cyrilzakka/clinical-trials huggingface dataset:
CPVI Alone Versus CPVI Plus Low-Voltage Areas Ablation During SR Versus CPVI Plus Low-Voltage Areas Ablation During AF for the Treatment of CAF

The primary objective of this investigation is to compare the efficacy of Three different AF ablation strategies in patients with Persistent atrial fibrillation: CPVI plus Low-Voltage Areas ablation during sinus rhythm Versus. CPVI Plus Low-Voltage Areas Ablation During AF and CPVI alone.


Eligibility Criteria:
Inclusion Criteria:

1. Patients age is 18-80 years;
2. Patients with non-paroxysmal AF; non-paroxysmal AF will be defined as a sustained episode lasting \> 7 days;
3. Patients can sign the written informed consent for the study;
4. Patients can endure the required follow-up.

Exclusion Criteria:

1. Patients who had previously undergone atrial fibrillation, atrial tachycardia, or atypical atrial flutter ablation
2. Preoperative combined atrial tachycardia (≥30S) and atypical atrial flutter
3. Left atrial diameter \>55mm
4. Left ventricular ejection fraction \<35%
5. Left atrial thrombus
6. Postoperative cardiac surgery
7. After valve replacement
8. After permanent pacemaker implantation
9. hypertrophic cardiomyopathy
10. Patients with moderate-to-severe aortic valve disease, moderate-to-severe mitral stenosis, and severe other valvular disease
11. Hemorrhagic stroke within 6 months
12. Transient ischemic attack or ischemic stroke within 1 month
13. Mental disorder or history of mental illness and inability to cooperate voluntarily
14. Breastfeeding, pregnancy and women planning or likely to become pregnant
15. Life expectancy \<12 months
16. Participating in other interventional clinical trials
17. The researchers judged that it was not suitable for inclusion in this study
A Clinical Study of AK139 in Healthy Subjects

This is a phase I clinical study on dose escalation evaluating the safety, tolerability, PK and PD of a single dose of AK139 administered subcutaneously in healthy subjects.

This is a phase I, dose escalation clinical study aimed to evaluate the safety, tolerability, PK and PD of AK139 in healthy subjects. This study will be conducted in a dose escalation design, sequentially increasing the dosage of the drug from low to high to complete a single subcutaneous dose escalation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily agree to participate and sign an informed consent form (ICF) before any study procedures begin.
* Male and female healthy subjects aged 18 to 55 at the time of signing the ICF.
* Male weight ≥ 50.0kg, female weight ≥ 45.0kg; Body Mass Index (BMI)=Weight (kg)/Height² (m²), within the range of 19.0\~26.0 kg/m².
* Female subjects with fertility tested negative for pregnancy during the screening period.
* The subjects are able to communicate well with the investigator and understand and comply with the requirements of this study.

Exclusion Criteria:

* Allergies to AK139 components and any monoclonal antibodies.
* Positive results of confirmatory serology test for hepatitis B, hepatitis C,HIV or syphilis at screening.
* have participated in any drug clinical study within 3 months prior to randomization, or are still within 5 half-lives after the last administration of other investigational drugs (whichever is longer)
* Previously or currently suffering from any diseases of the circulatory, endocrine, neurological, digestive, respiratory, urogenital, blood, immune, psychiatric, or metabolic systems that may interfere with the test results.
* History of parasitic infection.
* Drug abusers or individuals with positive urine drug results during screening.
* Have donated blood or experienced significant blood loss, received blood transfusions, or used blood products 3 months before screening.
* Investigator assessed that it is not suitable to participate in the study.
Design and Evaluation of Care Environment and Technology at Pediatric Radiotherapy

The purpose of the study is to evaluate the effect of changes in the care environment in pediatric radiotherapy. The definitions of the changes is a part of the study, and is constructed in collaboration with the institute of design at Umeå University. The implementation is however not part of the study, but done as part of Clinical routine.

