cyrilzakka/clinical-trials huggingface dataset:
Parental Cognitions and Children's Wellbeing

The current study aims to address the research limitations in previous studies by adopting a longitudinal design to investigate the associations between parental cognitions (parental expectations, parental beliefs, and parental attributional styles) and adolescents' wellbeing, resilience, and coping strategies across an extended period. Two main research questions were posed: 1) What are the associations between parental cognition factors (parental attribution, parental expectations, and parental beliefs and adolescents' outcomes (wellbeing, resilience, and stress-coping)? 2) Which parental cognition factor has the highest probability in predicting the changes of adolescents' wellbeing, resilience, and coping strategies over time? To answer these research questions, bayesian regression analysis was used to identify the best fitting model of adolescents' wellbeing outcomes and to discern the risk and protective roles of parental cognition factors within the model. Bayesian regression approach also enables the assignment of probabilities to each parental cognition factor, quantifying their credibly in relation to adolescents' wellbeing outcomes.

93 parents who has an adolescent aged between 11 to 16 years old were recruited. Only 65 of them had their adolescents to agree to sign up. This result in a 65 dyads of parents and adolescents in total. Parents and adolescents completed the measures on Qualtrics online survey site, respectively. After completion, researcher contacted parents to arrange a zoom call/phone call with their adolescents to complete measures on wellbeing and perceived stress. Among 93 parents who signed up the research, only 65 of their adolescents managed to complete both the online questionnaire and the call with the researcher at baseline. Six months after baseline, only adolescents were asked to repeat the above procedures as the follow-up. 37 adolescents completed the follow-up procedure, which makes this study sample ended up with 37 dyads of parents and adolescents. The primary objective of this observational study is to determine which parental factor, among the three primary parental cognition schemas (parental expectations, parental beliefs, and parental attributional styles), exhibits consistent effects on predicting the changes of adolescents' wellbeing over time.

Eligibility Criteria:
Inclusion Criteria:

* Criteria for participation were parents and their adolescents aged 11 to 16 years old who have no neurodevelopmental conditions reported by parents (specifically to developmental disorders that may include learning difficulties, such as ASD, ADHD, and intellectual disability).

Exclusion Criteria:

* Adolescents with neurodevelopmental disorders, adolescents aged younger than 11 years old or older than 16 years old, and adolescents and parents who are not fluent in English will also be excluded as the measurements in this study are written in English.
Combine Serratus Anterior Plane Block Versus Erector Spinae Plane Block in Coronary Bypass Surgery

Even though Erector Spinae Plane (ESP) Block is shown to be efficient in cardiac surgery, the Combine Serratus Anterior Plane (CSAP) Block is still controversial if it has an efficient analgesic effect for sternotomy and drain tube pain relief. This study aims to compare ESP block and CSAP block for postoperative analgesia in coronary bypass surgery patients.

Acute postoperative pain after cardiac surgery originates various surgical procedures that may cause pain including the incision of tissues, sternotomy, the separation of bone-joint structures, the severity and duration of these applications, the use of chest tubes, and the patient's personal inflammatory may affect the response to these stimuli. Postoperative pain is a critical risk factor for the development of pulmonary and cardiovascular complications such as atelectasis, cardiac ischemia, and arrhythmias. Researchers claim that adding techniques to iv drugs, such as thoracic epidural anesthesia, paravertebral block, or erector spinae plane block (ESP) to multimodal analgesia regimens positively affect recovery. Although the efficacy of ESP block in providing postoperative analgesia has been demonstrated in many studies, there is no study comparing CSAP and ESP block in cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who will undergo coronary artery bypass grafting surgery with median sternotomy

Exclusion Criteria:

* Emergency surgeries
* Patients with allergic reactions to anesthesia and analgesia drugs to be used
* Patients who do not want to participate in the study voluntarily
* Severe systemic disease (kidney, liver, pulmonary, endocrine)
* Substance abuse history
* History of chronic pain
* Psychiatric problems and communication difficulties
* Patients who need revision due to hemostasis in the postoperative period
* Patients with severe hemodynamic instability due to infection, heavy bleeding, etc.
LCAR-M61S and LCAR-M61D in Treatment of Relapsed/Refractory Multiple Myeloma

A prospective, two-cohort, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61S and LCAR-M61D in patients with relapsed/refractory multiple myeloma.

