cyrilzakka/clinical-trials huggingface dataset:
Low-dose Ketamine and Postpartum Depression in Parturients With Prenatal Depression

Postpartum depression is common in mothers early after childbirth and produces harmful effects not only on mothers, but also on infants and young children. Parturients with prenatal depression are at increased of postpartum depression. Low-dose ketamine can be used for antidepressant therapy. We hypothesize that low-dose ketamine has a therapeutic effect on parturients with prenatal depression. This study is designed to investigate whether low-dose ketamine administered during cesarean delivery can decrease the incidence of postpartum depression in parturients with prenatal depression.

Postpartum depression refers to maternal depression developed early after childbirth, with reported incidences varied from 15% to 20%. The development of postpartum depression produces harmful effects not only on mothers, but also on infants and young children. Prenatal depression or high depression score is an independent risk factor for the development of postpartum depression.

Ketamine is commonly used as an general anesthetic. In addition, low-dose ketamine is recommended for antidepressant therapy. We hypothesize that low-dose ketamine has a therapeutic effect on parturients with prenatal depression. However, evidences in this aspect are insufficient. The purpose of this study is to investigate whether low-dose ketamine administered during cesarean delivery can decrease the incidence of postpartum depression in parturients with prenatal depression.

Eligibility Criteria:
Inclusion Criteria:

* Parturients with age from 18 to 45 years and scheduled for elective cesarean delivery;
* Prenatal depression score (EPDS) of 10 or higher;
* Provide written informed consents.

Exclusion Criteria:

* Refused to participate in the study;
* History of schizophrenia or other disease that prevent normal communication before delivery;
* Presence of contraindications to neuraxial anesthesia, including central nervous system diseases (such as poliomyelitis), spinal diseases (such as spinal canal tumor, lumbar disc prolapse, history of spinal trauma), systemic infection (such as sepsis, bacteremia), local infection in the site of puncture, or coagulopathy;
* Severe complications during pregnancy (such as severe preeclampsia, placenta accreta, HELLP syndrome);
* Severe comorbidity before pregnancy (such as severe cardiac dysfunction);
* Scheduled to undergo cesarean delivery under general anesthesia;
* Other reasons that are considered unsuitable for study participation.
Bordetella Pertussis Carriage in College-aged Students

The objective in this observational cohort study of young adults sampled at three intervals during the academic year is to ascertain if there is carriage of B. pertussis in asymptomatic individuals. We hypothesize that in asymptomatic college students there is no carriage of B. pertussis detectable by polymerase chain reaction (PCR) assay.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Not immunosuppressed
* Not HIV positive (not known to be/self-reported)
* Able to tolerate swab procedures
* Able to provide consent

Exclusion Criteria:

* No antimicrobial or immunosuppressive medications taken for chronic conditions
The Usage of High-resolution Magnetic Resonance Imaging in Patients With Post-stroke Aphasia for Predicting the Outcome

Combined analysis of functional and structural language network changes may be a good model for predicting language outcome.

Background \& objectives:

Language impairment after aphasic stroke is both common and debilitating. However the mechanisms of language recovery after aphasic stroke is not fully understood. Investigators plan to detect the changes of functional and structural language networks after aphasic stroke by high-resolution MRI.Then Combined analyse functional and structural language network changes, establishing a prediction model for language outcome.

Methods:

The proposed study is a observational trial that will include 50 patients diagnosed with post stroke aphasia from the neurology clinics at The First Affiliated Hospital, Zhejiang University. Aphasia battery of Chinese(ABC) and functional magnetic resonance imaging (MRI) will be performed at acute(\~2weeks),subacute(3 months) and chronic phase(6months). Only routine drug therapy will be used.

Relevance:

Currently there is little known about the recovery mechanisms of post-stroke aphasia.The proposed study intends to analyse functional and structural language network changes by high resolution MRI, which may reveal the potential recovery mechanism underlying post stroke aphasia..

