cyrilzakka/clinical-trials huggingface dataset:
Study of Lamotrigine 2 x 25 mg IR Tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg Tablets of Glaxo-SmithKline, USA, in Healthy Human Adult Subjects, Under Fed Conditions

* Objective:

  * To assess the bioequivalence of Lamotrigine 2 x 25 mg IR tablets of Torrent Pharmaceuticals Pvt., Ltd., India and Lamictal ® (Lamotrigine) 2 x 25 mg tablets of Glaxo-SmithKline, USA, in healthy human adult subjects, under fed conditions.
* Study Design:

  * A randomized, open label, two treatment, two period, two sequence, single dose, crossover study, under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects of either sex between 18-55 years of age (inclusive), having a body mass index (BMI) between 18 and 27 kg/m2
* Subjects who have no evidence of underlying disease during screening and whose physical examination is performed within 21 days prior to commencement of the study.
* Subjects whose screening laboratory values are within normal limits or values outside normal limits considered by the physician/Principal Investigator to be of no clinical significance.
* Informed consent given in written form according to section 11.3 of the protocol.
* Female Subjects:

  1. of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
  2. postmenopausal for at least 1 year.
  3. surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria:

* Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
* Alcohol dependence, alcohol abuse or drug abuse within past one year.
* Moderate to heavy smoking (\> 10 cigarettes/day) or consumption of tobacco products.
* History of difficulty in swallowing tablet.
* Clinically significant illness within 4 weeks before the start of the study
* Asthma, urticaria or other allergic type reactions after taking any medication.
* Positive urine drug screening, HIV, Hepatitis B \& C tests.
* Any history of hypersensitivity to Lamotrigine.
* Existence of any surgical or medical condition, which, in the judgment of clinical investigator might interfere with the pharmacokinetics of the drug or likely to compromise the safety of the subject.
* Inability to communicate or co-operate with the investigator due to language problem, attitude, poor mental development/impaired cerebral function.
Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation

This is a experimental, randomised, parallel-group, clinical study.

A sample of university students will be divided into 4 groups, where one of them will act as a control group (no intervention), and the other three will undergo hand training with two different types of functional electrical stimulation devices and a final group will receive hand training with video games.

Inter-group analyses will be performed before the start of the training (pre-intervention), after the end of the programme (post-intervention), and three weeks after the end of the programme (follow-up assessment). Intra-group analyses will also be carried out to check whether the training has led to an improvement in the quality of motor imagination, as well as an improvement in manual dexterity in each of the groups.

In order to carry out the project, a collaboration agreement will be signed with the company FESIA

TECHNOLOGY S.L, which will provide a FESIA GRASP device for the study, as well as the consumables (electrodes).

The study aims to answer the research question:

P: healthy adults I: FES and, FES multi-field. C: video games O: Motor imagination, strength, manual dexterity.

The aim is to compare different tools in a population sector to see if there is an improvement in motor skills through the use of these devices.

General objective: To test the effects of functional electrical stimulation and virtual reality with respect to motor imagination, strength and manual dexterity.

Secondary objectives:

To find out whether functional electrical stimulation improves motor imagination, both kinaesthetic and visual, as well as manual dexterity and strength.

To find out if an intervention based on the use of virtual reality improves motor imagination, both kinaesthetic and visual, as well as manual dexterity.

To test whether there are differences between functional electrical stimulation, multi-field functional electrical stimulation and virtual reality in terms of visual motor imagination, kinaesthetic imagination and manual dexterity.

Eligibility Criteria:
Inclusion Criteria:

* Be of legal age and sign the informed consent form.
* Not suffer from any pathology in the upper limb such as tendinitis, oedema, fractures, etc.
* Intact skin (no breaks, scratches, cuts, and other superficial or deep injuries) on the arm where the devices will be placed if applicable.

Exclusion Criteria:

* Severe medical problems.
* Use of a pacemaker.
* Pregnancy.
* Cutaneous neuropathies.
* Presence of other neuromuscular pathologies.
Prognosis Stratification for Advanced HCC Receiving TACE with PD-1/PD-L1 Inhibitors and Molecular Target Therapies

The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage hepatocellular carcinoma (HCC) receiving transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies.

In patients with advanced-stage hepatocellular carcinoma (HCC), previous studies showed that transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies exhibited better efficacy (PFS and OS) as compared to the ICIs and molecular target therapies. However, there is a lack of effective tools to select those who will benefit the most from that combination therapy. The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage HCC who receive TACE and immune checkpoint ICIs plus molecular target therapies (including, VEGF-TKI/ bevacizumab). This real-world study may provide further information on treatment selection for clinical practice and trials.

