cyrilzakka/clinical-trials huggingface dataset:
The Efficacy of Inquiry Based Stress Reduction (IBSR) for Depression, a Clinical Trial

Background: Major depression is a common mental disorder with serious consequences. The societal costs of depression are high. Despite the existence of empirically-supported psychological therapies, many patients do not benefit from these treatments and relapse and recurrence percentages are high. Improvement of existing treatments or development of new and better treatments is badly needed. Inquiry Based Stress Reduction (IBSR) is a promising verbal therapy focusing on the inquiry of thoughts and could be a next step in improving psychotherapy for depression.

Objective: The objective of the current study is to assess the effectiveness of IBSR. Research to date has shown that IBSR is effective in reducing symptoms of anxiety and depression. The investigators want to know if IBSR is more effective in reducing symptoms of depression than the best psychotherapeutic treatment for depression at this moment, cognitive behavioural therapy (CBT). The investigators' secondary objective is to know more about the underlying mechanisms of change of these therapies.

Study design: A randomized controlled intervention study.

Study population: 88 patients with a mild to moderate depression as their principal diagnosis.

Intervention: IBSR or CBT


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older,
* Not making use of other treatment for depression at the time,
* No history of psychotherapy in the last year,
* No medication for depression or unchanged dosage of medication during the last two months ,
* All participants must be willing to refrain from engaging in additional psychological treatments or making changes to their medication status during the course of the trial. (changes in medication dosage will result in dropout),
* All participants must have at least a low average level of intelligence (IQ above 80). During regular intakes a clinical judgment is made. This is in accordance with the standard protocols used within the FortaGroep.
* All participants are required to have sufficient knowledge of the Dutch language.

Exclusion Criteria:

* Active suicidal intent (which is asked during the interviews and further operationalized with help of the ninth item in the BDI-II at pre-treatment: If patients marked the statement ''I would kill myself if I could'', they are classified as being at risk of suicide)
* If the DSM-IV criteria for severe major depressive disorder, psychotic disorder, or bipolar disorder are met
* A mental impairment or neurocognitive disorders such as Alzheimer
* Substance abuse requiring specialist treatment
* No time for homework.
Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3002

The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.

This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled (an inactive substance is given to one group of participants while active drug is given to another group of participants to see if there is a difference in response), parallel-group (study drugs given to participants in all treatment groups during the same time period) to evaluate the efficacy (capacity of the investigational drug to produce an effect), safety, and tolerability of fulranumab administered as monotherapy (alone; not in combination with other drug therapy) to participants with chronic moderate to severe pain and functional impairment from knee or hip osteoarthritis (OA) that is not adequately controlled by current pain therapy. The duration of participation in the study for an individual participant will be up to 67 weeks (includes a screening period of 3 weeks, a double-blind treatment period of 16 weeks, and a post-treatment follow-up period of up to 48 weeks).). All participants will be randomly assigned in a 1:1:1 ratio to 1 of 3 treatments (placebo, fulranumab 1mg, fulranumab 3mg) and given a single injection subcutaneously (under the skin) once every 4 weeks for up to 16 weeks. Blood samples will be collected from each participant at time points during the study. Safety evaluations will include assessment of adverse events, physical examinations, laboratory tests and vital signs which will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of osteoarthritis (OA) of hip or knee based on criteria defined by the American College of Rheumatology and radiographic evidence of OA (Kellgren-Lawrence class ≥2) of the study joint
* Scheduled joint replacement or planning to undergo a joint replacement surgery for the study joint
* Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAID, and an opioid); For participants in the USA and Canada: Must have an unsatisfactory response (inadequate efficacy or poor tolerability) that includes all 3 classes of analgesic medications (acetaminophen/paracetamol, NSAIDs, and opioids other than codeine or codeine combination products)
* Moderate to severe pain and functional impairment based on the NRS, WOMAC pain and physical function subscales, and PGA
* During treatment and within 24 weeks after the last injection of study drug: if female of childbearing potential, is not pregnant, breast-feeding, or planning to become pregnant, or if male, will not father a child

Exclusion Criteria:

* Increased risk of osteonecrosis (ON) or rapidly progressive osteoarthritis (RPOA)
* Unstable or progressive neurologic disorders
A Randomized, Open Label Study to Compare the Current Phase II and Planned Phase III Capsule Formulation of AZD6244

Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.

A Phase I, Single-center, Randomized, Open-label, Crossover Study to Compare the White (Current Phase II) and Blue (Planned Phase III) Capsule Formulations of AZD6244 Hyd-Sulfate in Healthy Male Subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers aged 18 to 55 BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg, inclusive Calculated creatinine clearance (CRCL) greater than 50 mL/min usin gthe Cockcroft-Gault formula

Exclusion Criteria:

* History or presence of gastrointestinal, hepatic, or renal disease or any other condition know to interfere with absorption, distribution, metabolism, or exertion of drugs.
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting dECG and any clinically important abnormalities in the 12-lead dECG that suggest a cardiac, metabolic or other noncardiac condition.
* Current or past history of central serous retinopathy or retinal vein thrombosis, intraocular pressure greater than 21 mmHg or uncontrolled glaucoma Known or suspected history of drug abuse, current smokes or those who have smoked or used nicotine-containing products within the previous 3 months
Traumatic Long-term Memory of Pain in Humans

Few studies have focused on understanding the mechanisms underlying pain memory in humans. Thus, this project aims to investigate the link between pain memorisation and memorisation of the associated context by addressing the issue of pain conditioning. The study is composed of two successive parts: one pilot then one experimental. The goal is to understand pain memorisation processes by analysing the parallel between pain memorisation and memorisation of a traumatic event. By using immersive virtual reality, investigators aim to show that contextual pain conditioning is associated with : 1- a specific neural networks; 2- a reactivation of vegetative and behavioural reactions related to pain as well as electro-physiological markers when re-exposure to the specific pain-conditioning-context; 3- an implicit hypermnesia of the pain-associated context and a struggle to extinguish conditioning; 4- a favoured elaboration of false memories of the contextual pain. The emitted hypothesis suggests that a cortical and behavioural mnemonic trace is created during encoding of pain in association with its context, and that the latter can reactivate although the pain itself has disappeared. This implicit cortical mnemonic trace, evoked by the simple pain-associated context, could explain the notion of pain print persisting at long-term in patients suffering from chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject
* Subject between 18 and 50 years old
* Subjects having given their written consent
* Subjects with health insurance

Exclusion Criteria:

* Prior addiction to drugs
* Prior neurological issues
* Chronic pain (neuropathic or non-neuropathic)
* Pregnant/breast-feeding women
* Absence of efficient contraception method for the duration of the study (1 month) for participants of procreation age (no inclusion limitation for male participants of procreation age)
* Subjects under chronic analgesic treatment or having taken an analgesic treatment in the 24 h preceding the experiment
* Heart issues
* Subjects under justice surveillance
* Subjects participating in another study which inclusion period overlaps with the one from this study
The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia

The cutaneous silent period is a non-invasive technique that gives insight into the function of thin A delta fibers and as such can be a complement to conventional electrophysiological methods used to study the peripheral nerves. Clonidine is a selective partial agonist of the alpha-2 receptors which, added intrathecally to levobupivacaine, enhances the effect of a local anesthetic, prolongs sensory and motor block during local anesthesia and extends the length of post-operative analgesia. It is believed that clonidine achieves this effect by activating the postsynaptic alpha-2 receptors in the gelatine substance of the spinal cord and blocking the conduction of A-delta and C fibers. The aim of the study is to examine functional changes of Aδ - fibers during the application of spinal anesthesia by measuring the cutaneous slinet period and compare the effect of intrathecal administration of a combination of local anesthetic and clonidine in the quiet skin period in relation to the application of local anesthetic only.


Eligibility Criteria:
Inclusion Criteria:

ASA one and two status BMI 18,5 to 24

Exclusion Criteria:

Coagulation disorders Polyneuropathy Diabetes mellitus Alcoholism Systemic inflammatory and malignant diseases Stroke
A Supervised Nutritional Program in Pregnancies and NF-κB Expression in Placenta

Nuclear factor kappa B (NF-κB) pathway and oxidative stress participate in endothelial dysfunction, which is one of the causes of preeclampsia. Among the human antioxidant mechanisms there are the enzymes catalase (CAT), glutathione peroxidase (GPx) and superoxide dismutase (SOD). Our aim was to measure NF-κB and oxidative stress in pregnant women submitted to an individualized diet during pregnancy.

Obesity during pregnancy is associated with exaggerated metabolic adaptation, endothelial dysfunction and an increased risk of adverse pregnancy outcomes, including preeclampsia, a major cause of maternal and fetal morbidity and mortality characterized by increased blood pressure, proteinuria and edema, which affects approximately 3% to 7% of all pregnant women. Other risk factors, besides obesity, that increase the likelihood of developing preeclampsia include chronic hypertension, and diabetes mellitus.

Reactive oxygen species (ROS) \[superoxide anions (•O2-), hydrogen peroxide (H2O2) and hydroxyl radicals (•OH)\],5 interact with proteins, nucleic acids and lipids and in a process called lipid peroxidation (LPO), can cause severe cell and tissue damage. There is current evidence that ROS are common activators of nuclear factor-kappa B (NF-κB), a factor that initiates a systemic inflammatory process by promoting the synthesis of cytokines, interleukin (IL)-6, IL-8, monocyte chemotactic protein-1 (MCP-1) and expression of intercellular adhesion molecule (ICAM-1).

To maintain balance of the oxidative state, the human body possesses intracellular antioxidant enzyme systems, including superoxide dismutase (SOD, glutathione peroxidase (GPx), and catalase (CAT), which is located mainly in peroxisomes and cytoplasm of the cell.

The epidemiology of preeclampsia, which is more common among poor women, had previously suggested that nutrients may be involved in the disorder, unfortunately, the nutritional data obtained from women with the syndrome has been poorly defined.

The objective of this paper was to provide an overview of the biological plausibility and potential mechanisms underlying associations among maternal nutrition, oxidative stress in placenta and the risk of preeclampsia.

Eligibility Criteria:
Inclusion Criteria:

* Women in their first trimester of pregnancy

Exclusion Criteria:

* multiple pregnancies
* prior history of chronic-metabolic diseases
The Association Between Parathyroid Hormone and Preterm Labor

This observational study aims to test the level of parathyroid hormone in pregnant women. The main question it aims to answer is:

n Pregnant women, are the levels of serum PTH, calcium, magnesium, phosphorus \& albumin similar in both preterm and term births?

* Approval from ethical committee will be sought.
* Patients will be enrolled from Ain Shams University Maternity Hospital labor ward and antenatal outpatient clinic.
* History, examination and fetal ultrasound will be done to identify eligible patients.

History: a full detailed history including personal, menstrual, obstetric, present, past history and family history will be obtained.

Accurate last menstrual period date will be obtained, and gestational age will be calculated using Naegele's rule or first trimester ultrasound to identify preterm patients with gestational age (28-36 weeks).

Examination: general, abdominal and vaginal examination to identify patients in established labor with Regular uterine contractions are at least 3 in 10 min each lasting 40 seconds. Progressive cervical dilatation (at least 4 cm). Ultrasound: for (viability of fetus, fetal biometry and estimated fetal weight, amniotic fluid, placental localization).

Thus, two groups of patients will be identified:

1. Cases: established preterm labor - gestational age: (28-36 weeks)
2. Controls: pregnant women not in labor - gestational age: (28- 36 weeks)

   * Venous blood samples will be withdrawn about (3ml) once from every patient within one hour from inclusion into the study to measure serum parathyroid hormone, calcium, magnesium, phosphorus and albumin levels.
   * Samples will not be collected from an arm with an intravenous catheter if alternate sites are available.
   * Patient collection site will be appropriately disinfected prior to sample collection.
   * After collection, samples will be put in a red or yellow tube (serum separating tube) with a serum gel separator.
   * Samples will be gently mixed immediately following collection into tube to ensure proper preservation of the analytes. 180° tube inversion, allowing bubble to travel the length of the tube, followed by return to upright position is one mix.
   * Samples will be delivered to laboratory within 30 to 60 minutes.
   * Data will be collected and recorded in a case report form (Age, parity, previous preterm births/ miscarriage, gestational age, measured levels of serum PTH, calcium, magnesium, phosphorus \& albumin , mode of delivery, birth weight).
   * Statistical analysis will be done to get results.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged (18-40).
* Gestational age (28-36 weeks).

Exclusion Criteria:

* Known maternal disease as diabetes, hypertension, renal disease, cardiac disease and liver disease.
* Known hypo or hyperparathyroidism
* Multiple pregnancy
* Polyhydramnios
* Premature rupture of membrane
* Antepartum Hemorrhage
* Uterine malformations e.g. bicornuate uterus
* Smoking
Blood Pressure and Central Vascular Stiffness in Obese Children. Relationship to Metabolic Disturbances and Subclinical Cardiovascular Damage. Effect of Weight Reduction

The global epidemic of obesity in childhood continues to evolve and threaten future health and life expectancy primarily due to the increased incidence of cardiovascular disease. Obesity is strongly related to high blood pressure (hypertension) and both conditions pose a risk for target organ damage, which can follow a subject from childhood into adult life. The AORTA study will investigate central hemodynamics and organ damage in 100 obese children and adolescents in order to gain insight to the complex interplay of hypertension, obesity and subclinical damage in order to intensify more precise prevention, thereby reducing the future development of cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* age 10-18
* BMI for age and sex above 95 percentile
* referred for treatment at the The Children's Obesity Clinic, Department of Paediatrics, Holbaek Hospital, University of Copenhagen
* oral and written consent by their parents

Exclusion Criteria:

* children who can not cooperate to DEXA scanning or other procedures
* linguistic difficulties that impair communication
Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections

Carbapenem-Resistant Enterobacteriaceae (CRE) infections are a growing national and international challenge in healthcare settings. This is not only due to the rapid spread of resistance and paucity of options of targeted-antimicrobial agents, but also owing to the high mortality of patients infected with CRE reaching up to 50% as per the Centers of Disease Control and Prevention.