The study consist of two parts, where the first 1.5 years are a Control phase where the changes are designed and also function as a baseline period. The following 1.5 years are the case period where the Changes that are accepted for Clinical implementation are implemented.

The impact of the changes are evaluated using surveys and interviews of both parents and children

The purpose of the study is to evaluate the effect of changes in the care environment in pediatric radiotherapy. The definitions of the changes is a part of the study, and is constructed in collaboration with the institute of design at Umeå University. The implementation is however not part of the study, but done as part of Clinical routine.

The study consist of two parts, where the first 1.5 years are a Control phase where the changes are designed and also function as a baseline period. The following 1.5 years are the case period where the Changes that are accepted for Clinical implementation are implemented.

The impact of the changes are evaluated using surveys and interviews of both parents and children. Interviews of the personnel regarding their experiences of the study and the changes is performed after the finalization of the case period.

Eligibility Criteria:
Inclusion Criteria:

* Radiotherapy treatment

Exclusion Criteria:

-
FGF21 and Its Role in Alcohol Dependence

Plasma fibroblast growthfactor-21 (FGF21) responses to acute alcohol exposure will be evaluated in three groups: A: 15 individuals diagnosed with alcohol dependence (ICD10 code F10.2) and no alcoholic liver diseases, B: 15 healthy individuals with one or two parents with alcohol dependence, and C: 15 healthy matched controls without history of or disposition to alcohol dependence. The experimental day consists of a load of 0.5 g ethanol per kg body weight ingested from time 0-10 minutes followed by a 7 h period in which blood will be sampled with frequent intervals, rating of preference for ethanol, salt, sour, bitterly and sweets, sensations of hunger, appetite, satiety, headache, and nausea will be evaluated using visuel analogue scale and resting energy expenditure will be evaluated using indirect calorimetry.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Caucasian males between 25 and 65 years of age
* BMI between 19 and 27 kg/m2
* Normal haemoglobin
* Normal fasting plasma glucose concentration (\< 6 mmol/l) and normal glycated haemoglobin A1c (HbA1c) (\< 42 mmol/mol)

Participants with a father diagnosed with alcohol dependence (group B):

* Father diagnosed with alcohol dependence
* Weekly alcohol intake of less than 14 units of alcohol (of 12 g)
* Normal Alcohol Use Disorders Identification Test (AUDIT) score

Healthy participants (group C):

* Weekly alcohol intake of less than 14 units of alcohol (of 12 g)
* Normal AUDIT score

Exclusion Criteria:

* Liver disease evaluated by plasma alanine aminotransferase (ALAT) \> 3 × normal level, an international normalised ratio (INR) below normal values, or biopsy-verified alcoholic liver disease
* Diabetes mellitus
* Anaemia
* Nephropathy
* Other diseases the investigator finds disruptive for participation in the study.

Participants with a father diagnosed with alcohol dependence (group B):

- Former alcohol dependence or abuse

Healthy participants (group C):

* First-degree relatives with diabetes, liver disease and/or alcohol dependence
* Former alcohol dependence
Recovery of Individuals With Alcohol Use Disorders Based on Roy Adaptation Model

Abstract Aim: This study aimed to determine the effect of individualized nursing interventions based on the Roy Adaptation Model on the recovery of alcohol addicts.

Method: This was an experimental study with pretest-posttest, follow-up, and a control group. It included 64 individuals who completed their detoxification process and met the inclusion criteria. The experimental group was provided with individualized care, and interventions were made in line with the Roy Adaptation Model. The personal behaviors that could be related to recurrence (physiological, self-concept, role function, and mutual commitment) and the stimuli that caused recurrence (focal and affecting) were assessed, objectives were determined, and nursing interventions were carried out in line with these objectives. The interventions planned for diagnosing ineffective coping were selected according to the patients' needs among the "support coping" interventions under the title of the behavioral area in the Nursing Intervention Classification (NIC).

The data were collected using an introductory information form, the Recovery Assessment Scale (RAS), the Turkish Version of the World Health Organization Quality of Life Instrument (WHOQOL-BREF-TR), and the Penn Alcohol Craving Scale (PACS).


