cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Hysteroscopic Morcellator in Hysteroscopic Treatment of Submucosal Fibroids

Hysteroscopic surgery is the gold standard for intra uterine pathology especially fibroma. Limit of this technic is duration of procedure which is correlated to operative complications. So, for patient with large fibrome or several fibromas, this technic is not indicated or performs in several times. A new technic of hysteroscopic surgery is available which is quicker than conventional technic. This technic is poorly evaluated. Aim of this study is to evaluate both technics on procedure duration.

Material and Methods

We propose a monocentric-randomised study. Inclusion criteria are women over 18 years requiring hysteroscopic surgery for fibroma. After informed consent, patients will be randomised in two groups: hysteroscopic surgery with morcellation technic and conventional hysteroscopy technic with resection. The main objective is duration of procedure. Secondary objectives are characteristics and perioperative complications (distension media quantity, cervical injury, uterine perforation), immediate et long term postoperative data's (postoperative pain and synechia). We hypothesis hysteroscopic with morcellation reduces duration of procedure of 50%. The estimated size of population number is 30 per group and 60 for the study.

Expected results

We expected a significant decrease of procedure duration with hysteroscopic morcellation. This data will be interesting according peroperative complications are correlated to procedure duration and allow hysteroscopic surgery to patients with large or several fibromas.

Eligibility Criteria:
Inclusion Criteria:- Patient who is at least 18 years.

* Patient under effective contraception.
* Patient who underwent ultrasound confirming the presence of at least one or both uterine fibroids with a diameter less than 6 cm for the largest fibroid.
* Patient who underwent diagnostic hysteroscopy confirming the presence of one or two uterine fibroids classified as Type 0, 1 or 2 according to FIGO classification (10).
* Patient with an indication of intrauterine fibroid resection (bleeding disorders fetilité) by hysteroscopy.
* Patient who agreed to participate in the study and who signed informed consent.

Exclusion Criteria:

* Early Removal linked to patient's wish
Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution

evaluation of occlusal force distribution was carried out with the aid of T-Scan device (Tekscan Inc., South Boston, MA, USA) for mandibular complete dentures before and after relining with long term soft liner for controlled type 2 diabetic patients.

A crossover clinical study was carried out with previously constructed and used conventional complete dentures before relining with soft denture liners and then with the same dentures after relining with soft denture liners. The study sample included 50 males completely edentulous contributors, All patients were controlled type 2 diabetes during the study period. All selected patients had previously constructed and used conventional heat cured acrylic resin complete dentures for not less than two years with history of retention and stability problems of mandibular dentures. Mandibular complete dentures had received the essential prosthetic adjustments aiming to achieve optimal retention, maximum stability and the necessary occlusal contacts. The first occlusal parameters were recorded before denture relining. Relining of mandibular dentures was performed and Patients were comfortably using their relined mandibular complete dentures for at least three months and the retention and stability of the conventional dentures were assessed before second recording of occlusal parameter. The evaluation of occlusal force distribution was carried out with the aid of T-Scan device (Tekscan Inc., South Boston, MA, USA). The first record was recorded before denture relining and the second record was three months after denture relining

Eligibility Criteria:
Inclusion Criteria:

* All patients were controlled type 2 diabetes
* All patients were non-smokers
* had an Angle class I maxillo-mandibular relationship.
* Patients having moderately developed maxillary and mandibular alveolar ridges lined with firm mucoperiostea.

Exclusion Criteria:

* history of temporomandibular disorders, or neuromuscular disorders like; bruxism or severe clenching
* presence of medical problems or severe chronic diseases
* any intraoral soft or hard tissue pathology.
Long-term Beneficial Metabolic Effects of Adrenalectomy in Subclinical Cushing's Syndrome of Adrenal Incidentaloma

Objective:

To determine the metabolic effects of the adrenalectomy in subclinical Cushing's syndrome of adrenal incidentaloma.

Methods:

234 subclinical cushing syndrome and adrenal incidentaloma will be randomly assigned into two groups(e.g adrenalectomy group and conservative treatment group).


Eligibility Criteria:
Inclusion Criteria:

* patients with both unilateral adrenal incidentaloma and hypercortisolism
* definition of hypercortisolism

  * overnight dexamethasone suppression test, serum cortisol\>1.8ug/dL
  * 24hr urine cortisol \> upper reference limit

Exclusion Criteria:

* patients who took medication influencing cortisol secretion
* patients with definite clinical feature of cushing syndrome

  * moon face
  * abdominal striae
  * skin or proximal muscle atrophy
* metabolic syndrome, hyperthyroidism, hyperparathyroidism, chronic renal failure, rheumatic disease, hematologic disease
* patients who took following medication

  * insulin
  * oral hypoglycemic agent
  * thyroid hormone
  * anti-hyperlipidemic drug
  * sex hormone
* patients who taking steroid hormone or who took steroid hormone more than 2 weeks within 1 year
* psychiatric disease
BioMEL- Diagnostic and Prognostic Factors in Melanoma.

The investigators' hypothesis is that cutaneous melanoma, melanoma in situ, dysplastic nevi and benign nevi all differ in not only clinical characteristics but also molecular and genotypic characteristics.

Patients with suspected primary cutaneous melanoma or a differential diagnosis, or secondary melanoma can be asked to participate in the first part of the project and patients with suspected or confirmed secondary (spread) melanoma can be included in the second part of the study. Participants included in the study answer a validated questionnaire regarding epidemiological and phenotypic factors to map medical history, prior UV exposure, family history of melanoma and/or other cancer types, skin type, smoking habits, alcohol use and quality of life.

Blood samples (whole blood) are collected before primary local excision and before secondary surgical procedures as well as during follow up of patients with secondary disease and oncologic treatment. During local excision of the primary pigmented skin lesion, full-thickness skin punch biopsies are taken by trained dermatologists. The biopsies, in the lesion and next to the lesion in the normal skin of the suspected melanoma, are taken, snap frozen and stored deep frozen. The primary lesions are documented by accurate imaging methods prior to excision.

Tissue samples from suspected or confirmed secondary melanomas are collected mainly through surgical and core needle biopsies before, during and after treatment and in case of disease progress or treatment failure. Tissue samples are snap-frozen and stored in the same way as samples from primary melanomas.

Comprehensive questionnaire based, imaging-based information, as well as histologic information provided from the pathologist report is included and stored in a secure database.

All the information in the database, along with information from molecular analysis of tissue and/or blood samples will then be used to find objective, molecular and clinical differences in melanoma, melanoma in situ, dysplastic and benign nevi along with potential information of biological aggressivity of both primary and secondary melanoma in order to find more objective diagnostic markers.

See above.

Eligibility Criteria:
Inclusion Criteria:

* Primary part of the project: Patients in dermatological outpatient routine care in Helsingborg, Lund or Malmö Hospitals. Patients are planned for surgical excision for an equivocal pigmented skin lesion that could be a primary melanoma or a differential diagnosis of melanoma
* Secondary part of the project: . Patient, in surgical or oncological routine care in Helsingborg, Lund, Malmö or Kristianstad Hospitals. Patients are planned for surgical excision or cytological diagnostics (needle aspiration) of metastatic melanoma.
* All subjects have to be able to provide written informed consent.

Exclusion Criteria:

* Patients with lesions, primary or secondary, that are so small that a punch biopsy for the study would risk affecting the histopathological diagnosis.
Automatic Physiotherapy and Rehabilitation System for Lower Body Total Joint Replacement

Physiotherapists spend a large amount of their time with patients observing their rehabilitation techniques. A patient going through rehabilitation exercises are routine and does not necessarily require the attention of the physiotherapist. This research will develop a sensor system that will be strapped onto the patients and will provide feedback on how accurately the exercise is being executed. This will free up the physiotherapist to focus on diagnosis and other tasks that will better utilize the physiotherapist's training. A previous study has shown that this system is feasible for healthy subjects. This study would test to see if this system is extendable to rehabilitation subjects.

Many of the tasks performed regularly by physiotherapists during any given rehabilitation session are repetitive and do not rely on the physiotherapist's expertise, and could be performed and observed by automated means. The developed system will detect patient body postures and movements with data collected through sensors such as accelerometers. This data will be pattern matched to a predetermined movement pattern and feedback will be provided for patients regarding accuracy of their exercises. This data can be logged for the physiotherapist to examine at a later time. By automating this component of a rehabilitation session, the system will allow the physiotherapist to focus diagnosis and other tasks that will better utilize their training. The specific application for this prototype will be post-operative knee/hip replacement patients, so all devices must be non-invasive and must not interfere with normal recovery processes.

