cyrilzakka/clinical-trials huggingface dataset:
A Clinical Evaluation of the Treatment of Spider Veins on the Ankles

To evaluate the safety and effectiveness of the Excel V system for the treatment of lower extremity spider veins on the ankles.

The purpose of this study is to evaluate the real-world effectiveness of the 532 nm and 1064 nm Nd:YAG lasers within the Cutera Excel V system for the treatment of lower extremity spider veins, specifically on the ankles, within a clinic setting.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females, 20 to 75 years of age (inclusive).
2. Fitzpatrick Skin Type I - III.
3. Having spider veins on at least 1 ankle measuring 2.0mm or less in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the investigator.
4. Having spider veins on the ankle that are appropriate for laser treatment, as assessed by the investigator.
5. Subject must be able to read, understand and sign the Informed Consent Form.
6. Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
7. Wiling to have limited sun exposure for the duration of the study, including the follow-up period.
8. Willingness to have digital photographs taken of ankle spider veins and agree to use of photographs for presentation, educational or marketing purposes.
9. Agree not to undergo any other procedure for the treatment of ankle spider veins during the study.

Exclusion Criteria:

1. Fitzpatrick Skin Type IV - VI.
2. Pregnant.
3. Having an infection, dermatitis or a rash in the treatment area.
4. Having significant varicosities or perforator veins.
5. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
6. Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
7. Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
8. In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systemic therapy that could interfere with this research study.
Cognitive-Behavior Therapy for Young Adults With Bipolar Disorder

The aim of the study is to develop and pilot test a cognitive-behavioral (CBT) intervention for young adults, ages 18-24 with bipolar disorder. The 14-week intervention focuses on improving management of bipolar disorder, reducing involvement in high-risk behaviors, and enhancing psychosocial functioning. The intervention also focuses on issues specific to transition-age youth. The study includes two phases: In phase 1, the intervention will be developed, refined, and openly piloted with several participants. In phase 2,the investigators will conduct a randomized clinical trial, in which 40 participants will be randomized either to receive the intervention right away, or to a 14-week waitlist condition. Participants will be evaluated at baseline, week 5, week 10, and week 14 of the study period, as well as at 3- and 6-month follow up, using measures of mood symptoms, high-risk behaviors, drug and alcohol use, and psychosocial functioning.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of bipolar spectrum disorder (Bipolar I, Bipolar II, or Bipolar NOS Disorder)
* ages 18-24 years
* able to understand the nature of the study as well as potential risks and benefits
* in treatment with a physician or nurse-practitioner for their bipolar disorder, or willing to seek and obtain such treatment if needed.

Exclusion Criteria:

* concurrent cognitive-behavioral psychotherapy
* documented mental retardation
* pervasive developmental disorder
* current serious medical illness
* inability to participate in the intervention because of acuity of symptoms
* current drug or alcohol dependence (other than marijuana dependence)
Effectiveness of the NeuroSENSE for Monitoring the Hypnotic Depth of Anesthesia

The objective of this clinical study is to investigate whether the NeuroSENSE is an adequate monitor of hypnotic depth-of-anesthesia (DOA). Therefore, this study will investigate whether the information provided by the NeuroSENSE Monitor can help in assessing the hypnotic effect of anesthetics in adult patients undergoing general anesthesia.

In particular, the study will focus on the correlation between the WAVcns index, a proprietary quantifier of cortical activity displayed by the NeuroSENSE, with (1) commonly assessed clinical endpoints/variables relating to the DOA, (2) changes in anesthetic drug administration, and (3) the anesthesiologist's assessment of the DOA based on standard of care monitors and his/her own observations of the patient state.

The hypothesis under evaluation is that the WAVcns index is an independent assessor of the progression of the anesthetic state and events of general anesthesia related to hypnotic endpoints.

Eligibility Criteria:
Inclusion Criteria:

* age 18-75 years
* ASA (American Society of Anesthesiologist) physical status I, II, or III
* ability to read and understand the informed consent form
* undergoing anesthesia procedure requiring intubation
* scheduled to undergo either open or laparoscopic abdominal surgical procedures (e.g. colectomy, hysterectomy, radical retropubic prostatectomy, nephrectomy, pancreatectomy, etc.), breast surgery including reduction, reconstruction and mastectomies, or orthopedic surgeries under general anesthesia, expected to last at least 1 hour.

