cyrilzakka/clinical-trials huggingface dataset:
Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis

This is a pilot study to lead to a larger prospective, randomized, controlled study of older adult (ages 50 and older) spinal patients with thoracolumbar/lumbar scoliosis evaluating improvement with physiotherapeutic scoliosis-specific exercise (PSSE) compared to traditional low back physical therapy (PT).

Adult scoliosis with chronic back pain is a very complex condition. Chronic back pain remains one of our country's most costly conditions to manage and treat. Many of these patients have difficulty with activities of daily living (ADL), household and community ambulation, and maintaining their professional career. The intervention options for this population remain limited, with surgery being the only one that has shown improvements in health related quality of life and an overall decrease in the complaints of pain. However, the costs of surgery and additional complications are limitations to this treatment option.There has been increased attention and interest in the medical community looking at the effects of Physiotherapeutic Scoliosis Specific Exercises (PSSE) on curve progression, improvements in health related quality of life, and pain. The investigators hypothesize that PSSE can directly affect radiological parameters, such as the sagittal vertical axis (SVA), as well as showing improvements in health related quality of life using subjective patient specific outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* 50+ years old
* Diagnosis of adolescent idiopathic scoliosis or adult idiopathic scoliosis; either with a Cobb angle ranging from 20-100 degrees
* Complaint of back pain that has lasted longer than 6 weeks

Exclusion Criteria:

* Any patient who has completed PSSE in the past
* Previous spinal surgery, trauma, or presence of neoplasms
* Diagnosis of congenital or neuromuscular scoliosis
* Subjects who are involved in concurrent interventions other than conventional physical therapy (PT)
Relationship Between Multi-exposure to Noise and Air Pollution and the Onset of Hypertension Disorders During Pregnancy

This retrospective study aimed to analyse the relationship between multi-exposure to noise and air pollution the onset of hypertension disorders during pregnancy

It will be conducted in 2650 mothers who gave birth at Dijon or Besançon CHU between 2005 and 2009 split into two groups:

* 530 cases (women who experienced hypertension disorders during pregnancy
* 2120 controls (women who did not experience a hypertension disorder during pregnancy)


Eligibility Criteria:
Inclusion Criteria:

* Women living in Besançon or one of the 15 communes of the Dijon conurbation
* Who gave birth at Dijon or Besançon CHU
* Between 1st January 2005 and 31st December 2009

Criterion for the inclusion of cases:

* Onset of a hypertension disorder during pregnancy defined according to expert recommendations

Criterion for the inclusion of controls:

* No hypertension disorder during pregnancy

Exclusion Criteria:

* Medical termination of pregnancy
* Opposition to the use of their data
Systemic Hypothermia in Acute Cervical Spinal Cord Injury

This study is a prospective multi-center trial designed to determine the safety profile and efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8) Spinal Cord Injury (SCI).

The purpose of the proposed clinical trial is to demonstrate the safety and efficacy of intravascular hypothermia as part of the early hospital management and treatment for acute cervical SCI. Each year in the US, there are over 11,000 new cases of para- and quadriplegia and 100,000 new cases of partial but permanent neurological losses due to acute SCI. Thus the potential for clinical hypothermia following SCI to improve neurological outcome has significant value. Many patients suffering SCI become permanently dependent on caretakers and become a financial liability to both the family and society. Hypothermia has the potential to improve outcome so that more patients suffering SCI can regain independent motor and sensory function and remain economically productive members of society. The use of modest hypothermia through intravascular cooling may ultimately lead to better care of the patient with acute SCI and may also have more widespread uses in patients presenting with stroke or cardiac arrest. In the long-term, this research may lend support to the use of hypothermia that could in turn save money for the patients, hospitals, the government and society as a whole.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 70 years of age
* AIS Grade A - C
* Glasgow Coma Scale ≥14
* Able to start hypothermia treatment within 24 hours of injury
* Non-penetrating injury. Patients urgently taken to the operating room for surgical reduction may also be included.

