cyrilzakka/clinical-trials huggingface dataset:
Oral Feeding Delay Prevention in Preterm Newborns

Preventing oral feeding delays in preterm newborns remains a stake for NICU nowadays. Indeed, it lengthens hospitalization duration, distorts parent-newborns relationships, and increases the risks of adverse nursing outcomes. Does a routine individualized developmental preventive feeding care implying parents favors earlier autonomous oral feeding achievement in preterm newborns as compared with a standardized routine program of orofacial stimulations, despite neonatal risks that every preterm newborn cumulates during hospitalization stay ?

The goal of this observational study is to compare the efficiency of two routine preventive feeding care in preterm newborns, taking into account neonatal cumulated risks for each preterm newborn participant. The main question it aims to answer is: Does a prospective individualized routine developmental preventive feeding care leads to earlier oral feeding achievement in preterm newborns despite individual risks, as compared with a retrospective standardized routine program. The group of preterm newborns prospectively assigned in the study will be included in NIDCAP strengthen with a parental support on nursing care named PARENTALIM. The group of preterm newborns retrospectively assigned in the study received orofacial stimulations in a standardized protocol way (SOFS) Researchers will compare prospective and retrospective groups to see if the prospective group achieve autonomous oral feeding, despite individual neonatal cumulated risks, significantly earlier than retrospective group.

Eligibility Criteria:
Inclusion Criteria:

* Parents of preterm newborns born before 34 weeks of amenorrhea
* Parents who agree participating in the study after signing an informed consent.
* Minimal delay of 72 hours and maximal delay of 15 days after birth to inform parents and wait their consent.

Exclusion Criteria:

* Parents of preterm newborns born after 35 weeks of amenorrhea
* Parents who disagree participating in the study, even after signing the informed consent.
* Parents of preterm newborns born with cerebral, maxillo-facial, digestive, cardiac, genetic or syndromic abnormalities.
The Effect of Fluid Management by Pleth Variability Index on Acute Kidney Injury in Obese Patients

This study was to find out whether laparoscopic colorectal surgery is detrimental to the kidneys via PVI monitoring. To detect the kidney injury, so-called kidney troponin NGAL ,which gives earlier information than creatin in renal ischemic injury, was used.

Our object in this study was to find out whether laparoscopic colorectal surgery is detrimental to the kidneys via PVI monitoring. To detect the kidney injury, so-called kidney troponin NGAL ,which gives earlier information than creatine in renal ischemic injury, was used.

Patients undergoing elective laparoscopic colorectal surgery, 18 to 75 years old, planned surgery duration longer than 2 hours, were included in this study. Patients were divided into 2 groups with respect to their fluid resuscitation, Group 1: goal directed fluid therapy via PVI monitoring Group 2: conventional fluid resuscitation. Blood samples were drawn from both groups for NGAL measurement before CO2 insufflation (T0), and at 6th(T1) and 12th(T2) hours after CO2 insufflation. At the end of the surgery, sugammadex was given to all patients for reversal of muscular blockade.

Eligibility Criteria:
Inclusion Criteria:

* laparoscopic surgery
* obese patient

Exclusion Criteria:

* patient refusal
* major comorbidity
* renal failure
* diabetes mellitus
Study Comparing a Cohort of Women Having a Classic Caesarean to a Cohort of Women Having a FAUCS Caesarean (FAUCS)

The main objective of this study is to compare the time taken to obtain "street fitness" status for women after extraperitoneal cesarean section compared to women after a classic cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for a caesarean between 38 and 42 weeks pregnant
* Patient aged between 18 and 42 years old
* Singleton
* Caesarean section with a theoretical operating time \< 1 hour (without major complications)
* Patient affiliated to a social security scheme
* Patient having signed the free and informed consent.

