cyrilzakka/clinical-trials huggingface dataset:
International Registration of Isolated STIC: to Report and Investigate the Risk of Serous Peritoneal Carcinomatosis

To prospectively assess the incidence of peritoneal carcinomatosis for women with isolated STIC (serous tubal intraepithelial carcinoma). Moreover, to identify histopathological characteristics of STIC which are reproducible and associated to the risk of peritoneal carcinomatosis and to report the findings of additional diagnostics.

Women with a BRCA pathogenic variant (PV) undergo a risk-reducing salpingo-oophorectomy (RRSO) to reduce their ovarian cancer risk of 17-44%. A residual risk for peritoneal cancer (PC) persists, with most patients having extensive tumour spread throughout the abdomen. Despite surgery and chemotherapy, the five-year survival rate of PC is only 14-30%. Recently it became apparent that PC is frequently preceded by a preinvasive serous tubal intraepithelial cancer (STIC) at RRSO. The entity STIC is often found conjointly with ovarian cancer, but can also be present as an isolated condition, mostly in high risk women. If this STIC is found at RRSO, the risk for PC was found to be 27.5% (95% CI, 15.6-43.9) after ten years whilst this risk was \<1% without STIC. The pathophysiological mechanism of this association is not yet known and it is unknown which women with STIC are most at risk. Moreover, the additional value of diagnostics and management is unknown as data is lacking.

Objective: To prospectively assess the PC incidence for women with isolated STIC, to identify histopathological characteristics of STIC which are reproducible and associated to the risk of PC, and to report the findings of additional diagnostics.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Bilateral salpingectomy (with or without oophorectomy)
* A serous tubal intraepithelial carcinoma at histopathological review

Exclusion Criteria:

* Invasive cancer at initial surgery or pathological examination (either macroscopic and/or microscopic)
Impacts of Exercise on Prognostic Biomarkers in Lung Cancer Patients

This randomized pilot clinical trial studies exercise intervention in improving quality of life and exercise capacity and reducing inflammation and oxidative stress in patients with lung cancer and their support persons. Exercise therapy may help improve quality of life, may increase exercise capacity, and may reduce inflammation and oxidative stress in patients with lung cancer and their supporters.

PRIMARY OBJECTIVES:

I. Determine the effect of an eight-week exercise intervention on biomarkers of inflammation, oxidative stress, exercise capacity, and quality of life in lung cancer patients.

SECONDARY OBJECTIVES:

I. Determine the effect of an eight-week exercise intervention on markers of stress and quality of life in the support person of lung cancer patients.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A: Patients and their support persons undergo a supervised combined aerobic exercise comprising walking, cycling, or video-based aerobics and strength training using resistance bands for 40 minutes 2 days a week at the University of Wisconsin Hospital and Clinic (UWHC) and 3 days a week at home over 8 weeks.

ARM B: Patients and their support persons undergo the usual care over 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* LUNG CANCER PATIENTS: A confirmed diagnosis of any stage lung cancer (non-small cell lung cancer \[NSCLC\] or small cell lung cancer \[SCLC\])
* LUNG CANCER PATIENTS: Can be receiving any type of treatment (chemotherapy, radiation therapy, both or neither) are eligible
* LUNG CANCER PATIENTS: Able to understand and read in English sufficiently to adequately complete informed consent to participate and to complete the questionnaires
* LUNG CANCER PATIENTS: For patients treated with curative intent, and who have not relapsed, they must be within 1 year of their diagnosis of lung cancer (determined by date of diagnostic pathology sample)
* SUPPORT PERSONS: Able to understand and read in English sufficiently to adequately complete informed consent to participate and to complete the questionnaires

Exclusion Criteria:

* LUNG CANCER PATIENTS: Symptomatic heart disease including congestive heart failure or arrhythmia
* LUNG CANCER PATIENTS: Documented myocardial infarction in the last three months
* LUNG CANCER PATIENTS: Central nervous system (CNS) metastases that results in impaired ability to participate in an exercise program at the discretion of the study physician
* LUNG CANCER PATIENTS: Any psychological or physical disease that would impair or prevent participation in an exercise program at the discretion of the study physician
* LUNG CANCER PATIENTS: Cognitive or reading impairments that would preclude them from completing questionnaires
* LUNG CANCER PATIENTS: Current participation in an exercise program
* SUPPORT PERSONS: Symptomatic heart disease including congestive heart failure or arrhythmia
* SUPPORT PERSONS: Documented myocardial infarction in the last three months
* SUPPORT PERSONS: Cognitive or reading impairments that would preclude them from completing questionnaires
Ultrasound Diagnosis of Cleft Lip and Palate

Cleft lips and palate are one of the most frequent congenital malformation. From 2005 to 2009, a French study, conducted by Dr Bäumler et al. evaluated the accuracy of prenatal ultrasound in the diagnosis of cleft palate when cleft lip is present.

