cyrilzakka/clinical-trials huggingface dataset:
Different Anesthesia Methods on Development of Postnatal Depression After Cesarean Delivery

Childbirth is one of the most painful experiences for a woman. Labor and period of pregnancy is associated with an increased risk of psychiatric disorders for a woman. The demands of pregnancy and childbirth make patients vulnerable to psychiatric disorders such as postpartum depression (PPD), anxiety, and stress disorders. Women with postpartum psychiatric disorders have high mortality rates. The most common postpartum psychiatric disorder is PPD. PPD occurs any time in pregnancy or in the first four weeks after delivery. It may lead to complications such as emotional lability in the mother. This situation may also effect the child.

Childbirth is one of the most painful experiences for a woman. Labor and period of pregnancy is associated with an increased risk of psychiatric disorders for a woman. The demands of pregnancy and childbirth make patients vulnerable to psychiatric disorders such as postpartum depression (PPD), anxiety, and stress disorders. Women with postpartum psychiatric disorders have high mortality rates. The most common postpartum psychiatric disorder is PPD. PPD occurs any time in pregnancy or in the first four weeks after delivery. It may lead to complications such as emotional lability in the mother. This situation may also effect the child.

Postpartum depression (PD) has become the most frequent complication of childbirth. Its prevalence has been estimated as 10%-15% and its formation is affected by several factors such as lack of social support, previous history of depression, and personal vulnerability. There are several studies about PD in the literature, some discuss about the relation of pain and PD, some discuss about the relation of epidural anesthesia and PD. However, there is no study that compares different anesthesia methods (general anesthesia vs spinal anesthesia) on development of postnatal depression after cesarean delivery.

The aim of this study is to compare the different anesthesia methods (general anesthesia vs spinal anesthesia) on development of postnatal depression after cesarean delivery. The secondary aim is to decrease the ratio of postnatal depression after cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21-50 years old
* 36 gestational weeks or more,
* American Society of Anesthesiologists' (ASA) I and II
* Able to communicate

Exclusion Criteria:

* history of bipolar or psychotic disorder
* suicidal state
* Chronic pain syndrome
* Intraoperative complication
* drug and/or alcohol abuse
* who did not want to participate
* emergency cases
* unable to communicate in Turkish
Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack

It is hypothesized that the addition of formal cardiac rehabilitation to standard care will result in long-term improvements in cardiovascular fitness and functional capacity in individuals who have suffered a transient ischemic attack (TIA) or minor stroke.

Furthermore, it is proposed that the addition of cardiac rehabilitation will influence depressive symptoms and cognition.

A transient ischemic attack (TIA) is defined as an episode of neurological dysfunction caused by focal brain ischemia lasting less than 24 hours. Once an individual has suffered a TIA, preventative measures can be taken to target modifiable risk factors, one of which is physical inactivity. The current proposal focuses on the use of an established model of care (cardiac rehabilitation (CR)) and applies it to those who have suffered a TIA in order to maximize physical activity and minimize risk of future cardiovascular events. This will be a one-group pre/post design study with a 3 month non-intervention period. Participants will undergo measures at baseline and 3 months (non intervention period) then after 6 months of cardiac rehabilitation (cardiovascular fitness, 6 minute walk test, cognition, and depressive symptoms).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with TIA
* Three months post-TIA
* Ability to understand the process and instructions for exercise training and provide informed consent

Exclusion Criteria:

* Resting Blood Pressure greater than 160/100 despite medication
* Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal BP responses or STsegment depression \> 2 mm, symptomatic aortic stenosis, complex arrhythmias)
* Current and extensive exercise participation
* Hypertrophic Cardiomyopathy
* Unstable Angina
* Orthostatic BP decrease of \> 20 mm Hg with symptoms
* Other musculoskeletal impairments which would limit the participants ability to walk sufficient durations
* Pain or other co-morbidities (e.g., unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation
* Cognitive or behavioural issues that would limit participation in exercise testing and training
Gabapentin for Headache in Aneurysmal Subarachnoid Hemorrhage

The purpose of this study is to see how much gabapentin will reduce headaches associated with subarachnoid hemorrhage (SAH) and to reduce the amount of narcotic pain medication prescribed.