Eligibility Criteria:
Inclusion Criteria:

* Healthy right-handed native Chinese speakers with more than 6-year education are recruited as healthy controls.

Exclusion Criteria:

* Not right-handed;
* Any use of psychoactive drugs;
* Less than 6-year education;
* Not suitable for MRI scan.
Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children After Road Traffic Accidents: a Randomized Controlled Trial

The purpose of this study is to study the effectiveness of an early psychological intervention 7-10 days after a road traffic accident on posttraumatic stress and behavior of children and adolescents

Within a randomized controlled design the effects of a brief psychological intervention (child, parents) after a road traffic accident shall be examined in a sample of 100 children and adolescents. After a baseline assessment 7-10 days after the accident participants are randomly assigned to an intervention or a control group. Both are re-assessed at 2 and 6 months after the accident by means of standardized questionnaires assessing posttraumatic stress symptoms, depression, and behavior.

Eligibility Criteria:
Inclusion Criteria:

Age 7-16 y Command of German language Road traffic accident inpatient or outpatient treatment at the University Children's Hospital Zurich no pretraumatic developmental delay

Exclusion Criteria:

severe head injury No command of the German language Age below 7 y or above 16 y Other major systemic illness
Patients Preference With Self-Injection: The PRISM Study

The purpose of this study is to determine which short-acting blood thinner (low-molecular-weight heparin \[Enoxaparin\] or unfractionated heparin) is associated with less discomfort and bruising when given as a subcutaneous (under the skin) injection before and after a planned surgery or procedure in patients who temporarily stop warfarin.

Increasing Patient Comfort and Compliance: The Bridging Anticoagulation Clinic strives to provide the highest quality of care to patients who require temporary interruption of warfarin therapy. An important component of optimizing patient care is minimizing patient discomfort with perioperative administration of short-acting anticoagulants (LWMH or UFH) used for bridging therapy, which, in turn, may optimize patient compliance with this treatment. This issue is especially relevant for patients who are receiving out-of-hospital treatment with LMWH or UFH because about 85% of such patients will be taught to self-administer this medication. This study seeks to determine if there is less discomfort and bruising associated with self-injection of LMWH than with UFH.

Minimizing Injection Site Bruising: No studies, to our knowledge, have assessed the characteristics or clinical importance of bruising in patients receiving subcutaneous LMWH or UFH. Thus, there is no evidence to support any association between bruising and discomfort. To bridge this gap in knowledge, we will document each injection site during the course of the study and measure the amount of bruising observed using a standardized photographic methodology. Injection site bruising has the potential to cause medical problems if an injection site hematoma develops, which can become infected or can cause long-term discomfort.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is receiving warfarin therapy with a target international normalized ratio (INR) of 2.0-3.5
2. Patient requires temporary interruption of warfarin because of elective surgery or procedure.

Exclusion Criteria:

1. History of allergy to heparin, including heparin-induced thrombocytopenia (HIT)
2. Bridging anticoagulation with low molecular weight heparin (LMWH) or unfractionated heparin (UFH) not indicated
3. Impaired cognitive function or language barrier
4. Creatinine clearance \< 30 ml/min
5. Patient declines consent
6. Patient is \< 18 years of age.
7. Patient is not willing and able to self inject.
8. Patient has significant visual or hand motor impairment
Study of the Natural Variation in Strokevolume

We would like to investigate the natural variation in the strokevolume of the heart. At the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in strokevolume, after a fluid bolus of 200ml Voluven, when using Esophageal Doppler.

We would like to investigate the natural variation in the strokevolume(SV) of the heart. At the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in SV, after a fluid bolus of 200ml Voluven, when using Esophageal Doppler.

Also we will compare the variation in SV both before and after the patients have been fluid optimized, using an algorithm of 10% increase in SV in order to receive another fluid bolus. The equipment used, will be the CardioQ from Deltex medical.