Exclusion Criteria:

* Age \> 70 years
* AIS Grade D
* Hyperthermia on admission (\>38.5ºC)
* Severe systemic injury
* Severe bleeding
* Pregnancy
* Coagulopathy
* Thrombocytopenia
* Known prior severe cardiac history
* Blood dyscrasia
* Pancreatitis
* Reynaud's syndrome
* Cord transection
Hematopoietic Stem Cell Transplant for High Risk Hemoglobinopathies

This is a study to collect the outcomes of stem cell transplantation for patients with hematologic diseases other than cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Sickle Cell Disease, Thalassemia, Diamond Blackfan Anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated
* Acceptable stem cell source identified
* Performance status of ≥ 70% (Karnofsky),or ≥ 70 (Lansky play score)
* Creatinine \<2.0 mg/dl for adults or glomerular filtration rate \> 50 ml/min for children
* Bilirubin, Aspartate Aminotransferase, Alkaline phosphatase \<5 times the upper limit of institutional normal
* Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \> 40%

Exclusion Criteria:

* active, uncontrolled infection
* pregnant or breastfeeding
* HIV positive
Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes

This trial is conducted in Europe and Asia. The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs
* HbA1c between 8.0-10.5%
* Body mass index (BMI) below 35.0 kg/m2
* Able and willing to perform self-monitoring of blood glucose

Exclusion Criteria:

* Total daily insulin dose of 1.80 IU/kg or more
* Known or suspected allergy to trial product or related products
* Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures
The Impact of Heart Rate on Central Blood Pressure in Sick Sinus Syndrome Patients With a Permanent Cardiac Pacemaker

This study is divided into two parts:

* The first part evaluates the acute effect of non-pharmacological heart rate change on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker
* The second part evaluates the acute effects of atenolol, nebivolol and ivabradine on central hemodynamic parameters noninvasively in sick sinus syndrome patients with a permanent cardiac pacemaker at different pacing rate levels

Patients with sick sinus syndrome and a double-chamber cardiac pacemaker are studied.

* To investigate the role of non-pharmacological heart rate change on central hemodynamics in the first part of the study, the investigators acutely change pacing rate from atrial paced-atrial sensed (AAI)-mode 60 to 40 to 90 bpm and obtain hemodynamic parameters noninvasively after a short stabilisation period after each pacemaker rate change.
* Subsequently, to investigate the acute effects of beta-blockers or ivabradine on central hemodynamics in the second part of the study, the investigators obtain central hemodynamic parameters noninvasively after acute administration of atenolol, nebivolol or ivabradine at the same pacing rate levels used in the first part of the study (AAI-mode 60, 40 and 90 bpm).

Eligibility Criteria:
Inclusion Criteria:

* age 18-75 years;
* dual-chamber pacemaker implanted due to sick sinus syndrome at least six months before; sinus rhythm

Exclusion Criteria:

* average seated office brachial systolic BP ≥160 mmHg and/or diastolic BP ≥ 100 mmHg; atrial pacing \<40%;
* ventricular pacing \>25%;
* unpaced QRS \>120 ms and/or QTc \>500 ms on 12-lead ECG;
* atrioventricular blockage at AAI-mode 90 bpm; resting HR \>60 bpm at AAI-mode 40 bpm; irregular heart rate;
* automatic mode switching \>10%;
* implantable cardioverter defibrillator or cardiac resynchronisation therapy pacemaker; treatment with digoxin, class Ic or III antiarrhythmic drugs;
* history of acute coronary syndrome;
* stable angina pectoris;
* heart failure with reduced left ventricular ejection fraction;
* history of cerebrovascular event;
* diabetes mellitus;
* chronic kidney disease with eGFR \<30 ml/min/m2;
* peripheral artery disease;
* clinically relevant heart valve disease;
* active cancer;
* acute or chronic inflammatory disease;
* severe chronic respiratory or liver disease;
* pregnancy or breastfeeding
* contraindication or intolerance to atenolol, nebivolol, ivabradine or adjuvants
Study For Evaluating The Value Of A Multi Biomarker Approach In Metastatic GEP NETs

This exploratory study aims to evaluate the diagnostic, prognostic and response predictive value of a multi biomarker strategy in patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP NETs) originating from the midgut or pancreas. Using a recently developed methodology enabling the evaluation of 92 concomitant cancer biomarkers will provide an interesting approach to solve this question (Lundberg et al 2011).


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent prior to any study related procedures.
* Suspected of suffering from a metastatic midgut NET or Pancreatic non-functional NET (WHO grade 1 or 2, up to 10% Ki67).
* Male or female aged 18 or older.

Exclusion Criteria:

* Previously treated for the NET disease with pharmaceutical treatment, Peptide Receptor Radionuclide Therapy (PRRT) or radiation therapy(surgery of primary tumour is accepted)
* Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
* Suffering from a malignant disease or previously treated for a malignant disease within the last 6 months.
* Suffering from a chronic inflammatory disease.
* Suffering from a renal and/or liver disease.
Fish and Marine Fatty Acids, Genetic Signatures of Diet Adaptation, and Long-term Weight Changes

the investigators tested whether genetic variants near FADS cluster, which were recently identified to be signatures of adaptation to fish- and n-3 PUFAs-rich diet, interacted with these dietary factors on long-term change of body mass index (BMI).