The investigators plan to use gabapentin (GBP), an FDA approved non-narcotic pain medication for neuropathic pain, which is also an alpha-2-delta (A2DR) receptor analogue to reduce the pain and decrease the need for narcotics in patients with aneurysmal subarachnoid hemorrhage (aSAH). GBP has been shown to decrease neuropathic and non-neuropathic pain in a variety of perioperative and postoperative conditions. A2DR affinity also has some neuroprotective effect in animal data. The investigators plan to conduct a prospective, double-blinded, randomized trial to further assess GBP-associated reductions in narcotic use and pain scores compared to the non-GBP (placebo) arm. To accomplish this aim, the investigators plan to randomize 20 aSAH patients with headache to either GBP and standard of care pain treatment versus placebo and standard of care treatment.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Have aneurysmal subarachnoid hemorrhage (aSAH) diagnosed by CT scan of the brain and/or angiogram evidence of intracranial aneurysm (CTA or digital subtraction angiogram or MRA)
3. Have symptomatic headache
4. Able to swallow and verbalize pain score
5. No known allergy to gabapentin or fentanyl
6. Numeric pain score ≥ 5
7. Ability to provide written personal consent

Exclusion Criteria:

1. Gabapentin use prior to SAH admission
2. Renal failure with creatinine clearance less than 30 mL/min
3. Unable to receive standard of care pain medications
4. Pregnant or breastfeeding patients
5. History of severe depression defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM IV)
Absolute Bioavailability of YH4808 With Accelerator Mass Spectrometry(AMS)-Based Microdose Study

This study aims to determine the absolute bioavailability of YH4808 using simultaneous oral therapeutic- and \[14C\]-labeled intravenous microdoses.


Eligibility Criteria:
Inclusion Criteria:

* healthy male subject aged 20 to 45 at screening
* subjects who have weight over 55 kg with BMI ranged from 20.0 to 25.0
* subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

* subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* clinically significant allergic disease (except for mild allergic rhinitis)
* subjects who have determined not eligible by screening test (medical history, physical examination, 12-lead ECG, laboratory test, etc) within 28 days of study start
* subjects considered unsuitable for inclusion by the investigator
Knowledge, Attitude and Practices of Flemish Midwifes Regarding Spontaneous Abortion

KAP-study in Flemish midwives with intramural employment

The study will be conducted using a self designed questionnaire administered in midwives who are employed within a Flemish hospital in one of the following departments: maternity, maternal intensive care, (intensive) neonatology, reproductive medicine, gynaecology, delivery and prenatal care. The questionnaire assesses the knowledge, attitude and practices of the midwives regarding spontaneous abortion.

Eligibility Criteria:
Inclusion Criteria:

* midwives who are employed within a Flemish hospital in one of the following departments: maternity, maternal intensive care, (intensive) neonatology, reproductive medicine, gynaecology, delivery and prenatal care

Exclusion Criteria:

* all others
Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

Patients with suspected or proven sigmoid colon adenocarcinoma, eligible for curative treatment whose MRI can be reviewed prior to surgery and has no decision regarding radical treatment are eligible. Patient are randomised to the control arm which the standard care of preoperative CT imaging and subsequent discussion by the Multidisciplinary Team or the interventional arm which has the additional use of MRI imaging and subsequent discussion by the Multidisciplinary Team. Patients are followed up at 1 and 3 years together with QoL questionnaires.

A randomised phase II multicentre trial, IMPRESS will determine whether the use of MRI imaging in staging sigmoid cancers results in a change to the treatment plan by identifying more high risk tumours compared to those patients who were staged using CT imaging. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.

Eligibility Criteria:
Inclusion Criteria:

1. Have a suspected or proven sigmoid colon adenocarcinoma
2. Is eligible for curative treatment
3. Has no irresectable metastatic disease
4. MRI can be reviewed by an MDT prior to surgery
5. Has no decision regarding radical treatment
6. Have provided written informed consent to participate in the study
7. Be aged 16 years or over

Exclusion Criteria:

1. Have metastatic disease (including resectable liver metastases)
2. Have a synchronous second malignancy
3. Are contraindicated for MRI
4. Are contraindicated for or have allergy to Buscopan (e.g. glaucoma, small or large bowel obstruction, GFR\<30)
5. Have severe co-morbidities or previous medical history that prevent the application of eventual chemo/radiotherapy
Surgery Following Immune Checkpoint Inhibitions for Controlled Disease in Recurrent or Metastatic dMMR/MSI-H Colorectal Cancer

Surgical resection for residual lesions could significantly improve the prognosis in metastatic colorectal cancers (CRCs) after systemic treatments, yet the necessity of resecting residual lesions after immune checkpoint inhibitions (ICIs) remains controversial in mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) diseases. We retrospectively enrolled recurrent or metastatic dMMR/MSI-H CRCs who received surgerys from Sun Yat-sen University Cancer Center. Patients without disease progression after at least 2 cycles of ICIs were included. Demographic and clinicopathological data were collected and analyzed. Relapse-free survival (RFS) after surgery were analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. pathologically confirmed CRC with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)20;
2. definite pathological or radiological evidence of recurrent or distant metastasis;
3. received at least 2 courses of ICIs;
4. confirmed as dMMR by immunohistochemical method or MSI-H by polymerase chain reaction or next-generation sequencing;
5. receiving therapeutic surgical treatment for residual lesions or tumor sites and achieving no evidence of disease (NED) ;
6. no progression within the duration of preoperative ICIs

Exclusion Criteria:

-
Observational Study of Oralair® in Children 5-9 Years With Grass-pollen-induced Allergic Rhinitis With/Without Conjunctivitis

Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days of treatment.

