cyrilzakka/clinical-trials huggingface dataset:
Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation

The goal of this clinical trial is to compare two different, market approved, cryoballoon devices for the treatment of paroxysmal atrial fibrillation (AF).

The main aims of the study are:

* to compare the efficacy of two ablation devices (acute and 1 year success rates)
* to compare the procedural characteristics (procedure duration, fluoroscopy duration, ablation time
* to compare the complication rates

Participants who have indication for cryoballoon ablation of AF will be randomized in 1:1 fashion to older fixed size cryoballoon and newer expandable cryoballoon. Standard of care cryoballoon procedure will be performed alongside with standard postprocedural follow-up.

• to compare the complication rates

Participants who have indication for cryoballoon ablation of AF will be randomized in 1:1 fashion to older fixed size cryoballoon and newer expandable cryoballoon.

Patients suffering from paroxysmal atrial fibrillation who are scheduled (independently of this study) for cryoballoon pulmonary vein isolation will be informed about the study and potential risks. All patients who give written informed consent will be randomized to 4th generation Artic Front Advance Pro device (fixed size balloon of 28 mm) and Polar X Fit device (28-31 mm expandable balloon). The ablation procedure will be performed in standard of care fashion. Also, standard postprocedural follow up of the patients will be scheduled with outpatient clinic visits and 24-hour Holters and 3, 6 and 12 months, and yearly thereafter. Extra visits will be scheduled in the case of symptoms/palpitations.

Standard patient and procedural data will be collected alongside with the information obtained in the follow up.

Eligibility Criteria:
Inclusion Criteria:

* paroxysmal atrial fibrillation
* patient scheduled for cryoballoon pulmonary vein isolation regardless of this study

Exclusion Criteria:

* unwilling to sing the informed consent Left atrium size \> 55 mm Uncontrolled heart failure (NYHA III-IV) Intracardiac thrombi
Antimullerian Hormone as an Indicator for Ovarian Response

Anti Mullerian hormone (AMH) is gaining place as ovarian marker, chiefly in infertility assistance.

Investigators explored its correlation with oocytes retrieval after long GnRH agonist protocol for stimulation, in younger and older infertile population. Methods: This prospective analysis compiled data of 66 females, receiving ICSI treatment from April 2016 to October 2017. Serum FSH, LH, Estadiol, AMH and antral follicle count were assessed. Outcomes were measured as good (5 to 19 oocytes) and bad responders.


Eligibility Criteria:
Inclusion Criteria:

1. Age:20-40 years old
2. BMI:20-40kg/m
3. Normal baseline hormonal profile (on the 2nd day of the cycle)

   * FSH: 2.5-10.2mlU/ml
   * LH:1.9-12.5mlU/ml
   * Estradiol (E2): \<50pg/ml
4. No Endometriosis by laparoscopy
5. No prior ovarian surgery; overectomy, ovariectomy or oophrectomy
6. Female subjects who have at least 1 wash-out cycle (defined as greater than or equal to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotrophin releasing hormone (GnRH) agonist therapy

Exclusion Criteria:

* 1. Age: \<20 or \>40 years old 2. BMI: \<20 or \>40kg/m 3. Female subjects with any contraindication for pregnancy. 4. Female subjects with history of tumors of the hypothalamus \& pituitary gland.

  5. Female subjects with history of ovarian, uterine or mammary cancer. 6. Female subjects with history of hypersensitivity to the active substance of the medications used for ovarian stimulation.

  7. Abnormal baseline hormonal profile 8. Endometriosis by laparoscopy 9. Previous ovarian surgery; overectomy, ovariectomy or oophrectomy 10. Female subjects with abnormal gynecological bleeding of unknown etiology
The IRESSA Novel Head and Neck Chemotherapy Evaluation Study

The purpose of this study is to compare the objectie tumour response rate between the cisplatin/5FU and cisplatin/5FU plus ZD1839 combination


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Patients with histologically proven primary SCCHN
* Aged 18 or over

Exclusion Criteria:

* Patients eligible for surgery with curative intent
* Other co-existing malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Exclude UCNT
Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).

For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.

To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.