Colistin-based combination regimens have been the mainstay for treating CRE-related infections. Ceftazidime-avibactam is a beta-lactamase inhibitor combination, a novel antibiotic, which recently showed a better clinical and microbiological cure against CRE along with the potential to reduce mortality and nephrotoxicity in comparison to colistin-based regimens in observational studies. However, randomized clinical trials are lacking.

This non-inferiority randomized controlled study aims to assess the efficacy and safety of ceftazidime-avibactam-based regimens in critically ill patients with CRE infections in comparison to colistin-based regimens.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 18 years.
2. Admitted to an intensive care unit (ICU).
3. Patients with hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP), complicated urinary tract infection (cUTI), bacteremia, complicated intraabdominal infection (cIAI), and complicated skin and soft tissue infection (cSSTI).
4. Confirmed infection with CRE, based on a culture and sensitivity obtained within the past 72 hours of study enrollment.
5. Suspected CRE infection according to one of the following: (1) positive Xpert Carba-R test screening for blaKPC or blaOXA-48 or blaNDM or blaVIM or blaIMI assessed on the admission to the ICU, (2) positive culture for CRE obtained within 3 months from time of enrollment.

Exclusion Criteria:

1. Acute Physiology and Chronic Health Evaluation II (APACHE II) score more than 30
2. known significant hypersensitivity reaction to beta-lactam antibiotics or colistin
3. Positive culture for Stenotrophomonas maltophilia or Acinetobacter baumannii within the current hospitalization.
4. Patients received the study intervention or control for more than 24 hours before the intended randomization.
5. Patient/substitute decision-maker or caring physician's refusal to enroll in the study.
6. Patient with concomitant suspected or confirmed meningitis.
7. Pregnancy.
8. Cystic fibrosis.
9. Patients with Do Not Attempt to Resuscitate (DNAR) code status.
10. Prior knowledge that the index CRE pathogen was resistant to colistin (MIC \>2 μg/ml) or ceftazidime-avibactam (MIC \> 8 μg/ml) before randomization.
11. Objective clinical evidence for any of the following infections that necessitate study therapy for \>14 days: endovascular infection, including endocarditis, osteomyelitis, prosthetic joint infection, meningitis, and/or other central nervous system infections
Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy

A prospective, multicenter, randomized controlled trial is designed to compare the recurrence rates and clinical outcomes in patients with chronic subdural hematoma using exhaustive drainage or fixed-time drainage after one-burr hole craniostomy.

Chronic subdural hematomas (CSDHs) are one of the most common neurosurgical conditions. The goal of surgery is to alleviate symptoms and minimize the risk of symptomatic recurrences. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural closed-system drainage. The drainage is removed after 48 hours, which can be described as fixed-time drainage strategy. According to literature, the recurrence rate is 5-33% with this strategy. In the investigators' retrospective study, postoperative hematoma volume (p=0.001, B=0.028, Exp(B)=1.028, 95% CI 1.011-1.046) was found to significantly increase the risk of recurrence. Based on these results, an exhaustive drainage strategy may minimize postoperative hematoma volume and achieve a low recurrence rate and good outcomes. This is a prospective, multicenter, randomized controlled trial designed to include 304 participants over the age of 18 years presenting with a symptomatic CSDH verified on cranial computed tomography or magnetic resonance imaging. After informed consent is obtained, participants are randomly allocated to an exhaustive drainage or fixed-time drainage group. The primary endpoint is recurrence indicating a reoperation within 6 months. Secondary outcomes include modified Rankin Scale, Markwalder Grading Scale, European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L), rate of complications, rate of adverse events and effect on comorbidity.

Eligibility Criteria:
Inclusion Criteria:

* Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of chronic subdural hematoma
* Chronic subdural hematoma verified on cranial computed tomography or magnetic resonance imaging
* Written informed consent from patients or their next of kin according to the patient's cognitive status

Exclusion Criteria:

* No clinical symptoms correlating with chronic subdural hematoma
* Lack of mass effect, less than 0.5 cm of midline structure shift, and no need surgery judged clinically by neurosurgeons
* Previous surgery for chronic subdural hematoma during the past 6 months
* Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before
* Existing poor medication condition or severe comorbidity so that surgery cannot be tolerated or follow-up cannot be completed
* Severe coagulopathy or high risk of life-threatening bleeding
* Postoperative cooperation is suspected to be insufficient for follow-up for 6 months
* Reproductive-age women without verified negative pregnancy testing
* Participating in other research