cyrilzakka/clinical-trials huggingface dataset:
Oxygen Therapy for Retinal Ischemia

The investigators will be using nocturnal normobaric hyperoxia therapy in patients with diagnoses of conditions related to retinal ischemia.

Patients who receive a diagnosis of a condition relate to retinal ischemia and who pass the eligibility criteria will receive an oxygen concentrator to use at home. They will report back in follow up monthly for three to six months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of retinal-ischemia related condition

Exclusion Criteria:

* Complicating other ocular condition
* History of smoking or lung conditions
Body Image and Psychosocial Functioning in Women With Breast Cancer: Can We Fix What We've Broken?

The purpose of this study is to test an innovative intervention geared towards issues of identity, body image and sexuality, and to examine the intervention for its impact on body image, quality of life, psychosocial/sexuality/relational functioning.

Breast cancer is the most frequently diagnosed cancer in women with 1 in 10 Canadian women being diagnosed in their lifetime. There has been an increase in the number of survivors due to advances in treatment and early detection, and increased scientific attention has been focused on patients' quality of life during and after treatment. The majority of survivors do well after the initial adjustment within the first 2 years post-treatment. However, depending on when assessed after treatment completion, a wide range of cancer survivors either score at levels suggestive of a psychiatric diagnosis or are diagnosed with a psychological problem. Furthermore, a subset of survivors experience adjustment problems long after treatment completion. Approximately 20% to 40% of survivors develop sexual and body image problems following breast cancer and treatment and these difficulties tend to persist several years after treatment completion.

This study aims to test an innovative intervention geared towards issues of identity, body image and sexuality and to examine the intervention for its impact on body image and quality of life, psychosocial and sexual functioning and relational functioning.

One hundred and eighty women who have completed treatment for breast cancer will be randomized into either intervention: an 8 weekly psychosocial group support or control condition (standard care + written educational material). All subjects will be followed for 1 year post-intervention. It is hypothesized that, compared to control subjects who receive standard care and educational materials, subjects participating in an 8 weekly psychosocial group support will have higher levels of relationship support/functioning, and that the group differences will be maintained over the 1-year follow up period.

Eligibility Criteria:
Inclusion Criteria:

* women with primary breast cancer
* age between 18 and 65 years
* completed adjuvant treatments
* Stage I,II,III cancer of the breast with no metastatic disease

Exclusion Criteria:

* presence of any metastases
* history of major psychiatric disorder as defined by the DSM-IV
* inability to speak or read English for questionnaire completion
* failure to provide informed consent
* currently participating in a therapist-led psychosocial support group
Truncal Vagotomy in Patients Undergoing Revisional Sleeve Gastrectomy to Gastric Bypass

The purpose of this study is to investigate the efficacy of performing a truncal vagotomy along with a sleeve to bypass revision surgery in reducing the severity and/or incidence of gastroesophageal reflux disease (GERD) post-surgery.


Eligibility Criteria:
Inclusion Criteria:

* Participating subjects will need to be \>18yrs of age and eligible for sleeve to bypass revision bariatric surgery.
* Undergoing sleeve to bypass revision bariatric surgery.

Exclusion Criteria:

* Patients who are under the age of 18.
* Not eligible for sleeve to bypass revision bariatric surgery.
Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)

The purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in patients with essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients who successfully complete the core study (Study CVAA489A1301.
* Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 had to be well controlled defined as MSDBP \< 90 mmHg and MSSBP \< 140 mmHg. At the investigator's or sub-investigator's discretion, those patients who were not well controlled (MSDBP ≥ 90 mmHg or MSSBP ≥ 140 mmHg), and whose MSDBP was \< 100 mmHg and MSSBP was \< 160 mmHg might participate in the extension if this was considered an acceptable level of blood pressure control for the patient.
* Male or female outpatients.
* Patients who have written informed consent to participate in this study.

Exclusion Criteria:

* Presence of major protocol violation in Study CVAA489A1301.
* Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.
* Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.
* Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or sub-investigator.
* Patients who have gout or gouty arthritis.
* Patients hypersensitive to diuretics (except for potassium sparing diuretics).

Other protocol-defined inclusion/exclusion criteria may apply
COMplete Versus PArtial Open inCisional Hernia Repair (COMPAC-TRIAL)

To compare the complete repair of the abdominal wall at the level of the former incision with only a partial repair at the level of the hernia in patients with an incisional hernia after median laparotomy in a prospective randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the patient or his/her legal representative
* Incisional hernia requiring elective surgical repair

Exclusion Criteria:

* No written informed consent
* Emergency surgery (incarcerated hernia)
* All incisional or parastomal hernias not originating at the midline
* All recurrent hernias
* All patients with mesh placed intra-abdominally during surgery have to be withdrawn
Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme

The purpose of this study is to determine whether low-dose contraceptive pills are effective in the improvement of quality of life in patients in the different phases of menacme.


Eligibility Criteria:
Inclusion Criteria:

* Fertile women with indication of use of contraceptive pills

Exclusion Criteria:

* Fertile women with any surgical contraceptive method
* Women in menopause
* Diseases the forbidden the use of the drug
Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer

This is a non-randomized, open-label, single-institution phase I/II therapeutic trial of bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC). This study will be activated at the UT Southwestern Medical Center, comprised of The Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Hospitals-St. Paul and Parkland Memorial Hospital System. Advanced HCC is defined as disease that is not amenable to surgical resection or orthotopic liver transplantation or is metastatic in nature.

The investigators are looking for men or women aged 18 years or older with hepatocellular carcinoma not suitable for surgical resection or hepatic transplantation. Prior locoregional therapy including but not limited to transarterial chemoembolization (TACE), radiofrequency ablation (RFA) or ethanol injection is allowed as long as the treatment was 4 weeks previous. Patients must be Child-Pugh A with no previous treatment with sorafenib or other vascular endothelial growth factor (VEGF) inhibitors.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:

   * Histologically confirmed.
   * MRI or CT consistent with liver cirrhosis and at least one solid liver lesion \>2 cm with early enhancement and delayed enhancement washout regardless of AFP.
   * AFP \>400 ng/ml and evidence of at least one solid liver lesion \>2 cm regardless of specific imaging characteristics on CT or MRI.
2. Locally advanced or metastatic disease.
3. Patients with locally advanced disease must have disease deemed to be unresectable or not eligible for hepatic transplantation. Determination will occur in the weekly GI DMT meeting by surgical oncologists and transplant surgeons.
4. Measurable disease, as defined as lesions that can accurately be measured in at least one dimension (longest diameter to be measured) according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at least 2 cm with conventional techniques or at least 1 cm with spiral computed tomography.
5. Child-Pugh Score A.
6. Age ≥ 18 years.
7. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
8. Absolute neutrophil count ≥ 1,500 cells/mm3.
9. Platelet count ≥ 75,000 cells/mm3.
10. Total bilirubin ≤ 3.0 mg/dl.
11. Hemoglobin ≥ 8.5 g/dl.
12. AST and ALT ≤ 5.0 times upper limit of normal.
13. D-dimer ≤ 3 times upper limit of normal.
14. INR ≤ 1.8 (therapeutic anticoagulation allowed as long as medically indicated.

Exclusion Criteria:

1. History of bleeding diathesis or coagulopathy.
2. Symptomatic or clinically active brain metastases.
3. Major surgery within previous 4 weeks.
4. History of thromboembolic events (including both pulmonary embolisms and deep vein thrombosis); central venous catheter-related thrombosis \> 6 months prior is allowed.
5. Prior adjuvant therapy with sorafenib or other Raf/MEK/RAS or VEGFR inhibitors. Prior adjuvant therapy is allowed provided it was completed \> 6 months ago and there is documented recurrence of hepatocellular carcinoma.
Predicting Toxicity in Elderly Patients With Head and Neck Cancer

Predicting toxicity in elderly patients with head and neck cancer:

validating a disease-oriented toxicity predictive tool and integrating it with avail-able screening tools for better outcomes.

We aim to analyze clinical and biochemical variables to prospectively create and validate an independ-ent predictive score to identify the probability of G3-5 toxicity in HNC elderly patients candidated to a curative treatment with radiation treatment +/- systemic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 70 years
* Histological diagnosis of squamous cell or undifferentiated HNC in stage III-IV AJCC ed VIII (si-nonasal, nasopharynx, oral cavity, oropharynx, unknown primary with HPV pos, larynx and hy-popharynx) and candidated to curative non surgical treatment (radiotherapy alone, Chemora-diation with platinum salts; radiation+cetuximab)
* Evaluable disease accordingly to RECIST criteria 1.1
* Willing of sign a written informed consent
* Adequate organ function

Exclusion Criteria:

Patient with cancer in other sites than HN \< than 2 years except for prostate cancer cT1-2, Gleason 3+3, NIMBC, initial Non Melanoma Skin Cancer, in situ cervical cancer)

* PS ECOG 3-4
* Patients who received systemic treatments in the past for other primary tumors
Pilot Open Label Use of the Hi-OXSR for the Treatment of Post COVID-19 Cognitive Dysfunction

During the worldwide COVID-19 pandemic a large number patients reported different functional complaints one month or later after recovery from the acute infection. This entity had a number of names including "long-COVID" or "post COVID condition". Long-COVID is on the rise and no effective treatment exists yet to improve cognitive function. Recent research has shown that people with even mild COVID had a greater decline in executive function, notably in their ability to perform complex tasks. What drives post-COVID cognitive changes is still a mystery and there are no effective treatments available. One hypothesis is that there is persistent immune activation resulting in reduction in cerebral blood flow. There is evidence that increased CO2 may decrease inflammation, and decreased CO2 may increase inflammation.

Objectives: The primary objective of this pilot study is to assess the safety and tolerability of the use of Hi-OX sequential rebreathing for the treatment of post-COVID cognitive dysfunction. The secondary objective is to identify the effects of the use of the Hi-OX rebreathing treatment in changing post-COVID cognitive dysfunction.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent.
2. Previously diagnosed with cognitive dysfunction following recovery from COVID.
3. Not pregnant at time of study.
4. Oxygen saturation on room air ≥92% at screening.
5. Willing and able to comply with the treatment schedule and procedures.

Exclusion Criteria:

1. History of cognitive dysfunction prior to COVID infection
2. Hospitalization for the treatment of COVID
3. Participating in another investigational trial or the use of an investigational drug within 30 days of screening
4. For individuals of childbearing potential:

   positive pregnancy test at screening or lactating or unwilling to practice a medically acceptable form of contraception from screening to Day 14 (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent)
5. History of pulmonary hypertension
6. History of narcolepsy
7. Moderate to severe COPD
8. Interstitial Pulmonary Fibrosis
9. End-tidal PCO2 \>55 mmHg during training treatment
10. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
Protective Effect of Propofol Against Hemolysis in Patients Submitted to Gastroplasty

The purpose of this study is to determine if propofol could protect erythrocytes by directly scavenging free radicals from the blood current and increasing resistance of their cell membranes in patients submitted to gastroplasty.


Eligibility Criteria:
Inclusion Criteria:

* patients between BMI 40-50 kg/m2

Exclusion Criteria:

* patients with BMI under 40 kg/m2 and over 50 kg/m2
* alcohol users
* illicit-drug users
* patients in regular use of anti-depressants, proton bomb inhibitors or calcium canal blockers
* patients transfused either recently, during the intra-operative period or within 10 hours post-operative
* patients previously known to be hypersensitive to any drug that is used during the study
* patients with any psychiatric disorder or dementia
EBUS Image Features in the Diagnosis of PPLs

The study is aimed to evaluate the sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate of endobronchial ultrasound (EBUS) image features in diagnosing peripheral pulmonary lesions (PPLs).

The study is designed as a single center prospective trial. The participating center is Department of Ultrasound, Shanghai chest Hospital, Shanghai Jiao Tong University, China. The study is expected to enroll 200 patients. The investigator evaluates the sensitivity, specificity, positive predictive value, negative predictive value and accuracy rate of EBUS image features in diagnosing PPLs. EBUS is performed using an endoscope ultrasound system, which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are older than 18 year-old.
2. Chest CT shows PPLs suspected to be malignant that need to be confirmed by pathology. The lesion is surrounded by lung parenchyma and invisible in standard bronchoscopy.
3. Patients who agree to undergo bronchoscopy without any contraindications.
4. Patients who have good compliance and sign informed consent.

Exclusion Criteria:

1. Absence of bronchus leading to or adjacent to the lesion from CT scan.
2. Refusal of participation.
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
4. Presence of concomitant endobronchial lesion during the bronchoscopy procedure
Risk Stratification in Acutely Admitted Medical Patients

The study has three main parts.

1. To see if we can develop a riskstratification tool that can be used to asses the risk for acutely admitted medical patients for inhospital death, admission to the ICU and death within 30 days of release.
2. To test existing tool as in 1.
3. To clarify if it is most reasonable to let the admitting doctor order blood test by clinical judgment or be using a predefined list of tests.


Eligibility Criteria:
Inclusion Criteria:

* Any patient acutely admitted to the medical department of Ribe County Hospital

Exclusion Criteria:

* Age below 15 years
* Unwilling to participate
Prehospital Traumatic Brain Injury

The aim of the study is to measure the effect of Finnish physician-staffed EMS unit treatment methods on traumatic brain injury (TBI) patient prognosis.

A secondary aim is to identify out-of-hospital treatment factors that can be influenced by education and protocols.

Eligibility Criteria:
Inclusion Criteria:

* TBI with GCS ≤ 8 or unconsciousness verified by an on-call neurosurgeon during admission to the hospital.

Exclusion Criteria:

* Multiple trauma
A Digital Intervention to Prevent Initiation of Opioid Misuse in Adolescents in School-based Health Centers

This study's specific aims were to: develop a digital intervention as a prevention intervention through focus groups with 40 youth; pilot-test the developed digital intervention with 30 adolescents, using methods from the investigator's prior research; develop implementation strategies and partners through focus groups with 50 School Based Health Alliance affiliates and 30 adolescents from an Advisory Council.