Eligibility Criteria:
Inclusion Criteria:

1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread and/or macrovascular invasion;
3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
4. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
5. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);
6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment;
7. Has repeated measurable intrahepatic lesions;

Exclusion Criteria:

1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
2. Unable to meet criteria of combination timeframe described above;
3. Child-Pugh C or PS\>2 or Severe hepatic encephalopathy
Curative Study of Chinese Traditional Medicine to Treat Lung Cancer

The purpose of this study is to observe the efficacy of chemotherapy combined with Chinese patent drugs for patients with advanced non-small-cell lung cancer, also to evaluate the adverse reaction and the reliability.

Lung cancer is the most common malignant tumor in the world with about 80%-85% non small cell lung cancer.

The investigators perform a multi-center, randomized, controlled, prospective study in patients with advanced NSCLC. Patients are randomized over observational group(Chinese patent drugs plus chemotherapy), and control group (chemotherapy). The investigators will observe 2 cycles and after that regular follow-up will be arranged.

The primary end point is: Objective response rate;

The secondary end points are:

1. progression-free survival(PFS);
2. overall survival(OS);
3. Time to Progression (TTP);
4. quality of life questionnaire（QOL);
5. other end points are: Toxicity, side effects and security of the treatments will be assessed at the same time.

The investigators expect that integrated TCM combined with chemotherapy has a better efficacy on enhancing Objective response rate，prolonging PFS, OS, improving QOL, reducing the adverse reaction of patients than that of chemotherapy.Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically or cytologically confirmed of stage Ⅲb-Ⅳ NSCLC
2. Ages Eligible for Study: 18-65 years old;
3. Physical status score (ECOG PS) ≤ 2 scores；
4. Estimated life expectancy of at least 6 months；
5. Participants have no major organ dysfunction and chemotherapy contraindications: hemoglobin ≥10g/dL, absolute neutrophil count (ANC) ≥1.5\*109/L, platelets ≥80\*109/L, Liver and kidney function is normal;
6. Informed consent from the patient.

Exclusion Criteria:

1. Patient with other malignant tumor except NSCLC 5 years previous to study entry.
2. Patients who have received targeted drug treatment；
3. Serious problem of heart, liver or kidney with severe dysfunction;
4. Pregnant or child breast feeding women;
5. Mental or cognitive disorders;
6. Participating in other drug trials;
7. Who are allergic to the study drug.
8. Diabetic patients.
Translational Cancer Observational Protocol

Observational study on relapse occurrence and on the quality of life in patients who underwent nephroureterectomy surgery

Monocentric prospective and retrospective observational study on the quality of life and on the pathological status in patients who underwent nephroureterectomy surgery. Oncological, psychological, sexual and quality of life-related data will be collected within a specifically created database that will allow us an easy and secure data extraction for the statistical analysis required by the clinical trial in terms of oncological relapse, clinical progression and improve the assistance and therapeutic strategy for each patient. Retrospective data for patients who underwent surgery between 1987 and today will be available in the form of clinical report stored in the hospital archives.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Upper tract urothelial cancer diagnosis
* Indication to cancer removal through nephroureterectomy surgery
* Ability to read and sign the informed consent

Exclusion Criteria:

* Age \< 18 years
* Absence of upper tract urothelial cancer
* Inability to read and sign the informed consent
Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device

The intended use of the RF (radiofrequency) device used in this study is to assess the efficacy of the handpiece for the treatment of facial wrinkles. If the other device (Intense Pulsed Light) laser in this study is used, the intended use will be for the treatment of benign pigmented and/or vascular lesions.


Eligibility Criteria:
Inclusion Criteria:

* A healthy male or female 18 years of age or older.
* Agrees to be treated with the TempSure device.
* Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
* Understands and accepts the obligation and is logistically able to be present for all visits.
* Is willing to comply with all requirements of the study and sign the informed consent document.

Exclusion Criteria:

* Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
* The subject has a cut, wound, or infected skin on the area to be treated.
* The subject is on local, oral, or systemic anesthetic agents.
* The subject has nerve insensitivity to heat in the treatment area.
* The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Exclusion Criteria for Icon Treatments Only:

* The subject is using systemic steroids (e.g. prednisone, dexamethasone) prior to or during the course of treatment.
* The subject has a medical condition or is receiving treatment that significantly compromise healing response.
* The subject has a history of light-induced seizures.
* The subject has a history of skin photosensitivity disorders.
* The subject has a history of hypertrophic scars or keloid formation.
* The subject has a history of radiation therapy in area to be treated.
Interest of SmartGuard Technology (Predictive System for Stopping Insulin Before Hypoglycemia) in Children With Type 1 Diabetes Treated With Insulin Pump

Management of children and adolescents with type 1 diabetes is essentially insulin therapy using insulin pump, allowing the improvement of the glycemic balance.

