exercise on spinal curvature and balance in patients with the upper cross syndrome. .

Upper crossed syndrome (UCS) is the most common postural dysfunction in the musculature of the shoulder girdle /cervicothoracic region, which creates joint dysfunction, particularly at the atlanto-occipital joint, cervicothoracic joint C4-C5 segment, glenohumeral joint and T4-T5 segment. Pilates is designed as a program that will work with other exercise programs to strengthen, rebalance and realign the body. Pilates trains individuals to identify their own musculoskeletal strengths and weaknesses and equips them with the knowledge to correct and rebalance their entire body mechanics (Worth,2004) thus, the focus is also placed on improving personal body awareness which further decreases the risks of strain or injury that can occur with imbalances. forty patients with UCS will be allocated randomly into two groups; one experimental group will receive pilates exercise and postural correction twice a week for four weeks, and the control group will receive postural correction exercise along twice a week for four weeks

Eligibility Criteria:
Inclusion Criteria:

* The patient's age ranged from 17 to 22 years
* Body mass index between 20-25 kg/m2
* The participants are diagnosed with upper cross syndrome
* Patients with normal cognitive aspects willing and able to participate in a program safely

Exclusion Criteria:

* The participants have experienced any recent trauma (within 3 months of the initial consultation)
* The participant's primary complaint is that of headaches or facial pain.
* Contra-indications to pilates are found pregnancy, hypertension, osteoporosis, and spinal tumors.
* Participants have any sort of structural abnormality in upper and middle back e.g., Scoliosis, or had a positive Adams test.
* Participants who are taking anti-inflammatory or muscle relaxant medication had to have a three-day "wash out" period before participating in the study
A Bioavailability Study of Two Different PEG-rhGH Preparations.

The purpose of this study is to compare the pharmacokinetics of the two different PEG-rhGH preparations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged ≥18 years old and≤45 years old;
* The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;
* Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.

Exclusion Criteria:

* Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing;
* Subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or other diseases deemed unsuitable for participation in the trials by the investigators;
* Subjects with severe infection, severe trauma, or major surgery prior to screening;
* Subjects who have received blood transfusions, had blood donors, or lost blood before screening;
* Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA);
* Subjects who have participated in clinical trials for medication or medical device prior to screening;etc.
Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD

An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea in subjects with acute exacerbation of COPD without acute hypercapnic respiratory failure. Subjects are recruited from the local respiratory ward. The main outcomes are the compliance of the subjects with the treatment and alleviation of dyspnea during the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* a previous diagnosis of COPD
* hospitalized due to acute exacerbation of COPD
* at least moderate dyspnea (NRS = Numeric Rating Scale ≥ 4)
* no acute hypoventilation (pH ≥ 7.35 and PCO2 ≤ 6.0 kPa)
* able to understand the study and to give informed consent

Exclusion Criteria:

* unable to participate and use MPV due to e.g. delirium or lack of co-operation
* acute hypoventilation (pH \< 7.35 or PCO2 \> 6.0 kPa)
* acute need for ventilatory support
* the cause of the dyspnea can be successfully treated
* unable to give informed consent
* a previous chronic hypoxemic or hypercapnic respiratory insufficiency that has been treated on a long-term basis also at home
Corifollitropin Alfa on D5 Versus D7 After Contraceptive Pill

To evaluate if the administration of corifollitropin alfa on day 7 instead of on day 5 after pre-treatment with oral contraceptive pill results in a reduced total rFSH (recombinant follicle stimulating hormone ) consumption in a GnRH antagonist protocol in donors.


Eligibility Criteria:
Inclusion Criteria:

* Women 18-35 y old ,with regular spontaneous menstrual cycles of 25-30 days length
* Who had vaginal sexual intercourse or have no inconvenient for vaginal explorations
* Donors can´t have more than 6 children (neither own or after donations)
* Not be adopted or being born after a gamete donation pregnancy
* BMI between 18-28 kg/m2
* Height \> 1.55cm
* Gynecological and general examination with Pap smear, HIV, HCV (hepatitis C virus ), HBV (hepatitis B virus ) and RPR(rapid plasma reagin test ) negative serology, and with normal karyotype
* No abnormal Psychological profile
* Discard any disease: blood disorders, neurodegenerative/psychiatric diseases, Fragile X Syndrome, cystic fibrosis carrier, oncology diseases.
* Without psychological/psychiatric family history
* Will conform to the protocol for the duration of the study
* Willingness of adhesion to protocol during the whole study period
* Signed informed consent

Exclusion Criteria:

* Polycystic ovarian syndrome
* Antral follicle count \> 20
* Hypersensitivity to the active substance or any of the excipients
* Abnormal vaginal bleeding of unknown ethiology
* Presence of ovarian cysts or increased size ovaries
* History of ovarian hyperstimulation syndrome
* Previous controlled ovarian stimulation cycle with more than 30 follicles ≥ 11mm
* Previous abdominal surgery that contraindicated the practice of follicular puncture
* HIV, HCV, HBV positive serology in women or partner
* Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors...)
Safety, Tolerability and Pharmacodynamics of CYT013-IL1bQb in Patients With Type 2 Diabetes

The purpose of this clinical trial is to test safety and tolerability of a vaccine targeting Interleukin-1 beta in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus, according to the American Diabetes Association diagnostic criteria, ≥ 3 months at time of randomization
* HbA1c in the range of 6.5 - 9.5% (inclusive) at screening
* Treatment with diet and exercise alone or a stable dose of metformin, or sulfonylurea, or metformin plus a sulfonylurea for at least 4 weeks prior to randomization
* Further criteria as defined in the clinical trial protocol

Exclusion Criteria:

* Symptoms of hyperglycemia (i.e. polyuria and polydypsia)
* History of significant weight gain or loss (+/-5%) during the 4 weeks before randomization
* Fasting C-peptide level \< 400 pmol/L at screening
* Change in the medicamentous treatment of elevated blood pressure, diabetes mellitus or dyslipidemia within 4 weeks prior to the randomization
* Use of any weight loss medication (over the counter prescription) or initiation of a prescribed weight management or exercise program within 4 weeks before randomization
* Current systemic anti-inflammatory therapy other than aspirin ≤ 100 mg/day or immunosuppressive treatment, in particular oral corticosteroids
Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer

Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.

PRIMARY OBJECTIVES:

I. To determine if adjuvant chemotherapy can favorably alter the prognosis of the subgroup of resected stage I patients who, following complete surgical resection of their disease, are defined as "high risk" based on the presence of a T2N0 tumor (according to the criteria of the International Staging System for lung cancer).

SECONDARY OBJECTIVES:

I To compare failure-free survival of patients with T2N0 stage I NSCLC who have and have not been treated with adjuvant chemotherapy.

II. To determine the toxicities associated with adjuvant chemotherapy. III. To describe the pattern of disease recurrence.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor histology (squamous cell vs nonsquamous cell), degree of differentiation (poorly differentiated vs other), and mediastinal node sampling at surgery (yes vs no). Within 4-8 weeks after surgery, patients are randomized to 1 of 2 treatment arms.

Arm I:Patients receive no further therapy.

Arm II: Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.

Patients are followed every 4 months for 2 years and then every 6 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented non-small cell carcinoma
* Completely resected T2N0M0 Stage I NSCLC as defined by the International Staging System
* Surgery shall consist of a lobectomy or pneumonectomy with resection of associated N1 lymph nodes (either by thoracotomy or thoracoscopy)
* Patients must be randomized within 4 to 8 weeks from the date of complete surgical resection
* No prior chemotherapy or radiation for non-small cell lung cancer
* Performance status of 0 or 1
* Women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study
* Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has bee disease free for five years
* Granulocytes \>= 1,800/ul
* Platelets \>= 100,000/ul
* Bilirubin \< 1.5 mg/dl
* SGOT (AST) \< 2.0 x ULN
Non Invasive Ventilation in Bronchiolitis

It is decided to perform a prospective study in a non-selected population of infants with bronchiolitis during one year ( October.2018 to October.2019) to study the characteristics, clinical course and outcome of the use of Non invasive ventilation in the management and compare the results with those treated with invasive ventilation to assess safety and efficacy and inform guideline construction.

Acute viral bronchiolitis is one of the most common respiratory diseases in early childhood and is a major health problem worldwide. The seasonal burden of the disease, the number of hospitalizations each year and the risk of subsequent asthma bring about substantial costs in developed countries. Respiratory syncytial virus and Human Rhinovirus seem to be the most frequent etiologic agents, but other viruses such as human Metapneumovirus, Influenza virus, and Parainfluenza virus can also be involved. The spectrum of clinical outcomes is wide, but bronchiolitis is more severe when caused by Respiratory syncytial virus. In contrast, while Human Rhinovirus is involved in milder forms, it is more likely to be associated with recurrent wheezing in infancy. Acute respiratory failure from pneumonia, influenza, and respiratory syncytial virus is responsible for 4.25 million deaths world-wide and the leading cause of mortality in low and middle-income countries. In the United Kingdom up to 7% of bronchiolitis admissions require intensive care for ventilatory support. One third of unplanned infant admissions to pediatric intensive care units have respiratory failure, the majority due to bronchiolitis, require invasive mechanical ventilation for 4-7 days and a prolonged hospital stay. In countries where there is no retrieval infrastructure, the need to develop safe and effective alternatives to invasive ventilation and pediatric intensive care unit admission is acute. However, none of the interventions commonly used for infants admitted with bronchiolitis is backed by robust evidence of benefit for clinically significant outcomes, making this a pressing subject for further study. Typically, intensive respiratory support for bronchiolitis is via invasive mechanical ventilation through an artificial airway, an intervention with recognized complications in infants. There is evidence to support the use of non-invasive ventilation in pediatric acute respiratory failure of variable causes.Although evidence for use in bronchiolitis is increasing,clinical acceptance is not universal and published best practice guidelines are not easily available.

