cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 in Chronic Cougher

This study is for therapeutic confirmation of AG1321001 to evaluate the safety and efficacy as an anti-tussive agent in cough patients.


Eligibility Criteria:
Inclusion Criteria:

1. Adult between the ages of 18 and 70.
2. Patient who has cough symptom caused by following diseases: chronic bronchitis, bronchiectasis, gastroesophageal reflux disease, postnasal drip syndrome caused by rhinitis, sinusitis, rhinopharyngitis, rhinolaryngitis.
3. Patient requiring internal treatment due to cough symptom, who has coughing more than 3 weeks.
4. patient who will continue to cough more than 1 week.(by physician's judgment)
5. Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
6. Patient who is trustworthy, ready for cooperation and observing the restrictions during the trial period.

Exclusion Criteria:

1. Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis.
2. Patient who has clinical history of sensitivity to Xanthine drug.
3. Patient who has Peptic Ulcer or Asthma (Except Cicatrix)
4. Patient whose liver or kidney function is seriously abnormal: Including the cases of sGOT, sGPT, bilirubin and blood creatinine value exceeding twice of their upper normal limit.
5. Patient whose heart function is abnormal: including the case of showing abnormal EKG test value that is clinically significant.
6. Patient who has experience to have participated in other clinical trial within two months before starting the trial.
7. Pregnant woman, lactating woman.
8. patient who has convulsion or alcoholism.
9. patient who take medicines which can not use combination with AG1321001.
Plethysmography Variability Index Monitoring for Parturients With Antepartum Hemorrhage

The purpose of this study is to evaluate the use of continuous noninvasive intraoperative plethesmography variability index in conjunction with Hemoglobin levels monitoring using Masimo Radical-7™ Pulse CO-Oximeter during elective cesarean sections in patients with antepartum and intrapartum hemorrhage as a guide for fluid and blood transfusion practice .


Eligibility Criteria:
Inclusion Criteria:

* Anesthesiologist (ASA) Physical status I - II.
* patients aged from 18 to 40 years
* full-term multigravida parturients
* antepartum hemorrhage
* singleton fetus

Exclusion Criteria:

* Patients with known cardiac problem
* peripheral circulatory failure of the upper extremities
* significant liver disease
* significant renal disease
* significant coagulopathy
Ventilation Strategies, Anesthetic Techniques and Cerebral Oxygenation in the Beach Chair Position

The seated or "beach chair" position during surgery and general anesthesia decreases brain oxygen levels and can result in stroke. As such, poor neurological outcome following beach chair positioning is a growing concern. In the proposed study the investigators test the hypothesis that changes in ventilation strategy and anesthetic technique can affect cerebral oxygenation in anesthetized patients in the beach chair position.

This is a prospective cohort study with randomized nested design. Patients presenting for shoulder surgery will be randomized to receive desflurane or total intravenous anesthesia with propofol. Regional cerebral oxygenation will be measured using the INVOS 5100C monitor (Covidien, Boulder, CO). Depth of anesthesia will be maintained within a Bispectral Index range of 40-60. Following positioning, inspired oxygen fraction and minute ventilation will be sequentially adjusted. At each set point, regional cerebral oxygenation will be recorded and venous blood gas analysis performed. Statistical analysis will be repeated measures analysis of variance in which ventilation strategy is the within-subjects factor and anesthetic technique is the between-subjects factor; post hoc Tukey's correction will be used for multiple comparisons. If simple maneuvers of ventilation and anesthetic technique can prevent low brain oxygen levels, patient outcome may be improved.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective arthroscopic shoulder surgery in the beach chair position under general anesthesia with supplemental interscalene block

Exclusion Criteria:

* refusal to give consent
* ineligible for interscalene block
* history of cardiovascular disease
* history of cerebrovascular disease
* hypertension
* respiratory failure
* non-English speaker
The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor

The current study is a randomized, controlled, double-blinded trial of Obstetric Cook Catheter combined with oral misoprostol for induction of labor in pregnant patients. The primary outcome to be studied is vaginal delivery rate for the Obstetric Cook Catheter in combination with oral placebo and the Obstetric Cook Catheter in combination with oral misoprostol. Secondary outcomes to be studied include the safety of the method, composite maternal morbidity and composite neonatal morbidity.

The hypothesis is that there is a higher vaginal delivery rate in the patient whom receive both the Obstetric Cook Catheter and the oral misoprostol.


