cyrilzakka/clinical-trials huggingface dataset:
Trial Protocol GlobiFer - Oral Iron Repletion

The haemoglobin level of the patients with iron deficiency should be increased clinical relevant after 12 weeks treatment with GlobiFer Forte.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 ≤ 60 years of age
2. Signed written informed consent
3. Hb ≥ 8 ≤ 10g/dl for
4. Female

Exclusion Criteria:

1. History of acquired iron overload, known haemochromatosis or first relatives with haemochromatosis, and allergic disorders (asthma, eczema, and anaphylactic reactions).
2. Known hypersensitivity to oral iron preparations.
3. Diseases, which an iron supplementation is not allowed or contraindicated.
4. Patients on current oral or intravenous iron supplementation
5. History of erythropoietin therapy in previous 30 days or scheduled for erythropoietin therapy or blood transfusion during duration of the study.
6. Patients who have had iron supplementation within the last 30 days.
7. Other reasons which in the investigator's judgment argue against inclusion of the patient into the trial.
8. Inability to comprehend study protocol
9. Participation in another clinical trial (currently or within the last 30 days)
Randomized Trial of Glutathione with Anti-PD-1 and Chemotherapy in Advanced NSCLC

Chemotherapeutic agents exert significant immunomodulatory effects by influencing tumor-infiltrating immune cells. However, the sequence and combination of chemotherapy regimens differentially modulate immune cell dynamics, ultimately impacting treatment efficacy and patient survival. Glutathione, a critical bioactive molecule, demonstrates broad potential in tumor immunotherapy. Through mechanisms such as scavenging free radicals, modulating immune cell proliferation and differentiation, and regulating cytokine expression, glutathione achieves precise modulation of immune responses to enhance immune system functionality. To investigate whether glutathione can enhance the clinical efficacy of current chemo-immunotherapy regimens in non-small cell lung cancer (NSCLC), investigators conducted this clinical study.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of lung squamous cell carcinoma or adenocarcinoma.
2. Documented disease progression following first-line chemotherapy or chemo-immunotherapy.
3. Age ≥18 years at the time of enrollment.

Exclusion Criteria:

1. Patients with small cell lung cancer or other histological subtypes of lung cancer.
2. Patients lost to follow-up, who discontinued treatment, or died within one year of diagnosis.
3. Pregnant or lactating women
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Defibrillator Patients

The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.


Eligibility Criteria:
Inclusion Criteria:

* Have an approved indication per ACC/AHA/HRS guidelines for implantation of heart failure or life-threatening ventricular tachyarrhythmias and will be implanted with a St. Jude Medical SJ4 system.
* Have the ability to provide informed consent for study participating and be willing and able to comply with the prescribed follow-up test and schedule of evaluations.

Exclusion Criteria:

* Be currently participating in a clinical investigation that includes an active treatment arm.
* Have a life expectancy of less than 6 months due to any condition.
* Be less than 18 years of age.
NYU Ovarian Cancer Early Detection Program Blood and Genetics

Improving current strategies for detection of early stage disease can impact favorably on long-term survival of women with ovarian cancer. To reduce the morbidity and mortality of ovarian cancer, screening for this disease must detect early stage disease rather than advanced stage disease. Thus the challenge for the future is to identify and develop highly sensitive and specific tumor markers that can be applied to population-based screening for the early detection of ovarian cancer.

The aim of NYU Ovarian Cancer Early Detection Program is to establish an effective, early detection program employing state-of-the-art science and technology in collaboration with other nationally recognized clinicians and scientists.

This proposed research study will foster collaboration between clinicians and scientists that will facilitate the rapid identification of a set of molecular, biochemical, functional, and genetic markers which can be employed to effectively detect and manage ovarian cancer and other gynecological malignancies.

Eligibility Criteria:
Inclusion Criteria:

Women enrolled in the NYU Ovarian Cancer Early Detection Program have at least one of the following risk factors:

* A personal history of breast cancer
* One or more first degree relatives (mother, sister, daughter) with ovarian cancer
* Multiple family members with either breast and/or ovarian cancer
* A personal history of a positive BRCA1 or BRCA2 genetic test result
* A close relative with a positive BRCA1 or BRCA2 genetic test result
* A personal history of colon or endometrial cancer with at least two relatives with a Lynch/HNPCC-associated cancer (colorectal, endometrial, small bowel, ureter, or renal pelvis cancer)
* Synchronous or metachronous endometrial and colorectal cancer
* A personal history of a mismatch repair gene mutation (MLH1, MSH2, MSH6 or PMS2)
* A close relative with a mismatch repair gene mutation (MLH1, MSH2, MSH6 or PMS2)
* A personal history of colorectal or endometrial cancer with a mismatch repair defect (ie. Microsatellite instability (MSI) or immunohistochemical loss of expression of MLH1, MSH2, MSH6, or PMS2)
* The use of fertility drugs for more than one year
The TARGET BP OFF-MED Trial

To obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in hypertensive subjects in the absence of antihypertensive medications.


