cyrilzakka/clinical-trials huggingface dataset:
A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly

The purpose of this study is to explore the experience with paliperidone palmitate 3-month formulation (PP3M) treatment of participants and their corresponding physicians, nurses and carers, to understand the impact of less frequent injections from their perspective.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of schizophrenia (according to International Classification of Diseases \[ICD\]-10)
* Be currently receiving PP3M and have previously received 4 to 6 injections of PP3M
* Have the required language skills to participate in the online questionnaire, in the opinion of the physician
* Be able and willing to provide their informed consent for study participation

Exclusion Criteria:

* Has received involuntary treatment with PP3M
* Was switched to PP3M treatment within a clinical trial
Predictive Factors for Postoperative Pain, Nausea and Vomiting in Oncological Patients

1809 patients were evaluated in postoperative period. They were asked about nausea, vomiting, retching and pain in the first postoperative 24 hours

Patients were prospectively evaluated , and nausea, vomiting and pain were recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients submitted to oncological surgeries

Exclusion Criteria:

* refusal to sign the agreement term
* lack of information in the records
An Epidemiological Study to Evaluate Standard Daily Practice in Managing Patients With Arterial Hypertension

This study is aimed to evaluate response rate of the antihypertensive treatment with a calcium antagonist in real life practice, to evaluate patients' quality of life and to collect the following Serbia-specific epidemiology data on hypertension: demographic data, patents characteristics, and patients' management/treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subject population with essential arterial hypertension currently receiving treatment with a calcium antagonist
Caesarean Wound Dressing Removal Study

An open labelled randomised trial on the timing of wound dressing removal for emergency caesarean delivery in labour.

The trial is unblinded randomised trial on surgical wound dressing at 24 versus 48 hours after the emergency caesarean delivery in labour.

The primary outcome is the prevalence of wound complications (hematoma, seroma, infection/ dehiscence) The secondary objectives are the maximum pain after the surgery (in ward) and the timing of the patient's first bath after the surgery

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-50
2. Lower segment caesarean delivery
3. Primary or repeat caesarean delivery
4. Caesarean section in active phase of labour.
5. Regional anaesthesia

Exclusion Criteria:

1. Upper segment or classical caesarean delivery
2. Massive postpartum haemorrhage \> 1.5 litre
3. Pre-delivery chorioamnionitis
4. Skin closure using interrupted suture
5. Acquired or congenital coagulation disorder
6. Associated medical or obstetric condition requiring prolonged hospital stay after delivery such as severe pre-eclampsia, uncontrolled diabetes mellitus, cardiac disease, systemic infection.
7. Inability to give consent
Adjuvant Chemotherapy in Patients With Lymph Node Metastasis After Radical Surgery in Cervical Cancer

Purpose Primary endpoint

* To evaluate the 3-year disease free survival Second endpoints
* To evaluate the 3-year \& 5-year overall survival To analyze the toxicity and the quality of life


Eligibility Criteria:
Inclusion Criteria:

* cervical cancer stage Ia2-IIa
* histology; squamous, adeno, adenosquamous subtype
* age; 20∼70 years
* performance status; GOG 0∼2
* no medical illness
* hematologic, renal, hepatic function; normal
* grossly no residual disease
* histologically confirmed lymph nodes metastases
* no parametrial extension and negative resection margin
* number of retrieved lymph nodes; ≥ 20

Exclusion Criteria:

* patients with grade 2 peripheral neuropathy
* patients with uncontrolled infection
The Objective is to Respond to Patients' Needs in the Field of Larynx Replacement

Supplement pharyngolaryngeal deficient functions by insertion of a prosthesis with valves in order to allow tracheotomy closing (when applicable) and / or to allow restoration of god swallowing capacity. The secondary objective is to study the concept of a special valves system for the development of an artificial larynx


Eligibility Criteria:
Inclusion criteria:

* Age more than 18
* Swallowing troubles

Exclusion criteria:

* Pregnant women
* Contraindications to general anesthesia
The Combination of Teriflunomide and Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia

To compare the efficacy and safety of teriflunomide plus danazol versus danazol in patients with steroid-resistant/relapse ITP

This is a prospective, multicenter, randomized, controlled trial of 124 adult patients with steroid-resistant/relapse ITP in China. Patients were randomized to receive either experimental teriflunomide plus danazol or active comparator danazol monotherapy. Treatment was discontinued if very severe or life-threatening adverse events developed or at the patient's request.