The aim of this study is to continue this study from 2009 till 2016. The hypothesis is that the diagnosis rate is constant since 2005.


Eligibility Criteria:
Inclusion criteria:

* Age over 18
* Prenatal ultrasound diagnosis of cleft palate/lip.
* Viable pregnancy or Intrauterine fetal demise or medical termination of pregnancy

Exclusion criteria:

- Diagnosis not confirmed at birth and ultrasound picture not interpretable
How to Reduce Dry Needling Pain in Treatment of Trigger Points of Muscle Triceps Sural in Ankle Post Fracture Patients

Ankle fractures are one of the main causes of hospitalization due to injuries in Chile, which also have a discharge and partial load time of approximately 12 weeks in the recovery process. This generates disuse and atrophy of the posterior musculature of the leg called the triceps sural, which makes it difficult to restart and perform the gait. We conducted this research because practically all patients with this type of diagnosis have trigger points in these muscles, and dry needling technique is one of the best for its treatment, but has the disadvantage that it produces post dry needling pain of 48 hours and there is not enough information, or consensus on which method is better to reduce post dry needling pain. This study aims to prove wich technique is most useful in reducing pain post dry needling for the treatment of trigger points in the triceps sural muscle in ankle post fracture patients.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 60 years of age.
* Man or woman.
* At least one trigger point, active or latent, in the triceps sural muscle of the fractured ankle.
* Perform full load without using technical aids.

Exclusion Criteria:

* Use of analgesics.
* Insurmountable fear of needles.
* Immune disease.
* Clotting disorders.
* Sensory disorders.
* Psychiatric / psychological illness.
* Cancer.
* Rheumatic diseases.
Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to Therapy

This study was planned to assess the concentration of antihypertensive drugs in the blood plasma in patients with controlled and uncontrolled arterial hypertension. Methods: it is planned to include patients with arterial hypertension taking 3 antihypertensive drugs (indapanide, lisinopril or valsartan, amlodipine). Based on the results of 24-hour blood pressure monitoring, the patients will be randomized into two groups: The first group - the patients with controlled AH; The second group - the patients with uncontrolled AH. Venous blood was taken in both groups of the patients in the morning before and 2 hours after taking drugs to assess the concentration of lisinopril, amlodipine, valsartan and indapamide. Concentation of assesed antihypertensive drugs will be compared in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form;
* An established diagnosis of AH based on the Clinical Guidelines "Arterial hyperten-sion in adults", approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020;
* Mandatory patient compliance with recommendations for lifestyle modification in accordance with the Clinical Guidelines "Arterial hypertension in adults", approved by the Scientific and Practical Council of the Ministry of Health of the Russian Federation, 2020 .
* Regular administration of any two antihypertensive drugs (lisinopril, amlodipine, valsartan) in combination with indapamide for a month, possibly in fixed combinations, in stable dosages;
* Fertile female patients must use proper methods of contraception throughout the study period.

Exclusion Criteria:

* Patient's connection with the organization or conducting of the study;
* Pregnancy.
Safety and Efficacy Study of Dutogliptin/PHX1149T to Treat Type 2 Diabetes Mellitus

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate Safety and Efficacy of PHX1149T as Monotherapy in Subjects with Type 2 Diabetes Mellitus


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus, drug naïve or willing to wash-out from existing oral therapy
* BMI 25 to 48 kg/m2, inclusive
* HbA1c 7.0% - 10.0%, inclusive
* Age 18 to 75 years, inclusive

Exclusion Criteria:

* Currently on 3 or more oral antidiabetic drugs or insulin.
* Type 1 diabetes mellitus
Evaluation of the Safety and Efficacy of Rigid Breathable Scleral Contact Lenses for the Correction of Ametropia

To evaluate the short-term efficacy and safety of scleral contact lens in the clinical treatment of patients with irregular astigmatism after corneal transplantation by analyzing ocular parameters and ocular surface conditions of patients after corneal transplantation.


Eligibility Criteria:
Inclusion Criteria:

1.8 ≤ age ≤ 55 years old;2.The diopter of one or both eyes is -25.00\~+25.00 D (including -25.00D and +25.00D), and corneal astigmatism caused by any reason (including keratoconus, irregular cornea) ≥0.75D.

