cyrilzakka/clinical-trials huggingface dataset:
Compassionate Use Study of Methylnaltrexone

This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.


Eligibility Criteria:
Inclusion Criteria:

* Advanced medical illness (that is; terminal illness, such as incurable cancer or end stage aqcuired immunodeficiency syndrome \[AIDS\]) with a life expectancy of one to six months.
* On an opioid regimen for the control of pain/discomfort for at least seven days.
* Has opioid-induced constipation.
* Stable vital signs and systolic blood pressure greater than or equal to (\>=) 85 millimeters of mercury (mmHg), and diastolic blood pressure \>=45 mmHg (Supine or sitting).
* Females of childbearing potential must have a negative pregnancy test (serum or urine).
* On a laxative regimen (for example, stool softener and SENNA or equivalent) for at least 3 days prior to treatment. Participants who have discontinued laxatives due to intolerability or lack of efficacy are also eligible.

Exclusion Criteria:

* Participants with known hypersensitivity to methylnaltrexone, naltrexone or naloxone.
* Participants who received any investigational new drug (experimental) except for methylnaltrexone in the previous 30 days.
* Participants who are constipated with a disease process suggestive of gastrointestinal obstruction, impaction or diagnosed with a current abdominal pathologic process which may represent a non-opioid cause of bowel dysfunction.
* Participants who are constipated and have active, clinically significant diverticulitis.
* Participants with a surgically acute abdomen.
* Participants being treated with opioids for diarrhea, dyspnea, cough, pulmonary edema, or congestive heart failure.
* Individuals with a known drug addiction.
* Females who are pregnant or nursing.
Effects of HFNC on Moderate and Severe Respiratory Failure Patients

Respiratory failure is the danger for the patients admitted in ICU, mechanical ventilation could save a lot of patients' life, however, it prolongs patients' ICU stay and hospital stay. High flow nasal cannula (HFNC) has advantages of PEEP effects, reducing dead space, increasing EELV and improving comfort, and it has been used to treat respiratory failure patients. In recent study, HFNC could improve mortality of respiratory failure patients with P/F\<200mmHg in the subgroup. The investigators want to start a randomized controlled study to evaluate the effects of HFNC on the patients with respiratory failure.

just as the brief summary

Eligibility Criteria:
Inclusion Criteria:

1. Age\>18 years
2. patients met all four of the following criteria:

   * a respiratory rate of more than 25 breaths per minute,
   * a ratio of the partial pressure of arterial oxygen (Pao2) to the Fio2 of 300 mm Hg or less while the patient was breathing oxygen at a flow rate of 10 liters per minute or more for at least 15 minutes,
   * a partial pressure of arterial carbon dioxide (Paco2) not higher than 45 mmHg, and
   * an absence of clinical history of underlying chronic respiratory failure

Exclusion Criteria:

1. Paco2 of more than 45 mm Hg
2. exacerbation of asthma or chronic respiratory failure
3. cardiogenic pulmonary edema
4. severe neutropenia
5. hemodynamic instability, use of vasopressors,
6. Glasgow Coma Scale score of 12 points or less (on a scale from 3 to 15, with lower scores indicating reduced levels of consciousness)
7. contraindications to noninvasive ventilation
8. urgent need for endotracheal intubation, a do-not-intubate order, and a decision not to participate.
The Emotional and Functional Benefits of Poly-L-Lactic Acid

This study will evaluates the emotional and functional benefits of Poly-L-Lactic Acid (Sculptra™), a cosmetic product used to fill defects of the skin. All participants will receive Sculptra™.

Facial volume loss can result in emotional distress and functional impairment in some affected individuals. Poly-L-Lactic Acid (Sculptra™) stimulates collagen production in the skin thereby replenishing some of the collagen lost to natural aging and ultraviolet damage. This study will assess the emotional and functional benefits of Poly-L-Lactic Acid treated subject's through self report measurement tools.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be an outpatient, male or female subjects of any race, 35 years of age or older.
2. Subject must have any degree of facial volume loss.
3. Subjects of all Fitzpatrick skin types are eligible.
4. Subject must be able to follow study instructions and likely to complete all required visits, as assessed by the Investigator.
5. Subject must sign an IRB-approved Informed Consent form, Photographic Release Form, and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed.

