cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Pattern Respiratory PNF Associated Aerobic Training on Lung Volumes and 6MWT Test in Parkinson Individuals

INTRODUCTION:

Parkinson's disease (PD) is a neurodegenerative disorder that causes motor disorders such as bradykinesia, rigidity and tremor. In addition to the motor symptoms occurring in the overall PD patients, mostly there is associated respiratory disorders. The respiratory impairment may be due by postural changes, limiting the flexibility and expandability of the chest wall causing decreased lung volumes and flows. So the exercise Proprioceptive Neuromuscular Facilitation (PNF) is a tool designed to reduce the changes in respiratory function, the commitment of the respiratory muscles, and allows greater flexibility of the chest wall, reducing the rigidity of the rib cage. To evaluate the effects of respiratory pattern of Proprioceptive Neuromuscular Facilitation on the distribution of pulmonary ventilation, compartmental volumes of diaphragmatic mobility and functional capacity in patients with Parkinson's disease.

METHODS:

The study is a clinical trial randomized, in which participants to be elected for the study should present diagnosis of PD, staging of disease between II and III according to Hoehn and Yahr. Initially, the participants will undergo the collection of data on medical history, assessment of pulmonary function by spirometry and respiratory muscle strength measured by the manometer. Then will undergo evaluation of the breathing pattern and tricompartmental distribution of the volume of the chest wall by hemithorax by Plethysmography Optoelectronic; Quantify the mobility of the right diaphragm in total lung capacity for maneuver and during the current volume by ultrasonography. After the evaluation, participants will undergo intervention which will consist of three stages: first occur first session of the PNF later aerobic training for 30 minutes, ending with one PNF session.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with stage II and III between the Hoehn and Yahr classification;
* minimum score of 28 on the Mini Mental Examination for Parkinson.

Exclusion Criteria:

* individuals with rheumatologic or orthopedic diseases or deformities / abnormalities in the spine that compromise the respiratory mechanics;
* respiratory comorbidities;
* history of smoking;
* history of thoracic or abdominal surgery;
* clinical instability characterized by infections and / or hemodynamic defined as greater than 150 bpm heart rate or systolic blood pressure less than 90 mmHg;
* Not present exchange of the drug in the last 30 days.
Continuous Infusions Vs Scheduled Bolus Infusions

To compare continuous infusions to bolus infusions and there affect on post-surgical pain.

Regional anesthetic techniques are an integral part to many anesthetic approaches, providing both intraoperative and postoperative anesthesia and analgesia. Regional anesthesia peripheral nerve blocks have been shown to reduce postoperative pain and improve measures such as opioid requirements and readiness for discharge. By using a catheter technique for continuous peripheral nerve blocks, analgesia can be extended well into post-operative days 2 and 3, further extending these benefits. Historically these catheters have implemented a continuous dosing regimen of local anesthetic, but increasingly there is evidence of improved analgesic outcomes without adverse effects by using a scheduled bolus dosing regimen. Many institutions have implemented this new protocol for catheter dosing. The beneficial effect of scheduled bolus dosing has not been studied in all blocks and all surgical procedures.

Eligibility Criteria:
Inclusion Criteria: Enrollment will be offered to adult patients with ASA physical status I, II, or III, presenting for nerve block catheters for post-operative analgesia.

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Exclusion Criteria: Exclusion criteria will include: pregnancy, incarceration, age \<18, BMI \>35, pre-operative opioid use \>30 mg morphine equivalents per day, inability to communicate with investigators by telephone, and pre-existing neuropathy of the operative extremity.
Haploidentical Transplantation in Severe Aplastic Anemia

This is a prospective case-control study on SAA patients treated with HSCT, order to further discuss and assess the safety, feasibility and effectiveness of HFD-HSCT which performed with reduced-intensity fludarabine-based conditioning regimen.Our findings would indicate that SAA patients who lack MSD benefited most if HFD-HSCT was performed with reduced-intensity fludarabine-based conditioning regimen, and our improved outcomes with HFD-HSCT may lead to a salvaged therapy and an expanded direct role for SAA in the future.


