cyrilzakka/clinical-trials huggingface dataset:
Postoperative Headache in Elective Surgery Patients

To evaluate the association of anaesthesia and surgery with postoperative headache in elective surgery patients By multiple logistic regression analysis of data collected during a six-month period from 446 patients undergoing elective surgery, a prospective single centre cohort study in a university hospital. Participants were interviewed preoperatively and for five days postoperatively regarding the appearance of headache; while demographics, life style, type of anaesthesia and surgery, the anaesthetic drugs administered and intraoperative adverse effects in elective surgery patients are recorded.

A dedicated team interviewed patients preoperatively and during the first five postoperative days and collected data regarding medical history, surgery, anaesthesia and the presence of postoperative headache by manual record review. The frequency of preoperative headache was assessed by asking the subjects on the appearance or not of headache within the last year. Additional information were obtained to distinguish migraine which was deemed present only when the participants reported two or more of the following specific symptoms supporting this diagnosis as proposed by the International Headache Society; episodic headache (4-72 hours) with the following features: moderate or severe throbbing pain, worsened by movement, associated with nausea/vomiting, photophobia or phonophobia, with or without visual aura.

Specifically, preoperative data included patients' demographics, marital status, life-style and habits, as caffeine consumption (\>200 mg/day or \>2 cups of coffee/day), alcohol (drink equivalent \> 15ml absolute alcohol) and tobacco consumption, previous experience or/and family history of headache. Intraoperative data included the type of anaesthesia (general, regional anaesthesia or their combination); anaesthetic drugs used; type and duration of surgery; intraoperative patients' position; and intraoperative adverse events including hypotension (decrease \>20% from baseline), hypertension (increase \>20% from baseline), hypercarbia (PaCO2 \>6 kPa) and hypoxia (SpO2 \<90%). Noticeably, the choice of anaesthetic technique and postoperative management were determined by the engaged anaesthesiologist.

Postoperative headache was defined as a dichotomous variable (i.e. present or not present) by asking the participants twice daily for the first five days (or less if discharged earlier) after anaesthesia and surgery.

Eligibility Criteria:
Inclusion Criteria:

* all adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ENT(ear nose and throat) and vascular procedures

Exclusion Criteria:

* patient refusal
* age under 18 years
* cognitive dysfunction
* head trauma or neurological disorders
* difficulty with language comprehension or any other inability to communicate verbally with the interviewer.
Pecs Block vs Local Infiltration in Mastectomy

Studied the comparison between PECS II block and LIA on pain intensity, opioid requirements, RNL, and postoperative IL-6 levels in MRM patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-60 years old.
2. Body weight (BW): 50-70 kg.
3. Height (TB): 150-170 cm.
4. Body mass index (BMI): 18.5-29.9 kg/m2.
5. American Society of Anesthesiologists physical status (ASA PS) class I-II.
6. Patients undergoing elective MRM surgery under general anesthesia.

Exclusion Criteria:

1. Patients with contraindications to PECS II block.
2. Patients with contraindications to LIA.
3. Patients with coagulation disorders or receiving anticoagulant therapy.
4. Patients with a history of chronic pain.
5. Patients with a history of allergy to study materials.
6. Patients with a history of previous breast surgery.
7. Patient refuses to participate in the study.
Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery

Vitamin C with its antioxidant role has many indications. The objective of this study is to demonstrate that taking vitamin C as a preventive significantly reduces the occurrence of complex regional pain syndrome (CRPS) type 1 in the aftermath of a scheduled surgery of the upper limb.

The preventive role of vitamin C on the development of CRPS type 1 was already demonstrated in traumatology and foot surgery.

The management of CRPS type 1 is long and expensive. A preventive care seems beneficial. Some studies already performed suggest a similar role in scheduled surgery of the upper limb, major provider of CRPS type 1.The aim of the study is to demonstrate a significant reduction of CRPS 1 when taking vitamin C during the perioperative period in upper limb surgery. It is a prospective, randomized, double-blind, with placebo use, in two parallel group, multicenter and national. Patients are followed by their surgeon, under the terms of monitoring their disease. Two visits are required: one at 6 months and at 12 months. The patients will be reviewed at least in the two consultations looking for CRPS type 1 according to the criteria of the International Association for the Study of Pain (IASP)

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 yo
* patients undergoing major surgery of the upper limb
* patients able to give their consent to follow the protocol of treatment and monitoring.

