cyrilzakka/clinical-trials huggingface dataset:
Hallux Valgus- Radiological and Clinical Predictors for Outcome After Surgery

Prospective observational study to evaluate the clinical and radiological predictors for outcome in hallux valgus (HV) corrective surgery.

Hallux valgus (HV) is the most common deformity in the adult forefoot. Characterizing and classifying HV primarily has been based on weightbearing radiographic imaging. Understanding of this pathologic process has mainly been confined to two planes, where the dominating modality of choice has been assessment by antero-posterior (AP) and lateral radiographs. From these two projections, imaging parameters have developed to define the severity of HV. With this understanding as the basis for describing the deformity, more than 140 operative techniques have been described. Although many of these techniques are of historical interest only, consistently favourable outcomes remain elusive even among more popular current techniques. HV corrective surgery is known to have mediocre results, with recurrence rate as high as 30-70%. Unsuccessful treatment of the condition is amongst the most common in the Norwegian patient injury compensation scheme. The variation in corrective techniques and the associated persistent and clinically significant rates of poor outcomes may indicate an incomplete treatment of the pathoanatomy of HV. Numerous recent publications have proved that the hallux valgus deformity should be viewed as a three-dimensional deformity. These recent studies have also pointed out new radiological parameters in AP and axial view, focusing on the multiplanar understanding of the deformity. The key challenge of the hallux valgus foot is the lack of clear guidelines for choosing the best treatment to these large group of patients. There is of today no guidelines nor consensus considering the indication for surgical treatment of the hallux valgus deformity. It is not known how much nuisance the patient should present before surgery could be worthwhile. Many studies have been made in the field of HV, but literature with the focus on comparing the surgical correction and the patient related clinical outcome is sparse and insufficient.

In this project the investigators primary aim is to investigate radiological and clinical factors that predict outcome in participants operated for hallux valgus deformity.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients accepted for hallux valgus surgery (mild, moderate, severe) at the ØHT will be asked to participate in the study

Exclusion Criteria:

* Previous hallux valgus surgery in the same foot
* Lack of compliance
* Not available for follow-up
* Language difficulties (not able to communicate in English or Norwegian)
Effects of Docosahexanoic Acid on Neurocognitive Impairment in HIV-infected Patients

Neurocognitive impairment (NCI) is one of the serious complications of elderly HIV-infected patients. The destruction of intestinal mucosal barrier and imbalance of bacterial flora caused by aging and HIV infection may be an important factor promoting the occurrence of NCI. Therefore, it is important to understand changes in gut microbiota of HIV-infected patients with NCI. Higher dietary intake of the essential fatty acid docosahexaenoic (DHA) has been associated with better cognitive performance in several epidemiological studies. To date, data are limited showing that DHA administration leads to benefits for behavioral disorders by modulating gut microbiota composition; the few studies on this subject, mostly completed in animal models. Moreover，low levels of DHA have been found in HIV-infected patients. The effect of DHA supplementation on gut microbiota and NCI status of HIV-positive patients have not been evaluated yet. Investigators aim to implement a case-control study to identify the relationship between gut microbiota and NCI in HIV-infected patients. At the meantime, investigators aim to implement a randomized, double-blind, placebo-controlled clinical trial to assess DHA supplementation in HIV-infected patients with NCI for 16 weeks. The effect of DHA on gut microbiota and NCI were evaluated. Also, investigators aim to identify if the benefits for NCI of DHA caused by modulating gut microbiota composition and metabolites.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients
* Age ≥18 years
* Established diagnosis of HIV-1 infection, under stable cART for the prior 6 months and throughout the study period
* Presence of neurocognitive impairment was assessed using the global deficit score (GDS), calculated as the average of deficit scores across all neuropsychological test. The cut-off for NCI was a GDS score ≥ 0.5

Exclusion Criteria:

* Age \<18 years,
* BMI \>30 kg/m2
* Pregnancy or lactation
* A history of diabetes mellitus, cardiovascular and cerebrovascular diseases, or serious diseases such as liver, kidney and hematopoietic system disease
* Known intolerance to n-3 PUFA preparations.
A Trial of the Launching! to Adulthood Program

