cyrilzakka/clinical-trials huggingface dataset:
Paclitaxel and Cisplatin for Thymic Neoplasm

To assess the efficacy and safety of the regimen in previously untreated, unresectable invasive thymoma or thymic carcinoma


Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed invasive thymoma or thymic carcinoma
* unresectable tumor: by either local invasion, distant metastasis, or recurred (assessed by investigator)
* no previous systemic treatment for invasive thymoma or thymic carcinoma
* at least one measurable lesion by RECIST criteria
* 18 years old or older
* ECOG performance status 0, 1, 2
* adequate lab. findings neutrophil ≥ 1.5 x 10\^9/L platelet ≥ 75 x 10\^9/L hemoglobin ≥ 9.0 g/dL bilirubin ≤ 1.5 x upper normal limit AST, ALT ≤ 2.5 x upper normal limit Alkaline phosphatase ≤ 2.5 x upper normal limit (if liver metastasis, ≤ 5 x upper normal limit) serum creatinine ≤ 1.0 x upper normal limit if serum creatinine \> 1.0 x upper normal limit, creatinine clearance ≥ 60 mL/min
* patient who agree to written, informed consent

Exclusion Criteria:

* other malignancy (exception: non-melanoma skin cancer, cervical carcinoma in situ, cancer without evidence more than 5 years since curative resection)
* active bacterial infection
* history of clinical trial with investigational drug within 30 days
* radiotherapy to thoracic or mediastinal area (other area radiotherapy is permitted)
* pregnant, or lactating women
* patient with organ transplantation
* peripheral neuropathy, grade 2 or greater
* severe, medical condition unstable cardiac disease despite of adequate management myocardial infarction within 6 months active ulcer disease refractory to medication chronic obstructive lung disease requiring admission treatment within 1 year
* uncontrolled seizure, cerebral nervous system disorder, psychiatric problem which decrease treatment compliance
Histopathological Evaluation of the Periodontal Ligament Subjected to Laser Ablation.

Laser Ablation therapy (LA) using an 810nm diode laser and Indocyanine Green (ICG) solution, which efficiently absorbs laser energy and increases the effectiveness of tissue removal. Intracanal heating can potentially cause damage to structures outside the tooth root. The study was to observe possible changes in the periodontal ligament and cementum resulting outside the root using this treatment. Histological and morphological examination of extracted cementum, ligament, and collagen post-exposure showed no difference in these structures vs. non-treated controls.

Laser Ablation therapy (LA) using 810nm diode laser and Indocyanine Green (ICG) solution which efficiently absorbs laser energy and the increased temperature results in an instantaneous flame that chars tissue and microbes. Intracanal heating can potentially cause damage to cementum structure and periodontal tissues. The objective of this study is to observe possible changes in the periodontal ligament and cementum resulting from the use of LA with ICG as an adjuvant therapy to endodontic treatment. Ten patients with lower incisors requiring extraction will be selected. Before extraction, chemical-mechanical root canal preparation will be carried out with a single file reciprocating system (35/04) and 2.5% sodium hypochlorite solution. Then, the canals will be dried and filled with 0.05% ICG, which will remain in place for 1 minute (pre-irradiation time). For the test group, a #20 laser fiber will be inserted into the root canal to the working length. The 810 nm wavelength infrared diode laser is activated with a power of 2.5W, an interval of 300 ms, and a duration of 100 ms. After activation commences, circular movements are made for a period of 30 seconds together with the fiber removal movement. After the first activation, there is a 30-second pause and a new 30-second activation cycle will then be performed in the same way as the previous one. After treatment, the tooth element will be extracted and the apical third of the root with the periodontal ligament is processed for histological analysis using hematoxylin-eosin and picrosirius red staining to evaluate the morphological structures. Two teeth extracted without treatment will be used as controls.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Requiring at a least one mandibular incisor to be extracted.

Exclusion Criteria:

* Evidence of periodontal disease anywhere in the mouth beyond the apical third of any tooth.
* Mandibular canines that do not require extraction.
* Presence of other dental or oral conditions of any type that require immediate intervention.
Tackling Intrusive Traumatic Memories After Childbirth

This single-blind waitlist randomized controlled trial aims to investigate the efficacy of a single-session behavioral intervention composed of a brief evocation of the childbirth memory followed by a visuospatial task (the computer game "Tetris"), on childbirth-related intrusive traumatic memories (CB-ITM) and other childbirth-related posttraumatic stress disorder (CB-PTSD) symptoms. Women who report CB-ITM after 6 weeks postpartum can be included in the study. Participants will be randomly allocated to either the immediate treatment (IT) group or to the waitlist (WL) group.

