cyrilzakka/clinical-trials huggingface dataset:
Ringer's Lactate Versus Normal Saline in Caesarean Section

The objective of this study is to compare the effect on mean maternal and neonatal pH, and 24-hour postoperative morbidity, following intraoperative infusion of Ringer's Lactated versus normal saline in caesarean section at Mulago Hospital.

The null hypothesis is that intraoperative infusion of Ringer's Lactate in caesarean section at Mulago Hospital will not result in 30% less mean maternal and neonatal pH change than intraoperative infusion of normal saline.

Fluid therapy in caesarean section surgery in Mulago Hospital is done mostly with 0.9% normal saline (NS). Several studies have highlighted the complications associated with large infusion of normal saline. Few studies have compared the effects of an alternative crystalloid, Ringer's Lactate (RL), on perinatal pH and postoperative morbidity in caesarean section surgery.

This trial will be performed in Mulago Hospital Labour Ward theatre on parturients who consent and are scheduled for either elective or emergency caesarean section under spinal anaesthesia from September 2011 to May 2012. Study fluid will be administered intraoperatively only. Preoperative and postoperative venous blood samples will be drawn for venous blood gases, serum urea and creatinine. Placental umbilical arterial cord blood will also be drawn for neonatal arterial blood gases. Mothers will be followed up for 24 hours for incidence of postoperative morbidity.

Eligibility Criteria:
Inclusion Criteria:

* All parturients who consent for the study.
* Up to American Society of Anesthesiology (ASA) class ІІ/E.

Exclusion Criteria:

* Failed spinal anaesthesia that has to be converted to general anaesthesia.
Effect of Omega-3 Supplementation on Child Behavior Problems

The primary purpose of this study was to assess the effectiveness of omega-3 supplementation on behavior problems in children.

This study consists of a randomized, placebo-controlled, double-blind trial of omega-3 on behavior problems in children. All behavior problem outcomes were assessed, although the primary focus was on antisocial and aggressive behavior.

Eligibility Criteria:
Inclusion Criteria:

* child
* age between 8 and 16 years
* residing in the community

Exclusion Criteria:

* fish allergy
* diagnosed mental disorder
* mental retardation
* on medication that may modify lipid metabolism
* extensive use of nutritional supplements within the previous 3 months
Flexor Hallucis Longus Tendon Transfer VS Gastrocnemius Augmented Flexor Hallucis Longus Tendon Transfer in Management of Achilles Tendon Defect

This study aims to compare the functional outcome of Isolated Flexor hallucis longus tendon transfer and Gastrocnemius Augmented Flexor hallucis longus tendon transfer in repair of Achilles tendon defects. Also, compare the two procedures regarding complication rate, time to restore the function, and the need for secondary procedures.

The Achilles tendon (AT) is the largest and strongest tendon in the human body, yet it is also one of the most commonly ruptured tendons, with an annual incidence of about 18 cases per 100,000 people. Around 75% of Achilles tendon ruptures (ATR) occur in middle-aged patients during sports activity or following trauma. These injuries typically happen in a region 2 to 6 cm above the tendon's attachment to the heel, an area that has a relatively poor blood supply, that reducing the probability of the healing of the tendon by conservative management. Because of the absence of significant pain and the ability to partially maintain plantar flexion, it has been reported that around 10-25% of Achilles tendon rupture (ATR) cases are overlooked or misdiagnosed during the initial medical assessment. The delaying of the diagnosis and by the way the treatment results in a greater separation between the tendon ends, with scar tissue filling the gap leading to lengthening to the gastrocnemius muscle decreasing its tensile forces. This makes the surgical intervention for repair of chronic tendo Achillis rupture necessary to restore normal leg function. Various surgical procedures such as reconstruction with V-Y advanced flap, gastrocnemius turn-down flap, local tendon transfer augments (Flexor hallucis longus (FHL) or peroneus brevis), semitendinosus autograft, free tissue transfer including synthetic grafts and allografts to bridge the gap have been described. Some techniques have been combined, such as tissue advancement and tendon transfer. Multiple studies have been done comparing two or more of the mentioned techniques, but to our knowledge there is no randomized controlled study comparing the isolated FHL tendon transfer to gastrocnemius augmented flexor hallucis longus (GAFHL) tendon transfer.