Eligibility Criteria:
Inclusion Criteria:

(i) Diagnosis of SAA, very SAA or SAA and paroxysmal nocturnal hemoglobinuria (PNH) according to the International Aplastic Anemia Study Group; (ii) SAA patients no response to previous IST; (iii) adequate performance status \[Eastern Cooperative Oncology Group (ECOG) score 0-2\].

Exclusion Criteria:

(i) Congenital forms of aplastic anemia; (ii)Patients with any severe pulmonary, cardiac, liver, or renal diseases or active infection.
Dose Esmolol Infusion Have an Adjuvant Effect to TAP Block for Pain Control in Laparoscopic Cholecystectomy.

Pain after laparoscopy differs considerably from that seen after laparotomy. Laparotomy results mainly in parietal pain (abdominal wall), where as Pain in laparoscopy results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity. The transverse abdominis plane (TAP) block is a peripheral nerve block designed to anesthetize the nerves supplying the anterior abdominal wall (T6 to L1). While esmolol is an ultra-short acting intravenous β-blocker having a rapid onset and offset effect. It provides an unprecedented level of tolerability and safety in the perioperative setting. When used as an adjunct, it has been shown to improve the postoperative recovery by reducing postoperative pain intensity and intraoperative anesthetic and opioid requirements and preventing opioid-induced hyperalgesia . The mechanism of this synergistic effect is uncertain, but both pharmacokinetic and pharmacodynamics interactions with anesthetic drugs have been proposed.


Eligibility Criteria:
Inclusion Criteria:

1. ASA grade I/II patients undergoing laparoscopic cholecystectomy .
2. Age group of 18 -60 years.
3. Patients giving valid informed consent.

Exclusion Criteria:

1. Patient refusal
2. Patients belonging to ASA grade III and grade IV .
3. Coagulation disorders.
4. Patients with known allergy to one of the used drugs.
5. Extreme obesity (BMI \>35)
6. Patients with cardiac, pulmonary, hepatic or renal disorders
7. Pregnancy
8. Drug abusers
The Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure

To evaluate therapeutic efficacy and predicting factors of entecavir for treating patients with acute on chronic hepatitis B liver failure (ACHBLF). A total of 108 patients with ACHBLF were allocated into either a treatment group (ETV group, n=53) or a control group (n=55). The HBV DNA level, liver function and survival condition of the patients were observed for 48 weeks after enrollment. The factors possibly related to entecavir treatment efficacy were also identified.


Eligibility Criteria:
Inclusion Criteria:

* ACHBLF was diagnosed according to the criteria from the APASL in March 200815 and the program of Prevention and Cure for Viral Hepatitis and Liver Disease amended by the National Symposium on Viral Hepatitis and Liver Disease in September 2000.
* age \>18 years
* HBV DNA \> 3log10 copy/mL

Exclusion Criteria:

* Pregnant or lactating women.
* Diagnosed or suspected as hepatic carcinoma patients.
* Cases with any serious disease besides CHB, including heart disease, immunologic disease, malignant tumor, etc.
* Patients hypersensitive to nucleoside or nucleoside (acid) analogues or with a history nucleoside antiviral drug treatment.
* A history of drug abuse or alcohol abuse.
* Hepatic encephalopathy degree IV patients who were unable to take orally administered drugs.
* A history of using immunomodulator including steroids
* Conclusive evidence of other co infection s: anti-HAV-IgM positive, anti-HCV positive, anti-HEV positive, anti-HIV positive, autoimmunity liver diseases, Wilson disease, etc.
A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia

To evaluate the safety and tolerability of multiple doses of PF 02545920 administered orally to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/- other adjunctive medication.


Eligibility Criteria:
Inclusion Criteria:

* Psychiatrically stable subjects with schizophrenia.
* Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.
* Subjects must be on a stable medication treatment regimen greater than or equal to 2 months, including concomitant psychotropic medications.