Women in the IT group will first report their CB-ITM in a daily diary during 2 weeks (diary 1). On the 15th day, they will meet a psychologist to receive the single-session behavioral intervention. They will then complete a daily diary during the 2 weeks post-intervention (diary 2) and during the 5th and 6th weeks post-intervention (diary 3).

Women in the WL group will report their CB-ITM continuously during 4 weeks in diary 1 and 2 before receiving the same intervention on the 30th day. They will also complete a last diary during the 2 weeks post-intervention (diary 3).

It is expected that women in the immediate treatment group (IT group) will have fewer CB-ITM in diary 2, in comparison to the WL group, for which we expect no significant change in the number of CB-ITM between diary 1 and 2.

This study will contribute to the development of a single-session behavioral intervention to reduce CB-ITMs and other CB-PTSD symptoms, which would reduce the distress experienced by mothers and may improve the well-being of the whole family.


Eligibility Criteria:
Inclusion Criteria:

* Signed written consent
* Gave birth in one of the study centres
* Gave birth to a live baby
* Had at least 4 CB-ITM over the past two weeks
* Childbirth happened at least 6 weeks ago

Exclusion Criteria:

* Is not fluent enough in French to participate in the assessments
* Life-threatening illness of mother or infant
* Has an established intellectual disability or a psychotic illness
* Takes propranolol medication
* Alcohol and/or illicit drug abuse
* Is not able to distinguish ITM linked to other traumatic events from CB-ITM targeted during the intervention
* Has an ongoing psychological treatment in relation to her childbirth experience
* Is under 18 years old
The Clinical Application and Popularization of Portable Home Noninvasive Ventilator

The subjects of this study are the chronic obstructive pulmonary disease (COPD) patients with chronic II respiratory failure. The participants will be divided into two groups: The Portable Home Noninvasive Ventilator treatment group and the routine home oxygen inhalation treatment group. All subjects will be given a stable COPD regimen and conventional oxygen therapy ,but the portable home noninvasive ventilator treatment group will need to wear a portable non-invasive ventilator. Objective evaluation indexes were established during the routine treatment, and two groups of subjects will be followed up for one year. Finally, the clinical data of all subjects will be analyzed，and then the practicability of portable wearable household noninvasive ventilator will be verified.The researchers will also build a remote breathing data-monitoring platform based on mobile internet,and a community home demonstration application point.


Eligibility Criteria:
Inclusion Criteria:

* 40 years old \< age \< 80 years old
* COPD diagnosis was made according to GOLD guidelines
* The subjects with chronic type II respiratory failure
* The subjects with structural lung disease
* The subjects signed informed consent.

Exclusion Criteria:

* The subjects suffering from COPD acute exacerbation
* The subjects currently participating in other related products
* The subjects with organ dysfunction because of liver,kidney, hematopoietic system and serious metabolic disease endocrine system
* The subjects with poor compliance
* The subjects refused to sign the informed consent
Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks

A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Viable, Singleton pregnancy
* Voluntarily seeking abortion between 19 and 24wks gestation
* Able to give informed consent and comply with study protocol
* Fluent in English or Spanish

Exclusion Criteria:

* Allergy to misoprostol or mifepristone
Laparoscopic Ventral Mesh Rectopexy Versus Delorme's Operation in Management of Complete Rectal Prolapse

A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications

A comparative randomized study between laparoscopic ventral mesh Rectopexy and Delorme's procedure in treatment of complete rectal prolapse to ass both efficacy and complications.

Follow up is scheduled for 18 months to evaluate recurrence, continence state and complications

Eligibility Criteria:
Inclusion Criteria:

* patients with complete rectal prolapse

Exclusion Criteria:

* patients who underwent previous surgery for complete rectal prolapse
* patients unfit for surgery
* patients with associated colorectal diseases or pathology
Evaluating Quality of Life for Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Lung Transplantation

Most people undergoing lung transplantation have chronic obstructive pulmonary disease (COPD), a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. This study will enroll people with COPD who are undergoing a lung transplant to examine how their quality of life changes after the transplant procedure.

Lung transplantation is one treatment option for people with end-stage lung disease. The majority of people undergoing a lung transplant have COPD, and while transplantation can potentially improve survival and quality of life, it may also carry substantial risks, including surgical complications, infections, and pneumonia. The impact of lung transplantation on survival and quality of life has not been extensively studied. In the United States, the United Network for Organ Sharing (UNOS) is the organization that allocates donor lungs to lung recipients. Before 2005, the length of time that a candidate had been on the transplant waiting list was the major determining factor for receiving a donor lung. In mid 2005, the UNOS system changed and began prioritizing candidates on the basis of risk of death prior to lung transplantation and the probability of death within the first year after transplantation. The purpose of this study is to evaluate quality of life factors for lung transplant patients with COPD, both before and after the lung transplant procedure. In addition, quality of life of patients in the new UNOS allocation system will be compared with that of patients in the old UNOS allocation system.