Exclusion Criteria:

* BMI \> 40
* High blood pressure treated intravenously
* Pre-existing diabetes in pregnancy
* Allergy to analgesics
* Prenatal depression
* Pathological insertion of the placenta (placenta previa or accreta).
* History of major pelvic or abdominal surgery (myomectomy, peritonitis) other than caesarean section or minor surgery.
* Addiction (drugs)
* Pre-existing psychiatric pathology leading to a risk of impaired judgment or behavior.
* Patient participating in another clinical study with a drug or medical device
* Protected patient: Adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Patient hospitalized without consent.
The Research of Standard Diagnosis and Treatment for HSPN in Children

This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN in children.

Henoch-Schonlein purpura nephritis (HSPN) is one of the most common complications of Henoch-Schonlein purpura, and has become one of the main causes of chronic kidney disease in children. However, the diagnosis and treatment of HSPN is still based on the clinical experience, lacking of evidence-based support. This study is performed to explore the biological marker for early prediction of the prognosis and evaluate the efficacy and safety of various measures in the treatment of HSPN in children.

The patients who are proved to get HSPN by renal biopsy will be given prednisone 2mg/kg/d, and randomized to receive cyclophosphamide pulse i.v.,mycophenolate mofetil p.o. or leflunomide p.o., we will follow up them for about 2.5 years and compare the efficacy and safety of these measures by monitoring several indexes.

Eligibility Criteria:
Inclusion Criteria:

* Renal biopsy proved HSPN Proteinuria ≥ 50 mg/kg/d

Exclusion Criteria:

* The children with congenital diseases Proteinuria \< 50 mg/kg/d
Thoracic Interfascial Plane Block Versus Thoracic Paravertebral Block in Gynecomastia Surgery

The growing increase in the number of gynecomastia surgeries has resulted in an increased need for anesthetic techniques with improved pain reduction, safety, and fewer complications.

The aim of this work is to compare the efficacy of ultrasound guided thoracic interfascial plane block and ultrasound guided thoracic paravertebral block for anesthesia in gynecomastia surgery.

This prospective randomized open label clinical trial will be carried out on 90 male patients undergoing elective idiopathic gynecomastia surgery in Tanta University Hospitals.

Study design:

Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes:

Group C: 30 patients will receive bilateral tumescent local anesthesia as a control group.

Group TPVB: 30 patients will receive bilateral US guided thoracic paravertebral block.

Group TIPB: 30 patients will receive bilateral US guided thoracic interfascial plane block.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 up to 65 years
* Male gender only
* ASA physical status I and II
* Weight 75-100 kg
* Duration of surgery ≤ 2 hours
* Scheduled for elective idiopathic gynecomastia surgery

Exclusion Criteria:

* Patient refusal.
* Uncooperative patients.
* Known hypersensitivity to local anesthetic (LA) (bupivacaine).
* Local infection at the site of injection (TPVB or TIPB).
* Coagulopathy.
* History of opioid abuse or chronic analgesic use.
Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Chronic Neuropathic Pain.

Evaluate long-term safety and efficacy of pregabalin in patients with chronic neuropathic pain.


Eligibility Criteria:
Inclusion Criteria:

* Must have met the inclusion criteria for the preceding double-blind BID study in diabetic neuropathy or postherpetic neuralgia.
* Must have received study medication under double-blind conditions.

Exclusion Criteria:

* Patients cannot participate if they experienced a serious adverse event during the previous double-blind BID study which was determined to be related to the study medication.
Transrectal Evaluation After Discoid Resection for Endometriosis Intestinal

Evaluating the success of rectosigmoidoscopy performed after intestinal resection in women with deep endometriosis during surgery

Endometriosis is an inflammatory, benign, oestrogen-dependent condition that affects 10-15% of women of reproductive age. It is characterised by the presence of endometrial tissue, glands and stroma, outside the uterine cavity. Endometriosis may present in the pelvis as superficial peritoneal, ovarian or deep infiltrating. The reported prevalence of bowel or recto-vaginal space involvement among women with endometriosis ranges from 5% to 25% (2). Surgery is the treatment of choice for deep endometriosis with bowel involvement when drug therapy alone is ineffective in treating symptoms. Surgical techniques for intestinal endometriosis can be divided into full-thickness techniques (discoid or segmental resection) and non-full-thickness techniques (shaving).