Exclusion Criteria:

* children,
* patients under guardianship,
* pregnant or lactating women,
* patients with hemochromatosis,
* allergy or known hypersensitivity to one of the molecules of treatment,
* patients suffering or having already suffered from complex regional pain syndrome type 1 or type 2,
* patients unable due to personal or professional mobility, to conduct post-operative follow up,
* patients undergoing surgery with nerve suture with nerve graft, emergency surgery,
* patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency,
* patients with chronic kidney disease
Myocardial Involvement of Severe Acute Respiratory Syndrome-Cov-2 (Covid19) Infected Patients

The effects of severe acute respiratory syndrome SARS-Cov-2 (Covid-19) on the myocardium and their role in the clinical course of infected patients are still unknown. Epidemiological studies report biological myocardial involvement in 10 to 25% of cases. The objective of this study is to cardiac phenotype using comprehensive cardiac imaging tools of patients infected with Covid 19 in order to explore the functional impact of the infection on the myocardium.

A large population of Covid 19 infected patients of different ages and severity levels will be explored by transthoracic echocardiography with measurement of myocardial functional parameters such as ejection fraction, longitudinal strain and relaxation parameters and will be compared to an uninfected population paired for age and sex.

Patients with biological myocardial involvement will be followed to determine the evolution of their myocardial functional parameters during the course of the infection.

Eligibility Criteria:
Inclusion Criteria:

* Major patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR

Exclusion Criteria:

* Underage patients. Patients refusing to participate in research. Patients with a history of heart disease.
Determines of Quality of Life in Patients

Pain, muscle spasm, loss of muscle strength and impaired posture adversely affect the daily life activities and quality of life of neck pain patients.However, the quality of life; It is a multifaceted concept that includes not only the age, sex, marital status, educational status and duration of pain, but also the number of children, BMI, depression, sleep quality, pain-related inadequacy and fatigue. Therefore, considering all these; quality of life; The aim of our study was to determine the factors affecting the quality of life in nonspesific neck patients with the effect that the determinants affecting physical, physical role difficulty, pain, general health, vitality, social function, emotional role difficulty and mental health may be different.

The study will include 93 people with a diagnosis neck disease who apply to the physical therapy outpatient clinic. After recorded sociodemographic and clinical characteristics of the individuals, some evaluations will be done only once. The evaluations to be used in the study are as follows: Pain Assesment will be evaluated with McGill Pain Questionnaire, Sleep disorders will be evaluated with Pitsburgh Sleep Quality Index (PSQI), Fatigue level will be assessed by the Fatigue Questionnaire, Beck Depression Inventory (BDI) will be used to determine depression levels. The quality of life of the subjects wiil be evaluate by using the Short Form-36 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

1) People 18 years and older

Exclusion Criteria:

1. Hospitalized people
2. Newly Operated People
3. People with psychological diagnosis
Weaning Preterm Neonates From Nasal Continuous Positive Airway Pressure

There is little data published concerning the best approach to nasal continuous positive airway pressure (nCPAP) weaning. Potential complications associated with prolonged nCPAP therapy include gastric distension, nasal trauma,pneumothorax,agitation and nosocomial infection. Moreover, Infants on nCPAP may also require more intensive nursing care and the use of extra equipment. Therefore, minimizing the amount of time that a patient requires CPAP may be beneficial. On the other hand, removing CPAP too early may lead to complications that include: increasing apnea, increased oxygen requirement, increased work of breathing, the need to re-start CPAP, and intubation and mechanical ventilation. Moreover, an experimental study have demonstrated an improvement in lung growth after the prolonged use of CPAP.

Nasal cannula (NC) flows at 1-2 L/min may also generate a positive pressure in the airway of preterm infants. The use of NC flow to generate positive airway pressure would minimize many of the application issues of nCPAP. However, NC systems used in neonates routinely employ gas that is inadequately warmed and humidified, limiting the use of such flows due to increased risk of nasal mucosa injury, and possibly increasing the risk for nosocomial infection.

The purpose of this randomized controlled trial is to evaluate the clinical impact of two methods for weaning preterm infants from nCPAP.

The objective of this study is to test the null hypothesis that in preterm infants with gestational age of 28 to 36 weeks who are stable on CPAP pressure of 5 cmH2O and with oxygen concentrations (FiO2) \<0.30, keeping these infants on CPAP or changing them to NC flow of 1-2 L/min will not make any difference in length of hospitalization, length of respiratory support and incidence of complications.