This study will enroll all COPD patients undergoing an evaluation for lung transplantation at the Washington University Medical Center and Barnes-Jewish Hospital in St. Louis, Missouri. Participants will attend study visits at the time of the transplant evaluation and again just prior to listing in the UNOS system. After the transplant, participants will attend study visits at Months 3 and 6 and then once a year for 5 years. During each study visit, participants will complete a computerized interview and health-related questionnaires that will assess quality of life factors, including social life, work life, and home life. Study researchers will also review participants' medical records to collect information on lung function and blood test results.

Eligibility Criteria:
Inclusion Criteria:

* Referred to the adult lung transplant program
* Undergoing evaluation for lung transplantation
* Very severe COPD (Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] class IV) that is predominantly due to emphysema
* Able to read English
* Able to adequately see a computer screen

Exclusion Criteria:

* Diagnosis other than COPD
* Inability to read English
Safety and Efficacy of SPD503 in Treating Attention-Deficit/Hyperactivity Disorder (ADHD) in Children Aged 6-17

The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged 6-17


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a primary diagnosis of ADHD
* Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

Exclusion Criteria:

* Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD) with significant symptoms
* History of seizure during the last 2 years
* Subject has any specific cardiac condition or family history of significant cardiac condition
* Subject is pregnant or lactating
A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer

The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.


Eligibility Criteria:
Inclusion Criteria:

Dose Escalation:

Have histologically confirmed, locally advanced, and unresectable cancer, or metastatic cancer and have progressed on or were intolerant to standard treatments or refused standard of care (SOC).

Dose Expansion:

Have documented histologically or cytologically confirmed adenocarcinoma of the prostate with documented PTEN loss or loss of function mutation, who have metastatic castration-resistant disease and have:

* Disease progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3)/modified RECIST 1.1 after the most recent regimen.
* Received androgen receptor directed therapy previously with or without chemotherapy consisting of no more than 2 prior taxane-based regimens.
* Been receiving androgen deprivation therapy with serum testosterone \<50 ng/dL (\<2.0 nM). Note: previously documented PTEN loss or loss of function mutation from archived tissue sample testing or cfDNA sample testing is acceptable if done in a CLIA certified lab or a locally certified lab.

Have an ECOG score of 0 or 1 Dose Escalation (Part 1): Have no measurable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Dose Expansion (Part 2): Have measurable or no measurable disease per PCWG3/modified RECIST 1.1

• No more than 30 patients with no measurable disease will be enrolled in Dose Expansion (Part 2).

Exclusion Criteria:

* Participating in medical research not compatible with this study
* Have not discontinued or recovered from previous treatments for cancer
* Have a significant cardiac condition
* Have untreated brain metastases
* Have a primary brain tumor
* Have a serious concomitant disorder
* Unable to swallow or digest pills
* Poorly controlled diabetes
* Concomitant medications or substances that are strong inhibitors/inducers of CYP3A.Study
The Use of Iron Therapy for Patients With Anemia After Caesarean Section

The purpose of this study is to determine whether oral or intravenous iron is effective in the treatment of anaemia (iron-poor blood) after caesarean section.

Anemia after caesarean section is often treated with iron therapy to ensure that the hemoglobin will return to normal more rapidly. Scientific evidence for this action is limited. Several studies, in which iron therapy was given after orthopaedic or cardiac surgery, show that after 6 to 10 weeks the hemoglobin was not significantly different between patients treated with oral preparations and patients treated with a placebo. These studies have not examined the hemoglobin level during the first few weeks after surgery including the quality of life analysis.

The purpose of this double blind randomized controlled trial therefore is to examine the effect of both oral iron therapy and intravenous iron therapy on hemoglobin level and on the quality of life during the first few weeks postcaesarean in patients with a moderate anemia.