Eligibility Criteria:
Inclusion Criteria:

1. Has 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥140 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg.
2. Subject is willing to discontinue any current antihypertensive medications during the run-in period and the post-treatment period.
3. Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings

Exclusion Criteria:

1. Subject has renal artery anatomy abnormalities.
2. Subject has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy.
3. Subject has documented sleep apnea.
4. Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association \[NYHA\] Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (\>60 mmHg pulmonary artery or right ventricular systolic pressure).
5. Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
6. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed.
7. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.
Simvastatin for Treating Erectile Dysfunction

This is a randomized clinical trial, double-blind, placebo controlled, to verify if simvastatin can improve erectile dysfunction in men with endothelial dysfunction, without any cardiac disease.It is hypothesized that the simvastatin can improve the endothelial function, improving the nitric oxide liberation in corpora cavernosa of the penis, resulting in improvement of erection.


Eligibility Criteria:
Inclusion Criteria:

* Erectile dysfunction
* Elevated C reactive protein
* Able to adhere the protocol

Exclusion Criteria:

* Diabetes mellitus
* Cardiac disease
* Cerebral vascular disease
* Hypogonadism
* Any contraindication to simvastatin
Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures

The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction.

Cholangiocarcinoma accounts for 3% of all gastrointestinal cancers and is the second commonest primary liver cancer. However only a few patients are suitable for surgical resection and therefore endoscopic biliary drainage is the most used palliative treatment modality for malignant hilar stricture. However, whether one or two stents can benefit the patients most is still to be defined. Numerous retrospective case series reached different conclusion, till now, only one randomized trial compared the effect of unilateral versus bilateral stenting in patients with malignant hilar obstruction, nonetheless, nearly one third of the patients had Bismuth Type I stricture, and one stent is enough for drainage in this situation, therefore, the best drainage strategy for patients with Bismuth Type II or Bismuth Type III malignant hilar obstruction is unknown. The aim of the present study was to compare the effect of unilateral versus bilateral stenting in patients with Bismuth Type II or III malignant hilar obstruction.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive untreated patients with biliary obstruction (Bismuth type II, III) at the hilum due to primary cholangiocarcinoma, gallbladder cancer, or periportal lymph node metastases. Diagnosis is based on US, CT, and MRCP.
* Histologic or cytologic confirmation of malignancy is established by percutaneous biopsy (US- or CT-guided) or by endoscopic tissue sampling, endoscopic brushing. Or the diagnosis is based on typical features on imaging and the expected clinical outcome during follow-up.
* All patients were considered unsuitable for resection on the basis of general medical condition and/or tumor extent.
* Full and informed consent is obtained.

Exclusion Criteria:

* Refuse to participate in this study.
* Refuse to provide informed consent.
* Refuse to be placed with plastic stents.
* Physically unfit for endoscopic treatment.
Clinical Characteristics, Management Patterns and Outcomes of Type A Aortic Dissection: A Sino-US Comparative Cohort Analysis

This study constructed a retrospective cohort study by retrospectively analyzing the data of all patients with aortic dissection from January 1, 2012 to December 31, 2021 from the Cardiovascular Disease Registration System of Jiangsu Province in China and the data of similar diseases in recent years from National Inpatient Sample database in the United States


Eligibility Criteria:
Inclusion Criteria:

1.Clinical diagnosis of type A Aortic Dissection

Exclusion Criteria:

1. age\<18, age unknown,
2. diagnosis of aortic aneurysm, transfer out within 1 day,
3. unknown vital status at discharge;
4. unknown treatment type: cardioplegia, valve or cardiac repair only without aortic repair or two types of treatments on different days
Food Intake and IgA Microbiota in Anorexia Nervosa

Anorexia nervosa is characterized by intestinal dysbiosis, related to the feeding behavior impairment presented by these patients. Pathophysiologic hypotheses are involving the trouble of the microbiota-gut-brain axis in the field of mental diseases.

Anorexia nervosa is characterized by intestinal dysbiosis, related to the feeding behavior impairment presented by these patients. Here we aim to characterize the IgA-coated fraction of bacteria from the intestinal microbiota, linked to the regulation of the mucosal immune system and the epithelium physiology. Abnormalities of this microbiota are reported in inflammatory bowel disease and are associated to immune trouble. As food intake plays a key role in shaping microbiota, we aim to correlate data from IgA microbiota to food intake specificity, and to anorexia nervosa phenotypes.

