cyrilzakka/clinical-trials huggingface dataset:
Tranexamic Acid for the Prevention of Blood Loss in High Risk Delivered Women

Postpartum hemorrhage and its complications are very well known causes for maternal mortality .Uterine atony is the most common cause for postpartum hemorrhage

Postpartum hemorrhage and its complications are very well known causes for maternal mortality and morbidity especially in developing countries. World Health Organization Recommendations for Active Management of the Third Stage of Labor (AMTSL), on 2012 included the use of uterotonics for the prevention of postpartum hemorrhage (PPH) during the third stage of labor for all births. Tranexamic acid (TA) is antifibrinolytic agent used to decrease blood loss in surgery and health conditions associated with increased bleeding.

A Cochrane Systematic Review from the best available evidence to determine whether TA is effective and safe for preventing PPH in comparison to placebo or no treatment the review concluded that TA (in addition to uterotonic medications) decreases blood loss postpartum and prevents PPH and blood transfusions following vaginal birth and abdominal delivery in women at low risk of PPH based on studies of mixed quality. There was insufficient evidence to draw conclusions about serious side effects and the effects of TA on venous thromboembolic events and mortality beside its use in high-risk women was not investigated on

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 year.
* Planed vaginal delivery
* Grand multiparity
* Twin pregnancy
* Polyhydramnios
* Previous history of PPH
* Macrosomic baby
* Prolonged labour
* HELLP syndrome
* Using of low-molecular weight heparin and Asprin during pregnancy.
* Vaginal birth after Cesarean section

Exclusion Criteria:

* Intrauterine death.
* History of thromboembolic disease
* Current or previous history of heart disease ,renal and liver disorders
* History of seizure or epilepsy
* Placenta previa
* Placental abruptio
Effect of Electroacupuncture at Neiguan on Cardiac and Gastric Function

Acupuncture have been used in clinical treatment of diseases for at least 3,000 years, and the efficacy of acupuncture has been recognized by countries all over the world. However, most of the selected points for acupuncture treatment of diseases are based on ancient books or inheritance of experience. For example, the " Shizong Acupoint Ballad " of acupuncture records: "Neiguan (PC6) care about the chest and stomach", that is, acupuncture Neiguan can be used to treat chest, heart and stomach diseases. However, there is no scientific evidence to verify this argument so far that the Shizong Acupoint Ballad mentions "Neiguan care for the chest and stomach", and that means that Neiguan acupoint can treat the diseases of cardiovascular system and gastrointestinal system. The purpose is to verify the argument of "Neiguan care about the chest and stomach", and design a clinical trial of the Neiguan and Jianshi (PC5) on both sides of the electroacupuncture (EA) to simultaneously evaluate the heart and stomach functions. We designed a crossover test; total 72 subjects randomly equally divide the into a sham group (sham electroacupuncture) and an EA group \[2Hz EA (PC6 is cathode) and PC5 is anode\]. At least one week of washing time, then the EA group changed to a sham group and the sham group changed to an EA group.

In this study, it is expected that the EA at PC6 and PC5 will affect the heart function and the function of the stomach at the same time, verifying the argument that "the PC6 care of the chest and stomach" recorded in the Shizong Acupoint Ballad.


Eligibility Criteria:
Inclusion Criteria:

* (1) Normal and healthy participants
* (2) Male or female
* (3) The age range is 20 to 40 years old.
* (4) Those who participates and signs informed consent after explaining the research purpose and process in detail.

Exclusion Criteria:

* (1) Those with serious diseases, such as heart failure, chronic failure or cancer patients, etc.
* (2) Those who are allergic to stainless steel needles for acupuncture.
* (3) Pregnant or breastfeeding
* (4) Those who are taking medicines or food such as coffee, etc. that will affect heart function such as heart rate, or gastric peristalsis.
* (5) Unable to cooperate with researchers such as mental instability.
* (6) Those who do not sign the consent form.
Maxillary Canine Retraction Assisted With Micro-osteoperforations Versus Injectable Platelet Rich Fibrin

The present clinical comparative study will be undertaken for assessment of two different modalities of maxillary canine retraction assisted with microosteoperforations versus injectable platelet rich fibrin.