This study was a prospective, two-cohort, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61S and LCAR-M61D in patients with relapsed/refractory multiple myeloma. All subjects who meet the eligibility criteria will receive intravenous injection of LCAR-M61S or LCAR-M61D cell injection. The study will include the following sequential phases: screening, apheresis, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily participate in clinical research;
* Age ≥18 years old;
* Eastern Cooperative Oncology Group (ECOG) score 0-2;
* Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria;
* Measurable lesions were present;
* Subjects have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression (PD confirmed according to IMWG criteria);
* Expected survival ≥3 months;
* Clinical laboratory values in the screening period meet criteria;

Exclusion Criteria:

* Received previous therapy targeting GPRC5D and/or CD19 targets;
* Prior antineoplastic therapy and meet exclusion criteria (before apheresis);
* Subjects had Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.
* Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;
* Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known.
* Serious underlying diseases were present;
* Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment.
* Also enrolled in other clinical studies.
Evaluation of Impaired Microcirculation During Septic Shock With Contrast Enhanced Ultrasound

Microcirculatory disorders play a central role in the pathogenesis of sepsis and septic shock. Without adequate therapy that may lead to multi-organ failure and death. Therefore useful therapeutic measures aim to improve the microcirculation, to avoid tissue hypoxia and thus multiple organ failure or death. Clinically, the microcirculation can currently be indirectly evaluated using the diuresis and metabolic parameters (eg, lactate). The aim of the present study is to measure the microcirculation in septic shock by means of contrast-enhanced sonography of the calf muscles. For this purpose, the method is applied to 24 subjects during and after septic shock. It will be investigated in this study whether the microcirculation measurement with ultrasound contrast reflects the severity of the disease. As well as to evaluate whether the use of this diagnostic method could lead to better treatment of the septic shock.


Eligibility Criteria:
Inclusion Criteria:

* septic shock

Exclusion Criteria:

* myocardial infarction
10 Year Review of the Experience of the PFNA ,TFNA the Affixus Nail

The aim of this study was to investigate the clinical effects of design changes from the use of three different IM nail designs in the management of extracapsular hip fractures.

Intertrochanteric hip fractures are one of the more common orthopaedic presentations, with an approximate incidence in Australia of 230 cases per 100,000 population. The importance of this pathology is well documented being the major fracture-related health care cost and cause of mortality in all sexes over 50 years of age.

Contemporary fixation of the proximal femur is performed utilising a number of implants adopting different concepts and techniques. Cephalomedullary/Intermedullary femoral nails (IM nails) over the last 15 years have gained popularity. IM nails are implanted via a small incision and intermedullary insertion through the greater trochanter, secured by passing a screw or blade through the femoral neck into the femoral head. This nailing technique offers the theoretical benefits of a smaller incision with less tissue dissection and hence reduced blood loss, infection and operating time. As well as a proposed biomechanical advantage due to a shorter lever arm, sharing the load and minimising proximal collapse.

Biomechanical studies of IM nails in the use of extracapsular fractures of the femoral neck have found benefit over existing sliding/compression hip screws (CHS). Advantages have been observed in combined bending and compression performance to failure. As well as postoperative rigidity in unstable subtrochanteric fractures, and load bearing capability. Significantly greater fatigue strength and fatigue life have additionally been shown in cyclic loading assessment and reduced incidence of cut out has been observed, showing benefit over the use of CHS.

Early trials however found a higher rate of operative complications involving IM fixation, including fractures at the tip of the nail or related to distal locking. Following this several studies have compared the clinical outcomes of CHS vs IM nails with varying findings questioning the overall patient benefit, especially in stable fracture patterns. From a review of the past literature the common trend is a longer operative time and higher associated blood loss with CHS, but fewer intraoperative surgical related complications and less fluoroscopic time with the use of nails. IM nail use has shown to offer better post-operative ambulatory function and reduced limb shortening but it appears due to the early complications of this technique numerous variations in implant design have emerged.

Purpose In recent years further development has occurred in nail design in an attempt to reduce the incidence of fixation failure. The aim of this study was to investigate the clinical effects of these design changes from the use of three different IM nail designs in the management of extracapsular hip fractures.

Eligibility Criteria:
Inclusion Criteria:

. fractured neck of femur

Exclusion Criteria:

. NOT fractured neck of femur
Comparison Study of Two Splints Used for Treatment of Acute Temporomandibular Pain.