Eligibility Criteria:
Inclusion Criteria:

* 11,323 women of European ancestry.
* Informed consent was obtained from all participants. The DNA extraction methods, quality control measures,
* SNPs genotyping and imputation data are available .
* Both cases and controls with genotyping data are available based on GWASs

Exclusion Criteria:

* participants without genetic data
BAY59-7939 Japanese in Atrial Fibrillation (2nd)

This study was a randomized, parallel group, open label trial using warfarin as comparator. Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups (originally described in Japanese).


Eligibility Criteria:
Inclusion Criteria:

* Japanese subjects with non-valvular AF who met all of the following criteria:

  * Persistent or paroxysmal non-valvular AF with \>/=2 episodes before enrollment, at least 1 of which had been verified by ECG recording within 4 weeks before randomization
  * Male subjects aged 20 years or older and postmenopausal female subjects
  * Subjects with at least one risk factor for thromboembolism or aged 60 years or older (Risk factor for thromboembolism: hypertension, diabetes mellitus, coronary artery disease, congestive heart failure).

Exclusion Criteria:

* History or presence of stroke or transient ischemic attack.
* History of intracerebral hemorrhage.
* History or presence of bleeding at randomization; intraocular or gastrointestinal bleeding within the last 6 months prior to randomization.
Longitudinal Mindfulness Intervention to Decrease Burnout in Medical Residents

This was a single-site RCT to assess the effect of a longitudinal mindfulness intervention on burnout for first-year (PGY-1) internal medicine (IM) and pediatrics residents. The primary outcome was Maslach Burnout Inventory MBI) scores at baseline and 12 month follow-up. Secondary outcomes were feasibility and perceived benefit of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Washington University (WUSM) first year residents in internal medicine and pediatrics

Exclusion Criteria:

* none
A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes

The objective of this study was to compare the safety and efficacy of 0.25% HL036 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Have a patient-reported history of dry eye for at least 6 months prior to Visit 1
* Be willing and able to comply with all study procedures
* Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2

Exclusion Criteria:

* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months
* Have any previous experience using HL036
Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.

To compare the efficacy of a novel partially covered (PC) versus uncovered (UC) pyloro-duodenal stents (DS) in unresectable malignant gastric outlet obstruction. We hypothesize that the use of PCDS could reduce the re-intervention rates when compared to UCDS.

This would be a prospective multi-centred double-blinded randomised controlled study including all patients suffering from malignant gastric outlet obstruction due unresectable primary gastro-duodenal or pancreatico-biliary malignancies. Five international institutions in Hong Kong, Singapore and India would participate in the study.

The procedure would be performed under conscious sedation or monitored anaesthesia. The patients would be randomised PCDS or UCDS after cannulation of the obstruction site is achieved with the guide-wire. The patients or assessors would be blinded to the type of stent that is inserted.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients ≥ 18 years old
* Confirmed unresectable gastro-duodenal or pancreatico-biliary malignancies
* Suffering from gastric outlet obstruction with a gastric outlet obstruction score of ≤ 1 (appendix 1) 19
* Performance status ECOG ≤3 (appendix 2)

Exclusion Criteria:

* Prior metallic stent placement
* Severe comorbidities precluding the endoscopic procedure (such as cardiopulmonary disease, sepsis, or a bleeding disorder)
* Life expectancy of less than 1 month
* History of gastric surgery
* Linitus plastica
* Coagulation disorders
* Pregnancy
* Unable to give informed consent
Clinical Impacts of Oral Gastrografin Follow Through in Adhesive Small Bowel Obstruction (SBO)

Mini abstract :

Altogether 100 patients with 117 episodes of ASBO were randomized into control and gastrografin groups. Eight episodes in eight patients were excluded. Gastrografin group showed a significant decrease of both the time between admission and operation and that of hospital stay .The need for surgery was reduced but statistically insignificant.

Abstract

Background:

Many published studies have shown that Gastrografin can be used for diagnosis post operative acute small bowel obstruction (ASBO) and assessing the need for surgical intervention .However,the studies have reported conflicting results hence the aim of our study to test this hypothesis.