Exclusion Criteria:

* history of major head injury (possible abnormal EEG)
* acquired scalp or skull abnormalities (e.g. psoriasis, eczema, angioma, scar tissue, burr holes, cranial implants)
* evidence of recent trauma or active neurological disorder, stroke, seizure disorder, intellectual disability, dementia or diagnosis of Alzheimer's disease
* major antipsychotic medications taken within last 7 days (eg. Lithium, risperidone, olanzapine)
* known history of alcohol or drug abuse within last 30 days
* body mass index (weight in kilograms divided by square of height in meters) \> 40.0 kg/m2
* uncontrolled hypertension with blood pressure recorded prior to surgery (systolic blood pressure \> 200 mmHg or diastolic blood pressure \> 110 mmHg)
* systolic blood pressure \< 90 mmHg, recorded prior to surgery
* heart rate (HR) \< 45 beats/min, recorded prior to surgery
* insulin-dependent diabetes mellitus
* pregnancy
* any serious medical condition that would interfere with cardiovascular response assessment or study results interpretation
FamilieTrivsel i Almen Praksis: a Mentalisation Programme for Families With Young Children

This cluster randomised trial aims to establish the effectiveness of an online intervention designed to improve the ability of parents to 'mentalise' - in other words to understand their own mental states and that of others including their partners and young children. Effects on maternal mental state, the quality of parent-child interaction and child language, social and emotional development will be assessed.

This is a cluster randomised trial based in Danish general practice. A number of general practitioners will be recruited, each of which will recruit successive women at their first routine antenatal appointment. All practices will receive standardised training in assessing maternal mental health, neurodevelopmental assessment of the child and assessment of the quality of parent-child interaction as well as in completion of an enhanced pregnancy or child development record.

Practices will be randomised either to receive additional training in the principles of mentalisation and in the use of an online resource (Robusthed) that parents can use to improve their mentalisation skills (https://robustbarn.dk) or not to receive this extra training. The trial is therefore comparing Robusthed plus enhanced care as usual with enhanced care as usual alone.

Baseline measures will be taken at recruitment into the trial and outcomes will be collected when the child is 15 and 30 months.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women presenting at their first GP-based antenatal assessment and their families

Exclusion Criteria:

* Non-Danish speaking women
* Families planning to move to a new general practice during the pregnancy or shortly after the birth of the child
* Mother has already participated in the trial (e.g., second eligible baby within life of the study)
* Presentation to the GP after the time for the third scheduled antenatal visit
* Miscarriage or other pregnancy loss after recruitment to the study will lead to late exclusion from the study
* Second pregnancies among already-participating families
Genetic, Environment and Its Interaction Analysis for Cardiovascular Autonomic Neuropathy

A large-scale, community-based, cross-sectional study was conducted to explore the extent to which genetic, environment and its interactions associated with cardiovascular autonomic neuropathy (CAN) in general Chinese population. A total of more than 2000 participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). Data involved in variables of genetic, environment were collected. Every participants was complete DNA extracted and genotyped by using single nucleotide polymorphism (SNP). Cardiovascular autonomic functions were measured by using short-term heart rate variability (HRV) to evaluate the outcome of CAN. Genetic analysis were employed to evaluate genetic variants, environmental risk factors and its interactions for CAN.

A large-scale, community-based, cross-sectional study was conducted to explore the extent to which genetic, environment and its interactions associated with cardiovascular autonomic neuropathy (CAN) in general Chinese population. A total of more than 2000 participants were recruited by using multiple stages sampling (first cluster sampling and then simply sampling). Data involved in variables of genetic, environment were collected. Every participant was complete DNA extracted and genotyped by using single nucleotide polymorphism (SNP). Cardiovascular autonomic functions were measured by using short-term heart rate variability (HRV) to evaluate the outcome of CAN. Genetic analysis were employed to evaluate genetic variants, environmental risk factors and its interactions for CAN.Univariate and multiple variables analysis have been performed to examine potential environmental and genetic risk factors of CAN.

Eligibility Criteria:
Inclusion Criteria:

* Survey Chinese participants with undiagnosed CAN Aged 30-90 years, were included in this study.

Exclusion Criteria:

-

Some subjects were excluded from the study to eliminate potential confounding factors that may have influenced their CA function. Briefly, the exclusion criteria were as follows:

1. history or findings of arrhythmia and hyperthyroidism or hypothyroidism
2. pregnancy or lactation
3. serious hepatic or renal dysfunctions (GFR \< 30 mL/min/1.73m2). Of these subjects, complete baseline data were obtained for 2,092 (69.46%) of the participants.
Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty

To determine the safety and efficacy of single intra-operative treatment of Botulinum Neurotoxin Serotype E (EB-001) intramuscular (IM) injections into the Rectus Abdominus (RA) in participants undergoing abdominoplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women 23 to 55 years of age, inclusive
2. Scheduled to undergo elective abdominoplasty surgery with full length plication from xyphoid to pubis, and removal of skin/fat flap under general anesthesia (endotracheal or otherwise) without liposuction
3. American Society of Anesthesiologist (ASA) Physical Class 1-2.