Eligibility Criteria:
Inclusion Criteria:

Diagnosed with alcohol use disorder according to DSM 5 Completed the detoxification phase were able to understand the scales and forms and maintain individual interviews were between 30 and 60 years of age

Exclusion Criteria:

* with a psychotic disorder
Efficacy and Safety Study of BIIB074 in Participants With Small Fiber Neuropathy

The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with confirmed small fiber neuropathy (SFN) that is idiopathic or associated with diabetes mellitus. A secondary endpoint that relates to the primary objective is the change from Randomization to Week 12 of the double-blind period in mean average daily pain score.

The secondary objectives of this study are to evaluate the effect on worst pain, neuropathic pain quality, sleep interference due to pain, patient global impression, use of rescue medication, and SFN symptoms in participants treated with BIIB074; to investigate the safety and tolerability of BIIB074 in participants with SFN; and to characterize the pharmacokinetics (PK) of BIIB074 in participants with SFN.


Eligibility Criteria:
Key Inclusion Criteria:

1. This study will be conducted in subjects who have had a diagnosis of at least probable SFN, length-dependent distribution, for 6 months and ≤10 years prior to screening, defined as a history of the symptoms and clinical signs based on discussions at the ACTTION CONCEPPT meeting on diagnosis of SFN, Washington, DC March 2018, and confirmed by intraepidermal nerve fiber density (IENFD) values, and weekly mean average daily pain (ADP) score of ≥5 and ≤9 on an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) over the last 7 days of prior to the Screening visit.
2. In addition to these criteria, subjects with diabetes will be required to have HbA1c ≤11%, treated with oral hypoglycemics and/or subcutaneous insulin or diet, no evidence of ulcers, advanced retinopathy (defined as greater than State 3 \[moderate non-proliferative diabetic retinopathy\]) (DCCT/EDIC Research Group 2017), severe nephropathy, or clinically significant obstructive atherosclerotic disease or current class IV heart failure to be eligible for the study.

Key Exclusion Criteria:

1. Previous exposure to BIIB074 (formerly known as CNV1014802 or GSK1014802).
2. Use of capsaicin patch within 3 months prior to Screening.
3. Unable or unwilling to discontinue concomitant medications for SFN pain prior to Day 1.
4. Unable or unwilling to comply with the prohibited concomitant medication restrictions, including but not limited to UDP-glucuronosyltransferase (UGT) inducers and inhibitors, monoamine oxidase inhibitors (MAOIs), and Nav blockers.
5. Use of over-the-counter medications, vitamin and mineral supplements, herbal remedies (including St. John's wort), dietary supplements, or foods (including grapefruit juice) that affect and UGTs.
6. Unable or unwilling to discontinue medications that are P-glycoprotein substrates with a narrow therapeutic index, including but not limited to digoxin.
7. History of hemophilia or Von Willebrand's disease, or use of anticoagulants that may result in bleeding risk during the skin biopsy.
8. Any contraindication, as determined by the Investigator, to performing a skin biopsy for intraepidermal nerve fiber analysis.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Men or women greater than or equal to 18 years old.
* Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.

Exclusion Criteria

* Active brain metastases from non-brain tumors.
* Myocardial infarction within 6 months of study day 1.
* Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Self-Administered Lidocaine Gel for Pain Management With IUD Insertion

For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit patients and providers. When patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

Elective IUD insertion (any type of IUD, copper or hormonal); at an out-patient setting at Stanford; English or Spanish speaking, and ability to give informed consent.

Exclusion Criteria:

Any pre-operative use of misoprostol; or use of PO pain control medication (i.e. ibuprofen or acetaminophen) prior to procedure. Allergy to study medications: lidocaine, or surgical lubricant jelly, known uterine anomaly; prior cervical surgery; and no prior use of tampons.
Mindfulness-based Intervention for Teenagers With Cancer

The purpose of this study is to evaluate the effects of a mindfulness-based meditation intervention on quality of life, sleep and mood in adolescents with cancer compared to a control group.