Eligibility Criteria:
Inclusion Criteria:

* female subject, adult, affiliated to a social security system, under the care of the eating disorder department of university hospital of st Etienne
* presenting a diagnosis of pure restrictive anorexia nervosa.

For acute subgroup : BMI between 11 and 17.5 kg/m2, patient with a first episode of restrictive anorexia nervosa or with hyperphagic episodes.

For the chronic subgroup: BMI between 11 and 17.5 kg/m2, disease evolving for more than 5 years.

For Healthy volunteer: BMI between 20 and 24 kg/m², stable weight for the last 3 months, no eating disorder or history of eating disorder

Exclusion Criteria:

* patient does not understand French.
* laxative treatment in progress or stopped for less than 15 days,
* antibiotic treatment in the two months preceding inclusion,
* pre-pro or symbiotic treatment in progress or in the month preceding inclusion,
* patient with one of the following comorbid disorders: celiac disease, chronic inflammatory bowel disease, lactose intolerance, unstabilized hyperthyroidism, unstabilized diabetes,
* subject under legal protective measures.
Dehydroepiandrosterone (DHEA) + Acolbifene Against Vasomotor Symptoms (Hot Flushes) in Postmenopausal Women

The purpose of this Phase III trial is to evaluate the efficacy of oral administration of dehydroepiandrosterone (DHEA) combined with acolbifene (a selective estrogen receptor modulator (SERM)) on vasomotor symptoms (hot flushes) in postmenopausal women.


Eligibility Criteria:
Main Inclusion Criteria:

* Postmenopausal women (non-hysterectomized or hysterectomized).
* Women between 40 and 75 years of age.
* Willing to participate in the study and sign an informed consent.
* Women having many moderate to severe hot flushes.
* For non-hysterectomized women, willing to have an endometrial biopsy at baseline and end of-study.

Main Exclusion Criteria:

* Undiagnosed abnormal genital bleeding.
* Hypertension equal to or above 140/90 mm Hg.
* The administration of any investigational drug within 30 days of screening visit.
* Endometrial hyperplasia (simple or complex hyperplasia with or without atypia), cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.
Affective Bonding in Mothers and Their Premature Newborn

This experimental study will determine the effectiveness of nursing intervention "the attachment promotion" to increase the affective bonds between mothers and their premature infants. The assignment of the mothers to the control group will receive usual care, the mothers will be assigned to intervention group will receive the intervention.

The premature newborn has a high need for positive interactions, which is a challenge for him, due to biological immaturity, and for his mother because of the level of stress that this situation generates. Behavioral and developmental interventions are needed to address the unique behaviors of preterm infants and the interactive capacities of the mother-newborn premature dyad. The project will be conducted in 18 months. The assignment of the mothers to each group will be like that: First at all, mother will be assignment to control group. They will received usual care when achieve the total of 74 mothers, the mothers will be assigned to intervention group.

Eligibility Criteria:
Inclusion Criteria:

Premature Infant:

* Neonates who had been hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks gestation at birth.
* Apgar to the minute and five minutes greater to 7/10

Mother:

* Mother with nursing diagnosis: Risk of impaired attachment.
* Mother with a neonate who had hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks of gestation at birth
* Mother living in the metropolitan perimeter of the city of Bucaramanga

Exclusion Criteria:

Newborn:

* Infants that underwent surgery
* Infants with neurological injury.
* Congenital cardiac abnormalities, severe deformities, grade III intraventricular hemorrhage.

Mother:

* Mother with limitations: hearing, motor and / or mental handicap-measured through the Abbreviated Mental Test (minimental), that prevent the intervention.
* Mother consuming psychoactive substances.
* With mental alterations, verified in the medical history.
Investigation of Physical Impairments in Young Adults

Physical inactivity is widespread among young adults due to different disasters like the COVID-19 and earthquakes. On the other hand, it is unknown how physical activity level affects cough strength and balance in young adults. In current study, it was aimed to investigate both cough strength, physical activity and balance status in young adults and the relationship between these parameters.

Participation in free time physical activities has various health benefits such as increasing academic success, improving quality of life. Physical inactivity in university students has been triggered by disasters such as COVID-19 and earthquakes that we have experienced. However, it is not yet known how physical inactivity and sedentary life affect cough strength and balance in these healthy young people. Thus, this study aimed to explore the cough strength, physical activity and balance status and the correlations between these parameters in young adults.

Eligibility Criteria:
Inclusion Criteria:

* being 18 years or older,
* volunteering to participate in the study
* understanding and answering the questionnaire

Exclusion Criteria:

* having any physical or mental disability/disease and/or cognitive impairment that would prevent physical activities
* being pregnant.
Amevive Wisdom Acquired From Real-Time Evidence (A.W.A.R.E™) Program

Purpose:

To develop a real time national clinical database to support and share best practices,

1. To generate hypotheses for future clinical research
2. To understand how AMEVIVE is used in routine clinical practice/real world setting.