The purpose of this study is to evaluate the effectiveness of the Launching intervention (Pagan et al., 2024) in improving adaptive functioning, transition readiness, and social cognition in young adults with Autism Spectrum Disorder (ASD), compared to a delayed treatment control group, to examine whether the Launching intervention leads to improvements in executive functioning, co-occurring mental health symptoms, and quality of life, as measured by caregiver and self-report assessments, to assess the maintenance of treatment gains 12 weeks post-treatment and to replicate the findings of the Launching pilot study in an independent sample of young adults with ASD.


Eligibility Criteria:
Inclusion Criteria:

* confirmed case of ASD from a licensed mental health or medical professional
* score of \>14 on the Social Communication Questionnaire-Lifetime (SCQ-L) completed with the mother or father
* meet DSM-5 criteria for ASD based on a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) ASD symptom checklist
* willing and motivated to participate in the treatment
* a parent willing to participate
* verbal intelligence quotient (IQ) score \>70 as assessed by the Kaufman Brief Intelligence Test 2nd edition revised (KBIT-2-R)

Exclusion Criteria:

* history of a psychotic disorder or current psychotic symptoms
* suicidal ideation with intent or plan
* current alcohol or other substance use disorder rated severe
* concurrent enrollment in another clinical trial for autism spectrum disorder
* expression of unwillingness to complete study procedures
Clinical, Radiological and Microbiological Outcomes of Implants With Two Different Connection Configurations, a Split-mouth RCT.

This study designed as a randomized controlled split-mouth trial will be conducted at the Dental Clinic of the University of Valencia. The aim will be to assess differences in clinical, radiological and microbiological outcomes between implants with 2 different connections: internal hexagon and conical connection. Following the premises, to minimize the bias related to prosthetic phase and maximize the effect of connections on MBL changes, a 1abutment-1time protocol will be used.

The study hypothesis is that there will be no statistically significant differences between both implant connections.


Eligibility Criteria:
Inclusion Criteria:

* able to sign an informed consent form
* aged 25 years or more
* Any patient requiring two implant-supported crowns in the lower or upper jaw
* Kennedy class I, II, and III;
* teeth extracted at least 6 months before implant placement;
* sufficient bone volumes to accommodate dental implants without augmentation procedure

Exclusion Criteria:

* General medical and/or psychiatric contraindications to implant surgery,
* Pregnancy or nursing,
* Heavy smoking (more than 10 cigarettes/day),
* Treatment with anticoagulant drugs (International Normalized Ratio under 1.8), bisphosphonates, steroid therapy or anticonvulsants drugs.
* No regenerated bone
* Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
* Patients with history of alcohol, narcotics or drug abuse. (Alcoholism: more than two bottles of beer per day)
* Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment, or who have been administered radiotherapy in the last 5 years. (Patients through at any time received radiotherapy to the head and neck region should be excluded anyway.)
* Metabolic bone disorders
* Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia.
* Degenerative diseases.
* Osteoradionecrosis.
* Renal failure.
* Organ transplant recipients.
* HIV positive.
* Malignant diseases.
* Diseases that compromise the immune system.
* Unbalanced diabetes mellitus. (HbA1c above 6.5), Uncontrolled endocrine diseases
* Psychotic diseases.
* Hypersensitivity to one of the components of the implant in general and titanium in particular.
* Women who are pregnant or lactating.
* Lack of patient cooperation.
* Parafunctional habits, such as Bruxism or Temporomandibular joint disease.
* Various pathologies of the oral mucosa for example: Benign mucous pemphigoid, desquamative ginigivitis, erosive lichen planus, malignancy of oral cavity, bolus erosive diseases of the oral mucosa.
Impact of HPV Vaccination on HPV Infection and Cervical Related Disease Burden in Real-World Settings (HPV-RWS)

Take AS04 adjuvanted HPV16/18 vaccine as an example to evaluate the impact of HPV vaccination on HPV infection and related disease burden in the real world based on prospective cohort and Yinzhou Regional Health Information Platform (YRHIP), in order to bridge the gap in relevant evidence in China.