Exclusion Criteria:

1. History of prior major abdominal surgery as judged by the investigator
2. Pre-existing lung disease that could impact participant safety in the opinion of the investigator
3. Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton- Lambert syndrome, or amyotrophic lateral Sclerosis)
4. At high risk of deep vein thrombosis as judged by the investigators determined by a Caprini score of 3 or higher
5. Slow vital capacity that is below 80% of normal value for respective race, age, height, and gender or below 2.5 Liters (L) of absolute volume
6. Pulse oximetry below 95%
7. Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32
8. Reported use of any botulinum toxin within 3 months prior to the date of surgery
9. Use of long acting opioids within 3 days or any opioid medication within 24 hours prior to surgery
10. Aminoglycoside intake within 48 hours prior to or during surgery
11. Participants on anti-depressant or anti-psychotic medications
12. Reported pain score of 2 or more at screening on the 11-point scale numerical pain rating scale-administered after an activity (NPRS-A) following an activity after and walking approximately 10 feet.
Metabolic Imaging Predict Histopathologic Response to Preop ChemoXRT for Locally Advanced Rectal CA

In this research study of metabolic imaging in locally advanced rectal cancer, we hope to learn whether new medical imaging technology can help predict the response of rectal cancer to preoperative chemotherapy and radiation therapy. Ultimately we hope this information will in the future help us predict which patients will benefit from more or less aggressive initial therapy for their rectal cancer.


Eligibility Criteria:
Inclusion Criteria:- You must be diagnosed with locally advanced rectal cancer and have chosen treatment with preoperative chemoradiotherapy followed by surgery, which is a standard treatment approach for this disease. Exclusion Criteria:- You are ineligible for this study if you are pregnant or under the age of 18 years old.
RIRS for Treatment of Stones in Congenital Anomalous Kidneys

The anatomic renal abnormalities like altered spatial relations with adjacent organs, abnormal calyceal orientation, and anomalous vascular patterns make the active treatment of stones in the congenitally malformed kidney a great challenge for urologists. In this prospective study, the investigators will evaluate the outcome of retrograde intrarenal surgery (RIRS) with extracorporeal shockwave lithotripsy (SWL) for the treatment of stones in the kidneys with rotation or position anomalies.

In current stone guidelines, the recommendations for stone therapy in the kidneys with normal anatomy are clearly stated; however, there is also no clear suggestion and treatment modality in regards to the stone treatment in anomalous kidneys. Nowadays, open surgery, percutaneous nephrolithotomy (PNL), SWL, and RIRS are used for the treatment of these kidney stones. However, there is no clear consensus on which treatment modalities should be used; each modality has its unique advantages and drawbacks. in this study, the investigators will prospectively evaluate the safety and efficacy of RIRS in treatment of stones in kidneys with rotation or position anomalies. The investigators will compare the results with a matched group of patients who were treated with SWL. The results of this study may help clarify treatment options in the management of patients with stones and renal anomalies.

Eligibility Criteria:
Inclusion Criteria:

* The study will include patients with renal stones up to 20 mm in size in a kidney with rotation or position anomalies.

Exclusion Criteria:

* Pregnant women.
* Uncorrectable coagulation disorders.
* Urinary tract obstruction distal to the stone.
* Active infection.
* Stone in a calyceal diverticulum
Phase II Trial of Combination Therapy With S-1, Irinotecan, and Bevacizumab (SIRB) in Patients With Unresectable or Recurrent Colorectal Cancer

Phase II trial of combination therapy with S-1, irinotecan, and bevacizumab (SIRB) in patients with unresectable or recurrent colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
2. Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
3. Patients with no previous treatment (radiotherapy or chemotherapy). Patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment.

   Preoperative or postoperative irradiation (\<30 Gy) for rectal cancer is possible
4. Age \>20 years
5. Life expectancy of at least 3 months
6. ECOG PS of 0 or 1
7. Adequate function of major organs as defined below:

   1. Hemoglobin \>9.0 g/dL
   2. White blood cell count \>3,000/mm3
   3. Neutrophil count \>1,500/mm3
   4. Platelet count \>100,000/mm3
   5. Total bilirubin \<1.5 mg/dL
   6. AST and ALT \<100 U/L (\<200 U/L in patients with liver metastasis)
   7. Serum creatinine \<1.2 mg/dL
   8. Creatinine clearance estimate by the Cockcroft-Gault method \>50 mL/min (reduce initial dosage by one step if ≥50 but \<80 mL/min)
8. Able to take capsules orally.
9. No electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.
10. Voluntary written informed consent.