However, the risk of hypoglycaemia inherent to the treatment persists. Hypoglycemia is an acute complication in the management of diabetes. It can be manifested by warning signs (tremors, sweats, feelings of hunger ...) but also occur during sleep and be ignored. It can be responsible for asthenia, difficulty concentrating and attention and memory problems.

In order to decrease time spent in hypoglycemia, insulin pump therapy can be coupled with a continuous glucose measurement system with a stop insulin pump function in case of hypoglycemia.

The aim of the study is to evaluate efficacy of the predictive system for stopping before hypoglycaemia "medtronic Minimed with SmartGuard technology" in type 1 diabetic children, especially on the time spent in hypoglycemia .

Management of children and adolescents with type 1 diabetes is essentially insulin therapy using insulin pump, allowing the improvement of the glycemic balance.

However, the risk of hypoglycaemia inherent to the treatment persists. Hypoglycemia is an acute complication in the management of diabetes. It can be manifested by warning signs (tremors, sweats, feelings of hunger ...) but also occur during sleep and be ignored. It can be responsible for asthenia, difficulty concentrating and attention and memory problems.

In order to decrease time spent in hypoglycemia, insulin pump therapy can be coupled with a continuous glucose measurement system with a stop insulin pump function in case of hypoglycemia.

The aim of the study is to evaluate efficacy of the predictive system for stopping before hypoglycaemia "medtronic Minimed with SmartGuard technology" in type 1 diabetic children, especially on the time spent in hypoglycemia .

Eligibility Criteria:
inclusion criteria :

* children aged between 1 and 17 years
* type 1 diabetes
* Duration of type 1 diabetes \> 1 year
* insulin pump therapy \> 3 months

exclusion criteria :

* Other diseases predisposing to hypoglycemia
* Oral glycemic medications
* have used continuous glucose monitoring during the last 3 months
* HbA1c \>10%
Yield Rate for Procurement the Histologic Core With Endoscopic Ultrasound-guided Fine Needle Biopsy With 20-gauge Ultrasound Biopsy Needles for Solid Pancreatic Masses: Pilot Study

To investigate the technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.

Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. Surgery remains the only treatment offering an advantage in terms of overall survival (5-year survival range, 15-25%), but unfortunately only 10-20% of patients present resectable disease at the time of diagnosis.

Regarding the diagnosis of pancreatic cancer, proper tool with high diagnostic yield is very important. The investigators investigated the technical feasibility and diagnostic yield of recent-developed new 20-gauge Procore needle for EUS-guided fine needle biopsy in pancreatic solid lesions.

The investigators applied the 20-gauge procore needle for EUS-guided fine needle biopsy in the diagnosis of pancreatic solid mass. A total of 30 patients will be enrolled for the present pilot study.

Eligibility Criteria:
Inclusion Criteria:

* patients who are at least 20 years of age
* patients who require endoscopic ultrasound-guided fine needle aspiration cytology or biopsy because of pancreatic or peripancreatic solid mass.

Exclusion Criteria:

* Cystic pancreatic mass in imaging tests such as CT or MRI or US
* haemodynamically unstable patients
* severe coagulopathy (international normalized ratio \[INR\] \> 1.5 or platelet count \< 50,000 cells/cubic millimeter \[cmm3\])
* patients unable to quit anticoagulant/anti-platelet therapy
* pregnancy
Motivations and Barriers to Participating in Ophthalmology Research Projects

The primary objective of this project is to understand the reasons why patients agree / disagree to take part in ophthalmology research. This will be done by asking participants to complete a Research Questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Over 16 years old
* Willing to participate by completing the questionnaire
* Must be able to speak and read English

Exclusion Criteria:

* Under 16 years of age
* Not willing to complete the questionnaire
Mesentery Guide Identify Microscopic Clean Resection and Reduces Crohn's Endoscopic Recurrence

Microscopic clean margin is associated with reduced endoscopic recurrence after bowel resection for ileocolic Crohn's disease (CD). We aimed to investigate whether the extent of creeping fat could help indicate microscopic inflammation beyond naked eye assessment of the bowel wall and reduce endoscopic recurrence after ileocolic resection.