Exclusion Criteria:

* History of seizures or of a condition with risk of seizures.
* Subjects who have had electroconvulsive therapy within the 6 months prior to randomization.
* Pregnant or nursing females, and females of child bearing potential.
Clinical Specimens Testing Program of Dengue Antigen Detection Reagents

Dengue virus serological reagent, included antigen and antiserum, is a serum test for identification of serum antibodies to dengue virus.

The developed assay helps to diagnose diseases caused by this virus and to provide information on disease epidemiology. This virus is mainly transmitted by mosquito bites to people and will make flu-like symptoms, including fever, fatigue, cough and headache, which can cause severe hemorrhagic dengue.

Eligibility Criteria:
Inclusion Criteria:A total of 95 cases and 100 controls (suspected cases(\>50 %) and normal subjects) are expected to enroll.

1. Case group: adults having a medical visit or admission due to dengue / dengue hemorrhagic fever / dengue shock syndrome, and medical care of by (defined by CDC). Any of the following positive test results for the case of 100 adults.

   1. clinical specimens (blood) isolated and identified dengue virus.
   2. clinical specimens positive for molecular detection of nucleic acids.
   3. serological antigen (referring to non-structural proteins of dengue virus non-structural protein 1, NS1) testing positive (based on the test of Bio-Rad DENGUE NS1 Ag STRIP).
   4. paired serum (restored period and acute phase), the dengue virus specific immunoglobulin M or immunoglobulin G antibodies or negative or ≧ 4 times increase.
2. Suspected cases: adults having medical visits or admissions due to infectious disease, but their NS1 (based on the test of Bio-Rad DENGUE NS1 Ag STRIP), immunoglobulin G,immunoglobulin M, real time-Polymerase chain reaction testing were negative.
3. Control group: adults without having medical visits or admissions due to Fever. - Exclusion Criteria:non-adult case -
Biomonitoring of Internal Exposure to MNPLs, and Its Effects, in Blood of Patients With Chronic Kidney Disease (CKD)

Micro and nanoplastics (MNPLs) effects on human heath is still preliminary. Chronic kidney disease (CKD) participants, specially does patients submitted to hemodialysis, are a population high exposed to plastics. The objective of our research is to be able to detect MNPLs on biological fluids of hemodialysis patients as well as their potential genotoxic and immunological damage.

The exponential increase in the production/use of plastic translates into a parallel increase of environmental plastic-waste that is continuously degraded into micro and nanoplastics (MNPLs). Information on the MNPLs' effects on human health is still preliminary and, furthermore, the limitations in current methodologies prevent accurate human exposure/risk assessment.

The study aims to analyse specific biomarkers of exposure to MNPLs in humans, as well as biomarkers of genetic damage, which will allow an association between exposure to these plastic materials and the optimisation of different techniques for the detection and characterisation of MNPLs.

The study will evaluate the effect of exposure to MNPLs, analysing the genotoxic damage, different biomarkers of exposure and the effects on microbiota, in different body samples (urine, blood and feces).

Eligibility Criteria:
Inclusion Criteria for Chronic Kidney Disease (CKD) submitted to Hemodialysis:

* Participant submitted to hemodialysis for more than 3 months
* Between 18 and 85 years old
* Stable haemoglobin (more than 10 gr/dl)
* Absence of infectious disease at the date of sample collection and for a period of more than two weeks
* Absence of active neoplasia
* Stable vascular access

Inclusion Criteria for Chronic Kidney Disease (CKD) pre-dialysis:

* No hemodialysis treatment
* Between 18 and 85 years old
* Stable haemoglobin (more than 10 gr/dl)
* Glomerular filtration ≤ 20 ml/min
* Absence of infectious disease at the date of sample collection and for a period of more than two weeks
* Absence of active neoplasia

Inclusion Criteria for controls :