A previous version of this experiment on healthy participants has been successfully performed. This study would like to examine the feasibility of this system on rehabilitation subjects, as the movement patterns of a subject in physical rehabilitation may be dramatically different then a healthy subject. No intervention is suggested by the system, as this study is observational.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who has had hip and/or knee total joint replacement and requires rehabilitation, and are assessed by physiotherapists as likely able to finish their rehabilitation cycle and be discharged to home.
* Patients with medical complications or other injuries will be not be excluded, as we are interested in seeing the movement profiles of a wide range of people.
* In-patients

Exclusion Criteria:

* Patients at risk of developing serious postoperative complications, such as an infection, myocardial infarction or anything that requires subsequent surgery, they may be excluded.
* Out-patients.
* Patients who cannot give explicit consent or understand the physiotherapist's instructions
* Patients who do not speak fluent English
Evaluation of the High Dose of Icotinib in Advanced Lung Cancer Patients After Failure of Target Therapy

The purpose of this study is to evaluate the efficacy and safety of dose escalation of Icotinib in advanced non small cell lung cancer (NSCLC) patients after the therapy of Icotinib, Iressa and Tarceva.

* 1:to evaluate the efficacy correlation between the tyrosine kinase inhibitor (TKI) drugs and high-dose Icotonib group in advanced NSCLC patients with high -dose Icotinib going on after the routine TKI therapy
* 2 to evaluate the efficacy correlation between different high-dose group in advanced NSCLC patients with high -dose Icotinib going on after the routine TKI therapy

Eligibility Criteria:
Inclusion Criteria:

1. NSCLC patients were confirmed by histology or cytology
2. The time interval must be over 4 weeks from previous chemotherapy to registration to participate in this experiment if he or she received chemotherapy,and also have any toxicity to recover.
3. at least one measureable lesion accord to RECIST 1.1 criteria and the lesion accepted no radiotherapy.

   * 1 at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology.
   * 2 a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm.
4. ECOG 0-2 score
5. at least 12 weeks of expected survival time
6. Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures
7. understand and sign a written informed consent voluntarily.

Exclusion Criteria:

If the subject meet any of the following exclusion criteria ,he is no eligible to participate in this study,

1. Before enrollment in this trial have used Erbitux, Herceptin and carried out anti-cancer therapy.
2. use of phenytoin, carbamazepine, rifampicin, phenobarbital or St. John's Wort when take this trial
3. severe allergies to Icotinib
Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome

The aim of the present randomized controlled study was to examine wether a clinical decision support stystem would increase the adherence to the Mediterranean diet (MD) of adolescent girls, aged 15-17 years, diagnosed with polycystic ovary syndrome. The intervention lasted for 3 months and in total, 40 girls were randomly assigned to either the MD group (n=20) or a Control group receiving general nutritional advice (n=20). Anthropometry, nutritional intake, psychological well-being, and blood markers were analyzed at the begninning and the end of the trial.

The aim of the present randomised controlled trial was to investigate the effects of a Mediterranean Diet (MD) intervention delivered through a Clinical Decision Support System (CDSS) on various dietary, health parameters and anxiety in adolescent females, aged 15-17 years, with PCOS. A randomized controlled trial was conducted with 40 adolescent females diagnosed with PCOS, randomly assigned to either an Intervention group (IG) (n=20) or a Control group (CG) (n=20). The IG received personalized dietary guidance based on the MD principles, delivered through a CDSS, while the CG received general nutritional advice. Measurements of dietary intake, anthropometric indices, biochemical markers, and psychological well-being were collected at baseline and after a 3-month intervention period. After 3 months, significant improvements were observed in the IG compared to the CG. Adherence to the MD increased significantly in the IG, leading to decreased caloric intake, fat, saturated fatty acids, and dietary cholesterol, and increased intake of monounsaturated fatty acids. Conversely, the CG experienced an increase in fat and dietary cholesterol intake. Both groups exhibited an increase in fiber intake, with a more pronounced rise observed in the MD group. Psychological well-being showed a significant reduction in anxiety levels in the IG group, while no significant change was observed in the CG. The intervention led to improvements in dietary patterns, body composition, and psychological well-being. These results underscore the importance of dietary interventions tailored to the MD principles in the management of PCOS among adolescent females.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed with PCOS females \<18 years of age.
2. Females with guardians who provided signed participation consent.