Exclusion Criteria:

1.Patients who are judged by the investigator to be unsuitable for corneal endothelial cells;2.Dry eye ;3.Abnormal IOP ;4.Overt strabismus;5.Bacterial, fungal, viral and other active corneal infections;6. Being used may cause dry eyes or affect the eyeball or affect vision or affect the angle drugs such as membrane curvature;7.Corneal sensory, active corneal lesions;8.Conventional slit lamp microscopy and ophthalmoscopy, corneal diseases, iris cyclitis, chronic uveitis, cataract and vitreoretina related eye diseases disease or active and progressive disease;9.Other eye diseases: such as dacryocystitis, eyelid diseases and eyelid abnormalities or infections, eye muscle-related diseases, optic pathway diseases, glaucoma;10.Patients with systemic diseases that cause immunocompromise;History of allergy to contact lenses or contact lens care solution;11.History of allergy to contact lenses or contact lens care solution;12.Pregnant, lactating or planning to become pregnant in the near future;13.Subjects who are considered by the investigator to be unable to wear rigid contact lenses after comprehensively considering the corneal parameters, morphological characteristics and refractive examination results of the examination results;14.Those who have worn hard contact lenses within 30 days or soft hydrophilic contact lenses within 10 days;15.Those who participated in other drug clinical trials 3 months before screening and participated in other medical device clinical trials within 30 days;16.one-eyed patients;17.Those who have a strong sense of foreign body and cannot tolerate it and have poor compliance, and cannot be timely and regular to the medical institution for medical treatment as required;18.Other conditions judged by the investigator that the patient is not suitable for enrollment.
Study of Genetic Differences in People With Depression

The purpose of this study is to identify genes involved in depression. Specifically, the investigators will analyze some genes that may be related to whether or not a person responds to antidepressant medication. This project is part of basic scientific research to increase understanding of the role of genetic influences in psychological and mental processes involved in the response to treatment for depression.


Eligibility Criteria:
Inclusion Criteria:

* History of Unipolar Major Depression
* Control subjects must be healthy normal adults

Exclusion Criteria:

* Subjects with mood symptoms that are not severe enough to qualify for MDD
* Subjects with any active medical illness that may be related to ongoing mood disorder
* Normal subjects must be free from: a psychiatric diagnosis, substance abuse, a history of seizure disorder, and any serious medical illness
The Active Mind Study

The purpose of this study is to explore whether physical exercise, mindfulness training, or both interventions together can improve cognitive function in individuals with multiple risk factors for the development of dementia in the future.

The investigators will test the feasibility and acceptability of a combined mindfulness training + aerobic training intervention, vs. either alone or none to improve cognitive function in older adults with cognitive impairment. The investigators will also obtain estimates of effect sizes (and confidence intervals) on cognitive function. Preliminary analyses will be conducted to explore the mediating role of changes in aerobic capacity, physical activity, vascular risk factors, and mindfulness skills. Assessments will be conducted at baseline, 3-, and 6- months since baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥55
2. Being physically inactive (defined as not meeting current AHA recommendations for physical activity, i.e., \< 150 min of moderate-intensity aerobic activity per week OR \< 75 minutes of vigorous aerobic activity per week
3. Cognitive complaint defined as answering yes to the question "do you feel that your memory or thinking skills have gotten worse recently?"
4. Fluency in English language

Exclusion Criteria:

1. Unwillingness/inability to provide informed consent
2. Contraindications to physical activity as per the participant's PCP assessment
3. Blood pressure \>200/110
4. Severe depressive symptoms (defined as Hospital Anxiety and Depression Scale \[HADS\] depression subscale scores \>14)
5. Acute psychosis (from medical record)
6. Severe cognitive impairment (Mini-Mental State Examination \[MMSE\] score \<24)
7. Recent hospitalization (\< 6 weeks)
8. Current (at least once a month) mind/body practice (i.e., mindfulness meditation, yoga, or tai chi)
Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial

The study involves the 'first-in-human' evaluation of a novel optical sensor which uses near-infrared spectroscopy (NIRS) technology to assess oxygenation and hemodynamics of the injured spinal cord. The NIRS sensor is laid on top of the dura, at the site of the SCI, and emits near-infrared light signals into the cord to measure tissue oxygenation and tissue hemodynamics in real-time. Our testing of this novel NIRS sensor in patients with acute SCI represents the first step in translating this technology for human use.

This single-center, prospective observational study will enroll 10 patients admitted to Vancouver General Hospital (VGH) for treatment of an acute traumatic spine injury.

Promising preclinical data demonstrates that the oxygenation and hemodynamic measures of our Near Infra-Red Spectroscopy (NIRS) system closely match the invasive intraparenchymal measures obtained within the injured spinal cord. Further, the NIRS sensor is responsive and reflective of systemic hemodynamic changes. This clinical protocol represents the first application of this novel NIRS sensor in human SCI. Following operative decompression of the spinal cord via a posterior approach, the NIRS sensor will be placed over the dura for 7 days to monitor spinal cord oxygenation and tissue hemodynamics. Patients will be followed for 6 months and data collection for safety, feasibly and efficacy of the NIRS System.