* Between 18 and 85 years old (paired by gender, age and lifestyle to the CKD patients)
* Absence of chronic kidney disease or dialysis treatment
* Absence of chronic pathology (including neoplasia)
* Absence of infectious disease at the date of sample collection and for a period of more than two weeks
* Spanish residence

Exclusion Criteria for both groups of CKD patients:

* Clinical instability
* Life expectancy of less than 12 months
* Coagulation system disorders
* Participation in other clinical study
* Pregnancy
* Unsigned informed consent

Exclusion criteria for controls:

* Participation in other clinical study
* Pregnancy
* Unsigned informed consent
A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers with Elevated Uric Acid Levels

This is a Phase 1, double-blind, placebo-controlled, single ascending dose study in participants with elevated uric acid levels. This study will be conducted in approximately 64 adult male and female participants in the dose escalation phase.

Participants will be assigned to 1 of 8 sequential dosing cohorts, each composed of 8 participants (6 active + 2 placebo) who will receive a single dose of PRX-115 or placebo by intravenous (IV) infusion.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females 18 to 65 years of age, inclusive.
2. Serum uric acid greater than 6.0 mg/dL (0.35 mmol/L) at the Screening visit.
3. Body mass index within the range 18.5 to 40 kg/m\^2, inclusive, at the Screening visit.
4. Women of childbearing potential may be included only if they have a negative beta human chorionic gonadotropin (β-hCG) test result at Screening.
5. Men and women of childbearing potential and their partners should use double barrier contraception.

Exclusion Criteria:

1. Has any condition known to have arthritis as a clinical manifestation
2. Had greater than or equal to 1 gout flare in the last year prior to either Screening or Day -1.
3. Has clinical evidence of subcutaneous tophi at either Screening or Day -1.
4. Estimated glomerular filtration rate (eGFR) value less than or equal to 60 mL/min/1.73m\^2
5. History of significant renal disease, and/or presence of renal stones at either Screening or Day -1.
6. Has a history of anaphylaxis, severe allergic reactions, or severe atopy.
7. History of autoimmune disorders, and/or participant is immunocompromised or treated with immunosuppressive medications.
8. Has evidence of cardiovascular or cerebrovascular disease.
9. History of congestive heart failure, New York Heart Association Class III or IV.
10. BP outside the range of 90 to 150 mm Hg for systolic or 50 to 95 mm Hg for diastolic.
11. Participants with hypertension who are not on stable medication for at least 6 months.
12. Has uncontrolled type 2 diabetes
13. Concurrent treatment with urate lowering drugs (ULDs).
14. Prior exposure to any experimental or marketed uricase (eg, rasburicase \[Elitek, Fasturtec\], pegloticase \[Krystexxa®\], pegadricase \[SEL-212\]).
15. Glucose-6-phosphate dehydrogenase (G6PD) deficiency or known catalase deficiency.
SEVERITY SCORE FOR COVID-19 PNEUMONIA

The outbreak of the coronavirus disease 2019 (COVID-19), first merged in China in December 2019, is now becoming a Public Health Emergency, recently confirmed as a pandemic disease by the World Health Organization.

In particular, since February 2020, a rapidly growing number of cases has been identified in Italy.

The clinical picture of ranges from asymptomatic cases, mild upper respiratory tract infections to severe pneumonia with respiratory failure and death. In most severe cases, COVID-19 disease may be complicated by acute respiratory distress syndrome (ARDS), septic shock and multiorgan failure.

It results fundamental to early identify those subjects who rapidly may worsen their clinical status, often requiring an intensive care unit (ICU) admission.

It has been showed that, mainly in more severe forms of SARS-Cov-2 disease, there is the development of an hyperinflammatory status resembling a cytokine storm syndrome, as already reported in SARS patients.

A recent study by Haung et al. reported that patients with COVID-19 infection showed high amounts of IL1B, IFN-gamma, IP10 and MCP1, probably linked to activated T-helper1 (Th1) cell responses. Those requiring ICU admission had higher levels of cytokines than those subjects not requiring ICU admission, thus suggesting that cytokine storm was associated with disease severity.