The purpose of this study is to further describe the safety and tolerability of ORALAIR tablets in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis with or without conjunctivitis.

Patients are followed for safety and tolerability during the first 30 treatment days.

Eligibility Criteria:
Inclusion Criteria:

Allergen immunotherapy naive male or female outpatients aged 5 to 9 years (inclusive) prescribed ORALAIR.

Exclusion Criteria:

Patients already participating in a clinical trial.
Chronic Pain After Cardiothoracic Surgery

This is a prospective cohort study to estimate prevalence of chronic pain after cardiothoracic surgery

This is a prospective cohort study of all patients undergo cardiothoracic elective surgery in Cipto Mangunkusumo Hospital using general anesthesia. Patients with emergency surgery, history of psychologic and neurologic disease which cannot reliably state their pain score, cannot communicate well, and disagree to follow the research will be exempted. The pain score will be recorded one week after surgery during walk-in consultation, followed by 3 months and 6 months after surgery via telecommunication.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergo elective sternotomy and/or thoracotomy using general anesthesia
* Patients agree to follow the study

Exclusion Criteria:

* Patients undergo emergency sternotomy or thoracotomy
* Patients with pyschological and neurological disorder, that it is not reliable to determine the pain intensity
* Patients who cannot communicate
* Patients disagree to follow the study
Is There a Benefit to Optimize Heart Failure (HF) Treatment in Aged Over 80 Year's Old Patients?

The purpose of this study is to determine if there is an interest to optimize HF (heart failure) management in patients over 80 years old. The primary objective is to assess the effect of HF (heart failure) optimized management (guidelines of the European society of Cardiology (ESC) on Quality of Life (QOL) in aged over 80 year's old at 6 months.

Aging population, and better management of various heart diseases including ischemic explain the growing up of incidence and prevalence of chronic heart failure. The aging of the population leads now to support services in cardiology and particularly in the units of heart failure in subjects over 80 years. It's a special population with several co-morbidities, in whom it is difficult to introduce all the recommended treatments with optimal doses. There is indeed a significant difference between the optimal doses of treatments tested in studies on heart failure and doses found on the orders of inpatients for HF (heart failure). Unfortunately clinical trials on heart failure have recruited young patients, mean age 65 years. Clinical studies in cardiology and particularly in heart failure recruit young subjects at the expense of seniors who are underrepresented in these studies.

The investigators will compare two groups: the first one with an "optimized" management and the second one as "usual care".

The primary endpoint will evaluate the quality of life at 6 months according to the scale of Minnesota. Secondary outcomes will be the quality of life at 12 months, quality of life measured by the SF 12 (to check what level is most suited to this population) at baseline, 6 months and one year, mortality at 12 months, the number of re-hospitalization and cardiovascular events at 12 months, New York Health Association (NYHA) class (at baseline, 6 months and 12 months) and walking test for 6 minutes (at baseline, 6 months and 12 months). Finally the investigators plan to conduct an analysis on the medical and economic interest of this support.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 80 year's old subjects
* Hospitalized for an acute heart failure
* Left Ventricle Ejection Fraction ≤ 35%
* Evaluated life expectancy (Seattle HF score) \> 1 year

Exclusion Criteria:

* Dementia
* Does not understand French language
* Followed with an optimized management
* With reduced mobility
* Recruited in another clinical trial or in a HF management network
* AHF with curable aetiology : cardiovascular surgery for CABG or valvular replacement, angioplasty
* MDRD \< 30 ml/min/1.73m²
Thumb vs Great Toe Recovery

Researches are comparing the accuracy of measuring muscle relaxation in the thumb versus the great toe.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years old
* Patients willing to participate and provide an informed consent
* Patients undergoing an elective surgical procedure that requires use of non-depolarizing NMBA agents administered intraoperatively.
* Patients with planned administration of sugammadex as a neuromuscular blocking reversal agent.

Exclusion Criteria:

* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
* Patients having surgery that would involve prepping the arm or leg into the sterile field
Vocal in Assessment of Endometrium in Postmenopause

The unbalanced estrogen with no progesterone will lead to endometrial thickening .This thickening result in endometrial hyperplasia \& carcinoma and lead to irregular bleeding

Recent advances in the screening and diagnosis of endometrial pathologies (eg,endometrial hyperplasia , endometrial carcinoma ,endometrial polyps and myomas ) are directed towards non invasive methods as Transvaginal ultrasound with 3 D application using different softwares .