Eligibility Criteria:
Inclusion Criteria:

1. Single, live fetus
2. Cephalic (head-first) presentation
3. Reassuring fetal health assessment
4. Gestational age between 23 and 42 weeks
5. Maternal age 18 and above
6. Bishop score less than 8 in primigravidae
7. Bishop score less than 6 in multigravidae

Exclusion Criteria:

1. Fetal demise 2. Fetal malpresentation 3. Estimated fetal weight less than 500 grams or more than 4000 grams 4. Placenta previa 5. Non-reassuring fetal health assessment 6. Active maternal asthma exacerbation requiring additional medications from the usual medication requirements.

7. History of cesarean section 8. Rupture of amniotic membrane 9. Latex allergy 10. Spontaneous labor 11. Other contraindication to vaginal delivery 12. Allergy to misoprostol of cook catheter
The Effect of IoC on Analgesia for Elderly Patients With Postoperative Effectiveness

The morbidity of colorectal cancer and the surgery number among elderly is growing. The investigators need to provide more advanced and specific monitoring technology for these patients. Index of consciousness (IoC) monitor is now widely used among endoscopy, cholecystectomy and other common clinical applications. The investigators goal is to verify whether using IoC monitor could help to improve the postoperative recovery after colorectal surgery.

Participants will be randomly assigned, in a 1:1 ratio, to receive IoC monitoring or BIS monitoring during the operation as the criteria for adjustment of analgesics use. The randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. The number of dialysis and patient's recovery after the transplantation will be recorded. The participation of each patient is scheduled till they discharge from hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 60 years old that underwent Colorectal surgery in the First Affiliated Hospital of Xi'an Jiaotong University.

Exclusion Criteria:

* Having severe comorbidity history,for example,severe cardiac dysfunction
* Having central nervous system disease, severe endocrine, and history of mental disorders
* Alcoholic and long-term use of sedatives and opioids history
* Drug allergy history.
A Nerve Block Therapy for Bulbar Palsy Pharyngeal Dysphagia

This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group or the control group. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.

Dysphagia is a frequent and potentially serious complication of stroke. However, there is no effective measure for the treatment of pharyngeal dysphagia in stroke patients. This study aims to explore the efficacy of stellate ganglion block in post-stroke pharyngeal dysphagic patients who received comprehensive rehabilitation. This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group or the control group. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
* Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study.
* Age \>18 years.
* First-time stroke.
* Steady vital signs,
* Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.

Exclusion Criteria:

* Allergy to Lidocaine injection or vitamin B12 injection;
* Severe cognitive impairment;
* Coagulation disorders;
* Severe dysfunction of organs including heart, lungs, kidney, liver, etc.;
* Complicated with other neurological diseases;
* Dysphagia caused by other diseases or reasons.
Radiological Riskfactors for Dislocation of Hip Hemiarthroplasty

Between January 1 2006 and December 31 2013, at our department 324 patients underwent hemiarthroplasty (HA) for displaced femoral-neck fracture with a bipolar prosthesis (Variokopf, Link®, Germany) by the use of the posteriolateral approach. Patients with pathological fractures and HA performed with direct lateral approach were excluded. A retrospective cohort study were conducted. Patients with prosthetic dislocation formed one group and patients without dislocation formed the control group.

As standard, post surgery radiographs (anteroposterior and lateral) were taken. After these were performed patient started weight bearing as soon as possible. Clinical data regarding patient demographics, details of the surgical procedure and the medical comorbidities were collected by the use of patient and operative records. Radiological analysis with position evaluation was performed using the post surgery radiographs by measuring Wiberg angle, inequality of leg length and femoral offset of the prostheses and compared with non-operated hip joint using the post surgery x-ray images.

Our hypothesis were that patients with single- or recurrent dislocations had shortened postoperative leg length, decreased femoral offsed and a Wiberg angle less than 25 degrees.


Eligibility Criteria:
Inclusion Criteria:

* Femoral neck fracture
* Treated with Hemiarthroplasty
* Through a posterolateral approach

Exclusion Criteria:

* Direct lateral approach
Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD

Pain is the primary complication of sickle cell disease (SCD), including vaso-occlusive crises and more persistent, chronic pain. SCD-related pain is associated with significant functional impairment, spanning poor school attendance, decreased quality of life, and stress and mood difficulties. Pharmacological approaches are the first-line treatment for SCD-related pain, but these can be costly and have unwanted side effects. Given limitations from pharmacological approaches and the influence that poor behavioral responses have on disease management and health outcomes suggest a critical need for alternative and adjunctive treatments. Due to gaps in available behavioral treatments specifically designed for addressing common challenges associated with pain management in pediatric SCD, the investigators developed a manualized behavioral therapy protocol by tailoring existing evidence-based treatments. The overall goal of the intervention is to reduce the impact of pain on daily functioning in pediatric SCD. This study will empirically test the feasibility and preliminary efficacy of this intervention for youth with SCD. Children and adolescents with SCD between the ages of 8 and 17 years old (n=20) will be recruited to complete the treatment protocol. Feasibility will be assessed by examining participation and program completion rates, as well as feedback from a treatment acceptability questionnaire and qualitative interview. Participants will complete baseline assessments, weekly questionnaires, and post-treatment assessments (post-intervention assessment, follow-up time points: 1-month following the intervention, and 3-months following the intervention).


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents with SCD (HbSS, HbSC, HbS-beta0 thalassemia, or HbS-beta+ thalassemia) between the ages of 8 and 17 years old with pain-related disability and who are currently prescribed short- or long-acting opioid medications.

  1. Participants will meet at least one of the following criteria for pain-related disability: 1) Have had at least 3 pain crises in the last year, 2) Have had at least one admission for pain in the last year, or 3) Have missed at least one week of school (5 days) in the last year
  2. Current prescription of opioids will be confirmed by participants' primary hematologist, review of the electronic medical record, and discussion with the family.

Exclusion Criteria:

* Patients and caregivers with limited English proficiency, a neurodevelopmental delay, or a visual or motor impairment that would interfere with their ability to complete the assessments and intervention.
* Documented history of major depressive disorder in medical record and/or through discussion with their primary hematology suggesting that patients may need a specific and higher level of therapeutic care.
* Patients have regularly scheduled outpatient therapy sessions outside of the study.
Expanded Access for Patients With Pulmonary Hypertension Associated With Pulmonary Fibrosis

An expanded access program that provides INOpulse treatment to patients with serious disease or conditions associated with pulmonary hypertension associated with pulmonary fibrosis who are not able to participate in the Sponsor's ongoing Phase 3 REBUILD clinical.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent Form (and assent as appropriate) prior to the initiation of any study mandated procedures or assessments.
2. Subjects greater than 18 years of age at the time of consent to study participation.
3. Subjects with pulmonary hypertension associated with a disease or condition that are not eligible to participate in current ongoing clinical trials.
4. Subjects are willing and considered in the judgement of the Investigator able to use the INOpulse device continuously for up to 24 hours per day.
5. Female patients of childbearing potential must have a negative pre-treatment pregnancy test (serum or urine). All female patients should take adequate precaution to avoid pregnancy.
6. Subjects, in the opinion of the Investigator that would benefit from iNO treatment.

Exclusion Criteria:

1. Subjects who require treatment with riociguat.
2. Clinical contraindication to inhaled nitric oxide, as deemed by the Investigator.
3. Subjects who require concurrent Positive Airway Pressure (PAP) or Positive End Expiratory Pressure (PEEP).
4. Concurrent use of benzocaine, dapsone, nitrites and nitrates (amyl nitrite, isosorbide, nitroglycerin, nitroprusside), phenazopyridine. or primaquine.
Application of Ultrasound Technique in Locating the End of the Gastric Tube in Children Aged 0-6 Years

Application of ultrasound technique to locate the end of the gastric tube in children aged 0-6 years

Bedside blind insertion is the most common method for gastric tube indwelling in clinical practice. The key problem is that the position of the tube cannot be accurately determined in real time.Bedside ultrasound has become a common medical technology, and resources are easy to obtain. Therefore, bedside ultrasound has the advantages of fast, accurate, real-time repeatable, and non-invasive in determining the position of the end of the indwelling gastric tube.The purpose of this study is to investigate the accuracy of bedside ultrasound in guiding gastric tube placement and judging the position of the end of the tube in children with CHD aged 0-6 years. To explore the feasibility and effectiveness of bedside ultrasound guided gastric tube placement during perioperative period in children with congenital heart disease (CHD), this study plans to procedure the prospective randomized controlled study.

Eligibility Criteria:
Inclusion Criteria:

* Children with CHD who needed gastric tube in CCU were admitted
* children aged 0-6 years
* Informed consent of parents

Exclusion Criteria:

* Children with delayed sternal closure
* The parents had cognitive impairment and mental disorders
Prevalence and Consequences of Urinary Incontinence in People with Chronic Pulmonary Diseases Referred for Pulmonary Rehabilitation

Urinary incontinence is a frequent chronic condition in general population. It is even more frequent in people with chronic respiratory disease due to several factors, including but not limited to frequent cough. Urinary incontinence may be more frequent during exercise so that it may contribute to the general deconditioning associated with chronic respiratory disease.

Although pulmonary rehabilitation is a cornerstone in the management of people with chronic respiratory disease to break this spiral of worsening dyspnea, little is known about the prevalence of urinary incontinence among those people referred for pulmonary rehabilitation nor about its impact on the effects of the program.

Experimental design:

People referred for pulmonary rehabilitation in two centres will be offer to participate in the study. Those people who will agree to participate and give their formal consent will be asked to answer two questionnaires about urinary incontinence symptoms (see outcomes) to assess the prevalence and the type of these symptoms.

They will subsequently participate in their usual pulmonary rehabilitation program consisting in 90min sessions (including endurance training, muscle strengthening and self-management), 3x/week for 8weeks (centre 1) or 2x60min sessions (including the same components), 3x/week for 8weeks (centre 2).

The effects of the pulmonary rehabilitation program on usual clinical outcomes (according to each centre routine practice; tests may differ between centres) will be compared between those people with or without urinary incontinence symptoms.

As no prevalence data about urinary incontience was available at the time of study design, we planned to recruit the first 100 participants within the first year and to update the sample size calculation based on these preliminary data.

Among the 70 people actually included, 21 (30%) experienced urinary incontinence. Therefore, assuming a true prevalence of 30% in this population and a total width for the 95% confidence interval of 10%, we planned to recruit a total 341 participants.

The ethical approval to recruit this updated number of participants and to increase the duration of recruitment accordingly was obtained.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 ans ;
* Referred for pulmonary rehabilitation ;

Non inclusion Criteria:

* History of pathology or prostate surgery ;
* Contra indication to pulmonary rehabilitation ;

Exclusion Criteria:

* Pregnant woman or likely to be ;
* Patient under guardianship ;
* Patient withdrawal ;
* Did not complete at least 18 pulmonary rehabilitation sessions.
Type 2 Diabetes Mellitus: New Approaches to Optimize Medical Care in General Practice

Patients with type-2 diabetes mellitus have an higher risk developing secondary disorders. In an epidemiological longitudinal study of about 1.150 patients with type 2 diabetes mellitus we investigate determinants and predictors for long-term prognosis. The patients are recruited and supervised in practices of general practitioners of the administrative district of Ludwigsburg/Heilbronn (Baden-Württemberg, Germany). In a subgroup of about 200 patients with a dissatisfactory metabolic status (HbA1c \> 7,5%) a randomised interventional study is performed. The intervention comprises a telephone counseling by the medical secretary of each practice executed in a predefined period of time. The outcome parameters of interest are the change of HbA1c, the development of secondary disorders and adverse events, quality of life and risk factor control, as well as hospitalization and mortality.

The aim of the study was to develop an patient-centred instrument implementable in the routine medical care in order to enhance the prognosis of patients with type-2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Patient with type-2 diabetes mellitus attending the general practitioner's in the time from October to December 2008
* Ability to take part in the study

Exclusion Criteria:

* Nursing home resident
* Insufficient knowledge of the German language
* Palliative health care with limited life expectancy
* Emergency outpatient
* All outpatients who attend the general practitioner by way of exception
Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer

This research study is looking at tumor tissue samples from patients who have undergone surgery for advanced stage III or stage IV ovarian epithelial cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn how tumor infiltrating T cells can predict how patients will respond to treatment.

PRIMARY OBJECTIVES:

I. To validate the ability of intratumoral tumor-infiltrating T lymphocytes (TILs) to predict progression-free survival (PFS) in patients with suboptimally debulked advanced stage III or IV ovarian epithelial cancer.

II. To validate the ability of intratumoral TILs to predict PFS in patients with optimally debulked disease.

SECONDARY OBJECTIVES:

I. To validate the ability of intratumoral TILs to predict overall survival of patients with suboptimally debulked disease.

II. To validate the ability of intratumoral TILs to predict overall survival of patients with optimally debulked disease.

OUTLINE:

Patients are stratified according to status of debulked disease (suboptimal vs optimal).

Previously collected tumor tissue samples are analyzed for tumor-infiltrating lymphocytes (TIL) via immunohistochemistry and double immunofluorescence assays using standard immunostaining.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stage III or IV ovarian epithelial cancer and enrolled on Gynecologic Oncology Group (GOG)-0136 and a GOG front-line platinum/taxol chemotherapy trial (GOG-0114, GOG-132, GOG-0158, or GOG-0162)
* Must have fixed and paraffin-embedded tissue from primary surgery available from 1 of the following sources:

  * Patients enrolled on GOG-0136 and a GOG front-line platinum/taxol chemotherapy trial(GOG-0114, GOG-0132, GOG-0158, and GOG-0162)
  * Patients who have had either optimal or suboptimal cytoreductive surgery
  * Patients for whom adequate demographic data, including major prognostic factors and follow-up information, were collected
* Evaluable patients must have had measurable or nonmeasurable disease
* Demographic and follow-up data available