Eligibility Criteria:
Inclusion Criteria:

* Gynecological surgery
* Hb 5-7 mmol/L

Exclusion Criteria:

* Pregnancy
* Oncological operations
* Infections (PID)
* Diagnostic procedures: level 1 laparoscopies (diagnostic, sterilization, tubal testing; Hysteroscopies
* Smaller therapeutic procedures: large loop excision of transformation zone (LLETZ), Conization,
* Small vulvar / vaginal operations such as (cysts, labia correction)
* Endometrial ablation
* Legal incapacity
* The patient has used pre-operatively an iron preparation and / or blood transfusion or during the surgery
* Hematologic disorders
* Erythropoiesis-stimulating agents \&lt; 3months ago
* Myelosuppressive therapy in history
* Hepatitis
* HIV
* Alcohol abuses
* Not understanding Dutch
* Allergic reaction to iron therapy in past
Predictors of Adherence to Orencia

The purpose of this study is to examine the relationship between loading dose and adherence to Orencia.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be identified based on the presence of first infusion claim during study period for Orencia
* At least 1 medical or facility claim for rheumatoid arthritis at the time of or 6 months prior to index date
* Patients are required to be continuously enrolled for a minimum pre-index and follow-up period as detailed below
* Patients with a minimum of 3 infusion claims for Orencia
* Only those patients will be included whose first 3 infusion claims occur within 84 days

Exclusion Criteria:

* Patients less than 18 years of age at index date.
* One or more diagnoses of regional enteritis (including Crohn's disease), ulcerative colitis, anal or intestinal fistula, ankylosing spondylitis or other inflammatory spondylopathy, psoriatic arthropathy, or psoriasis any time during the 6-month pre-index period
* Patients who switch between biologics within their first three infusion claims
* Restarts, defined as those patients who go back on Orencia after a gap of 42 days
* Patients who are on other biologics at the same time as Orencia
The Effect of a Single Intravitreal Anti-VEGF Therapy on Optic Nerve Head Perfusion

Age related macula degeneration is one of the most common sight threatening diseases of the elderly. The so called wet form of AMD is caused by choroidal neovascularisation (CNV) of pathological vessels, which lead to leakage, bleeding and macular edema. Several lines of evidence suggest that vascular endothelial growth factor (VEGF) plays a key role in the induction CNV. Recent evidence indicates that overexpression of VEGF in the retinal pigment epithelium may lead to the development of CNV in experimental models, and intravitreal injection of a VEGF blocker prevents the development of experimental CNV. This hypothesis is also supported by the promising effects of anti-VEGF treatment in patients with choroidal neovascularisation. The substances currently in clinical use include ranibizumab (Lucentis®), bevacizumab (Avastin®) and pegaptanib (Macugen®).

However, from a physiological point of view, VEGF also serves as a survival factor for existing vessels and for neuronal cells. Moreover, it has been reported that VEGF induces vasodilatation, most probably by an increased production of nitric oxide. Accordingly one may hypothesize that anti-VEGF treatment is associated with ocular vasoconstriction with unknown long term results. Thus, in the current study, the investigators set out to investigate whether the ocular perfusion is affected by a single intravitreal anti-VEGF.


Eligibility Criteria:
Inclusion Criteria:

* 40 subjects ≥ 50 years of age
* Subjects with all angiographic subtypes of neovascular wet AMD, already scheduled for intravitreal anti-VEGF therapy in one eye
* Good central or eccentric fixation

Exclusion Criteria:

* History or previous Anti-VEGF therapy
* History or previous intravitreal injection with any drug
* Intraocular pressure ≥ 25
* Glaucoma
* History or presence of thromboembolic events
* Diabetes mellitus
* Blood donation during the previous 3 weeks
* Ametropy ≥ 6 dpt
Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC)

This is a randomized, double-blind, placebo controlled multicenter study.

A total of 700 patients will be included.

The study will include patients with primary sclerosing cholangitis (PSC) for daily intake of 40 mg simvastatin/placebo for 5 years. The aim is to study effect of prognosis of PSC by long term intake of simvastatin. Outcome measures are death, liver transplantation, cholangiocarcinoma or bleeding from esophageal varices.

Subjects will be randomized (1:1) between Simvastatin and placebo.


Eligibility Criteria:
Inclusion Criteria:

* PSC verified by cholangiography or liver biopsy, with or without irritable bowel disease (IBD).
* Men and women between ≥18 years and ≤75 years.
* Written informed consent.
* A magnetic resonance imaging (MRI) or Magnetic resonance cholangiopancreatography (MRCP) performed within 4 months prior to randomization.
* Colonoscopy performed within 24 months prior to randomization, if known IBD.
* For women of childbearing potential efficient contraceptive.

Exclusion Criteria:

* Subjects on waiting list for transplantation
* Transplanted subjects
* Previous variceal bleeding
* Previous hepatobiliary malignancy
* Subjects with secondary sclerosing cholangitis
* Intake of any type of statins within 3 months prior to randmization
* Known intolerance to simvastatin.
* Pregnancy or breastfeeding.