Exclusion Criteria:

1. Any of the previous facial treatments:

   c. Any facial filler in the past 2 years d. Prior injection of permanent facial implant
2. Have any skin pathology or condition that could interfere with the evaluation of the face.
3. Be unable to communicate or cooperate with the Investigator due to a language barrier (non-English speaking), poor mental development, or impaired cerebral function.
4. Have evidence of alcohol or drug abuse (Investigator opinion), or history of poor cooperation, non-compliance with medical treatment, or unreliability.
5. Have used an investigational device, biologic or drug in the past 30 days, or be currently participating in an experimental drug, biologic or device trial.
6. Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
7. Be an employee (or a relative of an employee) of the Investigator, Sponsor or representative of the Sponsor.
Diaphragm Movement During Its Postural Function

The aim of this study is to describe the movement of the diaphragm during postural activation of the trunk muscles in comparison with tidal breathing.

Diaphragm movement will be measured by m-mode ultrasonography in a standing position. 30-35 healthy subjects will participate in the study. The movement of the diaphragm will be measured during tidal breathing then, during holding a load corresponding to 20% of the subject´s body weight and finally, during voluntary contraction of the trunk muscles. Trunk muscles contraction will be measured by a special device with pressure sensors placed on a trunk surface. Breathing activity will be measured by spirometry.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Able to comply with the study protocol, in the investigator's judgment
* Aged 20-40 years, inclusive
* Healthy as determined by the Investigator based on medical history, physical examination, vital signs and neurological examination
* Waist-to-height ratio \< 0,59

Exclusion Criteria:

* Low back pain (acute or chronic)
* Previous abdominal or spine surgery
* Acute or chronic respiratory or musculoskeletal disorder
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks before initiation of the study
* Pregnancy
Hernia Repair Four Arm Comparative Study

This study compares the outcome of the four most commonly used operations for the repair of primary groin hernia including the new key hole surgical techniques. It aims at answering the question of whether the new technology really improve the outcome, saves time and reduce patient suffering.

The study compares two traditional techniques of inguinal hernia repair; namely Lechtenstien repair and properitoneal repair versus two techniques of laparoscopic hernia repair, namely extraperitoneal and transperitoneal repair. It compares the operative time, complications, postoperative pain and the speed of patient recovery.

Eligibility Criteria:
Inclusion Criteria:

* adult male primary inguinal hernia

Exclusion Criteria:

* recurrent hernia previous lower abdominal surgery \[excluding appendectomy\]
Pediatric Cardiomyopathy Mutation Analysis

The goal of this protocol is to obtain information from individuals with cardiomyopathy and from their families in order to elucidate the molecular genetics of this disorder. This will provide the basis for future genetic counseling as well as contribute to elucidating the biology of normal and abnormal cardiac function.

Cardiomyopathy is a genetically heterogeneous heart muscle disorder that results in ventricular dysfunction. While significant progress has been made in identifying the genetic basis of cardiomyopathy in adults, molecular diagnosis in children has proven more challenging and current algorithms do not incorporate mutation analysis in the clinical protocol. However, recent studies indicate that cardiomyopathy outcomes in children are origin specific, highlighting the importance of precise diagnosis. The goal of this study is to identify the genetic causes of pediatric cardiomyopathy. Rapid, comprehensive and cost-effective detection of genetic causes of cardiomyopathy will aid management and development of novel treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with cardiomyopathy
* Family members of subjects with cardiomyopathy

Exclusion Criteria:

* Subjects without cardiomyopathy
* Family members of subjects without cardiomyopathy
Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Primary objective:

* To classify the 2 study groups, according to the tumoral response.

Secondary objectives:

* To evaluate the percentage of focused control per year.
* To calculate the time until progression.
* To evaluate the safety profile.


Eligibility Criteria:
Inclusion Criteria:

* Non small cell lung cancer confirmed by histology or by cytology.
* IIIB stage, except if existing pleural discharge, upper cava vein syndrome or supraclavicular affectation
* General stage 0-1 at the ECOG scale
* Loss of weight less than 5% in the 3 previous months from diagnose.
* Pulmonary function and gasometry results: FEV1 \> 30% or 1 l, DLCO (diffusing capacity of the lung for carbon monoxide) \> 30%, PCO2 \< 45 mmHg and PO2 \> 60 mmHg.
* Normal medullar function (hemoglobin \> 11 g/dl, total WBC \> 1,5 x 10\^9/l, platelets \> 100 x 10\^9/l)
* Appropriate renal and hepatic functions
* CTScan
* Anticonceptive method
* Available laboratory test (maximum 1 month before)

Exclusion criteria:

* Pleural discharge, upper cava vein syndrome or supraclavicular affectation.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Subcostal Approach to Anterior Quadratus Block Versus Thoracic Paravertebral Block for Laparoscopic Nephrectomy

In this study, it was aimed to evaluate the effects of subcostal anterior quadratus lumborum block (S-QLB3) and thoracic paravertebral block (TPVB) on postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic nephrectomy surgery.