The most commonly applied treatment against acute temporomandibular signs and symptoms is pharmacotherapy. The evidence on treatment efficacy of non-medication treatments (like splints) is very low. Two very commonly used splints are the Aqualizer® and the soft polyester splint. These are splints applied for a short period of time, until the treatment with a hard splint and/or physiotherapy begins. Aim of this study is to compare the clinical short-time efficacy of these two splints for the treatment of acute temporomandibular pain and compare it to a control group receiving no therapy for that short time.

The study hypothesis is that there is a difference in pain reduction between the three groups of patients (two intervention and one control group).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, non-chronic orofacial pain

Exclusion Criteria:

* Pregnancy, chronic orofacial pain, dental treatment need, dental pain, edentulous space larger than 5mm, more than three molars missing in the same quadrant, rheumatic disease, Injury/operation in maxillofacial area.
Comparing Patients' and Surgeons' Expectations of Lumbar Spine Surgery

The goals of this study are to assess concordance between the patient-surgeon pair regarding expectations of lumbar spine surgery.

Low back pain is a prevalent medical condition afflicting primarily older adults but affecting all age groups and due to acute and non-acute diagnoses. Multiple possible conservative therapies exist; however, their major drawback is that the time required to advance therapy is often prolonged and accompanied by persistent disability and psychological suffering. Thus, some patients seek surgery after exhausting other therapies and some patients seek surgery earlier in their course. For both groups, decisions to undergo surgery are based on personal circumstances, perspectives, and expectations of outcome. Prior studies have shown that patients typically have high expectations of orthopedic surgery. Although high aspirations can be motivating, they also may predispose to poor outcomes if they are unrealistic and cause patients to become discouraged with recuperation time and ignore recommended lifestyle changes that avert progression of disease. Expectations that are too low, conversely, also may predispose to poor outcomes if patients lack motivation to participate in rehabilitation and to follow postop precautions. In order to achieve maximum benefit from surgery, patients and surgeons need to share an understanding of what is possible, probable, and realistic, and to join together and work toward the same goals. The primary objective of this proposed cross-sectional study is to assess the concordance between patients and their surgeons regarding expectations of lumbar spine surgery. Patients scheduled for lumbar surgery will be dichotomized according to whether they have acute versus non-acute conditions. Several days before surgery patients will complete the validated Lumbar Spine Surgery Expectations Survey measuring their physical and psychological expectations. Also before surgery their surgeons will complete the surgeon's version of the same survey for each patient. The main outcome will be a comparison of the concordance within each patient-surgeon pair according to acute versus non-acute groups based on the concordance correlation coefficient. Multivariate regression analysis based on the GEE method will be used to assess covariates.

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible if they are ≥ 18 years old, speak English, and are scheduled for non-trauma-related lumbar spine surgery.

Exclusion Criteria:

* Patients will be excluded if they have cognitive deficits and cannot provide informed consent.
The Clinical Investigation of Colgate Dual Zinc Toothpaste as Compared to Colgate Cavity Protection Toothpaste in Controlling Established Plaque and Gingivitis

Qualified subjects will be enrolled and randomized to either one of the two study groups described above based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three months of product use. All subjects will be followed for adverse events throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects, ages 18-70, inclusive.
* Availability for the three-month duration of the clinical research study.
* Good general health.
* Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
* Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
* Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
* Signed Informed Consent Form

Exclusion Criteria:

* Presence of orthodontic bands.
* Presence of partial removable dentures.
* Tumor(s) of the soft or hard tissues of the oral cavity.
* Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
* Five or more carious lesions requiring immediate restorative treatment.
* Antibiotic use any time during the one month prior to entry into the study.
* Participation in any other clinical study or test panel within the one month prior to entry into the study.
* Dental prophylaxis during the past two weeks prior to baseline examinations.
* History of allergies to oral care/personal care consumer products or their ingredients.
* On any prescription medicines that might interfere with the study outcome.
* An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
* History of alcohol or drug abuse.
* Pregnant or lactating subjects
Is Acupuncture Able to Reduce Nausea and Vomiting in the Terminal Ill Patient