Focusing on women who underwent a discoid resection, 3.7% of 80 reported a recto-vaginal fistula and the same percentage showed early rectorrhagia requiring endoscopic treatment after surgery. In general surgery rectosigmoidoscopy has shown encouraging results as a feasible, safe and effective technique in reducing the risk of complications related to intestinal anastomosis. There are no studies in the literature evaluating the role of rectosigmoidoscopy as a routine practice in gynaecological surgery for endometriosis, so we rely on the experience of general surgeons. In particular, the lack of data does not allow us to evaluate the feasibility of rectosigmoidoscopy during deep endometriosis surgery in terms of the success of the procedure itself and the additional operative time taken. The latter aspect is also important from the point of view of health policy due to the increased cost of the operating theatre directly related to the time taken for the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 and 50 years
* Women with diagnosis made by instrumental examination such as transvaginal ultrasound, of deep endometriosis with suspected bowel involvement
* Women undergoing segmental or discoid resection for bowel endometriosis
* Obtaining informed consent

Exclusion Criteria:

* Patients who are candidates for elective laparotomic surgery
* Patients with concomitant inflammatory bowel disease known in history (inflammatory bowel syndrome)
Investigation Into the Infectivity Levels of Human Papilloma Virus (HPV) in Tonsillar Tissue

Human Papilloma Virus (HPV) has been shown to be a cause of Head \& Neck Squamous Cell Carcinoma (HNSCC) and the majority of current studies focus on what is happening in patients with a HPV HNSCC. But there is limited investigation into HPV infection in the oropharynx of patients who do not have HNSCC. The current incidence of oral HPV infection is not known in the general population locally and there is also limited information on what particular localities within the mouth that patients' harbour HPV infection what strains are present and if there are any differences in viral load.

Therefore the aim of this project is to investigate within patients that undergo tonsillectomies the rate of HPV infection in tonsils to determine the amount of HPV present within the community.

Patients are having no additional invasive testing than is all ready being carried out for their care pertaining to their tonsillar tissue. Patients are routinely swabbed pre-operative for evidence of MRSA, this trial would add an extra swabbing procedure for the mouth.

The ethical implications are related to the tissue which is being tested for a virus that can be implicated in head and neck squamous cancer. These patients would not normally be aware of HPV infection and this would raise an new health burden in these patient who are likely to be fit and well. The research team would be suitable to counsel patients from any worries related to HPV infection.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing routine tonsillectomies who can provide consent to participate over the age of 18 years old would eligible to enter the study. They would all ready be listed for a tonsillectomy after being seen by an ENT surgeon.

Exclusion Criteria:

* Patients unable to give informed consent
* If the tonsillectomy is carried out to diagnose cancer
* Patient chooses to decline recruitment into the study
Intraoperative Versus CT Guided Celiac Plexus Neurolysis in Unresectable Pancreatic Cancer

Many studies had stated that the coeliac plexus neurolysis (CPN) is a safe and effective treatment method of pain associated with pancreatic cancer. The neurolytic injectate is usually alcohol 50-100%; however, phenol \>5% is also possible to use. Nowadays, there are several techniques to access the coeliac plexus (per cutaneous using fluoroscopy or computed tomographic imaging (CT), surgical and endoscopic ultrasound). However, the percutaneous computed tomography guided technique is the gold standard technique, it has multiple drawbacks as availability and cost of imaging modality, exposure to radiation and multiple complications.Surgical technique in spite of being easy, cheap but there is a controversy about its efficacy. Also there is no head to head comparison between the surgical technique and the percutaneous technique.In this study we hypothesized that intraoperative technique has the same efficacy of percutaneous celiac block technique with less complication and cost

This study aimed to compare the efficacy of the surgical technique versus the per cutaneous computed tomographic guided technique of celiac plexus neurolysis for pain management in unresectable pancreatic cancer . all patients suffering from pain of pancreatic cancer with VAS≥5 undergoing laparotomy and proved to be unresectable either undergoing biopsy or bypass surgery will receive celiac plexus neurolysis either intraoperative or post operative CT guided . All patients will be managed by systemic analgesic if the block not sufficient . In this study we will give the patient the analgesic according to WHO recommendation as starting by non steroidal anti inflammatory drugs as diclofenac sodium, if it is not sufficient we will give them opioids as tramadol, and for neuropathic pain gabapentin. All drugs will be given with escalating dose . Failed block defined as change in VAS between VAS BASELINE AND ONE MONTH ≤ 3 may need to repeat the block by percutaneous technique .