Eligibility Criteria:
Inclusion Criteria:

* Infants born greater than or equal to 28 weeks (28+0) and less than 37 weeks (36+6) gestation
* CPAP pressure of 5 cm H2O
* FiO2 requirement = or \<0.30
* Clinically stable on these CPAP parameters for 24 hours pre-randomization:

  * Respiratory rate less than 60
  * No significant chest recession
  * No apnea requiring bagging and/or
  * Not more than 6 apneas requiring stimulation in the preceding 24 h.
  * Average saturation \> or = 87%
  * Satisfactory ABG (pH\> 7.25, PCO2 \< 60, and Base deficit \< -8)

Exclusion Criteria:

* Life threatening congenital anomalies
* Congenital cyanotic heart diseases
* Congenital airway or chest wall abnormalities
* Pulmonary hypoplasia
* Known or suspected to have a neuromuscular disorder
* Congenital neurological disorder, severe IVH (grade 3 or 4), PVL and hydrocephalus
Carpal Tunnel Release Under Local Anaesthesia With or Without Distal Median Nerve Block

Carpal tunnel syndrome is the most commonly appearing entrapment neuropathy of the upper extremity. Treatment options include both non-operative and surgical methods. Surgical treatment, carpal tunnel release (CTR), involves division of the transverse carpal ligament. Surgery can be done under an axillary- or intravenous block, or local or general anaesthesia. There are no randomised controlled trials comparing local infiltration anaesthesia with or without a distal median nerve block in carpal tunnel release.

The aim of the study is to investigate whether a distal median nerve block, in addition to local anaesthesia in carpal tunnel release, reduces pain during and after the procedure. The null hypothesis is that the use of distal median nerve block with local anaesthesia does not reduce pain after CTR compared to pure local anaesthesia.

This trial is a randomised controlled trial involving patients with carpal tunnel syndrome. Patients will be randomized into two study groups: local anaesthesia and local with a distal median nerve block. Fifty-nine patients will be needed for each group to have adequate power. The primary outcome is the pain level after the procedure for 72 hours using visual analogue scale. The secondary outcomes include expected pain; pain during the injection of the anaesthetic solution caused by pressure, burning, needle sting, and total pain; worst pain during the surgery; duration of anaesthesia; number of experienced needle stings; Boston Carpal Tunnel Syndrome Questionnaire; pain killer consumption, patient satisfaction, and safety .

There are no prior randomised controlled trials (RCT) comparing local infiltration anaesthesia to local infiltration anaesthesia augmented with a distal median nerve block in CTR. Distal median block in CTR is believed to reduce pain intra- and postoperatively. However, the superiority of distal median block with local anaesthesia compared to pure local anaesthesia alone has not been proven.


Eligibility Criteria:
Inclusion Criteria:

* Over 17 years of age
* CTS verified by nerve conduction studies
* Symptoms suitable for CTS

Exclusion Criteria:

* Recurrent CTS
* Peripheral neuropathies
* Known allergy to the trial drugs
* Profound cognitive impairment
* Pregnancy
Smartphone-based Aftercare for Inpatients With Anorexia Nervosa

Inpatient treatment for patients with anorexia nervosa (AN) is recommended in extreme or severe cases after failure of outpatient treatment and is highly effective. However, a number of patients show symptom increase and relapse after discharge. The aim of this study is to evaluate the efficacy of a guided smartphone-based aftercare intervention following inpatient treatment of patients with AN to support symptom stabilization or continued improvement.

Anorexia nervosa (AN) is a severe, often chronic and life-threatening disorder. Relapse after treatment is common with relapse rates ranging between 9 and 52% and being highest within the first year following treatment particularly as early as 3 months posttreatment. Even if weight restoration is achieved, it is quite difficult for patients to sustain improvements after treatment, so aftercare and relapse prevention are essential research topics. There is a recent review on internet- and mobile-based aftercare and relapse prevention in mental disorders that concludes that there is some evidence that such interventions are feasible instruments for maintaining treatment gains for some mental disorders, including eating disorders (EDs). However, the authors claim for further high quality, large-scale trials that are needed to expand research fields. So, the aim of this study is to prove the efficacy of a guided smartphone-based aftercare intervention for inpatients with AN. Our primary hypothesis is that at the end of aftercare intervention (T1), the intervention group shows a significantly lower eating disorder symptomatology than the control group.

Eligible patients with AN who are discharged from inpatient treatment are randomized either to receive a 4-month smartphone-based aftercare intervention with therapist feedback as an add-on element to treatment as usual (TAU) or TAU alone. Assessments include structured interviews as well as online questionnaires and are taken at baseline (discharge, T0), end of the aftercare intervention (T1) as well as 6-month follow-up (T2).

Eligibility Criteria:
Inclusion Criteria:

* primary diagnosis of AN (DSM-5: 307.1),
* sex: female,
* age: from 12 years onwards to 60 years,
* regular completion of inpatient treatment,
* at least a length of inpatient stay of 6 weeks,
* BMI at discharge at least 15, at least a 1-point BMI increase during inpatient treatment,
* owner of a smartphone,
* informed consent of the patient and, in case of minors, also of the parents.