Laparoscopic partial or radical nephrectomy is associated with severe acute postoperative pain. Acute pain is mediated by inflammation, activation of spinal pathways and muscle spasm. Poor pain control may reduce patient satisfaction, delay postoperative ambulation and increase the incidence of pulmonary and cardiac complications.

Facial plane blocks, an important element of multimodal analgesia, can reduce the dosage of opioids, minimize side effects and improve the quality of postoperative recovery. Quadratus lumborum (QL) block is a relatively new technique. Subcostal anterior QL block (S-QLB3) involves injection in the plane between the psoas and QL muscles. Thoracic paravertebral block (TPVB) is frequently used in thoracic and general surgery and its significant analgesic efficacy has been demonstrated in the literature. It has been used successfully as part of multimodal analgesia in renal surgery.

In this study, it was aimed to evaluate the effects of S-QLB3 block and TPVB block on pain scores and opioid consumption in patients undergoing laparoscopic nephrectomy.

Patients will be divided into two groups:

Group S-QLB3:A unilateral S-QLB3 block will be performed (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Group TPVB: A unilateral TPV block will be performed (0.4 ml/kg of 0.25% bupivacaine + 1:400,000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II patients aged 18-70 y, scheduled for elective laparoscopic unilateral nephrectomy(partial/radical)

Exclusion Criteria:

* Age \<18y, \>70y
* Obesity (BMI\> 30 kg / m2)
* Pregnancy
* Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
* Serious cardiac, hepatic, and cerebrovascular disease
* Hypersensitivity to local anesthetics or a history of allergy
* Patients with a history of opioid use longer than four weeks
* Patients with psychiatric disorders or communication difficulties
* Patients who do not want to participate
* Asthma/chronic obstructive pulmonary disease, chronic pain syndrome, substance use disorder, or sleep apnea
FolateScan in Autoimmune Disease

This study will gather information on the safety of FolateScan and the ability of FolateScan to detect inflammation in the joints and other organs in people with arthritis (rheumatoid arthritis and osteoarthritis), systemic lupus erythematosus, multiple sclerosis, interstitial pneumonitis, Crohn's disease as well as in healthy persons without these conditions.

The folate receptor is over-expressed on many types of cancer cells and in RA models, and new folate receptor targeted therapies are being developed to target cancer cells that over-express the folate receptor. As with other targeted therapies, it is important to develop diagnostic tests that will provide accurate information on folate receptor status and aid in selecting patients that may benefit from folate-targeted therapy.

EC20 concentrates in the extremities and liver and spleen of rats with adjuvant induced arthritis. The increased uptake is mediated by overexpressed folate receptor on macrophages, and the intensity of the uptake is greatly reduced by addition of excess folate, supporting the specificity of the uptake. Depletion of macrophages greatly reduced folate receptor and abolishes uptake of EC20. This suggests that EC20 may be useful in assessing macrophage involvement in the active inflammatory process of RA, and perhaps other systemic immune mediated disorders as well.

FolateScan may allow the clinician to get accurate real-time data on receptor binding, in a less invasive manner, at all actively inflamed sites throughout the treatment regimen. This kind of information may help the physician make better clinical decisions regarding therapy, including folate targeted therapies.

Eligibility Criteria:
Inclusion Criteria:

* Study will include 40 subjects with rheumatoid arthritis (active or inactive disease, defined as no swollen joints) and 5 patients in each of the following diagnosis: osteoarthritis, multiple sclerosis, Crohn's disease, systemic lupus erythematosus, interstitial lung disease and no autoimmune disease (healthy).
* Subjects must have disease duration of at least 6 months and creatinine level may not be greater than 1.5 mg/dL.

Exclusion Criteria:

* Subjects will be excluded if they are pregnant, have an active infection, received an investigational therapy in the past month or previous malignancy within the past 5 years.
The Moli-sani Study

Cardiovascular disease and malignancies account for more than 70% of all causes of mortality and morbidity in Italy. There is a subtle balance between genetic determinants and lifestyle, that often defines the line between health and sickness. So far studies aiming at identifying risk factors have mainly come from Northern Europe and the USA. It was to understand this balance between genetics and environmental determinants better, and to tailor appropriate preventive strategies for Italian and other Southern European populations, that the Moli-sani study was launched, transforming a small Italian region into a large scientific laboratory: the "Molise lab".