The specific aims of this project are to:

1. Establish the safety, feasibility, and efficacy of our NIRS system in monitoring tissue oxygenation and hemodynamics of the injured spinal cord in human participants.
2. Complete the technical refinement of the NIRS system utilizing an iterative process guided by participant recruitment and data accrual during the trial.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 17 years or older
* Spinal injury between bony levels C3 and L1 inclusive
* Motor complete acute traumatic SCI (AIS A or B) or motor incomplete SCI (AIS C) with a total lower extremity motor score of less than 5
* Blunt (non-penetrating) SCI requiring posterior laminectomy with stabilization/fusion surgery within 72 hours of injury
* Able to communicate in English and provide informed consent

Exclusion Criteria:

* Isolated radiculopathy or cauda equina injury
* Spinal cord impairment secondary to tumour, infection, epidural bleeding, or ischemia (in
* Any condition or injury (e.g. Morel-Lavellee lesion) that would interfere with the application or readings of the NIRS sensor
* Associated traumatic condition that would interfere with the informed consent process or outcome assessments (e.g. traumatic brain injury, pelvic, abdominal, or thoracic injuries)
* Any other medical condition that, in the investigator's opinion, would render the protocol procedures dangerous
* Female patients who are pregnant
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year

This study will assess the safety and efficacy of secukinumab compared to placebo in patients that have moderate to severe, chronic, plaque-type psoriasis.


Eligibility Criteria:
Inclusion criteria:

* Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.
* Severity of psoriasis disease meeting all of the following three criteria:
* Psoriasis Area and Severity Index (PASI) score of 12 or greater,
* Investigator's Global Assessment (IGA) score of 3 or greater,
* Total body surface area (BSA) affected of 10% or greater.
* Inadequate control by prior use of topical treatment, phototherapy and/or systemic therapy.

Exclusion criteria:

* Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate).
* Current drug-induced psoriasis.
* Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.
* Significant medical problems such as uncontrolled hypertension, congestive heart failure or a condition that significantly immunocompromises the subject.
* Hematological abnormalities.
* History of an ongoing, chronic or recurrent infectious disease, or evidence of untreated tuberculosis.
* History of lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
* Pregnant or nursing (lactating) women.
* Subjects not willing to limit UV light exposure during the study Other protocol-defined inclusion/exclusion criteria may apply.
Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding

Hypothesis: An educational intervention increases the proportion of mother-infant pairs using exclusive breastfeeding

Objective: Evaluate the effectiveness of an educational group intervention performed by primary healthcare professionals in terms of increasing the proportion of mother-infant pairs using exclusive breastfeeding at six months compared to routine practice. Design: cluster randomized trial. Setting: Multicentre. Primary Care Health Centres (PCHC). Madrid. Subjects: mother-infant pairs using exclusive breastfeeding who come for any query to the health centre, as long as the infant is not older than four weeks and who consent to participate in the study.

Sample size: N= 432 (216 in each arm). Randomisation: Unit of randomization: primary healthcare centres.

Analysis unit: mother-infant pairs, recruitment to consecutive sampling. Intervention: Educational group intervention in the treatment group and the usual intervention in the control group.

Variables: Main response variable: mother-infant pairs using exclusive breastfeeding (EBF) at six months. Secondary variables: type of breastfeeding at 6 months, duration of EBF, reasons for ceasing breastfeeding, satisfaction with the intervention (SERVQUAL). Prognostic variables: infant, mother and professional.

Data Analysis: Analysis of main effectiveness by intention to treat, comparing the proportion of mother-infant pairs using EBF at six months in both groups. The estimation adjusted using an explanatory logistics regression model. To assess the effect of the educational group intervention on the duration of the various type of breastfeeding, a survival analysis will be used comparing the two groups using the log-rank test. The control of potential confounding variables will be performed by the construction of various Cox regression models.

Eligibility Criteria:
Inclusion Criteria:

* Female 18 years old or older,
* mother-infant pairs using exclusive breastfeeding,
* Signed Informed Consent

Exclusion Criteria:

* Any medical conditions that prevents breastfeeding
* infant should be not older than four weeks
Effects of Neuromuscular Training on Functional Capacity in Acute Coronary Syndrome Patients

The purpose of this study is to analyse the effects of neuromuscular training on functional capacity in patients with acute coronary syndrome, compared to the classic strength training of the cardiac rehabilitation programs

So far, there are no previous studies that analyze the effects of neuromuscular training on functional capacity in patients with acute coronary syndrome.

Aim: The main objective of this study is to assess the effects of a 10 weeks neuromuscular training vs traditional strength training programme in patients with acute coronary syndrome.

Design: Randomized clinical trial

Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome patients
* Physical activity must have been prescribed

Exclusion Criteria:

* inflammatory cardiac disease
* severe or moderate ventricular dysfunction
* heart failure
* severe arrhytmias
* systemic hypertension \>95% percentile
* pulmonary hypertension \>40 mmHg
* aortic stenosis
* baseline O2 \<90%
* severe valve insufficiency