Exclusion Criteria:

1. Serious drug hypersensitivity or a history of drug allergy
2. Active double cancer
3. Active infections (e.g., patients with pyrexia of 38℃ or higher)
4. History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.
5. Uncontrolled hypertension
6. Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)
7. Moderate or severe ascites or pleural effusion requiring treatment
8. Watery diarrhea
9. Treatment with flucytosine or atazanavir sulfate
10. Metastasis to the CNS
11. Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
12. Severe mental disorder
13. Continuous treatment with steroids
14. Urine dipstick for proteinuria should be \<2+
15. Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
16. Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks
17. Long-term daily treatment with aspirin (\>325 mg/day)
18. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
19. Judged ineligible for participation in the study by the investigator for safety reasons.
Efficacy of Metacognitive Training for Schizophrenia - a Study Protocol

Metacognitive training (MCT) for schizophrenia has been used in several countries, but its efficacy remains unclear. MCT is a program group that consists of changing the cognitive infrastructure of delusions.

This study aims to evaluate the efficacy of the Portuguese version of the metacognitive training programme and its effects on psychotic symptoms, insight to the disorder and functionality

A randomized controlled trial that will be realized in six psychiatric institutions of Portugal. Pilot study will be carried out initially. The sample will be constituted by individuals diagnosed with schizophrenia (experimental group (n=30) and control group (n=30). The evaluation instruments will be utilized are PSYRATS, BCIS, PSP and WHODAS 2.0 applied to both groups in three different moments. In experimental group the eight MCT modules will be applied over four weeks.

The objective is to compare the outcomes associated with "treatment-as-usual" and the benefits of implementing the Metacognitive Training for Schizophrenia.

The hypothesis to be validated in this trial are:

* the schizophrenic patients who integrate the experimental group and participate in the MCT program will reduce the severity of psychotic symptoms and will present a better insight to disease and a better functioning on the final of the program than the control group;
* in participants that participating in the MCT program, the psychotic symptoms decrease at the end of the program and in the follow up (three months later) and the awareness for the disease and functioning improves.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years;
* diagnosis of schizophrenia evaluated by Psychiatrist Assistant;
* that didn't have any changes in neuroleptics medication four months before program.

Exclusion Criteria:

* substance dependence;
* very severe psychotic symptoms that impedes understanding the objectives of the sessions;
* had changes in neuroleptics medication four months before program.
Community Spirit in Residence for the Elderly

The objective of our study is to observe and understand factors that emphasizes the creation of a community spirit.

Specific objectives:

1. Explore and understand the facilitators and challenges of social participation in a residential context;
2. Explore and understand the facilitators and challenges of creating a sense of community in a residential setting.


Eligibility Criteria:
Inclusion Criteria:

For site managers

* Be a manager in the residences concerned
* Be a department manager or
* Hold a General Manager position or
* Be a member of the partner's head office

For residents

* Residents of the autonomous wing of the targeted residences
* Close caregiver of a resident of the residences included in the research project

Exclusion Criteria:

* Neurocognitive disorders
* Significant language difficulties
* Lack of verbal communication
ASSURE WCD Clinical Evaluation - Conversion Efficacy Study

A multicenter single arm open label evaluation of the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform in adult cardiac patients

The objective of this study is to evaluate Ventricular Tachycardia/Ventricular Fibrillation (VT/VF) conversion efficacy in adult human subjects using the ASSURE Wearable Cardioverter Defibrillator (WCD) defibrillation waveform.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females, age ≥ 18 years
2. Able and willing to provide written informed consent before undergoing any study-related procedures
3. Scheduled for any of the following procedures:

   1. Electrophysiology study for induction of ventricular arrhythmias
   2. Non-invasive electrophysiology testing using an existing implantable defibrillator
   3. Implantable cardioverter-defibrillator (ICD) replacement procedure during which induction of a ventricular arrhythmia is planned
   4. Ablation of ventricular tachycardia (patients undergoing ventricular tachycardia ablation in which only a substrate modification approach is planned, with no intention of inducing a ventricular arrhythmia, should not be included)

Exclusion Criteria:

1. Any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements
2. Pregnancy
3. Use of mechanical circulatory support (e.g. Left Ventricular Assist Device, Total Artificial Heart, intraaortic balloon pump or Impella)
4. Documented nonchronic cardiac thrombus
5. Atrial fibrillation or atrial flutter without therapeutic systemic anticoagulation
6. Critical aortic stenosis
7. Unstable coronary artery disease (CAD)
8. Recent stroke or transient ischemic attack (TIA)
9. Hemodynamic instability
10. Currently implanted Boston Scientific S-ICD (due to location of implant relative to test system)
11. Unstable angina
12. New York Heart Association (NYHA) Class IV
13. Left Ventricular Ejection Fraction (LVEF) \< 20%
14. Any medical condition that by the judgement of the physician investigator, patient participation in this study is not in the best interest of the patient
15. History of difficulty of ventricular arrhythmia induction
16. Amiodarone use within 3 months before the study procedure