A similarity between cytokine profile of COVID-19 disease and secondary haemophagocytic syndrome (sHLH) has been reported. Therefore, it was suggested to screen all patients with severe COVID-19 infection both for hyperinflammatory markers (like ferritin), and the HScore commonly used to generate a probability for diagnosis of sHLH (8), which includes some laboratory parameters like triglycerides, fibrinogen, ferritin, serum aspartate aminostransferase.

Based on our experience on patients affected by pneumonia from Covid19, we have observed that those subjects with a more severe prognosis might have some predictive markers. We intend to verify if these markers can identify those subjects with Covid19 infection who need a more intensive therapy and to find a prognosis score.


Eligibility Criteria:
Inclusion Criteria: Patients with diagnosis of pneumonia, confirmed by chest imaging, Covid-19 test positive

Exclusion Criteria: Age lower than 18 years, pregnancy or breast-feeding
Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis

The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs \& symptoms of blepharitis and tear cytokine and eyelid bacterial load levels


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe chronic blepharitis
* If female of childbearing potential, are non-pregnant and non-lactating

Exclusion Criteria:

* Had ocular surface surgery (LASIK, refractive, etc.) within the past year
* Unwilling to discontinue use of contact lenses during the study
* Have glaucoma
* Unable or unwilling to withhold the use of lid scrubs during the study
* Have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
* Currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation
Iodine Supplementation and Fertility Parameters

Iodine has been identified as a potential factor influencing female fertility during the childbearing years. The American Thyroid Association recommends that women attempting to conceive take a supplement containing 150 µg of iodine. However, no clinical trials have specifically examined the necessity of iodine supplementation in women experiencing infertility. Furthermore, no information is available on the optimal dose and duration of iodine supplementation to increase the chances of successful treatment in this group of women. Therefore, this study aims to investigate the effects of iodine supplementation on fertility parameters in infertile women.

This double-blind randomized clinical trial will be conducted in infertility clinic on women with diminished ovarian reserve and undergoing in vitro fertilization (IVF) cycle treatment. According to the Bologna criteria, decreased ovarian reserve is defined as having 3 to 5 antral follicles and an anti-Müllerian hormone concentration ranging from 0.1 to 1.5 ng/ml. All women diagnosed with diminished ovarian reserve who meet the inclusion and exclusion criteria outlined in the general information section of the clinical trial and have provided written consent to participate will be examined. Following enrollment and baseline measurements, women will be randomly assigned to treatment groups-placebo and iodine supplement (150 µg/day of iodine)-in a 1:1 allocation ratio, using a random number table. In the intervention group, women will take 150 µg of iodine daily (one tablet per day, Tavan Institute, Tehran, Iran) for two months prior to starting the new IVF cycle. In the control group, participants will take a placebo tablet daily (containing white wheat flour, designed to match the size, shape, and color of the iodine tablet, Tavan Institute, Tehran, Iran) for the same duration before beginning the new IVF cycle. Women of two groups will be followed until the end of IVF cycle. Women in both groups will be monitored until the completion of the IVF cycle. Throughout the study, the following parameters will be assessed based on the timeline of the IVF cycle: the number of retrieved oocytes, the number of mature (MII) oocytes, the number of embryos, embryo quality, biochemical pregnancy, and clinical pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Women with diminished ovarian reserve
* Willingness to participate
* Age range: 18 to 45 years
* Women with a menstrual cycle of 21 to 42 days
* Women who have not used any contraceptive methods in the past 12 months
* Women who have not had in sexual intercourse for more than 2 months

Exclusion Criteria:

* Unwillingness to participate
* Women with polycystic ovary syndrome or endometriosis
* Diagnosis of any thyroid disease
* Use of any medication that affects the thyroid function
* Use of dietary supplements containing iodine (excluding those considered in the present study)
* Use of iodine-containing disinfectants