Exclusion Criteria:

1. Females ≥18 years of age.
2. Females suffering from severe illnesses (i.e., organ failure, autoimmune diseases, congenital metabolic disorders), psychiatric disease or with emerging health issues that could hinder the trial.
3. Pregnant or lactating females.
4. Females diagnosed with alcoholism or drug addiction.
5. Females being under any drug treatment.
6. Females followed a specific type of diet within the past 5 years or have used nutrient or non-nutrient supplements within the last 6 months.
7. Females with guardians non able to read and understand the consent information.
Comparative Evaluation of CTG With and Without rhPDGF- BB Using Modified Coronally Advanced Tunnel for Root Coverage

The present study is a human, prospective, single centre, single blind, comparative controlled randomized clinical trial for the treatment of Miller's Class I, II or combination of class I and II mandibular recession and comparing the clinical outcomes prior to and 6 months after treatment. The trial is in accordance to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

24 recession defects were selected in patients who were systemically and periodontally healthy, satisfying the determined inclusion criteria. Patients with at least two or more teeth having Miller's class I , II or combination of class I and II mandibular recession defects were included in the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, surgical procedure involved, potential benefits and risks associated with the surgical procedure and a written informed consent was obtained from all patients.

The patients were assigned into two treatment groups (test and control). The test group was treated with recombinant human Platelet Derived Growth Factor-BB and Modified Coronally Advanced Tunnel +Connective Tissue Graft whereas the control group was treated by Modified Coronally Advanced Tunnel +Connective Tissue Graft alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling the following criteria were included in the study:-

  * Two or more teeth with Miller's class I and II or combined class I and II recession defects in mandibular anteriors.
  * Age group 21-58 years.
  * Patients with healthy or treated periodontal conditions.
  * Patients willing to participate in the study.
  * Absence of uncontrolled medical conditions.
  * Patients with full mouth plaque score \</= 10%(O'Leary 1972)
  * Patients with esthetic concerns.
  * Patients with thick gingival biotype \>0.8mm

Exclusion Criteria:

* Pregnant or lactating females.
* Tobacco smoking.
* Uncontrolled medical conditions.
* Untreated periodontal conditions.
* Use of systemic antibiotics in the past 3 months.
* Patients treated with any medication known to cause gingival hyperplasia.
* Drug and alcohol abuse
* No occlusal interferences.
* Patient with a known hypersensitivity to rhPDGF-BB.
Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification

The primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms

The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from March 2023 to January 2025 with 143 subjects recruited in around 10 China centers. The population for this study is subjects with wide-necked intracranial aneurysms who are suitable candidates for flow diverter implantation. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after offering informed consent form. The study consists of six visits including preoperative screening, operation date, 7days or at discharge, 30 days, 180 days, and 1 year. The primary endpoint is success aneurysm occlusion at 1 year post procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years to 75 years, male or non-pregnant female.
2. Unruptured wide-necked cerebral aneurysms confirmed by preoperative imaging (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio \< 2).
3. Parent vessel with a diameter range of 1.75-6.0 mm.
4. Those who voluntarily participate in the study and sign informed consent form.

Exclusion Criteria:

1. Subject with target aneurysms are blood blister-like aneurysms, pseudoaneurysms, arteriovenous malformation, moyamoya disease-related aneurysm, or multiple aneurysms that cannot be treated with a single stent.
2. Severe arteriosclerosis or tortuosity of intracranial artery, and the device is difficult to reach the target vessel.
3. Subject with target aneurysm previously treated with craniotomy or other endovascular interventional therapy.
4. Known sensitivity to antiplatelet medications, anticoagulant medications, radiographic contrast agents, anesthetic, nickel, platinum-tungsten alloy, platinum-iridium alloy, and poly-N-\[Tris(hydroxymethyl)methyl\] acrylamide (poly-NTMA).
5. Severe respiratory system, liver and kidney diseases (such as creatinine ≥ 3.0 mg/dL (except dialysis)) or blood coagulation disorders before operation.
6. Platelet count is less than 100×109/L, international normalized ratio (INR) is more than 1.5.
7. Hospitalized surgical treatment within the previous 30 days or planned within the next 180 days after operation.
8. Severe neurological deficit that renders the patient incapable of living independently (modified Rankin score ≥3).
9. The survival expectation is less than 1 year.
10. All subjects who are participating in other drug/medical device clinical trials and have not completed the programme requirements
11. Inapplicable for this study at the investigators' viewpoints.