Eligibility Criteria:
Inclusion Criteria:

* Age range: Adolescents and adults with skeletally mature feet (above 12 y in females and 14 years in males).
* Achilles Tendon defects more than 4 cm resulted from acute or chronic rupture, post-debridement defects in case of neglected insertional tendinopathy, spontaneous ruptures due to tendinosis or after tumor resection.

Exclusion Criteria:

* General medical contraindications to surgical interventions
* Calcaneal Fracture, subtalar fusion
* infection or previous surgery in the ipsilateral hindfoot or ankle
* Systemic disease including seronegative inflammatory diseases, spondyloarthropathies or sarcoidosis.
Dexamethasone and Dexmedetomidine as Adjuvants to Ropivacaine in Ultrasound-guided Multilevel Thoracic Paravertebral Block for Lobectomy: A Prospective, Randomized, Triple-blind Study

The hypothesis is whether perineural dexamethasone and dexmedetomidine prolonged the duration of analgesia as compared with either perineural dexamethasone or perineural dexmedetomidine after TPVB.

Design: A prospective, randomized, controlled study Setting: Single-center university hospital. Participants: The study included 90 patients undergoing lobectomy under general anesthesia.

Interventions: The patients were allocated randomly into the following 3 groups: 20 ml mixture of 37.5 mg ropivacaine with 5 mg dexamethasone (RS group) or 1 µg/kg dexmedetomidine (RM group), or with 1 µg/kg dexmedetomidine and 5 mg dexamethasone (RSM group). Ultrasound-guided TPVB was performed at 4 points-T4-5, T5-6, T6-7, and T7-8 of the surgical side; 5 mL of solution were injected at each point. Postoperatively, the PCIA was used as part of multimodal analgesia, and all patients recieve .

Eligibility Criteria:
Inclusion Criteria:

ASA physical status I-II grade Undergoing elective lobectomy under general anesthesia. Participants aged from 16-65 years old.

Exclusion Criteria:

Refusal for TPVB Inability to obtain informed consent Coagulation disorders, neuropathy, or body mass index greater than 40 kg/m2 Pregnancy Infections at the site of injection for the TPVB Allergy to dexamethasone; dexmedetomidine; ropivacaine Clinically significant cardiovascular, pulmonary, renal, or hepatic diseases
Efficacy of Osteopathic Treatment on the Side Effects of Curative Treatments of Lymphoblastic Leukemia in Pediatrics

During the curative treatment of cancer, pain often remains the dominant symptom affecting the physical and psychological state of the patient.

Osteopathy is an exclusively manual practice whose goal is to compensate for mobility dysfunctions of the tissues of the human body. It can be used as a complementary treatment for cancer pain when pain medications are not enough.

The aim of this study is to examine the effectiveness of osteopathy in reducing pain intensity and improving quality of life in patients treated for pediatric acute lymphoblastic leukemia.

During the curative treatment of cancer, pain often remains the dominant symptom affecting the physical and psychological state of the patient.

Osteopathy is an exclusively manual practice whose goal is to compensate for mobility dysfunctions of the tissues of the human body. It can be used as a complementary treatment for cancer pain when pain medications are not enough.

The aim of this study is to examine the effectiveness of osteopathy in reducing pain intensity and improving quality of life in patients treated for pediatric acute lymphoblastic leukemia.

Primary objective :

To evaluate the effectiveness of five osteopathy sessions at regular intervals on the characteristics of the pain felt in patients aged 1 to 10 years treated for acute lymphoblastic leukemia using the HEDEN scale (Hetero-Evaluation Pain Child).