A comparative effectiveness research design was used. The sample size was calculated to 136 patients, who were randomized to an intervention group and a control group respectively. The patients were terminal ill patients enrolled to three in-bed hospices in Denmark and nausea and vomiting were measured using EORTC QlQ-c15-PAL (European Organisation for Research and Treatment of Cancer, Quality of Life Questionaire, core 15, Palliation)

The terminal ill patient is suffering from many different symptoms. In total 70% are suffering from nausea and vomiting due to the wide spread of cancer or due to side effects of treatment. Often the antiemetic's are not able to reduce symptoms to a level that enable the patient to experience quality in life in the last days of his life. The investigators had some experience with acupuncture as a complementary therapy but the investigators wanted more systematically to investigate if acupuncture is able to reduce the terminal ill patient´s nausea and vomiting. Literature show that acupuncture is able to reduce nausea and vomiting in patients receiving chemotherapy, but there is no literature that support the ability of acupuncture to reduce nausea and vomiting in the terminal ill patient.

The purpose of this study was to generate evidence based knowledge close to practice regarding the effect of acupuncture in reducing nausea and vomiting in the terminal ill patient.

Participants:

Terminal ill patients suffering from nausea and/or vomiting

Interventions:

The intervention group received usual care plus acupuncture for three days. The acupuncture spots: Pericardium-6, Stomach-36, Liver-3 and Yin Tang were used. The control group received usual care.

Eligibility Criteria:
Inclusion Criteria:

* Able to participate due to cognitive ability
* Nausea
* Admitted to in-bed hospice

Exclusion Criteria:

* Not able to participate due to cognitive impairment
* Lymphedema in the area of acupuncture site
Phase 1 Drug Interaction Study of the Effect of Apixaban on the PK of Digoxin in Healthy Subjects

The purpose of this study is to assess the effects of Apixaban on the Pharmacokinetics (PK) of multiple-dose Digoxin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations

Exclusion Criteria:

• Any significant acute or chronic medical illness, history of important arrhythmias, history or evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years
Cell-free DNA in Acute Stroke

Cell-free DNA (cfDNA) is an important pro-inflammatory and prothrombotic mediator. With this study the investigators aim to gain new insights into the role of cfDNA in stroke and to perform a combined analysis of cfDNA in the hyperacute phase of the disease using blood and thrombus analyses. The main objectives are to analyse cfDNA in different stroke etiologies, to investigate the relationship between cfDNA and important procedural factors such as secondary embolisation and reperfusion outcomes, to analyse the correlation between blood and thrombus content of cfDNA and to investigate the specific source of cfDNA in distinct stroke subtypes.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke due to large vessel occlusion (LVO) who require mechanical thrombectomy (detected in CT-Scan or MRI-Scan)
* 18 years of age

Exclusion Criteria:

* Patients currently undergoing immunological therapies.
* Patients with immunological diseases
* Patients with systemic infections at the time of admission
Efficacy, Safety and Tolerability of Topically Applied LDE225 Cream (Hedgehog Pathway Inhibitor) in Adult Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)

This 22 week study will assess the efficacy, safety, and tolerability of LDE225 versus vehicle when applied topically to basal cell carcinoma (BCC) in patients with NBCCS. Patients will treat multiple BCCs for up to 12 weeks. Treatment success is defined as complete clinical clearance and complete histological clearance in BCCs.


Eligibility Criteria:
Inclusion Criteria:

1. Adult greater than 18 years old, male or female.
2. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study.
3. Typical presentation of NBCCS in the opinion of the investigator
4. At least one of the major clinical criteria of NBCCS.
5. Multiple BCCs during the screening period

Exclusion Criteria:

1. Any concomitant dermatological disease that could confound the evaluations, based on the discretion of the investigator.
2. Prior exposure to LDE225.
3. Use of systemic treatment for BCC in the 4 weeks prior to Baseline.
4. Use of topical treatment or photodynamic therapy (PDT) in the 12 weeks prior to Baseline.
5. Use of other investigational drugs at Baseline, or within 30 days or 5 half-lives prior to Baseline, whichever is longer.
6. Clinically significant medical condition, as per judgment of the investigator.
7. History of hypersensitivity to any of the ingredient of the study drug.
8. Pregnant or nursing (lactating) women
9. Women of child-bearing potential and fertile males, UNLESS they are using two birth control methods

Other protocol-defined inclusion/exclusion criteria may apply