Most opioid misuse begins during adolescence and young adulthood. Adolescence is the time to intervene with prevention interventions (i.e., interventions focused on adolescents who have not yet misused opioids) in settings like school-based health centers (HCs), yet few interventions exist that prevent initiation of opioid misuse. "Serious videogame" interventions can improve health behaviors. They meet adolescents "where they are," and compared to standard interventions, they can reach large populations, with consistent fidelity, place limited demands on personnel/resources, and facilitate rapid sustainable distribution, all at a potentially lower cost.

This study harnessed the power of videogame interventions and incorporated components of effective substance use prevention programs to develop an evidence-informed intervention to prevent the initiation of opioid misuse in adolescents. Building on our experience developing videogame interventions and in partnership with the national School-Based Health Alliance (SBHA), we developed and tested a new videogame intervention, PlaySmart.

PlaySmart was built upon our PlayForward videogame intervention platform that has demonstrated efficacy in improving attitudes and knowledge related to risk behaviors. Through rigorous formative work and with input from adolescents, and our SBHA and game development partners, we created the PlaySmart videogame intervention.

PlaySmart is designed to provide players with behavioral skills and knowledge through repetitive and engaging videogame play to target adolescent perception of risk of harm from initiating opioid misuse.

The gap in the research on preventing initiation of opioid misuse in youth and in implementing prevention programs with good fidelity needs to be urgently addressed given the high prevalence of adolescent opioid misuse and overdose. This research has the potential to create a videogame intervention to prevent initiation of opioid misuse with far-reaching and sustained impact on adolescents.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent participants must attend high school that has a school-based health center, to participate in pilot testing

Exclusion Criteria:

* Failure to meet Inclusion Criteria
Influence of Trabeculectomy and Phaco-trabeculectomy on Corneal Astigmatism

This study investigates the effects of trabeculectomy and combined phacoemulsification plus trabeculectomy on corneal astigmatism.

Prospectively, consecutive patients at the University Hospital of Zurich undergoing either trabeculectomy (trab) or phaco-trabeculectomy (phaco-trab) are included in this study between January and December 2017. The study interventions takes place 6 months after surgery and include examination of refraction, biometry and corneal topography in order to assess the patient's astigmatism. The values are compared to the preoperative baseline values, which are available from patient records.

Eligibility Criteria:
Inclusion Criteria:

* Trabeculectomy or Phaco-Trabeculectomy between 01/2017 and 12/2017
* Age ≥18 years

Exclusion Criteria:

* Acute or chronic corneal diseases
Iron Bioavailability of High Surface Area Ferric Phosphate

The primary objective of this study is to compare iron absorption of high surface area ferric phosphate with that of ferrous sulfate and bulk ferric phosphate in a rice-based meal in non-pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Women of reproductive age (18 to 49 years) in Thailand
* BMI \< 23 kg/m2
* Body weight \< 65 kg
* Mildly anaemic to normocythemic (Hb 80-110 g/L)
* Ferritin \< 25 µg/L
* Not pregnant (confirmed by pregnancy test stripe) or lactating
* No inflammation (CRP \< 5 mg/L)
* Having provided written informed consent

Exclusion Criteria:

* Haemoglobinopathies (except heterozygosity for haemoglobin E and alpha-thalassemia 1)
* Coeliac disease or other chronic diseases of malabsorption that could influence iron absorption or metabolism
* Blood donation or significant blood loss due to surgery or accident \< 4 months before start of the study
* Consumption of vitamin or mineral supplements 2 weeks before start of the study
* Regular use of medication (except oral contraceptives), that influences iron absorption
* Chronic inflammatory disease
* Smoking
Bupropion SR Plus Counseling for Smoking Cessation

The purpose of this study was to determine if bupropion plus counseling was more effective than bupropion alone or counseling alone in helping smokers quit smoking.


Eligibility Criteria:
Inclusion Criteria:

* Smoke 10 or more cigarettes per day
* Expired carbon monoxide (CO) level greater than 9 parts per million (ppm)
* Motivated to quit smoking (score of 3 on 4-point self-report scale)
* Willing to fulfill study requirements

Exclusion Criteria:

* Carbon monoxide breath test score below 9 ppm
* Serious psychopathology (bipolar disorder, psychosis)
* Center for Epidemiologic Studies Depression Scale CES-D)score over 16
* Contraindications for use of bupropion
* History of seizure disorder
* History of eating disorder
* Current heavy drinking
* Risk of pregnancy
* Current breastfeeding