Eligibility Criteria:
Inclusion Criteria:

* Patient managed and treated with a diagnosis of acute lymphoblastic leukemia
* Patient between 1 and 10 years of age
* Patient with pain at inclusion, or pain at diagnosis related to leukemia
* Social security affiliation or entitlement
* Signature of informed consent by both parents

Exclusion Criteria:

* No pain reported at the time of management or diagnosis
* Surgery less than 30 days old
* Patient with another contraindication to osteopathic treatment (worsening of the condition, bleeding syndrome), or a psychiatric pathology that prevents the scales from being used.
Spironolactone in Diabetic Nephropathy

The aim of the study was to evaluate the renoprotective effect (i.e. albuminuria- and bloodpressure lowering effect) of spironolactone 25 mg o.d. in type 1 and type 2 diabetic patients with albuminuria despite recommended antihypertensive treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus
* Diabetic Nephropathy
* Glomerular filtration rate \> 30 ml/min/1.73 m2
* Blood pressure \> 130/80 mm Hg

Exclusion Criteria:

* Child bearing potential
* Plasma-potassium \>4.5 mmol/l
* Breastfeeding
* Abuse of alcohol or drugs
* Non-diabetic kidney disease
Effectiveness Evaluation of the Sinopharm Vaccine in the Dondo District in Mozambique

Three complementary activities will be implemented:1) Baseline and repeat census of the catchment population; described in a separate protocol (IVI-ECOVA-03-WS1); 2) Enhanced surveillance for COVID-19 disease, and 3) AEFI-enhanced surveillance. The mass vaccination campaign will be conducted by the Government and is not part of this protocol.


Eligibility Criteria:
Inclusion Criteria:

1. They resided in the study area at the time of mass immunization with the Sinopharm vaccine; and
2. They are at least 18 years of age during first round of mass vaccination.
3. Their onset of symptoms was \<10 days prior to testing.
4. For each selected PCR test-positive case, we will select up to 3 test-negative controls from generally eligible subjects, matched to each case by age on the date of testing, sex, and calendar date of testing + 3 days.

Exclusion Criteria:

1. We will exclude subjects for selection as controls if they have had a positive test result within the following 21 days
2. Any Participant not matching the inclusion criteria mentioned above.
Somatuline Predictive Factors in Acromegaly and NET

The aim of the study is to identify predictive factors for the response to Lanreotide treatment in Acromegaly as well as in Neuroendocrine Tumours.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent (also mandatory in case of retrospective documentation of subject data)
* Diagnosis of acromegaly or NET with the intention to be treated with ATG or already on treatment with ATG

Exclusion Criteria:

* The subject has already been included in this study
* Participation in an interventional trial
Effects of Sitaglpitin on Endothelial Function During the OGTT in T2DM

To investigate whether single administration of sitaglitpin can restore acute endothelial dysfunction and ameliorate impaired increase of the number of endothelial progenitor cells (EPCs) after oral glucose loading in patients with T2DM.

To compare the effect of sitagliptin and glimepiride on endothelial function evaluated by flow-mediated vasodilatation (FMD) and the number of circulating EPCs in patients with T2DM.

Acute and chronic improvement of endothelial function is expected through the pleiotropic effect of DPP-4 inhibitors. A randomized, prospective, open-labeled, parallel design. The duration of treatments with sitagliptin or glimepiride is 12 weeks. The number of study centers is a single (Dokkyo Medical University Hospital). Participants will be randomized into the two treatment groups; (a) 50mg sitagliptin (N=15) and (b) 1mg glimepiride (N=15).

Anti-Hyperglycemic effect is expected to be similar according to our study

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent before any study specific procedures
* Type II diabetes who have inadequate glycaemic control (6.5%≦HbA1c\<9.0%)
* Age from 20 to 80 years old
* No history of using any antihyperglycemic drugs
* No history of cardiovascular complications
* No treatment or treatment with stable doses of lipid-lowering, antihypertensive, and antiplatelet agents for at least 3 months prior to randomization
* 4.5 % ≤ fasting FMD at baseline \< 8.0 %

Exclusion Criteria:

* ・Type I diabetes

  * Pregnancy
  * Liver disease (hepatic enzymes more than three times the upper limit of normal ranges)
  * Impairared kidney function (serum crearinine greater than 1.3 mg/dl in men, 1.2 mg/dl in women)
  * Cigarette smokers
  * Contraindications to glimepiride and sitagliptin
  * Active proliferative diabetic retinopathy
Single-Level TLIF: Post-Fusion Rehabilitation

This investigation will assess how the timing and type of rehabilitation after a transforaminal lumbar interbody fusion will affect the efficacy of the surgical procedure. The efficacy of the procedure will be evaluated through patients' quality of life, measured by health-related quality of life questionnaires up to 24 months following the procedure. These measures will be compared to the patients' baseline value.

