cyrilzakka/clinical-trials huggingface dataset:
Photodynamic Therapy With HPPH in Treating Patients With Non-Small Cell Lung Cancer

RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells.

PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have non-small cell lung cancer.

OBJECTIVES:

* Determine the systemic and normal tissue toxicity of photodynamic therapy with HPPH in patients with early stage or centrally obstructing non-small cell lung cancer.
* Determine, preliminarily, the efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study of HPPH.

Patients receive HPPH IV over 1 hour on day 1. Patients undergo laser light therapy via bronchoscopy on day 3.

Cohorts of 3-6 patients receive escalating doses of HPPH until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed for at least 6 months.

PROJECTED ACCRUAL: Approximately 15-17 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed microinvasive or centrally obstructing non-small cell lung cancer

  * Squamous cell carcinoma
  * Adenocarcinoma
  * Large cell carcinoma

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 50-100% OR
* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3

Hepatic:

* Bilirubin no greater than 3.0 mg/dL
* Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)
* SGOT no greater than 3 times ULN
* PT no greater than 1.5 times ULN

Renal:

* Creatinine no greater than 3.0 mg/dL

Pulmonary:

* No severe chronic obstructive pulmonary disease that would preclude study

Other:

* Not pregnant
* Fertile patients must use effective contraception
* No contraindications to bronchoscopy
* No porphyria
* No hypersensitivity to porphyrin or porphyrin-like compounds

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior biologic therapy for lung cancer allowed

Chemotherapy:

* At least 4 weeks since prior chemotherapy
* No concurrent chemotherapy

Endocrine therapy:

* Prior endocrine therapy for lung cancer allowed

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* No concurrent external beam radiotherapy

Surgery:

* No concurrent surgery

Other:

* Prior therapy for lung cancer allowed
Comparison of Quality of Life and Functionnal Resultats After Sigmodectomy Between Diverticulitis and Cancer

The aim of this present study is to compare functional results and quality of life after sigmoidectomy for diverticulitis and sigmoid cancer.

Rectal resection surgery can lead to numerous complications in term of gastrointestinal results with onset of fecal incontinence or in contrast constipation, and in term of genitourinary results with occurrence of dysuria, erectile dysfunction, or vaginal dryness. The low anterior resection syndrome is defined by the occurrence after rectal resection, of gastrointestinal symptoms like fecal incontinence or stool evacuation difficulties, which affect quality of life, despite conservation of anal sphincter. This syndrome is now well known and used in many countries.

However, there is a lack of data concerning gastrointestinal functional results after sigmoid surgery whether it is for cancer or diverticulitis. Some studies highlighted symptoms persistence in many patients after sigmoidectomy. Lately, the LARS score was used after sigmoidectomy for cancer. This study reveals symptoms of low anterior resection syndrome for 41 % of patients. The correlation between rectal resection and sigmoidectomy could be explain by the resection of the upper part of rectum in case of sigmoidectomy.

The issue of genito-urinary disorders after sigmoidectomy are poorly researched. Previous studies demonstrate a higher risk of erectile disorders after pelvic surgery and especially for cancer.

Currently, there is a lack of data on functional results and quality of life for patients who are going into sigmoid surgery, whether for cancer or diverticulitis. The aim of this longitudinal study is to compare digestive functional outcome, genitourinary outcomes and quality of life in patients who undergo sigmoid resection for diverticulitis and cancer.

Eligibility Criteria:
Inclusion Criteria :

* Adults
* Patients who undergo sigmoidectomy with end to end anastomosis for sigmoid cancer and symptomatic diverticulitis
* Preservation of the left colic angle for upper surgical resection
* Lower surgical resection located \< 5cm to the recto-sigmoid junction

Exclusion Criteria :

* Minors
* Adults under guardianship
* Protected persons
* Patients who undergo sigmoidectomy without anastomosis (ileostomy or Hartmann surgery)
* Patients who undergo surgery in emergency
* Cancer of recto-sigmoid junction
* Patients who undergo secondarily a stoma
Peripheral Venous Catheter and Masking Tape

urpose: This study will be carried out to determine the effect of two different catheter covers on the comfort, satisfaction, pain level of the patient and the satisfaction of the nurse.

Materials and Methods: This study, which is planned as an open-label randomized controlled post-test study, will be carried out between December 2021 and February 2022. Data; Descriptive Properties will be collected with the Information Form and Visual Analog Scale (Visual Analog Scale-VAS). Data will be collected face to face by researchers.

Peripheral venous catheter (PVK) is applied to patients who apply to the hospital due to outpatient chemotherapy and need to receive treatment by intravenous route. This application is carried out by nurses. During their education, nurses receive theoretical and practical training on PVC applications. Nurses; They are the primary health professionals who are responsible for determining the PVC site, deciding on the catheter number to be used, applying the correct technique, performing the recommended intravenous (IV) interventions, following the complications that may develop by performing the necessary controls, ensuring the continuity of the application and providing catheter care.

The effective application of interventions such as transfusion of intravenous fluids, chemotherapy drugs, blood and blood products, and total parenteral feeding in cancer patients is provided by PVK. The application of PVC is a necessity for the treatment of the individual receiving treatment and may cause pain, deterioration in comfort and dissatisfaction. Although the widespread use of peripheral venous catheters provides great benefits, it has been reported that undesirable events such as phlebitis, infiltration, obstruction, leakage, and rarely infection occur when applied incorrectly and inadequately. In order for peripheral venous catheters to be used effectively in treatment, it is important to fix them with the correct technique. Detection becomes more important in the use of chemotherapy agents. The patches used for fixation adhere to the glove and are difficult to remove from the patient's skin. Therefore, both the nurse and the patient feel discomfort. For this reason, it would be appropriate to use a material that can be easily torn off with a glove, does not adhere to the glove, and fixes the patient's catheter well. This product should also be able to be easily removed without harming the patient's skin.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Being open to communication and cooperation
* Being conscious and able to answer questions
* Volunteering for research
* Being receiving chemotherapy treatment with a peripheral venous catheter

Exclusion Criteria:

* Having a disease that may affect the ability to make decisions (dementia, psychological disorders, etc.)
* Having sensory losses such as vision and hearing
* Being in terminal period
Personalized Mobile Phone Video Recording to Improve Inhaler Techniques in Asthma Patients.

To investigate the effectiveness of addition of recording video of the patient performing inhaler techniques using mobile phone for discussion with the patient, to standard care inhaler education compared to standard care inhaler education alone, in improving inhaler technique of asthma patients.

This is a single-centre, randomized, controlled, parallel group, assessor-blinded trial to evaluate the effectiveness of Personalized Mobile Phone Video Recording in addition to standard care, compared to standard care alone, in improving inhaler technique among patients with asthma.

Patients are randomised to either Personalized Video Recording with standard clinical practice group (intervention) or to standard clinical practice group (control) in 1:1 ratio.

Subject's inhaler technique assessment is performed by using a standard checklist of steps according to the type of inhaler used by subject.

All inhaler technique assessment and asthma control questionnaire will be administered before the intervention/control treatment by a blinded assessor. Both intervention and control treatment will be administered by the same investigators.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old and above
2. Informed consent
3. Established clinical diagnosis of asthma by patient's treating doctor
4. Prescribed with inhalers (any type) for therapeutic indication for at least 3 months

Exclusion Criteria:

1. Unable to converse/understand Malay or English
2. Not able to perform inhalation on his/her own self
3. Using spacer/valved holding chamber in addition to MDI
4. Not able to comply with study procedures in the opinion of investigators
5. More than two different types of inhaler which require different techniques
Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis

To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[68Ga\]Ga-PSMA-D5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[68Ga\]Ga-PSMA-11.

\[68Ga\]Ga-PSMA-D5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[68Ga\]Ga-PSMA-11 PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 90 years old;
* Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
* Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
* simultaneous \[68Ga\]Ga-PSMA-D5 and \[68Ga\]Ga-PSMA-11 examinations within two weeks;
* Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
* Sign informed consent.

Exclusion Criteria:

* Patients who cannot cooperate with the examination;
* Concurrent malignant tumors;
* Previous alcohol allergy;
* Patients with liver and kidney dysfunction;
* Other circumstances deemed by the investigator to be inappropriate for trial participation.
Navigation Guidance Gestures Carried Out Under CT

The purpose of this study is to assess the contribution of navigation systems recently developed to guide the punction needle.


Eligibility Criteria:
Inclusion Criteria:

* more or equal than 18 years old
* patient affiliated to social security or similarly regime
* patient sent to hospital for drain under CT

Exclusion Criteria:

* Pregnant women and lactating mothers
* Ward of court or under guardianship
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
* Person under legal protection
* Person participating in another clinical study
Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D

This study aims to evaluate the effect of vitamin D3 supplementation on disease activity and quality of life in IBD patients deficient in vitamin D, and also help determine the optimal dose of vitamin D3 for them.

Hypothesis: Supplementation of vitamin D3 in IBD patients with hypovitaminosis D can improve their quality of life and decrease IBD activity.

The incidence of hypovitaminosis D has been reported to be as high as 75% in patients with IBD. However, it is unclear whether low vitamin D levels contribute to the pathogenesis of IBD or are a consequence of IBD. Recent animal data studies suggest that maintenance of the epithelial barrier integrity in the large intestine by vitamin D is important in preventing IBD.

However, more evidence is required to determine the effect of vitamin D3 supplementation in patients with IBD. Furthermore, there is no clear consensus regarding the appropriate dose of vitamin D supplementation in IBD patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis)
* 18 years of age or older
* 25(OH)D levels \<30ng/ml
* willing to give informed written consent

Exclusion Criteria:

* Age \< 18 years
* Women who are pregnant or planning to become pregnant
* Patients already taking vitamin D3 ≥2,000 IU/daily prior to study enrollment
The SAM Project: Science Against Malnutrition Project

The latest data from the World Health Organization (WHO) shows that malnutrition in all its forms affects over 2.5 billion people globally. This condition is constantly increasing and affects the entire population, from childhood to the elderly. Malnutrition in all its forms negatively impacts the quality of life of patients affected and increases the risk of morbidity and mortality, as well as healthcare costs. Considering the complexity and multifactorial nature of malnutrition, the integration of multi-omics data obtained from analyzes with high-throughput technologies such as epigenomics, metagenomics, metabolomics, could benefit the prediction and evaluation of prognosis and/or response to specific treatments; this could pave the way for personalized precision medicine interventions for patients suffering from malnutrition. The SAM study aims to characterize malnutrition through the identification of specific biomarkers of the condition with the aim of developing innovative prevention and treatment programs.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian ethnicity;
* both sexes;
* age between 0 and 85 years;
* affected by malnutrition due to deficiency or excess in association with other patology and sex- and age-matched healthy controls not affected by malnutrition due to deficiency or excess and any pathology
* Written informed consent

Exclusion Criteria:

* Non-Caucasian ethnicity;
* Age \> 85 years.
Ventricular Rate Regularization for Improved Quality of Life in Patients With CHF and AF

Single center investigator initiated sponsored by Guidant Boston Scientific Corp. to evaluate the benefit of ventricular rate regularization (VRR) in patients with congestive heart failure (CHF) and significant atrial fibrillation (AF) burden.


Eligibility Criteria:
Inclusion Criteria:

* Be between 18-85 years old
* Be willing and able to give informed consent
* Patient currently has a CRT-D or ICD with \> 20% atrial fibrillation burden as recorded by defibrillator follow up report or a history of atrial fibrillation prior to implant.
* Patient has the ability to complete a Six minute walk test with the only limiting factors to be fatigue or shortness of breath.

Exclusion Criteria:

* Expected mortality less than 6 months due to non-cardiac causes.
* Pregnant women.
* Creatinine greater than or equal to 2.5 mg/dl.
* Anemia (HCT less than 30)
* COPD causing significant dyspnea
* Orthopedic problems affecting 6 minute walk.
The Effectiveness of a Running-related Injury Prevention Program in Runners

Running is effective in increasing levels of physical activity and promotes a number of beneficial health effects. However, running can lead to running- related injuries (RRI). In theory, such injuries can be avoided with the implementation of prevention programs. But in practice, there is a paucity of prevention programs that are effective in reducing the risk of RRIs. In a previous study, the investigators developed an RRI prevention program using the Intervention Mapping framework. The RRI prevention program was named RunIn3. The present study will evaluate the effectiveness of the RunIn3 RRI prevention program.

Objective: To investigate the effectiveness of an RRI prevention program (i.e., RunIn3).

There will be recruited 530 runners of the state of São Paulo aged 18 years or older. After inclusion, participants will be randomly assigned and allocated in two groups: (1) intervention group, which will be the target of the implementation of the RunIn3 prevention program; and (2) control group, which will receive a minimal intervention (i.e., feedback based on surveillance).


Eligibility Criteria:
* Running experience of at least three months;
* Residents of the state of São Paulo;
* No running-related injury (RRI) at baseline;
* No history of RRI in the past three months.
Effects of the Örebro Prevention Program on Youth Drinking

The Örebro prevention program is a brief (6 x 30 minutes)program administered to parents of 13-16 year old youths in regular parental meetings. The program aims to encourage parents to maintain a restrictive attitude towards youth drinking throughout their children's teenage years, and thereby postpone and reduce youth drinking. A previous quasi-experimental study by the program developers showed a sustained alcohol-specific restrictivity among parents exposed to the program, and also a reduction on drinking measures among the youths of the exposed parents (Koutakis, Stattin \& Kerr, 2008). This study aims to investigate whether these effects are sustained also when the program has gone into wide dissemination in Sweden.


Eligibility Criteria:
Inclusion Criteria: Municipal schools in counties with local ÖPP program presenters, comprising grades 7-9, with at least two 7th grade classes in parallel, and with no previous experience of the Örebro prevention program.

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Exclusion Criteria:

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Use of Axillary Ultrasound to Guide Breast Cancer Management in the Genomic Assay Era

The investigators aimed to determine if axillary ultrasound can reliably distinguish between patients with limited or high nodal burden, so that the patients with limited nodal burden can potentially avoid chemotherapy and instead receive upfront surgery followed by gene assay testing.


Eligibility Criteria:
Inclusion Criteria:

* breast cancer patients with T1-3, HR-positive and HER2-negative disease.
* aged≥ 50 years old
* had axillary ultrasound prior to operation
* axillary lymph node dissection

Exclusion Criteria:

* Patients with neoadjuvant chemotherapy
* bilateral cancers
A Registry for Patients Taking Uptravi

This is a US multi-center, prospective, real world, observational drug registry enrolling patients actively treated with Uptravi. Participating patients will be followed prospectively for a maximum of 18 months from the date of enrollment into the registry.


Eligibility Criteria:
Inclusion Criteria:

* Signed patient informed consent form (ICF).
* Patients ≥ 18 years of age at time of Uptravi initiation, and
* Patients who initiate Uptravi:

  * at enrollment, or
  * less than or equal to 60 days prior to enrollment and have a documented titration regimen (defined as all documented dose changes including, but not limited to: starting dose and dates and highest tolerated dose and dates)

Exclusion Criteria:

* Patients previously exposed to Uptravi treatment during a clinical trial.
* Patients that previously discontinued Uptravi for any reason, prior to study enrollment (discontinuation defined as an interruption of therapy greater than or equal to 30 days).
* Patients enrolled in a blinded clinical trial or in a clinical trial involving an unapproved drug.
Methods for Fertility Preservation: Impact of Vitrification on in Vitro Matured Oocytes

During the last decades, there was an improvement of the cancer treatments of the woman and the teenagers. Therefore higher survival rate is described. However, cancer treatments can alter the reproduction functions and reduce considerably the window of the fertility to the adulthood. Therefore, it is recommended to proceed to a fertility preservation by oocytes vitrification when it is possible. The vitrification is a freezing technique allowing high survival rate and similar results by assisted reproductive technologies compared with the use of fresh oocytes. An innovative method of automated vitrification was recently developed. The usual protocol consist to vitrify mature oocytes. However, this strategy cannot be used for hormone -sensitive cancer or when ovarian stimulation is not possible. In these situations, immature oocytes can be collected. It is also necessary to realize an in vitro maturation step for a use by assisted reproductive technology.

According to the recent data of the literature, it remains unclear whether the vitrification of ovocytes must be performed before or after in vitro maturation (IVM). Therefore the aim of this study is to study the impact on structure and functions of ovocytes when vitrification is performed before or after IVM. The vitrification will be performed by a semi-automatic method which is an innovative method.

To perform this study, investigator will compare three groups. Group 1: immature ovocytes vitrified before IVM; Group 2: immature oocytes vitrified after IVM; Group3: fresh immature oocytes treated by IVM (without vitrification, control group).

The immature oocytes provide from ICSI patients. In routine these oocytes (germinal vesicle) are normally destroyed because they cannot be used for injection. The women will give an informed and written consent. Inclusion criteria are women less 37 years without dysovulation.

The vitrification will be performed with the semi-automatic method (Gavi, Merck). The kinetic and maturation rate will be analysed by time lapse (Primovision, Vitrolife) In the mature oocytes, the actin and tubulin cytoskeleton, the spindle organization and the cortical granules will be studied by immunofluorescence and 3D confocal microscopy. The expression of maternal factors transcription will be analyzed by RT-PCR. The ploidy will be analysed by multiFISH and/or CGH array.

Eligibility Criteria:
Inclusion Criteria:

* ICSI treatment
* Immature oocytes
* Without ovulation pathologies

Exclusion Criteria:

* Polykistic ovarian syndrome
* Endometriosis
* Ovulatory disease