Eligibility Criteria:
Inclusion Criteria:

1. Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;
2. Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid tapering or after its discontinuation;
3. Patients with a platelet count \<30,000/μL or a platelet count \<50,000/μL with bleeding manifestations at the enrollment;
4. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Secondary immune thrombocytopenia (e.g. patients with HIV, HCV, Helicobacter pylori infection, or patients with confirmed autoimmune disease);
2. Active or a history of malignancy;
3. Pre-existing acute or chronic liver disease, or serum alanine aminotransferase (ALT) greater than two times the upper limit of normal (ULN);
4. Pregnancy or lactation;
5. Current or recent (\< 4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection;
6. Active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
7. Have evidence of active tuberculosis (TB), or have previously had evidence of active TB and did not receive appropriate and documented treatment, or have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB;
8. Have experienced a clinically significant thrombotic event within 24 weeks of screening or are on anticoagulants and in the opinion of the investigator are not well controlled;
9. Patients who are deemed unsuitable for the study by the investigator.
Effect of Tramadol Versus Morphine on PD1 and PD1-ligand in Patients With Chronic Cancer Pain

this work is looking for comparison between the effect of tramadol versus morphine on PD1 and PD1-ligand in patients with chronic cancer pain

The use of opioids is the mainstay in the treatment of many types of chronic pain, including cancer and non-cancer-related pain\]. Opioids are known to suppress immune function following both acute and chronic administration; however, they appear to be different according to the schedule of administration as well as the state of the organism. Programmed death-1 (PD-1, also known as CD279) belongs to the CD28 receptor superfamily. It is an inhibitory receptor, and its expression is upregulated on activated leukocytes, resulting in an inhibited immune response. PD-1 interacts with two ligands: programmed death ligand-1 (PD-L1, also referred to as B7-H1) and programmed death ligand-2 (PD-L2, also known as B7-DC). PD-L2 is expressed mainly on activated dendritic cells (DCs) and macrophages, whereas PD-L1 is distributed widely. In addition to immune cells, some subsets of tumor cells also express PD-L1 to escape from immunosurveillance. It has been reported that the PD-1/PD-L1 pathway could be activated by surgical stress.

Eligibility Criteria:
Inclusion Criteria:

* patients with cancer pain of varying etiology,
* documented metastatic cancer, currently on step I WHO ladder and whose pain necessitates a shift to step II,
* those who have never received radiotherapy, chemotherapy, or immunosuppressive drugs, -- and in good general and nutritional condition and without infectious diseases at the time of investigation.

Exclusion Criteria:

* abnormal hepatic, renal, and pulmonary function, gastrointestinal pathology, and
* those with cerebral metastases and/or psychological disorders,
* patients with contraindication to morphine or tramadol according to their respective data sheets, and
* patients who could not complete the diary information correctly.
An Assessment of Bone Augmentation in Post-Extraction Sockets

When a tooth is extracted the ridge of bone that held the tooth in place begins to heal and over time new bone grows to fill the empty space left by the missing tooth. Sometimes this process works very well and new bone grows to completely fill the socket, at other times new bone fails to fill in the space completely and patients are left with uneven bone-fill.

Grafted extraction sockets may fill with bone faster and more evenly than those without grafts, allowing the dentist to have greater control over the healing process and to repair the area with dental implants in a shorter period of time.

This study will help determine if grafting an extraction socket, with or without enriching the graft material, is an added benefit when compared to allowing the socket to heal naturally.

The study will also assess how well two different dental implant designs used to restore the area will function over time.