One of the applications of 3D Transvaginal Ultrasonography is Vocal technique ( Virtual Organ Computer aided Analysis ) that can measure volume especially in tissues with irregular borders And this technology is considered to be superior than the conventional 2 D ultrasound . .

Eligibility Criteria:
Inclusion Criteria:

-Postmenopausal women who were Complaining of Post-menopausal vaginal bleeding.

Exclusion Criteria:

* Women with hormone replacement therapy.
* Women showing intra-cavitary fluid collection at ultrasound examination
* Women with other gynecological lesions in the pelvis other than the uterus
* Previous diagnosis of endometrial pathology.
RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD)

This is a phase 1 open-label trial to evaluate the safety, pharmacodynamics and clinical activity of RRx-001 administered in combination with irinotecan.

RRx-001 is associated with resensitization to irinotecan in tumors that are previously refractory. This effect has been attributed to the ability of RRx-001 to restore the expression of aberrantly silenced genes, thus re-establishing pathway functions. However, resensitization may have more than one mechanism, among them Pgp pump inhibition and vascular modulation, leading to improved penetration of standard chemotherapy.

This dose escalation study consists of 5 sequential dose cohorts each administered RRx-001 with irinotecan. After the first 3 subjects of each cohort complete Cycle 1, the safety will be assessed before moving to the next dose level. Subjects in the current cohort will continue treatment immediately following the completion of Cycle 1, for as long as therapy is tolerated and the RECIST v.1.1 definition of progression is not met.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of an advanced, malignant, solid tumor(s) with all standard treatment options having been exhausted or declined.
* Eastern Cooperative Group (ECOG) performance status is 0-2 at Screening.
* Measurable disease per RECIST v1.1 by radiographic techniques
* Acceptable liver function, serum creatinine and hematological status
* Female subjects of childbearing potential, and male subjects with partners of childbearing potential, must agree to use medically acceptable methods of contraception beginning on Study Day 1 and continuing until at least four weeks after administration of the subject's final dose of RRx-001.
* Subjects with brain metastases are eligible

Exclusion Criteria:

* Concurrent anticancer therapy; however, radiotherapy is allowed
* Any history of hypersensitivity to irinotecan
* Cholangitis that required treatment or intervention within 4 weeks of study enrollment
* Bilirubin \> 2.0 mg/dL
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study
* If female, subject is pregnant and/or breastfeeding.
* UGT1A1\*28 homozygote or heterozygote
* BMI \>35
Effects of Heart Rate Reduction on Central Arterial Pressure in Healthy Individuals

The purpose of this project is to determine the effects of slowing heart rate upon both central and peripheral blood pressures using Ivabradine. The effects of Ivabradine will be compared to Metoprolol and placebo.

Participants will attend the hospital for 3 visits where they will be randomised to receive either Ivabradine, Metoprolol and placebo on each visit. Non-invasive measures of blood pressure will be recorded before and after consuming the study drug.

Participants will undergo three days of laboratory testing, each visit separated by at least seven days.

In order to assess each potential participant's suitability for the study based upon the relevant inclusion and exclusion criteria, the first visit will involve a medical consultation (history and physical examination), venepuncture (for full blood examination, lipid profile and biochemistry) and a 12-lead surface electrocardiogram. Baseline measurements of central and peripheral arterial and pulse wave velocity will be made at baseline, and 4 hours following the administration of either placebo, 50mg of metoprolol or a 10mg oral dose of ivabradine. The placebo will contain lactose powder.

Subjects will be randomized according to a 3-by-3 Latin square design. Central pulse pressure will be assessed using carotid artery tonometry using a non-invasive Millar Mikro-tip pressure transducer. The transducer is used to applanate the carotid artery and calibrated using brachial mean and diastolic blood pressure (automated oscillometric sphygmomanometer).

Pressure waveforms will also be recorded at the radial, brachial and femoral arteries to permit study of wave reflection at these sites.

Measurements will be taken be taken before and 4 hours following the oral administration of metoprolol/ivabradine/placebo.

Bias will be minimized by blinding both the participants and research staff responsible for data collection to the administered drug.

Any potential patient-specific confounding factors will have minimal impact, as the same participants will be studied after the administration of the three agents.

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers:

* aged 18 - 25 years OR
* aged \>60 years

Exclusion Criteria:

* Chronic disease
* Unable to give informed consent
* Treated or untreated systemic arterial hypertension (SBP \>160mmHg and/or DBP \> 90mmHg)
* Resting bradycardia (heart rate \< 60 beats/minute)
* Pregnancy or active lactation