Patients and methods :

Altogether 100 patients with 117 episodes of ASBO were randomized into control and gastrografin groups in a double blinded fashion. Eight episodes in eight patients were excluded due to protocol violation. In Gastrografin group,100 ml of the dye administered through a nasogastric tube and complete obstruction has been considered if the contrast failed to reach the colon on the 24-hour film. Patients were operated on only if they developed signs of strangulation or failed to improve within 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to our surgical department by postoperative SBO were considered for inclusion in this trial.

Exclusion Criteria:

* Age less than 18 years
* Large bowel obstruction
* Recent (within 4 weeks) abdominal surgery
* Ileus
* Cancer peritonitis
* Peritonitis
* Strangulation symptoms and signs
* Obstructed abdominal wall or groin hernia
* Subtotal or total colectomy
* All patients in whom the final diagnosis was not SBO
Program for Cardiovascular Prevention and Randomized Clinical Trial

Develop and evaluate a model of organization and management in the management of patients with cardiovascular risk factors (hypertension, diabetes mellitus, smoking, obesity, physical inactivity, dyslipidemia and family history) in primary care aimed at the compliance, control and treatment effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hypertension (\> 140/90 mmHg)
* Age \> 40 years
* Sitting: USF da Restinga e Extremo Sul - USF Chapéu do Sol and USF Paulo Viaro

Exclusion Criteria:

* Institutionalized individuals
* Patients with mental illness or disabling chronic illnesses
* Users of health services belonging to the supplementary health
* Individuals with life expectancy less than 1 year
Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.

Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment approaches to locally advanced pancreatic cancer management.

Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients.

Study population: Locally advanced unresectable pancreatic cancer patients

Elegibility criteria:

* Written informed consent
* Age \>18 \< 75 years
* Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
* At least one lesion measurable with CT or MRI scan
* Performance Status (ECOG) 0-1 at study entry
* Life expectancy of at least 3 months
* Adequate marrow, liver and renal function
* Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \>18 \< 75 years
* Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
* At least one lesion measurable with CT or MRI scan
* Performance Status (ECOG) 0-1 at study entry
* Life expectancy of at least 3 months
* Adequate marrow, liver and renal function
* Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported)

Exclusion Criteria:

* Previous chemotherapy or radiotherapy for pancreatic cancer
* Severe cardiovascular disease
* Thrombotic or embolic events
* Acute or subacute intestinal occlusion or history of inflammatory bowel disease
* Known hypersensitivity to study drug
* Known drugs or alcohol abuse
* Pregnant or breastfeeding women
* Previous or concurrent malignancy; except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and with evidence of no recurrence for at least 5 years prior to randomization
* Unable to sign informed consent
Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis

Purpose:

This study is a prospective clinical trial to investigate the efficacy of a chitosan-coated nasal packing (ChitoFlex® used in conjunction with the HemCon Nasal Plug) in the management of difficult spontaneous epistaxis and to evaluate its healing effect on nasal mucosa.

The introduction of products that enhances hemostasis can have clinical advantages when associated with traditional nasal packing. These advantages include a better hemostatic control and the reduction of nasal packing duration. Furthermore, this study will help determine if there are any non-desirable effects that chitosan may have on the nasal cavity, such as the production of fibrosis and foreign body reaction.

Epistaxis is a common reason for emergency department visits and otolaryngology referral. Management methods of epistaxis include nasal packing, chemical or electric cauterization, and arterial ligation or embolization.

There are numerous nasal packing products available in the market, and are used to stop or prevent nasal bleeding. The ideal nasal pack should be efficient in controlling bleeding, have antimicrobial properties and be well tolerated. Currently, there is no perfect nasal pack, but some are closer to ideal than others. Nasal packs can be classified into non-absorbable and absorbable nasal packs.

Recently, a new hemostatic product has been introduced in the market, and used as a military wound bandages, the ChitoFlex®. ChitoFlex® is made of chitosan, a naturally occurring, bio-compatible polysaccharide. Because chitosan has a positive charge, it attracts red blood cells, which have a negative charge. The red blood cells create a seal over the wound as they are drawn into the bandage, forming a very tight, coherent seal. The ChitoFlex® -dressing has been demonstrated by AATCC Test Method 100-2004, Evaluation of Antibacterial Finishes (Technical Manual of the America Association of Textile Chemists and Colorists) as an antibacterial barrier in laboratory testing with a variety of gram-positive and gram-negative bacterial organisms.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years.
* Epistaxis despite nasal packing or rebleeding after removal of the packing.

Exclusion Criteria:

* Patient unable or unwilling to provide informed consent.
* Prior diagnosis of disease or medical condition affecting the ability of blood to clot (e.g., hemophilia.)