Eligibility Criteria:
Inclusion Criteria:

* Permanent female resident in the Yinzhou District (i.e. at least residing in the Yinzhou District for a 3-year period and at least 6months in every 12-month period).
* Between 9 and 45 years old at time of the enrollment.
* Receiving first or second dose of the AS04 adjuvanted HPV 16/18 vaccine (exposed group). Or without any HPV vaccination history (non-exposed group).
* Subjects and their parents / legal guardians agreed to comply with the requirements mentioned in the protocol (e.g., physically and mentally healthy, be able to complete the baseline and follow-up survey and would comply with the visits, etc.).
* Written informed consent will be obtained from the subject. For subjects who are below the legal age of consent, written informed consent must be obtained from the parent(s)/LAR(s) of the subject and informed assent must be obtained from the subject according to EC requirement as well as local law. Subjects must understand the protocol and be voluntarily willing to join this study with written informed consent form.

Exclusion Criteria:

* Pregnancy at the enrollment.
* Females with historical cervical diseases (i.e., CIN1, CIN2, CIN3, and cervical cancer) before the recruitment.
* After hysterectomy.
* Females with malignant tumor history or other severe diseases (e.g., liver failure, heart failure, etc.) whose life expectancy is less than 12 months.
* Females who (1) have historical HPV vaccination, or (2) are in non-exposed groups but have clear intention for HPV vaccination in next 3 years.
Decatecholaminisation of Septic Shock With Dexmedetomidine and In-hospital Mortality

The study aims to determine whether the infusion of DEX in septic shock can reduce in-hospital mortality, norepinephrine infusion, need and duration for mechanical ventilation, and acute kidney injury without significant adverse events.

During septic shock, acute stress response includes neural and humoral autonomic flaring, which tend to be beneficial in the short term. Once shock occurs, it is a failure of the compensation trial. In addition, chronic autonomic stimulation risks myocardial injury, immunosuppression, insulin resistance, and thrombo-embolic tendency.

The investigators hypothesized that dacatecholaminisation with dexmedetomidine - as calibrated by heart rate control - would reduce the in-hospital mortality in septic shock, whether the patient is mechanically ventilated or not. The study aims to determine whether the infusion of DEX in septic shock can reduce in-hospital mortality, norepinephrine infusion, need and duration for mechanical ventilation, and acute kidney injury without significant adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years) patients of either sex who develop septic shock with heart rate (HR) \> 90 beats per minute (bpm).

We choose the definition of septic shock as the start of norepinephrine (NE) infusion to maintain the mean arterial blood pressure (MAP) of ≥ 65 mmHg in a case of sepsis (≥ 2 SIRS criteria plus suspicion or confirmation of infection).

Exclusion Criteria:

* Patient refusal or inability to obtain consent
* Failure of hemodynamic stabilization or hemoglobin \< 7 gm/dl at time of inclusion
* Severe cardiac dysfunction (Ejection Fraction (EF) \< 30%)
* History of heart block or patient on pacemaker
* Chronic liver Disease (Child-Pugh classification C)
* Severe valvular heart disease
* Pregnancy
New Approach for Ovarian PRP Injection for Poor Responders

New Approach For Ovarian PRP Injection for poor responders

Poor ovarian responders are at high risk of unsuccessful IVF/ICSI trials. In the last few years, many studies showed significant improvement of ovarian reserve parameters after PRP injection. There was no consensus regarding the route of injection, the volume injected, the location of PRP injection inside the ovary, the number of injection and the number of the cycle in which PRP is injected.