Eligibility Criteria:
Inclusion Criteria:

* Adult patients suffering of pain from pancreatic cancer with baseline VAS≥5, scheduled for surgical assessment
* patients proven histololgically to be unresectable
* patients undergoing either biopsy or bypass surgery

Exclusion Criteria:

* patient with resectable tumour will be excluded.
* Patient with coagulopathy.
* patient with aortic aneurysm.
* patient with any disease contraindicating any sympathetic blockade as advanced cardiac disease .
Acute Tocolysis With Terbutaline for Suspected Fetal Distress

The trial was to determine the effect of administrating subcutaneous terbutaline prior to emergency caesarean delivery for suspected fetal distress

The trial was a double-blinded, placebo-controlled study using subcutaneous terbutaline for acute tocolysis prior to emergency caesarean delivery in suspected fetal distress. The intervention (subcutaneous terbutaline) was compared to placebo looking at the neonatal and maternal outcomes.

The primary outcome was the proportion of babies with neonatal acidosis (based on umbilical artery blood sampling at delivery). Other outcome of interest were the mean cord pH and base excess, the Apgar score at 5 minutes after delivery, he proportion of babies requiring intubation and admission to the Neonatal Intensive Care Unit. The maternal outcomes of interest were the changes in mean arterial pressure (before and after the drug or placebo injection), the maternal heart rate changes, the estimated blood loss, and the hematocrit changes.

Eligibility Criteria:
Inclusion Criteria:

* term singleton pregnancy
* cephalic presentation
* in labour with cervix dilatation \> 4cm and regular uterine contractions of 3 or more 10 min
* abnormal fetal heart rate status diagnosed using standard electronic FHR according to NICE guideline (2014)
* acceptance of participation by the signing of a written consent.

Exclusion Criteria

* maternal cardiopathy
* hyperthyroidism
* abruptio placentae or other placental accidents
* hypertensive disease of pregnancy
* hyperstimulation with oxytocin
* multiple gestation
* abnormal fetus planned for conservative management
* evidence of intrauterine growth restriction
* patient on medication which will interact with terbutaline (tricyclic antidepressants, beta-blockers, diuretics and sympathomimetic medicine).
Impact of Adjuvant Chemotherapy in Patients With Colon Cancer

The present study aims to investigate the impact of adjuvant chemotherapy with 5-FU isolated and associated with oxaliplatin in cardiac autonomic control and endothelium-dependent vascular function in patients undergoing colectomy for stages II and III colon cancer. Will be performed evaluation of cardiac and vascular function, autonomic control, functional capacity and blood evaluations.

Cancer is a major public health problem. Colorectal cancer is the third most common cancer in men and women around the world. Despite advances in surgical and pharmacological treatment, this type of cancer remains a leading cause of cancer death in Western countries. The adjuvant chemotherapy treatment based on the use of fluoropyrimidine, especially 5-fluorouracil (5-FU) is the mainstay of the pharmacological treatment of colorectal cancer. This treatment showed benefit in overall survival and progression-free survival in the adjuvant treatment of patients with stage II and III disease. In the last decade, the combination treatment with oxaliplatin has shown benefit in patients with either metastatic disease as with locoregional disease who underwent surgical treatment. However, the increased use of 5-FU and oxaliplatin, and increased patient survival have caused increased incidence of adverse events. 5-FU has cardiotoxic effects that may range from 1.2 to 18% depending upon the drug administration. Another adverse event of chemotherapy for colon cancer is neurotoxicity. Peripheral neuropathy is one of the toxicities associated with treatment with Oxaliplatin and its characteristics to be dose-dependent and cumulative. Thus, the adjuvant chemotherapy with 5-FU and oxaliplatin may cause cardiotoxicity, changes in vascular function and increased oxidative stress. What is not known are the effects of treatment of 5-FU and oxaliplatin in cardiac autonomic modulation and peripheral vascular function. Therefore, the present study aims to investigate the impact of adjuvant chemotherapy with 5-FU isolated and associated with oxaliplatin in cardiac autonomic control and endothelium-dependent vascular function in patients undergoing colectomy for stages II and III colon cancer. Will be performed evaluation of cardiac and vascular function, autonomic control, functional capacity and blood evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Scale of Performance Status 0 - 1
* Patients submitted to colectomy for adenocarcinoma of colon stages II and III.