Each participant received a thorough medical check-up at no cost to either him/her or the national health service, resulting in thousands of hours of free public health care. With a completely computerized system, Moli-sani is a "paperless" study, in which researchers and participants communicate using recently developed technologies such as mobile phone text messages (SMS). The biological data bank (the "MoliBank") is one of the largest in Europe. Paying particular attention towards innovation and new technologies, the Moli-sani study has placed itself at the cutting edge of a new paradigm crossing research and prevention

The cohort of the Moli-sani study has recruited 24,325 persons, aged \>35 years, resident in the Molise region.The latter covers an area of 4,438 Km2, including 136 towns. Participants are recruited from city-hall registries by a multistage sampling. Firstly townships were sampled in three major areas of Molise region, starting from the main cities (Campobasso, Termoli, Isernia) by cluster sampling, then, within each township, participants are selected by simple random sampling, using electronically generated numbers.Exclusion criteria are pregnancy at the time of recruitment, disturbances in understanding or willingness, current poly-traumas or coma, refusal to sign the Informed Consent form. All subjects identified are sent a letter inviting them to participate in the project, followed a few days later by a phone call. The recruitment started in the area of Campobasso, then it moved to the areas of Termoli.

Eligibility Criteria:
Inclusion Criteria:

* Resident in the Molise region (Italy), aged \>35.

Exclusion Criteria:

* pregnancy at the time of recruitment, disturbances in understanding or willingness, current poly-traumas or coma, refusal to sign the Informed Consent form.
Identification of Genomic Changes in Families Having Multiple Members With Tumors

This study will compare genomic alterations between the parents and the patients with high-grade glioma.

Genomic changes leading to the formation of brain tumors are slowly being discovered. Despite advances in genomic technology, much analysis is hindered by the lack of control samples that could better delineate genomic alterations leading to disease. The ideal genomic control would be the genetic material of the parents of afflicted individuals. The researchers propose to then compare the genomic material from parents of siblings, both of whom have a diagnosis of a high-grade glioma. Additionally, the researchers will then compare the genomic alterations between the parents and the patients. This analysis will provide an unprecedented insight into genomic level changes that take place between parents and patients that resulted in the formation of a high-grade glioma.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Family history of brain tumor in first degree relative

Exclusion Criteria:

* less than 18 years
Prevention of Contrast Induced Nephropathy in Oncology Patients With Sodium Bicarbonate

Contrast induced nephropathy is a rising cause of acute renal failure in all patients. A study published in JAMA 2004, show a superiority of a hydratation with sodium bicarbonate in comparison with the same volume hydratation with sodium bicarbonate. The investigators will try following the original protocol making 2 randomized groups of patients, with cancer diagnosis, \>18 years old, with a GFR \<60 and \>30 ml/min/1,73m2 by MDRD formula and/or diabetic patients. In the group 1 the patients will receive a solution with 154 mEq/L of a sodium bicarbonate, 3 cc/Kg/h at 1 hour before the injection of contrast and 1 cc/Kg/h during and 6 hours before the injection. The primary end point will be the rise of 25% or more in creatinine or dialysis needed.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old
* cancer diagnosis
* GFR \< 60 and \> 30 ml/min/1,73m2 by MDRD formula or diabetic
* CT with contrast

Exclusion Criteria:

* dialysis needed
* uncontrolled hypertension
* changes in serum creatinine levels of at least 0.5 mg/dl during the previous 24 hours of procedure
* recent exposure to radiographic contrast agents (within previous two days of the study)
* administration of dopamine, mannitol , fenoldopam or N-Acetyl Cystein during the intended time of study
Designing and Evaluating a School-based Hand Washing Program in Malawi

The aim of the study is to design and evaluate a school-based hand washing program for children in Malawi, Sub-Saharan Africa, using a cluster randomized controlled trial (CRCT), so as to improve proper hand washing, increase knowledge level and also reduce school absenteeism.

A cluster randomized controlled trial (CRCT) design with pre-, mid- and post-interventions and follow-up measures will be randomized into intervention or control groups. A simplified 5-steps hand washing program will be implemented in the intervention group while the control group will continue with their usual practice where schoolchildren do not follow any standard recommended handwashing technique.

Eligibility Criteria:
Inclusion Criteria:

* Schools that have piped tap water source situated in Mzuzu City,
* Private primary schools,
* Children in elementary one and six,
* Written parental consent allowing their child to participate in the study.

Exclusion Criteria:

* Schools without piped tap water source,
* Government primary schools,
* Children whose parents will not give consent.
Differences in Quality of Life After Thoracic Outlet Syndrome Surgery

Quality of life evaluation after thoracic outlet surgery with Quick-DASH and SF-36 forms


Eligibility Criteria:
Inclusion Criteria:

* thoracic outel syndrome surgery scheduled in the vascular and thoracic surgery department of Angers ; age \> 18 y ; french language understood

Exclusion Criteria:

* denied of consent