Tooth extraction is often associated with resorption of the alveolar ridge height and width and with compromised soft tissue contours. A variety of methods have been proposed to overcome varied patterns of post-extraction healing.

An increasingly common practice combines skilled surgical technique with post-extraction site grafting utilizing both natural and synthetic bone-graft materials. These procedures are thought to retard resorption of the socket volume while lending some control over bone-fill - thereby preserving the integrity of the alveolar ridge for future reconstruction with dental implants.

Limited evidence-based data exist to support a variety of bone-graft materials including grafts enriched with autologous platelet-rich plasma(PRP)and grafts enriched with recombinant human platelet-derived growth factors(PDGF). Despite emerging clinical acceptance the most efficacious intervention remains undetermined.

In an effort to establish clinical evidence, this study will assess the efficacy of ridge preservation using three different bone grafting applications in post-extraction sockets compared to extraction alone.

The study will also asses longitudinal success of restoring the study sites with dental implants. Two innovative dental implant designs will be used in the study; an implant with a resorbable blast textured(RBT)surface and an implant with a laser thread-textured (LTT)surface.

Eligibility Criteria:
Inclusion Criteria:

* Needed extraction of Maxillary and/or Mandibular Incisors and/or Pre-molar teeth

Exclusion Criteria:

* Inability to provide informed consent in English
* Pregnant women
Implicit and Explicit Assessment of Suicide Risk

In 2007 Nock \& Banaji developed a so-called implicit suicide risk measurement using a computer tool: the Implicit Association Test (IAT). This measurement, associated with traditional evaluations, makes it possible to better predict suicidal recurrence. In 2020, the Poitiers team of Tello was able to replicate these results on a French population. However, although a high IAT score predicts the onset of suicide at 1 year, there is no data on how this score changes over time nor even data concerning the measure's ability to differentiate a population with explicit suicidal ideation from a population without explicit suicidal ideation. The investigators therefore seek to demonstrate an evolution of implicit suicidal ideation over time by replicating the measurement at inclusion, at 6 months and at 12 months, for different patient profiles: Suicidal ideation vs No suicidal ideation and suicide attempt vs no suicide attempt. Patients will be recruited from the emergency-unit of CHU Amiens-Picardie and will take the suicide-IAT as well as various questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Person presenting to emergencies for psychiatric reasons
* Adult person
* Free and informed consent signed
* Person speaking and writing French fluently

Exclusion Criteria:

* Neurological disorders or major cognitive deterioration: presence of confusion
* Acute psychotic decompensation
* Troubled acute behavior
* Abuse Impregnation of a toxic substance and / or drug impairing cognitive functions at the time of assessment
* Adult under protective measure.
Effectiveness of Group CBT in Children With Mixed Psychiatric Disorders

This study aims to examine the immediate and longer-term effectiveness of a group cognitive behavioral therapy intervention (GCBT) in reducing internalizing and externalizing symptoms in children treated for mixed psychiatric disorders in naturalistic clinical settings. Further, the effectiveness of GCBT is compared to a treatment-as-usual condition (TAU). Within this study, it is hypothesized that children with mixed psychiatric disorders will exhibit improvements in parent-rated internalizing problem behavior and parent- and teacher-rated externalizing problem behavior following GCBT.


Eligibility Criteria:
Inclusion Criteria:

* Helsinki University Hospital child psychiatric outpatient clinic patients with symptoms of anxiety or depression, deficiencies in emotional and behavioral skills impairing functioning, and sufficient social and cognitive skills to participate in group work.

Exclusion Criteria:

* Helsinki University Hospital child psychiatric outpatient clinic patients with excessive physical aggression, excessive physical restlessness to enable skill training, or whose severity of psychiatric symptoms required individual psychotherapy (e.g., acute suicidality or psychosis).
Prospective Multicentre Non-interventional Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer

The aim of this non-interventional (observational) study is to document, in collaboration with established urologists in Scandinavia, experience gained from routine use of Vantas® for the treatment of patients with advanced prostate cancer. In this observational study particular attention will be directed to treatment duration, quality of life and patient and physician acceptance of the medicinal product for long-term therapy. Patient-based measurement parameters such as quality of life and degree of satisfaction will allow registration of information that extends beyond the clinical parameters. The knowledge gathered will enable patient acceptance of long-term therapy to be evaluated. Clinical outcome will also be documented by measuring serum testosterone and prostate specific antigen (PSA) levels.