Eligibility Criteria:
Inclusion Criteria:

* all infants with acute severe bronchiolitis,
* infants aged below 1 year.

Exclusion Criteria:

* patients who have contraindications for NIV (patients with maxillofacial trauma, gastrointestinal obstruction and severe secretion),
* Children who had suspected or confirmed underlying chronic diseases (i.e., cystic fibrosis, chronic pulmonary disease, congenital heart disease, bronchopulmonary disease, prematurity,
* Children who had already more than one wheezing episode.
Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS

Objectives of the study are to evaluate the safety, tolerability, and efficacy of two different doses of AVP-923 (capsules containing either 30 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate \[AVP-923-30\] or 20 mg of dextromethorphan hydrobromide and 10 mg of quinidine sulfate \[AVP-923-20\]) when compared to placebo, for the treatment of PBA in a population of patients with amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS) over a 12-week period. An additional objective is to determine the pharmacokinetic parameters of the two different doses of AVP-923 in a subset of the study population.

Pseudobulbar Affect (PBA) is a condition characterized by involuntary, sudden and frequent episodes of laughing and/or crying out of proportion or incongruous to the underlying emotion of happiness or sadness Other terms used to describe this condition include emotional lability, emotionalism, emotional incontinence, emotional discontrol, excessive emotionalism, and pathological laughing and crying. The outbursts can occur spontaneously or in response to provocative stimuli such as questions or events.

A body of evidence suggests that PBA can be modulated through pharmacologic intervention.

Dextromethorphan (DM) is a low-affinity uncompetitive antagonist of the N-Methyl-D-aspartate (NMDA) receptor, reducing the level of excitatory activity. DM also acts at the phencyclidine-binding site, which is part of the NMDA receptor complex. DM is a sigma receptor agonist, suppressing the release of excitatory neurotransmitters.

Quinidine (Q) is a known potent inhibitor of cytochrome P450 2D6 (CYP2D6), that decreases the metabolism of dextromethorphan and helps to achieve sustained and therapeutic levels of this drug.


Eligibility Criteria:
Main Inclusion Criteria:

* The patient has a diagnosis of Amyotrophic Lateral Sclerosis (according to El Escorial Criteria, WFN, 1998) and the time from diagnosis of ALS is not be longer than 30 months, or the patient has a diagnosis of multiple sclerosis or probable multiple sclerosis (according to McDonald criteria, 2001)
* The patient has a clinical history and clinical relevant symptoms of Pseudobulbar Affect (PBA)
* CNS-LS score at baseline is 13 or greater

Main Exclusion Criteria:

* Patients with myasthenia gravis
* Any personal history of complete heart block, QTc prolongation, or torsades de pointes
* Any family history of congenital QT interval prolongation syndrome
* Patients with known sensitivity to quinidine, dextromethorphan or opiate drugs (codeine, etc.)
Effect of Additional Clofazimine on Erythema Nodosum Leprosum (ENL) Reactions in Leprosy

This study is a double-blind, randomized controlled trial examining the effect on ENL reactions of giving an additional year of clofazimine after completion of MDT in leprosy.

Clofazimine is an anti-bacterial agent used to treat leprosy; it is a normal component of WHO-recommended multi-drug therapy (MDT). It is also known to have a beneficial effect in one of the common immunological reactions that occur in leprosy, known as erythema nodosum leprosum, or ENL. When MDT was reduced in length from 24 to 12 months, evidence suggests that ENL became worse. This study is a double-blind, randomized controlled trial examining the effect of giving an additional year of clofazimine after completion of MDT. The endpoints are the incidence and severity of ENL over a period of 3 years in the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* 15 to 70 years of age
* MB leprosy
* Pretreatment BI of 4 or more at any site
* Consent

Exclusion Criteria:

* Presence of another serious illness
* Refusal of informed consent
Combination Therapy of Anthracyclines for Children With Nephroblastoma

This study aims to estimate the efficacy and side effects of study drugs in children with nephroblastoma who are treated with combination therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age 6 months old to 14 years old.
2. No smoking history.
3. Pathologically confirmed nephroblastoma.
4. Informed consent and assent has been obtained before any study assessment is performed.
5. Good compliance.
6. Need to be applied to anthracycline chemotherapy according to the diagnosis and treatment recommendations for Chinese children with nephroblastoma (current version CCCG-WT-2016).
7. Need to be applied to doxorubicin according to the diagnosis and treatment recommendations for children with nephroblastoma (CCCG-WT-2016).