Eligibility Criteria:
Inclusion Criteria:

* Male/female adult subjects (≥ 16 or 18 years)
* Diagnosis of epilepsy (all types of seizures may be included)
* Subjects who completed N01175 (NCT00175903) trial and benefited from levetiracetam monotherapy

Other inclusion criteria may apply

Exclusion Criteria:

* Subjects withdrawn from N01175 (NCT00175903) trial for any reason
* Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial
* Subject requiring add-on antiepileptic treatment
* Subjects from countries where levetiracetam is authorized for use as monotherapy in epilepsy treatment
* Sexually active woman with childbearing potential who is not using a medically accepted birth control method
Treatment of Peri-implant Mucositis by Sodium Hypochlorite Gel and Cross-linked Hyaluronic Acid Gel

The aim of the study is to evaluate the potential of the combination of a sodium hypochlorite-based gel and a hyaluronic acid-based gel as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up. After a meticulous selection, patients will be randomly assigned to Test (Sodium Hypochlorite-based gel + NSMD + Hyaluronic Acid-based gel ) or Control (NSMD) group. All clinical parameters will be recorded and the final evaluation will be performed.

The aim of the study is to evaluate the clinical results of the combination of a sodium hypochlorite-based gel (NaOCl gel) and a cross-linked hyaluronic acid-based gel (HA gel) as an adjuvant to Non-Surgical Mechanical Debridement (NSMD) in the treatment of mucositis, after 6 months of follow-up (Clean \& Seal concept). Following the selection through inclusion and exclusion criteria, all patients will be randomly assigned to Test NaOCl-based gel + NSMD + HA-based gel) or Control (NSMD) group.

Patients will be recruited at Department of Periodontology (Univeristy of Naples "Federico II") and at Department of Periodontology (University of Budapest "Semmelweis").

Subsequently, after recording of the clinical parameters (BoP, FMPS, FMBS, PD), in the Test group a NaOCl-based gel will initially be applied in the peri-implant sulcus for 30 seconds, without the need for flushing. Furthermore, mechanical therapy (NSMD) will be performed by means of an ultrasonic scaler with a plastic tip. Finally, HA-based gel will be applied in the peri-implant sulcus by means of a blunt-tipped needle. Conversely, Control group will be treated only through the NSMD.

All clinical parameters (BoP, FMPS, FMBS, PD) will be recorded again after 6 months for the final evaluation. Data analysis will be performed using statistical software.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Non-smokers and smokers ( ≤ 10 cigarettes/day);
* Presence of at least 1 implant in mucositis, clinically and radiographically detected;
* The implant in mucositis (tissue-level or bone-level) must support a fixed prosthetic device (single crown, 3-element bridge), cemented or screwed.

Exclusion Criteria:

* Cancer patients;
* Uncontrolled diabetic patients;
* Prolonged antibiotic treatment or anti-inflammatory treatment in the previous 6 months;
* Pregnant or breastfeeding patients;
* Implants that support mobile prosthetic products;
* Implants in peri-implantitis, detected clinically and radiographically.
Mindfulness for Medical Students

Burnout is common among medical students. Previous studies had shown that mindfulness based interventions may improve burnout and quality of life in medical students. Mindfulness-based cognitive therapy (MBCT) is one of the most often used mindfulness based interventions.

Medical students in the Chinese University of Hong Kong are invited to a MBCT on voluntary basis. They will be asked to fill in questionnaire that measures burnout, depression/anxiety, quality of life, and mindfulness at beginning and end of the MBCT. The pre-group and post-group data will be compared and analysed


Eligibility Criteria:
Inclusion Criteria:

* Medical students studying in Chinese University of Hong Kong

Exclusion Criteria:

* The investigators did not set any exclusion criteria
Blood Sample Markers of Reproductive Hormones in Assessing Ovarian Reserve in Younger Patients With Newly Diagnosed Lymphomas

This clinical trial studies blood sample markers of reproductive hormones in assessing ovarian reserve in younger patients with newly diagnosed lymphomas. Studying samples of blood from patients with cancer in the laboratory may help measure the effect of curative therapy for lymphoma on ovarian failure.

PRIMARY OBJECTIVES:

I. Compare anti mullerian hormone (AMH), follicle stimulating hormone (FSH), and estradiol (E2) between patients at baseline and cross section of controls and again between patients at 12 months off therapy and cross section of controls.

II. Describe the trajectory of AMH, FSH, and E2 from baseline to 12 months after completion of gonadotoxic cancer treatment.

III. Evaluate degree of change of AMH/FSH/E2 from baseline to end of therapy in patients.

IV. Evaluate degree of recovery of AMH/FSH/E2 from end of therapy to 12 months off therapy.

SECONDARY OBJECTIVES:

I. Describe acute ovarian failure (AOF) prevalence 12 months post-therapy. II. Collect blood samples for future evaluation of drug metabolizing enzyme polymorphisms.