Group I: will include 9 patients who willreceive MOPs with maxillary canine retraction that will be performed on intervention sides according to a standardized protocol.

▪ Group II: will include 9 patients receive i-PRF that will be performed on intervention sides according to a standardized protocol.

Eligibility Criteria:
Inclusion Criteria:

1. An age ranges from 15-22 years.
2. Severe crowding or protrusion requiring 1st premolars extractions followed by symmetrical canine retraction.
3. All permanent teeth present, 3rd molars are excluded.
4. Good oral and general health.
5. No systemic disease/medication that could interfere with OTM.
6. No previous orthodontic treatment.

Exclusion Criteria:

1. Patient diagnosed to have an indication for non-extraction approach.
2. Poor oral hygiene or periodontally compromised patient.
3. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
4. Previous orthodontic treatment.
Investigating RELEARN Neurofeedback as Treatment for Chronic Musculoskeletal Pain

This clinical investigation will be carried out as a randomized controlled trial conducted at the Northern Regional Hospital, Hjørring. This investigation will enrol 36 patients suffering from severe knee osteoarthritis pain, primarily from the orthopaedic ward at Hjørring Hospital, where potential participants will be identified during routine consultations.

The RELEARN intervention consists of encephalography (EEG) neurofeedback of cerebral movement evoked signatures of pain, where the participants will be instructed in attempting to manipulate these signatures to reduce pain perception. This investigation is carried out to analyse the clinical performance and safety of the RELEARN neurofeedback software.

The participants will be randomized into treatment group A and control group B, 1:1 and be stratified based on age, sex, and ethnicity. Group A participants will be asked to attend eight sessions of RELEARN neurofeedback with an approximate duration of 45 minutes per session, and group B participants will be asked to attend eight sessions with no intervention and serve as no-treatment controls with an approximate duration of 5 minutes per session. Both groups (A and B) will undergo three follow-up sessions: one month, three months, and five months post intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old
2. Knee arthrosis (Kellgren-Lawrence score of ≥ 2)
3. 24h VAS ≥ 4
4. Ongoing pain, lasting more than three months

   Exclusion Criteria:

   Participants who meet any of the below criteria will be excluded from the investigation:
5. Pregnant or lactating woman
6. Use of opioids or cannabis
7. Active drug addiction defined as the use of cannabis, opioids, or other drugs
8. Previous or current neurologic, systemic, or mental illness, including any liver, kidney or metabolic disease.
9. Rheumatoid arthritis
10. Evidence of other pain types such as visceral, neuropathic, or malignant pain.
11. Evidence of other sources of ongoing pain such as root affect, traumas, or congenital malformation
12. Severe inflammation in the area of interest
13. Blindness or deafness
14. Consumption of alcohol, caffeine, nicotine on test day
15. Recent history of fractures or surgery in the area of interest
16. Participation in other clinical trials throughout the study period and one month prior to participation
17. History of epilepsy
18. Obesity class III and above. I.e. BMI \> 39,9
Tacrolimus Treatment for Refractory Autoimmune Cytopenia

Autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA), pure red cell aplasia (PRCA), Evans syndrome (ES), usually has good responses to steroids therapies as first line, but there is a considerable percentage of patients who relapse, become refractory or dependent on steroids to maintain an acceptable level of hemoglobin or platelets. The effects of the second line therapy are also not satisfactory and sometimes not available. The investigators aim to explore the efficacy and side-effect of tacrolimus for refractory autoimmune cytopenia.