Despite proactive prophylactic treatment administered after surgery for Crohn's disease (CD) patients, early postoperative endoscopic recurrence (EPER) still occurs in 50-80% of patients within six months, increasing the risk of long-term clinical and surgical recurrence. Risk factors for EPER have already been identified, including active smoking, disease behavior, younger age, concomitant perianal disease, prior intestinal resections, and microscopic resection margin positivity. Recently, the influence of microscopic inflammation at the resection margin on EPER has been highlighted by various studies and meta-analysis.

From a surgical perspective, it has become common practice to conservatively resect 2cm width from the gross lesion to lower re-operation risks, while the optimal strategy to attain the microscopic clean margin and minimize EPER remain unclear, considering the limited accuracy of frozen-section examinations. More importantly, the diseased mucosa proximal to the ileal lesion can be healed by preoperative optimization, potentially concealing deeper lesions at the muscularis propria and serosal levels from visual assessment during surgery. Therefore, identifying a macroscopic marker that highly correlates with microscopic inflammation is essential to help locate the clean division.

As a hallmark of CD, the hyperplasia of mesenteric adipose tissue (MAT) or "Creeping fat," was found directly triggered by transmural inflammation and bacterial translocation from CD affected lumen11. Correspondingly, creeping fat has been found to correlate with macroscopic mucosal abnormalities observed after opening the bowel12. However, its relationship with microscopic inflammation, as well as its potential role in determining the division position to achieve better EPER outcomes, remains to be clarified.

Eligibility Criteria:
Inclusion Criteria:

* Localized ileocolic CD

Exclusion Criteria:

* Patients with a stoma,residuallesion ,history of bowel resection,or post-operative abdominalinfection were excluded
A Study of Fluzoparib（SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer

This is a multicenter， open-label study to evluate the efficacy and safety of a novel PARP 1/2 inhibitor fluzoparib （SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer.

Fluzoparib (SHR-3162) is an orally available, small molecule inhibitor of poly-adenosine diphosphate \[ADP\] ribose polymerase (PARP) 1/2 being developed for treatment of BRCA1/2-mutant solid tumor. The tolerability, safety and PK of fluzoparib has been evaluated in Phase 1 study. An oral formulation is the focus of current development efforts.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of high grade serous or Grade 2/3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer；
* Confirmed documented BRCA1/2 mutation;
* Received 2\~4 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen；
* Relapsed/progressive disease as confirmed by radiologic assessment；
* Have measurable disease as defined by RECIST v1.1.

Exclusion Criteria:

* Any previous treatment with a PARP inhibitor;
* Patient with any other malignancy which has been active or treated within the previous 5 years;
* Patients with symptomatic uncontrolled brain metastases;
* Patients unable to swallow orally administered medication.
Impact of Different Separation Methods on Proximal Contact Tightness and Contour of Compound Class ii

The aim of this study is to evaluate the interdental separation of various separation systems and their impact on the proximal contact tightness and contour in compound class II nanohybrid resin composite restorations.

The target population consists of adult patients aged 25-40, with posterior compound proximal carious cavities (ICDS score 4 or 5) in molars. The interventions under investigation include three different separation systems: the Resin ring (DR-Resin ring, Egypt), Elliot separator (Pfingst \&amp; Co, USA), and Stainless Steel Metal ring (TOR VM ring, Russia). These systems will be compared to a Nickel titanium 3D-fusion ring (Garrison, USA). The primary outcomes assessed are proximal contact tightness and form/contour, measured visually according to FDI criteria, with scoring systems adapted from Hickel et al. (2023). Secondary outcomes, such as patient comfort (measured by a pain rating scale), and the emergence profile (assessed via bitewing radiographs), will also be considered. Data will be collected immediately postoperatively (T0), at 30 days (T1), and after 6 months (T2). The study will be conducted as a randomized clinical trial. The null hypothesis suggests that there will be no significant differences in proximal contact tightness or contour across the different separation systems used.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals with posterior compound proximal carious cavities in molars.
2. Age of (25-40) years.
3. Molars with compound proximal carious cavities score 4 or 5 ICDS.
4. Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
5. Presence of adjacent and opposing teeth with normal occlusion

Exclusion Criteria:

1. Patients with major systemic disorders or xerostomia.
2. Patients with periodontal disease.
3. Patients with para-functional habits.
4. Presence of malocclusion or signs of pathological teeth wear
5. Non vital teeth or teeth with signs of pulpal pathology.
6. Teeth mobility or clinical attachment loss.