OUTLINE:

Patients complete a menstrual diary to document vaginal bleeding and undergo blood sample collection at baseline, the 3rd course of chemotherapy, at the end of chemotherapy, and at 6 and 12 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have had first menses \>= 6 months prior to enrollment
* Patients must be newly diagnosed with lymphoma; this includes but is not limited to Hodgkin lymphoma, Burkitts lymphoma, diffuse large B cell lymphoma, and anaplastic large cell lymphoma
* Planned cancer treatment must include an alkylating agent: i.e. procarbazine, cyclophosphamide, ifosphamide; planned cancer treatment must be less than one year
* Patients with any performance status are eligible for enrollment
* Patients may take hormone medications excluding gonadotropin-releasing hormone (GnRH) analogues
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

* Patients who have previously received chemotherapy other than steroids and intrathecal chemotherapy are not eligible
* Patients who have a secondary malignancy are not eligible
* Patients with known history of ovarian disease: e.g. Turner syndrome or polycystic ovarian syndrome are not eligible
* Patients in whom planned therapy includes: removal or uterus or ovary(ies), pelvic irradiation, cranial irradiation or hematopoietic stem cell transplantation are not eligible
* Patients who previously have had their uterus or ovary(ies) removed are not eligible
* Patients who have received gonadotropin release hormone agonist or antagonist (e.g. Lupron) prior to study entry are not eligible
* Patients who are pregnant or breast feeding are not eligible
* Patients who have undergone or are planning to undergo ovarian tissue, oocyte or embryo cryopreservation prior to treatment are not eligible
Quality of Care in Relationship to Aborted Cancer Surgery

Surgery is often a central curative treatment for gastrointestinal tumors. Surgical treatment of diagnosed cancer tumors is decided after a comprehensive assessment of the patient's physical status, radiological assessments and after careful evaluation at the multidisciplinary conference. Despite the careful preoperative assessment of patients for curative surgery, the planned operation may unexpectedly need to be canceled. Of the patients who were planned for curative resection for pancreatic cancer in 2021 in Sweden, 90% received the intended surgery, and 10% of planned surgery was canceled. The reason for this was disseminated cancer or locally advanced disease in which radical resection is considered impossible to carry out. A systematic review of knowledge reveals a significant lack of evidence regarding patient-centered research and aborted cancer surgery.

The studies in the project have different study designs and methods, and include focus group interviews with staff, translation and validation of a questionnaire to measure care needs, estimation of supportive care needs and patient experiences.

An improved understanding and knowledge of patients' preferences and needs is needed to design interventions that can improve health-related quality of life. This project is dedicated to studying patients undergoing aborted cancer surgery, with the aim of improving the quality of care and meeting patients' care needs.

The overall objective of this research project is to:

* describe the patients experiences and assess supportive care needs following aborted cancer gastrointestinal surgery
* increase knowledge of the healthcare professionals' experiences of aborted cancer surgery from a multi-professional and continuum of cancer care perspective
* increase our clinical knowledge of patient preferences and healthcare professionals' perspective to develop tailored patient-centered interventions with the goal to improve quality of cancer care

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* cancer patients with different gastrointestinal cancer diagnosis

Exclusion Criteria:

- not able to answer the questionnarie SCNS-SF34 in Swedish.
Effect of Patient Position on Computerized Tomography Guided Celiac Trunk Neurolysis

Computerized tomography-guided Celiac plexus neurolysis has become a popular technique. As, it has Cross-section imaging system to avoids anatomic structures injury, it has high density resolution that clearly display the retro-peritoneal anatomic structures ,it allow an optimal puncture site selection and measured the angle and depth of the needle insertion accurately with display the range of the neurolytic agent diffusion

The aim of this study was to evaluate analgesic efficacy of a computerized tomography guided left lateral antero-crural approach near the origin of celiac trunk with patients position on their right side immediately after the procedure using a single needle injection technique for upper abdominal malignancy compared with the classic 2 needle posterior antero-crural injection technique and possible complications.

All patients will take thin computerized tomography section in the axial plane to detect the site of celiac plexus and coronal plane for correct site for needle placement.

Computerized tomography slices thickness will be from 3 mm at 5mm interval through all the abdominal and lower thoracic area. The celiac and superior mesenteric arteries will be identified after contrast injection.

When an ideal needle position and tip were confirmed, the stylet was removed and aspiration was performed to ensure that there was no blood is withdrawn.