Patients will undergo transforaminal lumbar interbody fusion for degenerative pathology at the L4-5 vertebral level. They will be randomized to one of three postoperative rehabilitation groups. Group 1 will receive "structured early rehabilitation" beginning at 7 weeks. Group 2 will receive "Delayed rehabilitation" beginning at 13 weeks postoperatively. Group 3 will undergo "Self Rehabilitation" beginning at 7 weeks postoperatively. Groups 1 and 2 will undergo rehabilitation under the supervision of a certified physical therapist for 10 total weeks. Group 3 will undergo non-supervised rehabilitation for 10 total weeks, and will be given educational materials regarding which exercises to perform and at which intervals.

Eligibility Criteria:
Inclusion Criteria:

i. Single-level L4-L5 TLIF for degenerative pathology, including: radiculopathy, neurogenic claudication, intervertebral disc disease, facet joint disease, degenerative spondylolisthesis, degenerative myelopathy degenerative kyphosis and scoliosis ii. Back and/or leg pain iii. Failed at least 3 months of conservative treatment

Exclusion Criteria:

i. Older than 65 years of age ii. Prior spinal surgery excluding laminectomy/discectomy iii. Greater than Grade 2 spondylolisthesis iv. Greater than 10 degrees scoliosis v. Not worked for greater than 6 months or unemployed as a result of lumbar condition vi. History of spinal infection
Psychoeducational Programme for PD Patients With STN-DBS

Bilateral subthalamic deep-brain stimulation is a well-established therapeutic option to improve motor signs and reduce dopaminergic treatment and related motor complications in patients with severe forms of Parkinson's disease (PD). However, psychological disorders and socio-familial maladjustment are less clearly improved with subthalamic stimulation with an aggravation of the social adjustment described in about 1/3 of cases, with work disruption, divorce or familial conflict. The caregivers have also been reported to present negative well-being after surgery with an aggravation of the quality of life. In the present study, the investigators evaluate the effects of a perioperative psychoeducational programme to avoid postoperative socio-familial maladjustment in PD patients candidate for subthalamic stimulation, and their caregivers, in a randomized controlled study.

After inclusion, patients (and their caregivers) are randomized into two groups stratified on their preoperative social adjustment scale couple domain score : usual treatment and psychoeducational programme or usual treatment alone (Figure). The psychoeducational programme focuses on 3 domains: 1) neurosurgical procedure and neurological outcome, 2) social life including work, social and familial relationship, 3) couple relationship. The programme consists of 7 sessions with 3 to 4 couples at the same session, except for the 'couple relationship' domain. Each domain is tackled in a two-way manner with information/education proved by the investigator and discussion of the patients' and caregivers' expectations during one session. The following session started with a 'Questions and Answers' on the previous domain and then information on another domain. Four sessions were carried out prior to surgery and 3 after.

Eligibility Criteria:
Inclusion Criteria:

* Parkison's disease
* Patients candidate for STN DBS
* Caregiver agreeing to participate
* Signed informed consent

Exclusion Criteria:

* Contra-indication to STN-DBS
* No caregiver agreeing to participate
* Dementia
* Severe ongoing psychiatric disorder
Cognitive Behavioral Social Skills Training for Youth at Risk of Psychosis