Eligibility Criteria:
Inclusion Criteria:

* AMH : \< 0.5 ng/ml
* FSH: \> 10 miu but \< 25 miu.
* AFC : \< 5 in both ovaries
* Poor ovarian response, in a previous IVF/ICSI trial , resulting in 3 or fewer oocytes.
* Normal uterine cavity , demonstrated by a recent hysteroscopy

Exclusion Criteria:

* Primary ovarian insufficiency with FSH \> 25 miu.
* Previous ovarian surgery or Chemotherapy.
* On going Anticoagulant use.
* Carcinomas or a history of chronic pelvic pain.
* Present infection.
* Hemoglobin level lower than 11 g/L
* platelet count lower than 150 x 10³/μL.
Phenotypic Characterization and Biomarkers Investigation for Eosinophilic Esophagitis in Pediatric Patients

The purpose of this study is to find out some potential biomarkers for the Eosinophilic Esophagitis (EoE) in pediatric patients through the prospective clinical characterization and assessment of samples collected during the diagnostic process

This study collects clinical information from pediatric patients between 0-18 years old who have been undergoing upper gastrointestinal endoscopy due to general complaints. The demographic, clinical symptoms, endoscopy, pH monitoring, and histology data are assessed during the diagnostic process. In the baseline endoscopy procedure samples (blood, saliva, esophageal tissue, and esophageal mucus) are taken. After diagnostic process of EoE and Gastroesophageal reflux disease (GERD) supported by International Guidelines the patients are divided into three groups - EoE, GERD, and Control.

The techniques are used for patients characterization and assessment:

1. Symptoms score: General symptom score and/or Pediatric Eosinophilic Esophagitis Symptom Score (PEESS v2.0) - translated and adapted version for Brazilian Portuguese
2. Endoscopic Score: Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS)
3. Peak eosinophil count (PEC) and histological features description
4. Proteomic analyses
5. Microbiome analyses
6. Immunohistochemistry analyses

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients who are undergoing upper gastrointestinal endoscopy for diagnostic purpose

Exclusion Criteria:

* Pediatric patients who are undergoing upper gastrointestinal endoscopy for therapeutic procedures
* The presence of other eosinophilic diseases
* Patients have been taken corticosteroids and/or gastric acid secretion inhibition drugs for the last four weeks
A Phase I Study of QL1604 for Advanced Solid Tumors

In this study, patients with advance solid tumors will be treated with QL1604 monotherapy.


Eligibility Criteria:
Key Inclusion Criteria:

* 18-75 years;
* At least one measureable lesion as defined per RECIST Version (v) 1.1
* Histologically or cytologically confirmed、failed to standard therapy or lack standard therapy(except immunotherapy) advanced solid tumors; for cervical cancer, only squamous carcinoma、adenocarcinoma、adenosquamous carcinoma could be enrolled； hepatocellular carcinoma could be enrolled by clinical diagnosis
* Adequate important organ function

Key Exclusion Criteria:

* Active autoimmune disease orautoimmune disease history
* Meningeal metastasis,or brain metastasis( except asymptomatic brain metastasis, or symptomatic brain metastasis but stable for more than 4 weeks after treatment, and have stopped systemic hormone treatment (prednisone of \> 10 mg/day or equivalent hormone) for more than 2 weeks)
* Known hypersensitivity to protein macromolecules, and/or any of QL1604 excipients
* Radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy within 4 weeks prior to study drug (for micromolecule targeted therapy, within 2 weeks)
* Active hepaititis B or C infection
* Both HBsAg and anti-HCV Ab positive
Propofol/Dexmedetomidine Versus Desflurane Effects on Post Hepatectomy Hepatocellular Injury

This study will compare the effects of propofol/dexmedetomidine versus desflurane for maintenance of general anesthesia on hepatocellular injury in patients undergoing partial hepatectomy.

Postoperative impairment of liver function is common after hepatectomy. It may be caused by surgical trauma, loss of hepatic mass, stress response, hepatic oxygen deprivation, infection and drug toxicity.

Anesthetic agents used in general anesthesia for liver surgery have a big effect on hepatic blood flow, oxygen delivery and liver function This study will compare the effects of propofol/dexmedetomidine versus desflurane for maintenance of general anesthesia on hepatocellular injury in patients undergoing partial hepatectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients American Society of Anesthesiologists physical status (ASA) I to II.
2. Patients Child Pugh classification A to B.
3. Both sexes.
4. Aged between 18 years and 70 years
5. Scheduled for more than 1 segment hepatectomy.