Eligibility Criteria:
Inclusion Criteria:

* Planned abdominal surgery

Exclusion Criteria:

* Oesophageal pathology,
* Age \>90 yr or \<18 yr,
* Alcohol abuse,
* Aneurism in thoracic aorta
Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface

Diagnosis of Group A beta hemolytic strep tonsillitis -

* cultre of tonsills (gold standard)
* culture from bucal surface (test)

This study will examine 2 groups. first group of 50 children aged 3-18 years and the second group of adults aged 18-65 with a clinical diagnosis of tonsillitis and centor criteria of 2 or more (fever, exudates on tonsills, no cough, enlarged lymph nodes).

In each patient we'll take 2 cultures - the first from the tonsills and the second from the bucal surface. both of them will be sent to MEGA-LAB .

the treatment will be based only on the gold standrad culture from the tonsills.

Eligibility Criteria:
Inclusion Criteria:

* tonsills exudates
* Centor criteria - 2 or more

Exclusion Criteria:

* tonsillectomy
Technetium Based Radioguided Surgery for Prostate Cancer (TRACE) Study

PSMA-radioguided surgery

Given the difficulty visualizing lymph node involvement with pre-operative imaging alone, and the potential to miss metastatic nodal involvement on template PLND, radioguided surgery has been proposed as a technique to improve intra-operative detection and clearance. 99mTechnetium (99mTc) is a frequently used radioisotope in nuclear medicine, with favourable radiation properties and commercial availability\[11\]. It has a 6-hour half-life, and is suited to allow target tissue accumulation, while minimizing patients and investigator radiation exposure. Novel molecule-targeted radiopharmaceuticals using 99mTC and other radioisotopes in the setting of PC have increasing potential for diagnostic imaging, monitoring of therapeutic interventions and directed surgery\[11, 12\]. In relation to radioguided surgery, 99mTC -based PSMA-radioguided surgery (99mTc-PSMA-RGS) was deployed in a feasibility study. Using a specifically designed 99mTc based tracer, 99mTc-mas3-y-nal-k(Sub-KuE), or in short Tc-99m-PSMA I\&S, combined with a gamma probe, guidance of the surgical resection of recurrent PC lymph node metastases was undertaken in 132 patients, yielding a sensitivity of 84% and specificity of 100% and detecting metastases as small as 3mm\[15, 16\]. This raises the question as to whether a combination of PSMA PET/CT imaging and PSMA-radioguided surgery may increase the cure rate in patients undergoing operative management of PC, by increasing detection sensitivity and specificity of nodal metastases.

Eligibility Criteria:
Inclusion Criteria:

* Male, aged ≥ 18 years.
* Hormone-sensitive recurrent prostate cancer after radical prostatectomy
* \<3 soft tissue lesions (lymph node; connective tissue) within the pelvis or retroperitoneum with sufficient PSMA expression (≥3 times regional vascular activity level) as determined by PSMA-based PET
* PSA-value \<4ng/mL
* Had a PSMA PET/CT within 60 days before surgery
* Suitable for salvage lymph node dissection, as per institutional guidelines.
* WHO performance status 0,1, or 2.
* Written informed consent.

Exclusion Criteria:

* Suspicion of local recurrent prostate cancer within the prostatic fossa not treatable by surgery
* Nonregional lymphadenopathy (cM1a) or distant metastases (cM1b/c) as assessed by preoperative PSMA PET/CT.
* Ongoing androgen deprivation therapy (ADT) or within 6 months prior to surgery.
* Severe claustrophobia interfering with PET/CT or SPECT/CT scanning.
HANDLE-a Real World Study on Satralizumab in NMOSD

This study is a single-center, retrospective-prospective, non-interventional cohort study to assess the clinical outcomes of Chinese NMOSD patients treated with satralizumab in a real-world patient management model by collecting follow-up data in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Patients have been diagnosed with NMOSD and tested seropositive for AQP4 antibody, ≥ 12 years old;
2. EDSS score ≤ 8.5 at baseline;
3. Patients have experienced ≥ 1 relapse of NMOSD in the last 12 months or ≥ 2 relapses in the last 24 months;
4. Patients should have received or be anticipated to receive satralizumab treatment for at least 12 months;
5. Patients understand the study procedures and sign the informed consent form indicating willingness to participate in the study (for those \< 18 years of age, the guardian should sign the informed consent form on behalf of the patient).