Eligibility Criteria:
Inclusion Criteria:

* Teenagers (ages 12-18) with cancer

Exclusion Criteria:

* No ongoing or lifetime severe psychopathology, such as schizophrenia, psychosis, delusional disorders or organic mental disorders
Salpingectomy vs Tubal Sterilisation in Low Risk for Ovarian Cancer Women and Its Effect on Ovarian Reserve

Randomised study to investigate if salpingectomies done to women wishing tubal sterilisation has an effect on ovarian reserve.


Eligibility Criteria:
Inclusion Criteria:

* Women seeking for tubal sterilisation

Exclusion Criteria:

* women older than 45
* family history of ovarian cancer
* presence of menopausal symptoms
* irregular cycles
* Hormone Replacement Therapy or hormone contraceptions the last 3 months
* history of previous ovarian or uterine surgeries
* imaging suggesting an ovarian cyst or other adnexal pathology during investigation
* previous salpingectomy
Comparison of Cytokines Profile in Aqueous Humor and Tear Before and After UCP Treatment

Glaucoma is the leading cause of irreversible vision loss in people aged 50 years and older worldwide, second only to cataracts. Ultrasound Cyclo Plasty was first proposed as a new minimally invasive technique in the 1980 s. In recent years, many clinical studies at home and abroad have confirmed the effectiveness, safety and repeatability of UCP. The ciliary body is the target organ of UCP, and the range and accuracy of intraoperative destruction of the ciliary body are the key factors affecting the success or failure of the operation. The production of aqueous humor is closely related to the ciliary body. The dynamic balance of its production and discharge can affect IOP, and its content can directly reflect the intraocular environment. Besides,tears are easy to collect and can be used for follow-up. Previous studies have shown that various proteins in aqueous humor or tear can provide a basis for the pathophysiological changes of glaucoma, and can also be a potential biomarker for predicting the success of anti-glaucoma surgery.

At present, UCP related research focuses on its effectiveness and safety, mainly reflected in three aspects : postoperative intraocular pressure, number of anti-glaucoma drugs and complications, and lack of relevant indicators that directly reflect postoperative intraocular environment changes. The purpose of this study was to reveal the changes of cytokines in aqueous humor after UCP in patients with primary glaucoma, to analyze the possible causes of these factors, and to speculate the effect of their interaction on the surgical effect, in order to increase the predictability of UCP procedure.


Eligibility Criteria:
Inclusion Criteria:

* The patient was definitely diagnosed as glaucoma, No age or gender limitation, IOP(intraocular pressure) ≥ 21mmHg under the maximum tolerated dose of antiglaucoma medication, or IOP \< 21mmHg and glaucomatous optic nerve damage progressed.

Exclusion Criteria:

* Other eye diseases that could affect IOP; preoperative use of systemic steroid drugs; history of other anti-glaucoma surgery within 3 months; ocular infection 2 weeks prior to UCP
Efficacy of Plyometrics to Increase Bone Mass in Men With Osteopenia

This study will compare the ability of two types of long term (12 months) weight-bearing exercise treatments (1. high-intensity jumping and 2. weight lifting) to increase bone mass of the total body, spine and hip in physically active men with osteopenia.

The overall goal of this project is to determine the efficacy of chronic (12 months) plyometric jump training exercise on bone mineral density (BMD) and markers of bone turnover in physically active males cyclists diagnosed with osteopenia below normal bone mineral density of the lumbar spine or hip.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 25-60 years
* No symptoms of disease
* Currently participating in cycling activities an average of 4 hr/wk for the previous 24 months
* Osteopenia of the lumbar spine and/or hip (T score \< -1.0 and \> -2.5 )

Exclusion Criteria:

* Medications or supplements that affect bone metabolism or prevent exercise
* Previous or current medical condition affecting bone health
* Osteoporosis of the lumbar spine and/or hip (T score \> -1.0 or \< -2.5)
* Cardiovascular disease
* Metallic implants
* Current smoker
* Current regular participation in high-intensity resistance training and/or plyometrics
Brief Shame Intervention Study

The current project will develop and test a brief 2-session shame intervention in individuals diagnosed with social anxiety disorder (SAD). Using a non-concurrent multiple baseline design, the investigators will determine whether the brief shame intervention leads to reductions in trait self-reported shame and state shame in response to an in vivo stressor task. The investigators will also evaluate the effect of changes in shame on trait SAD symptoms.