Exclusion Criteria:

* major depression (BDI-II \> 29 at discharge),
* suicidal tendency (item 9 of BDI-II \> 1 at discharge),
* very high level of care after inpatient treatment (e.g. therapeutic living community, day clinic),
* pregnancy.
Racecadotril Versus Standard Treatment in Decreasing the Duration of Acute Diarrhoea in Children

Acute watery diarrhea is defined as the passage of 3 or more loose or liquid stools per day for 3 or more days but less than 14 days, including patients with mild to moderate dehydration per WHO classification. The study's outcome variables are stool frequency, measured by the total number of stools passed during 24 and 48 hours from the initiation of treatment, and hospital duration, measured by the total duration of hospital stay in hours. The null hypothesis states that racecadotril combined with standard treatment has no effect on reducing the mean number of stools passed during 48 hours compared to standard treatment alone in pediatric patients with acute watery diarrhea, while the alternate hypothesis suggests that racecadotril combined with standard treatment will significantly reduce the mean number of stools passed during 48 hours compared to standard treatment alone in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized Patients with acute watery diarrhea of both genders who are

  1. Age: 03 months to 05 years
  2. Present in first 24 hours of onset of disease.

     Exclusion Criteria:

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  1. Parenteral Diarrhea
  2. Chronic Diarrhea like Coeliac disease, Lactose intolerance
  3. Mal-absorption Syndromes
  4. Diarrhea related to food poisoning, dysentery as suggested by history
  5. Severe dehydration patents who are vitally unstable.
  6. Diarrhea associated with measles.
  7. Persistent vomiting
  8. Abdominal distention
  9. Patients allergic to racecadotril
  10. Patients managed before enrolled to study
Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications

The aim of this interventional study is to optimize the movements and discipline of surgical staff in order to improve the quality of care, the safety of the patient in the surgery and to prevent the postoperative complications in the broad sense and in particular the infection of the surgical site. The intervention will be carried out using tools of new technologies allowing the monitoring of the movements and the sound level associated with techniques of behavior change inspired by those used in the human and social sciences.


Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient agreeing to participate in the study
* Patient who will benefit from orthopedic surgery for hip or knee arthroplasty with prosthesis placement

Non-Inclusion Criteria:

* Patient with previous history of surgical site infection
Phase I/IIa Study of BR1733 in Subjects With Advanced Cancers

This study is a Phase I/IIa, multi-center, open-label study of BR1733 with a dose escalation part followed by a dose expansion part in adult subjects with advanced cancers.

This treatment to characterize the safety, tolerability, PK, PD and preliminary antitumor activity.

The study treatment will be administered until the subject experiences unacceptable toxicity, progressive disease, and/or has treatment discontinued at the discretion of the Investigator or the subject, or due to withdrawal of consent.

This is a multi-center, nonrandomized, open-label study to evaluate the safety, tolerability, pharmacokinetics/ pharmacodynamics, and efficacy of BR1733 in patients with advance cancer, such as recurrent/refractory follicular lymphoma, peripheral T cell lymphoma(PTCL), diffuse large B cell lymphoma(DLBCL) and advance solid tumors.

Phase Ⅰ (Dose Escalation Phase): According to the incidence of DLT in BR1733 tablets in the treatment of advanced cancers, MTD and the Phase 2 clinical trial dose (RP2D) combining PK, PD, efficacy and safety data were determined.

Phase IIa (Dose expansion stage): Evaluate the efficacy and safety of BR1733 monotherapy (Cohorts 1-5) in five separate cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. Sign informed consent voluntarily.
2. Subjects with PTCL, DLBCL or advance solid tumors diagnosed by histology or cytology，whose disease progressed after standard treatment or have no standard treatment.
3. ECOG≤2.
4. Expected survival period ≥ 3 months.
5. Adequate organ function reserve at baseline.

Exclusion Criteria:

1. Subjects with symptomatic central nervous system (CNS) metastases or carcinomatous meningitis;
2. Subjects with a history of other primary malignancies within 5 years (except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumor), subjects with other primary tumors who had no evidence of disease for 5 years or more and did not require treatment could participate in the study;
3. Subjects with any severe uncontrolled disease such as liver disease such as cirrhosis, decompensated liver disease, kidney failure needs for hemodialysis or peritoneal dialysis, etc.
4. Subjects with HIV disease or a positive HIV test; or active hepatitis.
5. Subjects with organ transplantation (apart from keratoplasty) or allogeneic hematopoietic stem cell transplantation.
6. Subjects with impaired or clinically significant cardiac cerebrovascular disease.
7. Subjects known to be allergic to experimental drugs or similar compounds.
8. Subjects known with psychotropic substance abuse, alcohol or drug abuse, or mental disorders.
9. Any previous treatment with other EED inhibitors (e.g., MAK683, FTX-6058, etc.).
10. Females who are pregnant or breastfeeding.