Exclusion Criteria:

-
The Presence of Friends Increases Food Intake in Youth

Participants will be matched with either their friend or an unfamiliar peer who is the same gender and about the same age. Participants will have 45 minutes of free-play in an experimental room where they will have free access to energy-dense and nutrient-dense foods and an assortment of games and puzzles.

The investigators predict that participants eating with a friend will eat significantly more than participants eating with an unfamiliar peer. The investigators also predict that overweight participants eating with an overweight partner will eat significantly more than participants eating with a non overweight participant.


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls ages 9-15
* Between 15th and 95th BMI percentile for their age

Exclusion Criteria:

* Sickness, psychopathology or developmental disabilities
* Participant has a cold or upper respiratory distress
* Food allergies to the study food
* Participant is on medication or has a medical condition that could influence taste, appetite or olfactory sensory responsiveness.
Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly

Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis


Eligibility Criteria:
Inclusion Criteria:

* Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis
* Use of highly effective contraceptive method and a negative serologic pregnancy test (beta - HCG), if female in fertile phase
* Agree and sing informed consent form

Exclusion Criteria:

* Previous treatment with leishmanicidal drugs in the last 6 months
* Pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin B (QTc greater than 450ms)
* Serum creatinine or urea 1.5 times the upper limit of normal
* Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus
* history of any hypersensitivity reaction to liposomal amphotericin B, miltefosine and/or pentoxifylline
* Pregnant and breastfeeding women
* Patients with Acquired Immunodeficiency Syndrome (AIDS) or other immunodeficiency
Chinese Versions of the Swanson, Nolan, and Pelham, Version IV (SNAP-IV) Scale and Strengths Difficulties Questionnaire.

Background: Attention-Deficit/Hyperactivity Disorder (ADHD) is a common childhood-onset neuropsychiatric disorder (7.5% in Taiwan) with great impact on individual, family, and society. The diagnosis of ADHD is mainly based on clinical interview of parents and children with assistance of teachers' reports. Self-administered rating scales are useful for screening, assistance of diagnosis, and measurement of symptom changes over time or due to treatment effect. The goals of this study are to establish the norms and psychometric properties of the Chinese version of teacher and parent forms of the Swanson, Nolan, and Pelham, version IV (SNAP-IV) and the teacher, parent, and student forms of the Strengths and Difficulties Questionnaire (SDQ) for future studies on ADHD in Taiwanese populations.

Subjects and Methods: This is a cross-sectional, school-based survey with a multi-stage sampling method. The participants include a school-based sample of 3534 first to eighth graders was recruited from four areas: Taipei City, Taoyuan County, Tainan City and Chiayi County. Among them, 200students will be reassessed at 2-week interval for the test-retest reliability study. The instruments comprise the Chinese version of Child Behavioral Checklist (CBCL), SDQ, SNAP-IV, and Adult ADHD Rating Scale. The informants include student participants older than 10 years old, their parents, and teachers. The main statistical methods include Pearson correlation, intraclass correlation, Chronbach's α for internal consistency, and mixed model to address lack of independence within the same classes and schools.

Anticipated Goals: We expect that this study will reach the following objectives:

1. to obtain the primitive information about the prevalence of ADHD symptoms and emotional/behavioral problems among children and adolescents in Taipei and Yun-Ling;
2. to enhance the awareness of school teachers and counselors about ADHD and other behavioral/emotional problems among students;
3. to establish psychometric properties of the Chinese versions of SNAP-IV and SDQ for future use in clinical, school, and research settings.