Each patient visit will include the following observational endpoints:

1. AMEVIVE dosing
2. Number of courses
3. Concomitant treatment
4. Response to treatment (patient and physician global assessments)
5. Status of other psoriasis-related medical conditions
6. Time to re-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Amevive is clinically indicated for the patient

Exclusion Criteria:

* Amevive is contraindicated for the patient
Measurements of Exhaled Nitric Oxide in Healthy Subjects in Thailand

The purpose of this study is to determine fractional exhaled nitric oxide (FeNO) level in healthy subjects among Thai populations.

Fractional exhaled nitric oxide (FeNO) were produced from epithelial cells of inflammatory airways and eosinophils and this gas was discovered since 1991.

Fractional exhaled nitric oxide (FeNO) has direct association with severity of inflammation of bronchial trees and sputum eosinophils and use for additional investigation for diagnosis asthma or inflammatory airway diseases.

There are many factors from previous studies that associate with level of fractional exhaled nitric oxide (FeNO), one of that factors is race therefore we can't use level from another studies with different race for use as reference and there is no study about level of fractional exhaled nitric oxide in Thai population.

It is therefore desirable to examine level of fractional exhaled nitric oxide (FeNO) in healthy subjects among Thai population and will be the main objective of this research.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects in community

Exclusion Criteria:

* smoker or past history of smoking
* asthma, allergic rhinitis, chronic respiratory disease or other chronic illness
* history of wheezing within 12 months before enrollment
* history of upper or lower respiratory tract infection within 6 weeks before enrollment
* drink ethanol within 48 hours before enrollment
* drink caffeine within day before enrollment
* during pregnancy
* chronic use of any drugs
* participate other project within 30 days
Testing the Effectiveness of a Graphic Novel Health Education Curriculum for Patients With Addiction

This study deploys a strategy to develop and evaluate a training-efficient, multimedia patient-centered Health Education Toolkit to promote shared decision making between counselors and patients. An existing evidence-based toolkit intervention will be adapted and redesigned by a patient and provider team into an engaging, narrative graphic novel curriculum useful in group and individual counseling. The proven behavioral interventions will be augmented with health education material focused on medication assisted treatment (MAT). We will assess feasibility and acceptability, and pilot test whether exposure to the Toolkit (TK) can shared decision making conversations, reduce substance use, and increase engagement with MAT.

An existing evidence-based toolkit intervention will be adapted and redesigned by a patient and provider team into an engaging, narrative graphic novel curriculum useful in group and individual counseling. The proven behavioral interventions will be augmented with health education material focused on medication assisted treatment (MAT) and HIV risk reduction. Together, these materials will comprise the Health Education Toolkit. The Health Education Toolkit (TK) will employ a shared decision making model to encourage 1) increased recovery engagement by patients, and 2) patient engagement in deciding whether to initiate and adhere to MAT. We will conduct a randomized pilot trial of 50 patients with active alcohol substance use disorders (SUDs) enrolled in inpatient or outpatient treatment and will follow them over 3 months. We will test whether patients randomized to receive the TK curriculum will report increased shared decision making conversations, report greater satisfaction and acceptability of their treatment sessions, demonstrate larger reductions in substance use (drug and alcohol) and increases in abstinence, demonstrate improved alcohol severity scores, attend more attendance at specialty substance abuse intervention and treatment sessions, and demonstrate greater rates of initiating MAT for alcohol dependence over the 3-month follow-up period as compared to patients receiving treatment-as-usual (TAU).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Screening score of at least 16 on the AUDIT
* Meets criteria for a DSM-V substance use disorder as assessed via the MINI Plus 5.0.
* Reports at least two heavy drinking episodes in the previous 4 weeks

Exclusion Criteria:

* Reports plans to leave the Philadelphia greater metropolitan area within the next 6 months
* Does not speak English
* Unable to provide valid informed consent
Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding

The study is to evaluate the effectiveness and safety of CELSTAT vs active control.


Eligibility Criteria:
Inclusion Criteria:

Preoperative

1. Subject is undergoing planned cardiothoracic, general or vascular surgery

Intraoperative

1. Mild or moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after standard conventional surgical hemostatic methods prove to be ineffective or impractical.

Exclusion Criteria:

Preoperative

1. Subject needs emergency surgery
2. Subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery
3. Subject will undergo neurological or ophthalmological surgery
4. Subject will undergo urological or gynecological surgery
5. Subject has congenital coagulation disorder
6. Subject is pregnant or lactating at the time of enrollment, or becomes pregnant prior to the planned surgery

Intraoperative:

1. Occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of target bleeding site
2. Disseminated intravascular coagulopathy