Exclusion Criteria:

* Severe pulmonary disease
* Decompensated cardiovascular disease
* Neurological disease
* Insulin-dependent diabetes mellitus
* Dialysis renal insufficiency
Quality of Life in Patients With Multiple Myeloma

The purpose of this study is to determine Clinically important difference and Response shift in quality of life in patients with Multiple Myeloma.

Multiple myeloma is a plasma cell tumor with an annual incidence of 6 pr. 100 000. In the absence of curative treatment, the aim of the therapy is not only to induce an objective response and a prolongation of survival but also to improve the patients quality of life.

This project will raise two problems which make QoL-data hard to interpret

1. In a clinical trial where many patients are included, statistically significant differences are obtained. However, there is widespread agreement that p-values do not indicate whether a particular finding has clinical significance because statistical significance does not necessarily equate to a meaningful difference or change in QoL. A crucial task for clinicians in interpreting trial-based QoL results is to determine if the observed change is clinically important to the patient.
2. When measuring changes in QoL in a pretest-posttest design,response shift can affect results. Patients with advanced disease can report surprisingly good QoL.Including response shift into quality of life research would allow a better understanding of changes in the QoL that patients report.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Myeloma
* Age \> 18 years
* Informed consent

Exclusion Criteria:

* Terminal illness with life expectancy less than 3 months
* Unable to fill in a questionnaire in norwegian
Phase 1 RCT of tDCS in Adults With ASD and/or ADHD Without Intellectual Disability

The goal of this clinical trial is to learn about the safety and tolerability of transcranial direct current stimulation (tDCS) combined with cognitive training in adults with Autism Spectrum Disorder (ASD) and/or Attention-Deficit/Hyperactivity Disorder (ADHD).

The main question it aims to answer is:

Is tDCS safe and well-tolerated in adults with ASD and/or ADHD?

Researchers will compare active tDCS to a sham (placebo-like) stimulation to evaluate safety and tolerability.

Participants will:

Receive either active or sham tDCS for 20 minutes daily over 10 consecutive workdays

Undergo stimulation with the anode placed at F3 and the cathode at Fp2

Complete daily cognitive training exercises using the NeuronUP platform during stimulation

Attend baseline and follow-up assessments to monitor for any side effects or discomfort related to the intervention


Eligibility Criteria:
Inclusion Criteria:

Adults aged 18 to 55 years

Clinical diagnosis of Autism Spectrum Disorder (ASD) and/or Attention-Deficit/Hyperactivity Disorder (ADHD) confirmed via medical records or structured clinical interview

Able to provide informed consent

Fluent in the language used for assessments and cognitive training tasks

Stable medication regimen (if applicable) for at least 4 weeks prior to enrollment

Willing and able to attend 10 consecutive weekday sessions and follow-up assessment

Exclusion Criteria:

History of epilepsy, seizures, or significant neurological disorder (e.g., traumatic brain injury, stroke)

Current diagnosis of psychotic disorder or bipolar disorder

Presence of metal implants in the head (excluding dental work), pacemaker, or other contraindications to tDCS

Current substance use disorder (within past 6 months)

Pregnant or planning to become pregnant during the study period

Participation in another intervention study within the last 30 days

Any condition that, in the opinion of the investigators, may make participation unsafe or interfere with study procedures