A volume of 3 ml of lidocaine mixed with contrast was injected to confirm the position, after injection another cut has been taken to show the spread of contrast freely in the retro-peritoneal space around the celiac plexus and the aorta. After confirmation, that contrast was injected to surround the artery and make sure that there was no dorsal spread to avoid injury to somatic nerves. Also to make sure that there was no spread to the renal pelvis , injection of phenol 10% mixed with contrast through needle

Eligibility Criteria:
Inclusion Criteria:

* Patients with gastric carcinoma
* Patients with hepato-biliary-pancreatic cancer
* Patients with colonic malignancy
* Patients with peritoneal metastasis
* Patients with extensive hepatic metastasis
* Patients having intractable pain to opioids and other analgesics.
* Patients experienced adverse effects to opioids or other analgesics.
* Patients experienced improved intractable pain after diagnostic celiac plexus block

Exclusion Criteria:

* Patient's refusal
* Patients with bleeding tendency
* Patients with coagulopathy
* Patients who were benefited from oral analgesics with no serious side effects
* Patients with significant cardiac diseases
* Patients with organ failure
* Patients with distant vertebral metastasis
* Evidence of local infection at the puncture site
* Patients who did not experience improved pain after receiving a diagnostic celiac plexus block
A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency

The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

Eligibility Criteria:
Inclusion Criteria:

1. Investigator-determined diagnosis of GHD prior to the historical initiation of daily rhGH trerapy
2. Participant must be 6 months to 17 years old
3. Tanner stage \<5 at Visit 1
4. Open epiphyses
5. Normal fundoscopy at Screening
6. Written, signed, informed consent of the participant's parent(s)/LAR(s) and written assent of the participant

Exclusion Criteria:

1. History or presence of malignant disease
2. Children with diabetes mellitus
3. Major medical conditions and/or presence of contraindications to GH treatment
4. Pregnancy
5. Participation in any other study of an investigational agent within three months prior to Visit 1
6. Prior exposure to investigational drug or any other long-acting growth hormone
7. Any other reason per investigator's discretion
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 2-month old infants (55-89 days, inclusive)

Exclusion Criteria:

* Prior vaccination with routine infant vaccines (Diphtheria, Tetanus, Pertussis, Polio, Haemophilus influenzae type b (Hib), and Pneumococcal antigens)
* Previous ascertained or suspected disease caused by N. meningitidis
* History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
* Any serious chronic or progressive disease
* Known or suspected impairment or alteration of the immune system
The BEACON Study (Breast Cancer Outcomes With NKTR-102)

The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.

The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.


Eligibility Criteria:
Inclusion Criteria (major highlights):

* Patient is an adult female with histologically or cytologically confirmed carcinoma of the breast for whom single-agent cytotoxic chemotherapy is indicated
* Patient can have either measurable or non-measurable disease by RECIST.
* Patient has received prior therapy (administered in the neoadjuvant, adjuvant and/or metastatic setting) with an anthracycline, a taxane and capecitabine
* Patient has minimum of 2 and a maximum of 5 prior cytotoxic chemotherapy regimens with the last dose administered within 6 months. A minimum of two chemotherapy regimens had to be for locally recurrent and/or metastatic disease. All therapy received prior to a diagnosis of metastatic disease (eg, neoadjuvant, adjuvant or repeated adjuvant therapy following a second resection) is counted as one regimen.
* Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematopoietic, liver and kidney functions.

Exclusion Criteria (major highlights):

* Patient with chemotherapy within 21 days, radiotherapy within 14 days, biological therapy with 14 days, hormonal therapy within 7 days and investigational therapy within 21 days prior to randomization.
* Patient with any major surgery within 28 days prior to randomization.
* Patient with concurrent use of biologic agents for the treatment of cancer including antibodies or any investigational agent(s).
* Patient with prior treatment for cancer with a camptothecin derivative.
* Patient with chronic or acute GI disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care to control diarrhea in the 28 days prior to randomization.
* Patient received pharmacotherapy for hepatitis B or C, tuberculosis or HIV.
* Patient with known cirrhosis diagnosed with Child-PUGH Class A or higher liver disease.
* Patient with prior malignancy (other than breast cancer) except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 5 years prior to randomization.
* Patient requiring daily use of oxygen supplementation in the 28 days prior to randomization.
* Patients with significant cardiovascular impairment.
VIS Opti-K Vision Improvement for Presbyopes

The VIS Opti-K device and procedure were used to provide vision improvement to patients with presbyopia.

The VIS Opti-K device was used to irradiate the cornea with light that changed corneal shape.

Eligibility Criteria:
Inclusion Criteria:

Female or male Any race 40 years of age or older Presbyopia

Exclusion Criteria:

None

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