Eligibility Criteria:
Inclusion Criteria:

-≥ 18 years old

* fluent in English, in terms of verbal and written competence
* meet diagnostic criteria for social anxiety disorder (as assessed by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders; Tolin et al., 2016)
* have elevated levels of shame (i.e., score 1 SD above the Test of Self-Conscious Affect-3 \[TOSCA-3\] means reported by an unselected undergraduate sample \[M = 33.62, SD = 8.64\])
* endorse a desire to decrease their levels of shame and/or social anxiety.

Exclusion Criteria:

* currently receiving cognitive-behavioral therapy specifically for social anxiety or shame
* have begun taking or had a change in dosage of psychotropic medication in the past six weeks
* do not achieve baseline stability
Intra-Operative Radiation Registry

This registry trial is designed to track the local control rates and side effects of IORT, which will be implemented for women who are suitable PBI per the latest ASTRO guidelines.

Eligible patients will be referred for radiation oncology consultation by the operating surgeon. Patients will be presented with all radiation options and if they choose IORT, they will be offered enrollment onto the registry trial and consented accordingly. The registry will collect treatment data from the operation, radiation and pathology notes post IORT for each patient enrolled. Sources of research material, i.e. resected breast tissue and lymph nodes, will be obtained as part of routine clinical care. No additional tissue will be collected from patients due to enrollment on this registry trial. No additional studies will be performed outside of the routine standard of care.

Post treatment, the registry will collect data based on the standard of care follow up schedule. Follow-up visits will be scheduled 2-3 weeks post-operatively, as per standard of care, to review the final pathology and for the initial toxicity assessment. Patients found to have positive margins and/or lymph node involvement may require further surgery and/or additional external beam radiation. Additional follow-up visits with radiation oncology will be scheduled at 6 months and 1, 2, 3, 4, and 5 years following IORT. Toxicity will be scored using CTCAE v4.03. Local control will be evaluated using clinical exam and semi-annual to annual mammograms. All such information will be tracked and recorded into the registry database.

Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Age ≥ 45
* cT1-2N0, \<3.5cm invasive breast cancer, estrogen-receptor positive or DCIS of breast, Grade 1-2, mammographically detected, \< 2.5 cm, estrogen-receptor positive
* Suitable for breast conserving surgery
* No contraindication to radiation
* Mammogram within 6 months of planned procedure
* Fitness for lumpectomy under general anesthesia
* Planned to receive IORT

Exclusion criteria

* Known axillary lymph node positive breast cancer (negative biopsy not required)
* Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound, MRI or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy.
* Patients known to have BRCA 1/2 (breast cancer 1, breast cancer 2) gene
* Patients undergoing neoadjuvant chemotherapy
Clinical Outcome Of Hormonal Receptor Positive, Her-2 Negative Breast Cancer In Taiwan

Breast cancer is the most common cancer in Taiwanese women. Most of them were diagnosed in relatively early stages. Only 700 metastatic breast cancer were registered in Official Cancer Registration 2012, while more than11,305 were registered as early breast cancer. With broadly application of aromatase inhibitors, hormonal-receptor-positive breast cancer patients can survive longer and longer. However, there is no prevalence of metastatic breast cancer can be available yet. NHIA database coverage is more than 90% population in Taiwan, thus it can be an appropriate surrogate of prevalence. In this retrospective database analysis, we will explore the real world experience on aromatase inhibitor use for breast cancer in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer

Exclusion Criteria:

-