Exclusion Criteria:

1. Patients with Child Pugh classification C.
2. Patients younger than18 years old or older than 70 years old
3. Patients performed additional ablation therapies (cryosurgery or radiofrequency ablation).
4. Prior liver resection for donation.
5. Scheduled resection not requiring inflow occlusion (Pringle's maneuver).
6. Hypersensitivity to any of the used drugs.
Digital Occlusal Analysis of Ultra Suction Retained Complete Denture

Bite testing using T-Scan allows the evaluation of occlusal contacts prior to making a bite adjustment. The T-Scan can indicate premature contact and the load distribution on teeth, and provide measurable force and time information that ensures proper occlusal adjustment.

Prior to employing T-Scan occlusal analyzer to assess the occlusion on the complete denture, complete denture was seated and checked for fitness, stability, pressure areas with pressure indicating paste and border evaluation and extension. The peripheral seal should be evident so that the denture-maintained suction against maxillary tissues. Upon completion of these fit and stability assessments, the occlusion could then be addressed.

The method considered for the occlusal analysis was a computerized system . The system was composed of a computer with a specific board and software capable of converting information recorded by the sensor to visual and numerical information on tooth contact. For Tekscan system to function properly, computer system must meet or exceed specified system requirements.

The Tekscan USB handle, does not require an additional interface card or parallel box in order tobe connected to computer. When inserted into computer, the computer's operating system will automatically detect and configure the hardware for use. The T-Scan sensor was an ultra-thin (.004", 0.1 mm), flexible printed circuit that detected the patient's occlusal parameters.

Eligibility Criteria:
Inclusion Criteria:

* All implant indicated.

Exclusion Criteria:

* All implant contraindicated
Real-World Treatment Study of Soliris (Eculizumab)

As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients who are treated with Soliris in normal clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Soliris under conditions of routine daily medical practice in Korea.

This study will provide information on the population of Korean patients who are treated with Soliris.

The Korea Risk Management Plan (K-RMP) of Soliris Inj. 300mg (eculizumab, hereinafter referred to as 'Soliris' or study drug) includes Post-Marketing Surveillance (PMS) as part of the pharmacovigilance plan in accordance with 'Article 7-2 of Regulation on Pharmaceuticals Approval, Notification and Review'.

This study will be conducted to prepare data on drug use results required for post- marketing re-examination application of Soliris and the purpose of the study is to identify the safety under real world practice.

Soliris was approved by the Ministry of Food and Drug Safety on February 18, 2021 for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP-4) antibody positive, and a 4 years of re-examination period was given based on the approval date of the indication and usage change.

The re-examination period for Soliris is calculated as February 17, 2025 in accordance with the 'Standards for Re-examination of New Drugs, etc.' This study includes about 11 adult patients with NMOSD positive for anti-aquaporin-4 (AQP-4) antibody currently treated with or initiating treatment with Soliris .

It will be conducted as a total surveillance method in which each subject who received the drug is recorded in the case report form during the study period. In addition, efforts will be made to conduct investigations on safety and efficacy, such as onset of side effect and expected effects, for all patients who received the product up to two years from the marketing date.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 19 or older with NMOSD positive for anti-aquaporin-4 (AQP-4) antibody who are receiving or starting treatment with Soliris according to the product label
2. Patients who have been vaccinated against Neisseria meningitidis at least 2 weeks prior to receiving the first dose of Soliris. However, patients who receive Soliris within 2 weeks after Neisseria meningitidis vaccination should receive treatment with appropriate prophylactic antibiotics for 2 weeks after vaccination
3. Patient who understood and consented to the written informed consent provided.

Exclusion Criteria:

1. Patients with hypersensitivity to eculizumab, murine protein, or any other component of Soliris
2. Patients with untreated serious Neisseria meningitidis infection.