Tacrolimus binds FKBP12 with high affinity after entry into cytoplasm, suppresses calcineurin activity and prevents nuclear translocation of transcription factors such as NF-AT that are involved in IL-2 gene transcription. As a result, T-cell activation is inhibited with a subsequent reduction in the production of cytokines that include IL-2, TNF-α, IL-3, IL-4, IFN-γ, IL-6 and IL-10; B-cell activation, class-switching and immunoglobulin production are also attenuated. Reports on the use of tarcrolimus in the treatment of autoimmune cytopenia are anecdotal and describe therapy with a variety of drug dosages.

The purpose of this study is to evaluate the effect of tacrolimus on patients with refractory autoimmune cytopenia, the side-effects will be documented and plasma concentration of tacrolimus will be monitor.

Eligibility Criteria:
Inclusion Criteria:

* Refractory autoimmune cytopenia, including autoimmune hemolytic anemia, pure red cell aplasia, Evans syndrome.
* 18-80 years old.
* No response or intolerant to first and second line therapies.
* ECOG Performance Status of 0-2
* Written informed consent.

Exclusion Criteria:

* Other diseases which might cause hematological abnormalities.
* Response and well tolerate to first or second line therapy.
* Patients who are under 18-year-old or over 80-year-old.
* Pregnant or lactating.
* Patients unwilling to or unable to comply with the protocol.
Health Education in Perimenopausal Women to Promote Self-care and Quality of Life

Objective: To evaluate the efficiency of a group intervention opposite to the usual care to improve the quality of life, measured with the SF-12 questionnaire, in women between 45-55 years to the primary health care centres.

Methods: clinical controlled trial with parallel groups, random assignment of primary care units and blinded evaluation of principal label.

Setting: study in primary health care centres (PHCCs) of Madrid Health Service and Castilla León Health Service.

Subjects: Women between 45-55 years to medical consultation in primary care. Intervention: application of good clinical practice procedure and cognitive - behavioural grupal intervention.

Sample size: N=355 patients. Data: Principal response variables: quality of life measured with the SF-12 questionnaire. Secondary response Variables: visits number, medicine /month number, and transitory disability days. Other prognosis and descriptive variables.

Data analysis: Main effectiveness will be analyzed by comparing the improvement in 4 or more points in the SF-12 Mental Health area at 6, 12, 18 y 24 months post- intervention, between intervention and control group. Logistic regression will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect, recorder will be taken in account in this analysis. All statistical tests will be performed with intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* 45-55 years women
* users of the Health Center
* able to follow the demands of the study: does not have the intention to move from home in the next 24 months
* have ability to read and write the Spanish language and agreeing to participate by giving their informed consent in writing.

Exclusion Criteria:

* Women immobilized at home, with mental disorder or cognitive impairment and/or sensory impairments that prevent to participate in a group intervention.
Efficacy of Intrathecal Administration of Liposomal Amphotericin B in Cryptococcal Meningitis

The main purpose of this study is to observe the clinical effect of intrathecal administration of liposomal amphotericin B in Cryptococcal Meningitis without Acquired Immune Deficiency Syndrome (AIDS).


Eligibility Criteria:
Inclusion Criteria:

* Cryptococcus neoformans are found in CSF

Exclusion Criteria:

* Patients with serious heart, lung, liver and renal insufficiency.
* Patients who took broad-spectrum antibiotics and corticosteroids for a long-term.
* Patients with AIDS or obvious immunodeficiency.
* Patients with long term dialysis or intravenous catheter.
* Patients with other brain organic disease such as purulent meningitis, intracranial swelling, etc.
Ti-Mesh Frame Comparison for Alveolar Bone Augmentation

This research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-assisted manufacture (CAD-CAM) Titanium Mesh frame. In addition, a novel method of measuring soft tissue thickness will be tested using an Optical scanner at various times during the sequence of surgeries.

The device used for shaping is a very thin, perforated titanium metal sheet with numerous small perforations (referred to as Micromesh). The construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect. An alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface. A digitally designed frame can then be printed using CAD-CAM software prior to surgery. This should reduce surgical time.

A randomized control trial of 30 patients needing 3-D bone augmentation will be conducted comparing chairside fabrication of Ti-MESH or TEST- CAD-CAM designed and preprinted Ti-MESH to investigate these objectives:

1. Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications
2. Compare post-op wound healing -Ti MESH exposure rates, bone production (volume, contour, and quality) and soft tissue thickness changes during the 1-year study period.


Eligibility Criteria:
Inclusion Criteria:

* Partially edentulous
* Adult dental patients that require moderate 3-D bone augmentation for dental implant site improvement

Exclusion Criteria:

* Poor oral hygiene indices for microbial plaque (PI) and gingival inflammation (GI)
* Patients who have been on Chemotherapy or Radiation therapy within last 5 years.
* Patients under active treatment with following medications: Bisphosphonates, Gabapentin, Glucocorticoids, Methotrexate, or Estrogen supplements.
* Subjects under the direct supervision of the PI
* Smoking more than 10 cigarettes per day
* Uncontrolled diabetes or other metabolic disorders
Validation of "Escala de Conductas Indicadoras de Dolor" ESCID Scale for Measuring Pain in Critically Ill Patients

Pain is an unpleasant and important stress factor, and a potentially harmful experience for critically ill patients. Pain is harder to evaluate in non-communicative patients, who can´t report their own pain. Behavioral indicators have been proved as useful and reliable for detecting and measuring pain in these patients, and have been the basis for constructing scales for measuring pain, such as the Behavioural Pain Scale (BPS), the Critical Care Observation Tool (CPOT) and the Scale of Behaviors Indicating Pain (ESCID) .

The BPS and ESCID were tested in a study with a sample of 42 critically ill patients in Spain, showing good validity and reliability.

The objective of this Spanish multicentre study is to test the validity and reliability of the ESCID scale in a large sample of critically ill patients with medical and postsurgical pathology for the detection and measurement of pain.

The specific Aims for the study are :

To determine the validity and reliability of the ESCID scale to assess pain in non-communicative critically ill patients on mechanical ventilation, in a large sample of critically ill medical and surgical patients.

To assess the relationship between the application of a common and painful procedure, usual in daily practice, and its associated changes in physiological indicators of pain: variation of heart rate, blood pressure, respiratory rate, sweating.

To assess the degree of pain when applying two painful procedures documented as common in the usual care of critically ill patients, and one non-painful procedure, using two pain scales: ESCID and BPS.

To assess the differences in the employment of the pain scales in patients with medical and surgical pathology.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older
* Patient's primary language spanish where the evaluation is performed
* Patient meets IRB/Central EC requirements of the institution/ country where the evaluation is performed
* Patient is receiving the study's procedures as part of standard care, excepting the non painful procedure

Exclusion Criteria:

* Patient's condition is very unstable at the time of measurement of pain
* Patient is receiving neuromuscular blocking medications at the time of measurement of pain
* Patient´s probable or diagnosed delirium
REDUCE Trial: Perineural Dexamethasone on Scalp Nerve Blocks

Pain is common in the first 2 days after major craniotomy. Inadequate analgesia may lead to an increased risk of postoperative complications. Most pain following craniotomy arises from the pericranial muscles and soft tissues of the scalp. Scalp nerve blocks with local anesthesia seem to provide effective, safe, however transient postoperative analgesia which does not seem to meet the requirements of craniotomy. Currently, peripheral dexamethasone has been observed to significantly prolong the duration of analgesia of nerve blocks (e.g., saphenous nerve block, adductor canal block, thoracic paravertebral block, brachial plexus nerve block). On the contrary, a study reported that perineural dexamethasone did not appear to prolong the analgesic time after supratentorial craniotomy. However, all patients in this study were given 24 mg of oral or intravenous dexamethasone regularly at least 7 days during the perioperative period, which possibly masked the role of single local low doses of perineural dexamethasone. Therefore, the analgesic effect of single dexamethasone for scalp nerve blocks without the backdrop of perioperative glucocorticoid deserves further clarification.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective supratentorial craniotomy under general anesthesia;
* age 18 to 64 years;
* an American Society of Anesthesiologists (ASA) physical status of I, II or III;
* preoperative Glasgow Coma Scale (GCS) score of 15/15.

Exclusion Criteria:

* History of chronic headache or chronic pain syndrome of any cause, psychiatric disorders, or uncontrolled epilepsy;
* Inability to understand or use the pain scales before surgery;
* Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 hours before surgery;
* Request of oral/intravenous glucocorticoid to decrease cerebral edema within 1 week before surgery;
* Pregnancy or breastfeeding;
* Extreme body mass index (BMI) (\< 15 or \> 35);
* Participation in another interventional trial that interferes with the intervention or outcome of this trial;
* Refusal or inability of the patient and/or legal guardian to provide informed consent;
* Coagulopathy;
* Infection around the puncture point;
* History of allergies to any of the study drugs.
Performance of Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip -,Knee- Arthroplasty,Primary Spine Surgery in Comparison to a Standard Wound Dressing

Male or female subjects, 18 years and above, undergoing hip, knee or spinal surgery with an expected hospital stay for 4 days or more will be included in the trial. Individual trial duration will be for 7 days (follow-up). Two hundred subjects will be included in the trial, i.e. 100 subjects per arm. The treatment arm (either new or standard wound dressing) will be assigned by randomization stratified by type of surgery (i.e. hip, knee or spine).

At the baseline visit:

* Subject demographic details
* Inclusion and exclusion criteria
* Vital signs
* Medical and surgical history
* Skin status at incision site
* Mobilisation (subject mobility, mobilisation in bed and chair)
* Medication
* AE/ADE/ SAE/SADE/DD
* Informed consent
* Randomization

At visit 2:

* Type of surgery
* Length of incision
* Intraoperative antibiotic given
* Length of anesthesia

At each visit from visit 3:

* Surgical incision condition (condition under the dressing, condition outside the dressing, exudates amount, exudates nature, wound odour, dressing capacity of handling blood, signs of systemic infection, systemic antibiotic given for the systematic infection, blistering, skin stripping
* Skin status at incision site (type of skin, skin temperature, skin perspiration, oedema, tissue consistency, sensation)
* Mobilisation (subject mobility, mobilisation in bed and chair)
* Dressing change (application and removal)
* Drainage (drainage used, application of the drainage)
* Compression Medication (pain medication and systematic antibiotic treatment)
* Photo (photo before and after dressing removal and if signs of infection)
* Investigator/nurse evaluation (ease of application of the dressing, size of the dressing, shape of the dressing, visibility beneath the dressing, notice any pain at dressing change, ease of removal of the dressing, overall experience)
* Patient evaluation (the patient's overall experience of the dressing, comfort when wearing the dressing).
* Contentious pain - measured by Visual Analog Scale (VAS) Prüfplan: CLOSE 2.0F 28.10.2013 5(40)
* Product application (time application start, time application ended, staff involved, material)
* AE/ADE/SAE/SADE/DD

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18years
2. Have an expected total length of stay of 4 or more days
3. Undergoing elective primary arthroplasty of the hip or knee or spinal surgery
4. Undergoing hip surgery with a standard access
5. Give their written informed consent to participate

Exclusion Criteria:

1. Dressing size does not fit the incision area
2. Known allergy/hypersensitivity to any of the components of the dressing
3. Multi-trauma
4. Undergoing arthroplasty due to tumor
5. Fractures
6. Wound at the surgical site prior to surgery
7. Neurological deficit of operated side (hemiplegia, etc.)
8. Subject has documented skin disease at time of enrolment, as judged by the investigator