Eligibility Criteria:
Inclusion Criteria:

* Male patients for whom hormone treatment for advanced prostate cancer is indicated
* Age \> 18 years.
* Documented elevated PSA levels.

Exclusion Criteria:

Contraindications for Vantas® (in accordance with Summary of Product Characteristics (SmPC))
Investigating the Role of Mucin and Mucin Glycosylating Enzymes in Nasopharyngeal Carcinoma and Salivary Gland Cancer and Their Correlation With Clinical Prognosis

Nasopharyngeal carcinoma (NPC) is the tenth leading cancers in Taiwan and investigating its biomarker is important for understanding the mechanism of its pathogenesis.

NPC is the tenth leading cancers in Taiwan and investigating its biomarker is important for understanding the mechanism of its pathogenesis.

Eligibility Criteria:
Inclusion Criteria:

* NPC and salivary gland tumor diagnosed and treated in HTUH

Exclusion Criteria:

* previous treatment or surgery
A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa

This is a 112-week (approximately two-year) open-label extension study of Beremagene Geperpavec (B-VEC), for participants aged 2 months and older, who have been diagnosed with Dystrophic Epidermolysis Bullosa (DEB). Participants will be dosed weekly with the topical B-VEC therapy. The primary endpoint will be to assess long term safety and tolerability of the topical gene therapy. The study is for those who participated in Phase 3 study, as well as, new participants who were unable to participate in the Phase 3 study, who meet all enrollment criteria.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give consent/assent
* Clinical diagnosis of epidermolysis bullosa
* Confirmation of diagnosis (either DDEB or RDEB) by genetic testing including COL7A1.
* Age: 2 months of age and older at the time of informed consent/assent
* Women of childbearing age must be willing to use reliable birth control method throughout the treatment duration and for 3 months following the last treatment application

Exclusion Criteria:

* Diseases or conditions that could interfere with the assessment of safety of the study treatment and compliance of the participant with study visits/procedures, as determined by the Investigator
* Pregnant or nursing women
* Active infection in the area that will undergo administration, that the Investigator believes will negatively impact the IP application
* Known allergy to any of the constituents of the product
* Concurrent skin transplant or mesh skin grafting; if the participant is currently having transplantation or grafting surgeries they must wait until the transplant has begun to heal and the graft has absorbed prior to initiating B-VEC therapy
* Participation in an interventional gene therapy clinical trial within the past three (3) months (not including B-VEC administration)
Development and Validation of the SWADOC Tool

Background: After a period of coma, patients with severe brain injury may present disorders of consciousness (DOC). A wide proportion of these patients also suffer from severe dysphagia. Assessment and therapy of swallowing disabilities of DOC patients are essential because dysphagia has major functional consequences and comorbidities. Dysphagia evaluation in patients with DOC is hampered by the lack of adapted tools. The first aim of the study was to develop a new tool, the SWallowing Assessment in Disorders Of Consciousness (SWADOC), and propose a validation protocol. The SWADOC tool has been developed to help therapists to apprehend components related to swallowing in patients with DOC. The second aim is to appreciate the relationship between patients' level of consciousness and SWADOC items and scores.

Method/design: In this multicentric prospective cohort, 104 patients with DOC will be tested three times during two consecutive days with the SWADOC tool. Statistical analyses will focus on the reliability and validity of the SWADOC tool, especially the intra and inter-rater reliability, internal consistency, measures of dispersion and concurrent validity with the FOTT Swallowing Assessment of Saliva (FOTT-SAS). The level of consciousness will be assessed with the Simplified Evaluation of CONsciousness Disorders (SECONDs) and the Coma Recovery Scale-Revised (CRS-R)

Discussion: The assessment of swallowing abilities among patients with DOC is the first necessary step towards the development of an individualized dysphagia care plan. A validated scoring tool will be essential for clinicians to better apprehend dysphagia in DOC patients and to document the evolution of their disorders.


Eligibility Criteria:
Inclusion Criteria :

* Age above 18-year-old
* Perfect knowledge of French language before the injury
* Previous event of coma phase caused by a severe acquired brain injury
* Medical stability (absence of mechanical ventilation and sedation, no acute medical pathology such as infection or respiratory distress)
* No neurological or otorhinolaryngological disease which can impact swallowing prior to the brain injury
* Minimum of 28 days since the acquired brain injury at inclusion
* Diagnosis of UWS, MCS-, MCS+ or EMCS based on the CRS-R or SECONDs
* Informed consent from legal representative of the patient
* Affiliated patient or beneficiary of a health insurance plan (for French participants only).
A Study of Inclisiran in Participants With Renal Impairment Compared to Participants With Normal Renal Function (ORION-7)

This study is a Phase I, single-dose, open-label trial to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of a single dose of inclisiran subcutaneous (SC) injection in participants with mild, moderate, and severe renal impairment compared to participants with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants 18 to 80 years of age
* Participants should be qualified for inclusion based upon estimated CrCl ranges for normal renal function group and mild, moderate, and severe renal impairment groups

Exclusion Criteria:

* Participants with acute renal disease and/or history of renal transplant
* Urinary incontinence without catheterization
* Participants requiring hemodialysis
* Participants with LDL-C \<60 mg/deciliter (dL) (or less than 1.55 millimoles/liter \[mmol/L\])
* Participants with Amyloid Kidney (if known by pathology)
* Participants with any significant hepatic, cardiac, or pulmonary disease or participants who are clinically nephritic

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
YSGG Application in Periodontal Treatment

Adjunctive use of Er,Cr:YSGG (erbium-chromium-yttrium-scandium-gallium-garnet) laser in combination with conventional, mechanical periodontal treatment may benefit in complete decontamination of the periodontal pocket leading to improved early healing and better long term clinical result. Radial firing periodontal tip (RFPT) offered by the Er,Cr:YSGG system is devised to let irradiation primarily in radial pattern (85%) with lesser portion in straight manner (15%), meaning laser beams are effectively emitted to affected root surface and inner epithelium of periodontal pocket with simple tip management. Therefore, using Er,Cr:YSGG laser with RFPT could be the best option for periodontal laser therapy. The aim of this study is to investigate adjunctive treatment effect using Er,Cr:YSGG laser and RFPT in moderate to severe periodontitis patients. Study subjects are randomly allocated to either 'scaling and root planing (SRP) only' or 'SRP + laser therapy' group. Periodontal parameters including probing pocket depth (PPD), clinical attachment level (CAL), modified gingival index (MGI), and plaque index (PI) are recorded at baseline and 8 weeks after treatment. Gingival crevicular fluid (GCF) samples are obtained using paper strips at baseline, 1w, 2w, 4w, and 8w post op. to determine laser-induced effect in early wound healing. Cytokine levels are evaluated from the GCF samples taken.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of stage III or IV periodontitis based on the 2017 periodontitis classification (Tonetti, Greenwell, \& Kornman, 2018);
2. minimum of two teeth with probing depth (PD) ≥ 6 mm and radiographic bone loss in at least two quadrants of the whole dentition;
3. each quadrant with a minimum of four teeth; and
4. systemically healthy patients.

Exclusion Criteria:

1. history of periodontal treatment in the previous six months;
2. antibiotic medication in recent three months;
3. under steroid therapy or taking any anti-inflammatory drugs in recent three months;
4. history of any systemic disease that may influence the periodontal condition and treatment outcome, including diabetes mellitus, cancer, metabolic diseases, cardiovascular disease, and rheumatoid arthritis;
5. pregnancy or breastfeeding; and
6. smoking habits.