Schizophrenia and other psychotic disorders are serious and debilitating mental illnesses that incur substantial suffering for patients and major challenges to the investigators health care and legal systems. The prodrome is the period prior to onset of psychosis when functional decline and clinical symptoms gradually emerge. The presence of a clinical high-risk (CHR) syndrome in young adults is associated with heightened risk (25-35%) for the later development of psychosis, and for those who do not necessarily go on to develop a psychotic illness, research has suggested that the majority continue to have fluctuating subthreshold symptoms and poor social and role functioning. There are no specific treatments to help with these functional difficulties. However, recent findings suggest that in people with schizophrenia, Cognitive Behavioral and Social Skills Training (CBSST) leads to significantly greater increase in the frequency of social functioning activities compared to treatment as usual or goal-focused supportive therapy, and preliminary data suggest CBSST is a feasible treatment for CHR. This proposal is a competitive application for a three-site, longitudinal study aimed at testing the effectiveness and feasibility as well as mediators and mechanisms of action of a manualized CBSST intervention that will target functional difficulties associated with clinical risk states for psychosis. The goals are 1) to examine whether CBSST compared to a placebo intervention (psychoeducation) matched for group involvement and therapist time improves functioning in youth at CHR and 2) to determine whether reduction in defeatist beliefs and improvement in social competence mediate change in psychosocial functioning in CHR youth in the CBSST. In this single-blind randomized 2-arm trial participants will be randomized to one of two treatments: CBSST, an 18-week group comprised of three modules; 1) Cognitive Skills; 2) Social Skills; and 3) Problem Solving, or a psychoeducation support group that does not teach active cognitive behavioral therapy or social skills training. Over a five-year period, the multi-site collaboration will follow large CHR sample that will undergo comprehensive assessments of psychosocial and behavioral changes, to examine changes in social and role functioning, as well as symptom changes from baseline to the end of treatment, and to 6 month follow-up. This approach will demonstrate the feasibility of a treatment for which it is easy to train therapists and which can readily be disseminated to regular clinical community practice. In addition, it will provide insights into likely approaches to halting or mitigating the pathological process and advance the investigators understanding of risk prediction; both critical steps in prevention.


Eligibility Criteria:
Inclusion Criteria:

* have prodromal criteria in the past 4 years
* one attenuated psychotic symptom rated 3 or more
* rating on social functioning \<6

Exclusion Criteria:

* meet criteria for a psychotic disorder neurological disorder IQ\<70
Bio-assay Development and Implementation for Fungal Infection Detection

The purpose of this study is to determine whether the newly developed biosensor can be used to detect and quantify fungal cells in human blood samples.

The study discussed here is part of a broader research project (IOF project) that is aimed at the development and implementation of a point-of-care devices, in which Fiber-Optic Surface Plasmon Resonance (FO-SPR) is used as a detection system. This project includes the development and implementation of the (FUNGDETECT) sensor for fast and accurate detection of fungal pathogens in human blood samples. In first instance, the sensor will be tested in buffer solutions spiked with a known amount of Candida albicans cells. Further validation of the prototype includes detection of these cells in human blood samples. In a first experiment, detection of yeast cells will be performed in blood samples from 5 healthy volunteers each spiked with yeast cells from different Candida spp.. A second experiment includes the detection in blood samples from 15 patients who suffer from a candidemia. The blood samples will be collected from patients of University Hospitals (UZ) Leuven.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers for validation of the (FUNGDETECT) sensor (Spiked blood samples)
* Candidemia

Exclusion Criteria:

* None
NOX4 and Related Biomarkers in ADPKD

To determine the value of NOX4, markers of mitochondria injury and function, and oxidative stress as real-time biomarkers to assess disease severity in patients with early autosomal dominant polycystic kidney disease (ADPKD).

This will be a cross sectional study and will include male and female, young (15-40-years) well characterized patients with early (eGFR\>70mL/min/1.73m2) ADPKD. Patients with different classes of disease severity will be selected using the ADPKD imaging classification. The study will include 60 class-1 (A-E) patients (N=12 per each sub-class).

Eligibility Criteria:
Inclusion Criteria:

* ADPKD (based on Ravine et al. criteria)
* Class 1 A-E according to imaging classification
* Male and female subjects 15 - 40 years of age
* Estimated GFR\> 70 mL/min/1.73 m2 (CKD-EPI)
* Ability to provide written, informed consent

Exclusion Criteria:

* Class 2 according to imaging classification
* Concomitant systemic disease affecting the kidney
* Diabetes mellitus
* Predicted urine protein excretion in \>1 g/24 hrs
* Use of antioxidants i.e. vitamins, Nrf2 activators
* Abnormal urinalysis
A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee

The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in overweight and obese subjects with knee osteoarthritis. The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged \>= 40 years with a BMI \>= 25 and \<= 40 kg/m2
* In the past, has been diagnosed with knee OA
* Radiographic evidence of OA in the study knee

Exclusion Criteria:

* A diagnosis of any other rheumatic disease
* Current conditions in the study knee that would confound efficacy
* Selected, traditional clinical safety and laboratory parameters