cyrilzakka/clinical-trials huggingface dataset:
Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation

The primary objective of the study is to determine changes in cerebral nociceptive hemodynamic response (blood oxygenation/flow) before, during and following spinal cord stimulation (SCS). Objective measurements of cerebral nociceptive hemodynamic responses will be obtained with the CereVu sensor and ROPA system and will be analyzed offline and compared against subjective measures of pain. Proprietary analysis algorithms will be incorporated and developed to understand how the objective measurements correlate with subject reported pain levels


Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years of age or older at the time of enrolment
2. Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months
3. Subject has a minimum Visual Analog Scale (VAS) score of 50 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline or a 5 on a Numerical Rating Scale (NRS)
4. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
5. Be willing and capable of giving informed consent
6. Be willing and able to comply with study-related requirements, procedures, and visits

Exclusion Criteria:

1. Subject is pregnant or nursing
2. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator
3. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes
4. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS)
5. Have prior experience with SCS
6. Be concomitantly participating in another clinical study
7. Subject has secondary gain issues that could interfere with the study measures or outcomes
8. Subject is contraindicated for use of non-invasive cerebral oxygenation measurements (e.g., at risk for sensor displacement such as facial cosmetic. Non-intact skin on the forehead, or ENT surgery)
9. Subject is allergic to any adhesives, materials or fluids in or used in conjunction with the CereVu sensor
Respiratory Morbidities and Outcome in Late Preterm in Neonatal ICU

Aim of the work:

To assess the respiratory morbidities \& outcomes in late preterm infants in the neonatal ICU of Assiut university children's Hospital.

In the world, Preterm birth rates continue to rise. Many reasons account for this increase, such as demographic changes, infertility treatments, increases in maternal age, more multiple gestations, increasing obesity rates, and maternal comorbid conditions.

To evaluate the occurrence and impact of a condition, a precise definition and its related outcomes are necessary. Thus, a general classification for selected gestational age categories has been reported. Preterm birth refers to all deliveries \< 37-0/7 weeks; this classification includes very preterm (\< 32-0/7 weeks), moderately preterm (32-0/7 to 33-6/7 weeks), and late preterm births (34-0/7 to 36-6/7 weeks). Term births refer to deliveries that occur from 37-0/7 to 42-0/7 weeks, and post-term births refer to any delivery occurring after 42-0/7 weeks.

Neonates born between 34 and 36 weeks of gestation (late preterm or near-term births) comprise 71% of all preterm births in the United States.

Late preterm neonates have significantly higher rates of morbidity and mortality relative to those born at term (37-42 weeks).

In addition to higher risks for serious health complications, the mortality rate for late preterm infants is 3-fold higher than that for term infants (7.7 vs 2.5 per 1000 live births).

Late preterm delivery (71% of all preterm births) increases the incidence of respiratory pathology as respiratory distress syndrome (RDS), Transient tachypnea of the newborn (TTN), pneumonia with chest x-ray verification, persistent apnea and bradycardia, pulmonary hypertension, pneumothorax, meconium aspiration, pulmonary hypoplasia,( respiratory failure ) and the need of ventilator support when compared to term delivery.

Late preterm newborns increase other risks for feeding difficulty, jaundice, hypoglycemia, temperature instability, apnea, and respiratory distress.

Eligibility Criteria:
Inclusion Criteria:

* late preterm neonates admitted to the Neonatal intensive care unit (NICU) at Assiut University Children's Hospital for one year.

Exclusion Criteria:

patients with congenital heart diseases and multiple congenital anomalies.
HighCycle Study: Effect of Acetazolamide on Sleep Disordered Breathing in Women Compared to Men

Randomized clinical trial evaluating the effect of acetazolamide on sleep disordered breathing in women compared to men travelling to 3600 m.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking men and women, age 18-44 years, without any diseases and need of regular medication (including oral contraceptives).
* BMI \>18 kg/m2 and \<30 kg/m2
* Born, raised and currently living at altitudes \<1000 m
* Written informed consent
* Premenopausal women with an eumenorrheic cycle

Exclusion Criteria:

* Other types of contraceptvies (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others)
* Pregnancy or nursing
* Anaemic (haemoglobin concentration \<10g/dl)
* Any altitude trip \<4 weks before the study
* Allergy to acetazolamide and other sulfonamides
The Effects of Disease Management Training and Telephone Counseling Service for Elderly Patients With Osteoarthritis

The study will be conducted to determine the difference on functional status, self-efficacy, and quality of life between groups with and without telephone counseling and training on disease management for participants.

When the literature is examined, in patients with osteoarthritis who receive face-to-face training and intermittent telephone counseling; It is observed that the level of self-efficacy, compliance with the disease and quality of life have increased. It is stated that face-to-face training and telephone counseling services provided to participants on disease management will increase the effectiveness of education and as a result; It is thought that participants may have positive outcomes such as expressing their problems more easily, feeling safer by communicating frequently, and developing methods of coping with nurse-patient cooperation. When the studies conducted in our country are examined, while there are studies examining the effect of non-pharmacological interventions such as acupressor, hot-cold application, exercise training, mud pack treatment in patients with osteoarthritis; No study was found in the elderly patient group in which education and telephone counseling were conducted. The results of the research are thought to be beneficial in managing the disease in addition to in addition to pharmacological treatment.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 and over
* OA was diagnosed by the physician according to the American College of Rheumatology (ARD) criteria,
* Being able to answer research questions
* Individuals who gave their oral and written consent to participate in the study were included.

Exclusion Criteria:

* Having a history of malignancy
* Those who score above 5 points from the Visual Analogue Scale
* With a neuro psychiatric illness
* Having vision and hearing problems
* Receiving intraarticular medication (steroid, chondramine, hyaluronic acid) in the last month
* Surgery applied to the knee joint in the last 3 months
* Having inflammation in the joints
* Have an open wound in the OA area
* Individuals with a diagnosed vascular disease will not be included.
Efficacy of Metacognitive Training Single Modules: Jumping to Conclusions and To Empathize...

The purpose of this study is to determine whether modules of Metacognitive Training: Jumping to Conclusions and To empathize... are effective in the treatment of patients with schizophrenia. Also it was investigated whether these modules have specific impact on cognitive biases severity.

Investigators employ randomized controlled trial design. Patients in ward were recruited for the study in three waves. In each wave patients were assessed pre-intervention, then randomly allocated in one of three groups: with modules of Metacognitive Training or control group. Then patients were assessed post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of psychotic disorders
* informed consent

Exclusion Criteria:

* neurological disorders
MRI T2* Mapping of Myocardium, Liver, Pancreas and Pituitary Gland

All patients were investigated using a 3T MRI and 1,5 T MRI scanners. For myocardium, pancreas and pituitary gland iron overload quantification in children we have used special sequences for T2\*-mapping.

Miocardium, pancreas and pituitary gland T2\* relaxometry maps were calculated automatically by commertial application ReportCARD Functool (GE Healthcare) and integrated Philips T2\* maps. Then for selected ROI T2\* data acquisition in milisecond \[ms\] were performed and calculated automatically.

All patients were investigated using a 3T MRI scanner (Philips Achieva) and 1,5 T MRI scanner (GE Signa) with 8-channel surface coil for body scanning. For myocardium, pancreas and pituitary gland iron overload quantification in children we have used special sequences for T2\*-mapping based on fast gradient echo sequences - multi-phase fast gradient echo and ultrashort gradient echo (uTE) in axial and coronary plane. For breath-hold acquisition due to failure of communication and invariable behavior some children received anaesthetic support with mechanical ventilation. Miocardium, pancreas and pituitary gland T2\* relaxometry maps were calculated automatically by commertial application ReportCARD Functool (GE Healthcare) and integrated Philips T2\* maps.

The placement of region of interest (ROI) in target organ were performed by following criterion: for the myocardium - in the interventricular septum in short axis plane; for the pancreas - in corpus in axial plane; for the pituitary gland - in adenohypophysis; for all organs the area of large and small blood vessels, which can introduce distortions of the obtained results were excluded. Then for selected ROI T2\* data acquisition in milisecond \[ms\] were performed and calculated automatically by approximating the attenuation curve with the highest likelihood method.

Eligibility Criteria:
Inclusion criteria:

1. Age under 25 y.o.;
2. A history of transfusion-dependent anemia of various origins.
3. indications for the appointment of chelation therapy

Non-inclusion criteria:

1. Age over 25 y.o.
2. The number of RBC transfusions previously received by the patient is less than 10

Exclusion criteria:

1. Absolute contraindications to magnetic resonance imaging (pacemaker, ferromagnetic implants, etc.);
2. Refusal to sign the informed consent.
Osteoporosis Awareness Survey of Women in Champagne Ardenne

Osteoporosis is characterized by low bone mineral density and alterations in bone microarchitecture, leading to bone fragility and high risk of fractures. In the peri-menopausal period and during menopause, estrogen deficiency is responsible for an acceleration of bone remodeling. It is therefore important to sensitize women to this pathology at the beginning of menopause.

Osteoporosis is a public health issue with more than 3 million women in France suffering from almost ¼ of the population over 50 years old. Paradoxically, the number of bone densitometry and prescribed osteoporosis drugs are decreasing. There is an under-screening and a disinterest of the pathology on the part of the medical world and the patients.

The investigators hypothesize that women lack knowledge about osteoporosis. This study will identify these gaps, and put in place appropriate strategies to improve this knowledge.

For this purpose, a descriptive cross-sectional observational study will carry out, through the fulfillment of self-administered questionnaire for women over 30 years old. The main objective is to assess the knowledge of women, about osteoporosis and its consequences. The judgment criterion is based on a percentage of correct answers per question. The interests of the study are to identify gaps in knowledge, to optimize the investigator's therapeutic education, to fight patient wait-and-see and false beliefs, and finally to improve adherence and longer-term adherence.

This is a descriptive cross-sectional observational study, recruiting women over 30 years old, by the diffusion of the questionnaire in the general practices of Champagne-Ardenne, and the rheumatology department of CHU de Reims.

The main objective of the study is to assess the knowledge of women over 30 on osteoporosis and its consequences. The judgment criterion is a calculation of the percentage of correct answers per question. The investigation plan is based on a self-administered questionnaire survey .The statistical analysis plan is based on a descriptive analysis with sorting flat and sorted; The questionnaires will be disseminated from March 2018 to May 2018, with the valuation of results on June 1, 2018.

This questionnaire includes:

* 6 questions relating to the patient : risk of osteoporosis and specific management.
* 17 questions about osteoporosis knowledge
* 8 questions about information resources received on osteoporosis ( media, general practitioner ...) The questionnaire will be accompanied by a cover letter and a consent form. The filling of the questionnaire should last between 5 and 7 minutes. The patient will then give back the questionnaire directly to the person who has offered him to fill it out (general practitioner, rheumatologist, nurse).

The questionnaires will be placed in waiting rooms of doctors, dentists, and paramedics of the Marne, the Ardennes, and the Aube.

Eligibility Criteria:
inclusion criteria :

* gender : women
* age over thirty years old

exclusion criteria :

* Cognitive state incompatible with the collection of information
* women doctors
Observational Study With Mixtard® 30 NovoLet® to Assess Patient Satisfaction

This study is conducted in Asia. The aim of this study is to assess patient satisfaction after switching to biphasic human insulin 30 treatment using the NovoLet® insulin device as treatment for diabetes mellitus under normal clinical practice setting.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus (type 1 or type 2)
* Patient not presently using Mixtard® 30 NovoLet®
Post Operative Quality of Life After Patulous Eustachian Tube Treatment

Patulous eustachian tube (ET) is a usually asymptomatic poorly known ET pathology. When it becomes so and thus impairs the eardrum (retraction pockets, cholesteatoma) or patients' quality of life (QoL), therapeutic management is proposed. The surgical treatment has diversified in recent years but remains dominated by filling spaces around the ET (autologous fat and/or septal cartilage grafting). Efficiency is traditionally objectivized by dynamic otoscopy, tubomanometry and audiometry, but QoL must also be taken into account and its postoperative assesment was the objective of this work.

Materials and Methods This is a unicentric retrospective study conducted from November 2016 to March 2019 on all patients with a disabling patulous ET, single or bilateral, managed surgically by autologous fat and/or septal cartilage grafting in investigators ENT department. Patients for whom a concomitant procedure was performed were excluded from the study.

The post-operative QoL assessment was performed using the Glasgow Benefit Inventory (GBI), postoperative self-administered questionnaire validated in ENT, including a general, physical and social evaluation. Predictive factors for QoL improvement were investigated among pre-, per- and post-operative clinical data.


Eligibility Criteria:
Inclusion Criteria:

* any surgically treateble patient with a unilateral patuluos eustachian tube

Exclusion Criteria:

* any patient for whom an other surgical step than the eustachian tube one was needed,
* bilateral desease ,cholesteatoma
Donidalorsen Expanded Access Program for Patients With Hereditary Angioedema

The purpose of the Expanded Access Program is to provide pre-approval access of donidalorsen to eligible patients with Hereditary Angioedema (HAE) who complete the ISIS 721744-CS3 clinical trial.

The Expanded Access Program (EAP) is intended to provide pre-approval access to donidalorsen for eligible patients with HAE who complete the ISIS 721744-CS3 clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the ISIS 721744-CS3 (Open-Label Extension \[OLE\] Study) who have completed 205 weeks of treatment.
* Female patients of childbearing potential, and male patients with partners of childbearing potential must be willing to use acceptable contraception, or refrain from sexual activity.

Exclusion Criteria:

* Any patient who is pregnant or plans to become pregnant.
* Any patient who was withdrawn from the ISIS 721744-CS3 OLE study due to a serious adverse event (SAE) related to donidalorsen therapy or who voluntarily withdrew prior to 205 weeks of treatment.
Comparison of the Therapeutic Effects of Intra-Articular Injection of Ozone and Corticosteroid in Knee Osteoarthritis

This clinical trial aimed to involve patients aged 40-85 years who had been experiencing knee pain for at least 6 months and had received a clinical diagnosis of knee osteoarthritis through radiologic imaging. The patients were randomly assigned to two groups. One group received a 3-week intra-articular injection of 15 mg/ml ozone, while the second group received a 1 ml intra-articular injection of betamethasone. All patients were evaluated before treatment, as well as 4 and 12 weeks after the first dose of treatment. The study evaluated treatment efficacy using the Visual Pain Score (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC).


Eligibility Criteria:
Inclusion Criteria:

* 40-85 years old,
* have experienced knee pain and/or limited joint range of motion for at least 6 months,
* have a diagnosis of KOA supported by radiographic imaging.

Exclusion Criteria:

* patients had undergone knee joint surgery,
* had a history of previous intra-articular injections,
* had any rheumatological disease or malignancy,
* being pregnant,
* had pain radiating to the knee and leg.
Safety Study of Calcineurin Inhibitor Free GvHD Prophylaxis in Allogeneic Stem Cell Transplantation

In stem cell transplantation as treatment for malignant diseases, calcineurin inhibitors like cyclosporine A are commonly used to prevent tissue destruction (GvHD) by activated donor immune cells. The hypothesis for this study is, that replacing calcineurin inhibitors by everolimus and mycophenolate as GvHD prophylaxis not only reduces toxicity of the treatment but also improves tolerance induction of the donor T cells toward the host, eventually increasing the safety of stem cell transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hematologic malignancies, indicated for allogeneic stem cell transplantation:
* acute myeloid leukemia (AML), in CR1, ≥ CR2, primary refractory, relapse
* chronic myeloid leukemia (CML), in chronic phase, in acceleration or blast crisis
* myelodysplastic syndrome (MDS), RA/RARS (transfusion dependent), RAEB, RAEB-t and CMML
* Lymphoma:

  * plasmocytoma
  * immunocytoma (M. Waldenström)
  * chronic-lymphatic leukemia (CLL)
  * additional low and high grade Non-Hodgkin Lymphoma
* Hodgkins disease
* HLA-matched (HLA-A, -B, -DRB1) related or unrelated donor available
* Signed informed consent

Exclusion Criteria:

* CNS involvement by underlying disease
* Pulmonary disease with VC \< 55%, DLCO \< 40%
* Cardiac ejection fraction \< 30%, uncontrollable arrhythmia
* Creatinin \> 1,5 mg/dl or Creatinin-Clearance \< 30 ml/min
* Bilirubin \> 2 mg/dl
* Active Hepatitis B or C
* HIV serologic positive
* Pregnancy and lactation
* Pre-menstrual women without medical safe contraception
* Participation on another clinical trial in between 30 days before start or during the study only if the clinical trial interferes with the outcome measures.
* Known allergy to study medication or ingredients of the formulation
* Drug- or alcohol abuse
* Non-compliance
Does a Relationship Exist Between Fetal Hiccups and Computerised Cardiotocography Parameters?

BACKGROUND: The physiological function of fetal hiccups and its correlation with fetal well-being is unexplored. No previous study examines the correlation between the maternal perception of the fetal hiccups and the antepartum cardiotocography.

OBJECTIVE: To evaluate the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies.


Eligibility Criteria:
Inclusion Criteria:

* physiological nonlaboring term singleton pregnancies

Exclusion Criteria:

* . Gestations complicated by fetal malformations, stillbirth, preterm deliveries or patients with missing data were excluded.
To Investigate the Impact of Analgesic Management Guided by qNOX Monitoring on the Comfort and Prognosis of Mechanically Ventilated ICU Patients

Purpose: To explore the effect of analgesic management under the guidance of qNOX monitoring on the comfort level and prognosis of patients with mechanical ventilation in ICU.

Method:After admission to ICU, the patients were randomly divided into the analgesia group guided by BPS（Behavioral Pain Scale） and physiological indicators monitoring and qNOX-guided analgesia group (qNOX group). Sedation and analgesia program after admission to ICU (continuous injection pump) : propofol 1.5-4.5mg/kg.h, remifentanil 5-8ug/kg.h, maintain sedation goals RASS（Richmond Agitation-Sedation Scale）-3 to -4 scores, BPS（Behavioral Pain Scale）3 to 4 scores. The researchers worked with the bedside nurse to plan different care procedures, including :1) central venous catheter or arterial catheter puncture; 2) The patient is turned over completely so that the back can be washed and the sheets changed; 3) Endotracheal sputum aspiration (patients with intubation or in tracheotomy state ); 4) Dressing the wound.

Primary outcome:Value of qNOX at BPS（Behavioral Pain Scale）≥5 (qNOX sensitivity, specificity, positive predictive value and negative predictive value) Secondary outcome:To investigate the patient baseline variables that may affect qNOX; Variables that may influence qNOX in relation to critical illness.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older who are undergoing abdominal, orthopedic, ENT（ear-nose-throat）, urological, neurosurgical or cardiothoracic surgery and require ICU treatment with mechanical ventilation while having an RASS（Richmond Agitation-Sedation Scale）-3 or -4 score;
2. Patients unable to self-assess pain intensity using NRS（Numerical Pain Rating Scale）;
3. Patients who have provided informed consent.

Exclusion Criteria:

1. \< 18 years of age;
2. Pregnant individuals;
3. Patients with communication impairments, such as those who have experienced cerebrovascular accidents;
4. A decision to withdraw life-sustaining treatment or an unstable medical condition that disrupts planned routine care.