Exclusion Criteria:

1. Patients with cardiovascular disease in addition to nephroblastoma.
2. Patients with digestive, neurological, circulatory, renal or liver disease, blood disorders or growth abnormalities unrelated to the tumor.
3. Patients have been treated with chemotherapy or cardiotoxic nephrotoxic drugs in the past 4 weeks.
4. Patients have participated in other clinical trials in the past 4 weeks.
5. Patients with mediastinal disease.
6. Patients who have undergone mediastinal radiotherapy due to other tumors or received other treatments that may cause heart damage.
Evaluation of Contrast Medium Enhanced Post-mortem CT in Virtual Autopsy

The study aims to compare the value of contrast medium enhanced post mortem CT to classic autopsy.


Eligibility Criteria:
Inclusion Criteria:

* Patients dying in the ICU
* age \>18y

Exclusion Criteria:

* relatives refusing to participation in the study
Ultrasound Assessment of Preoperative Gastric Volume in Children

The purpose of this study is to compare the gastric volume in pediatric patients who followed preoperative fasting guideline using ultrasound.


Eligibility Criteria:
Inclusion Criteria:

- Pediatric patients scheduled for elective orthopedic, otolaryngologic, ophthalmologic, plastic, and urologic surgery under general anesthesia

Exclusion Criteria:

* History of surgery on the esophagus or stomach
* History of gastrointestinal disease
* Ambulatory surgery
* Considered inappropriate by the investigator
Comparison of Different Types of Resistant Starch

This study is to determine whether different types of resistant starch have different effects on blood glucose in healthy adults.

Each volunteer will visit the laboratory in a 10-12 hour fasted state on three occasions over a three-week period, up to two visits/wk, with at least 48 hours between visits. Volunteers will be asked to refrain from vigorous physical activity and the consumption of alcohol the day before each testing visit. Randomization using a Latin Square design was applied to minimize confounding issues associated with the order of administration.

In the morning of each test, a finger-prick capillary blood samples will be collected to determine fasting (baseline) blood glucose levels. The volunteers will then consume the test solution assigned for that trial. Ten minutes will be allowed for the test solution to be consumed. Over the two hours following the start of each test, finger-prick capillary blood samples were collected at 30, 60, 90, and 120 min. Blood glucose levels will be immediately measured in duplicate using an automated blood glucose analyzer (YSI 2300, Yellow Springs, OH). Analysis of the collected sample was repeated if the difference between duplicate samples was greater than 0.1 mmol/L. Once the samples were analyzed, the data was entered and the incremental area under the curve was calculated using the trapezoidal model (GraphPad v5.0, La Jolla, CA).

Eligibility Criteria:
Inclusion Criteria:

* apparently healthy

Exclusion Criteria:

* diagnosis of any chronic disease
* wheat allergy
A Phase 2, Double-Blind, Multiple-Dose Escalation Study to Evaluate NKTR-118 (Oral PEG-Naloxol) in Patients With Opioid-Induced Constipation (OIC)

Study (07-IN-NX003) is a Phase 2, multi-center, placebo-controlled, double-blind, randomized, dose-escalation trial. It is designed to investigate the safety, efficacy and tolerability of NKTR-118 (PEG-naloxol) in patients with opioid-induced constipation (OIC) and other clinical manifestations of opioid-induced bowel dysfunction (OBD). The objective of this study is to evaluate the safety, effectiveness and pharmacokinetics of NKTR-118 at 4 different doses.


Eligibility Criteria:
Main Inclusion Criteria:

* 18 years of age or older, male or female
* Receiving a stable opioid regimen
* Documented opioid-induced constipation
* Willingness to stop all laxatives and other bowel regimens. The use of constipation rescue medication will be allowed during the study.

Main Exclusion Criteria:

* Life expectancy less than 6 months
* Active substance abuse
* Fecal incontinence, irritable bowel syndrome, inflammatory bowel disease, or other active medical disorders associated with diarrhea or intermittent loose stools or constipation
* Pregnant or breast-feeding
* Any receipt of an investigational medication within 30 days of screening
* History or presence of specific cardiac, neurologic, endocrine and/or psychiatric conditions