This protocol was prepared in Chinese

Eligibility Criteria:
Inclusion Criteria:

* School-based subjects: around 3600 grade 1 to grade 8 students aged 6-16 from four sites in Taiwan and their parents (n = 7200)
* Clinical subjects with ADHD: children and adolescents ages 6-16, who are diagnosed with ADHD, IQ \>70, parents and teachers consent to completion of questionnaires.

Exclusion Criteria:

* Clinical subjects with ADHD: those who are comorbid with pervasive developmental disorder and/or mental retardation or other severe psychiatric disorders. Oppositional defiant disorder and conduct disorder are not excluded.
Clinical Performance Of Lithium Disilicate Crowns Restoring Endodontically Treated Teeth With Two Occlusal Preparation Schemes

The aim of this study is to evaluate the clinical performance of lithium disilicate crowns restoring endodontically treated teeth with two occlusal preparation schemes.

Statement of the problem:

The endodontically treated teeth need to be restored back to form, function and aesthetics. The quality of the coronal restoration will directly impact on their survival and success. The aim of the coronal restoration of endodontically treated teeth is to provide the necessary strength for the restoration/tooth complex through tooth preparation in order to withstand functional stress and prevent crown and/or root fracture. The use of ceramic crowns has increased substantially in recent years because of their superior esthetics and high mechanical properties. Long term success of all ceramic crowns is affected by many factors and the failure patterns of these all ceramic crowns should be inspected closely to detect their clinical performance.

Rationale for carrying out the trial:

Endodontic treatment weakens posterior teeth and ought to be covered by crowns.The capability of these crowns to bear load relies on the preparation of an appropriate design and the selection of a crown material with adequate fracture strength and thickness. In vital teeth, the anatomic occlusal preparation design is followed such that the occlusal surface is reduced uniformly, maintaining the cusps and normal inclined planes but at a reduced height. This aids in minimizing the risk of pulp injury. In contrast, in non-vital teeth, this design can be modified such that the occlusal surface is prepared in two planes (buccal and lingual planes). A flat prepared occlusal surface provides less quantitative and better qualitative stresses when compared to an anatomically prepared surface

Eligibility Criteria:
Inclusion Criteria:

* Have no active periodontal diseases or periapical pathosis
* No tooth mobility or furcation involvement with sufficient occluso-gingival height
* Psychologically and physically able to withstand conventional dental procedures
* Patients with good endodontically treated teeth indicated for full coverage restorations
* Able to return for follow-up examination and evaluation

Exclusion Criteria:

* Patient with active resistant periodontal diseases
* Patients with poor oral hygiene and uncooperative
* Pregnant women that won't be able to come for follow-up visits
* Patients in the growth stage with partially erupted teeth
* Psychiatric problems or unrealistic expectations
* Lack of opposing dentition in the area of interest
* Patients with poor root canal treatment
* Patients with parafunctional habits (eg. Bruxism)
Hämeenlinna Metabolic Syndrome Research Program: Effects of Rapeseed Oil on Serum Lipids and Platelet Function

In this study, the effects of dietary intake of cold-pressed turnip rapeseed oil (CTPRO) and milk fat are compared in men with metabolic syndrome having already participated in HMS-02 study.

This open and balanced cross-over study consists of two dietary treatment phases (either Virgino (R) CTPRO or butter) for 6 to 8 weeks. They are separated from each other with an eight-week washout period. At the end of both periods and 12-hour fasting an oral glucose-fat tolerance test is carried out. Except glucose, the test consists cream (after the butter phase) and CTPRO (after the CTPRO phase).

Otherwise, the subjects (n=43) are asked to maintain their normal dietary habits.

Eligibility Criteria:
Inclusion Criteria:

* 43 men with metabolic syndrome having already participated in the HMS-02 Study
* Willing to participate in a demanding dietary study

Exclusion Criteria: