cyrilzakka/clinical-trials huggingface dataset:
Phenethyl Isothiocyanate in Preventing Lung Cancer in People Who Smoke

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Phenethyl isothiocyanate may be effective in preventing lung cancer in smokers.

PURPOSE: Phase I trial of phenethyl isothiocyanate in preventing lung cancer in people who smoke.

OBJECTIVES: I. Determine the maximum tolerated dose of oral phenethyl isothiocyanate in smokers. II. Measure the steady state pharmacokinetics of phenethyl isothiocyanate required to maintain a steady state of this substance during the hours of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) exposure in these patients. III. Obtain preliminary data on the perturbation of NNK metabolism by phenethyl isothiocyanate in these patients.

OUTLINE: Patients complete a questionnaire containing a smoking and dietary log to assess cigarette and cruciferous vegetable consumption. Patients receive phenethyl isothiocyanate orally 4 times a day for 30 days. Cohorts of 3-6 patients receive escalating doses of phenethyl isothiocyanate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed on days 35, 36, and 43.

PROJECTED ACCRUAL: A total of 15-27 patients will be accrued for this study over 4-6 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Asymptomatic smokers who either refuse to or cannot stop smoking Urinary cotinine levels greater than 100 ng/mL Willing to adhere to certain dietary restrictions limiting intake of cruciferous vegetables (watercress, broccoli, radishes, mustard, brussels sprouts) while on study

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.6 mg/dL Transaminases less than 2 times normal Renal: Creatinine less than 1.6 mg/dL Urinary RBC levels 0-2 Urinary WBC levels at least 0-2 Pulmonary: No dyspnea at rest Other: No concurrent illness, condition, or symptom that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Not specified
Pragmatic Clinical Trial of Two Recommendations Regarding Alcohol Consumption: a Pilot Study NAMETI_ALCOHOL

NAMETI-Alcohol, from the acronym for Navarra Medical Trialist Initiative, is a pilot study in which two patterns of alcohol consumption, abstention and Mediterranean alcohol-drinking pattern, and their effects on health in the short and medium term will be compared.

Background: Alcohol is the most consumed psychoactive substance in Spain. In 2016 it was the seventh leading risk factor for death and disability-adjusted lost years worldwide, and the first one in people between 15 and 49 years old.In the scientific community there is some controversy about what would be the best approach to face this great problem. On the one hand, there is evidence to recommend that there is no safe level of alcohol. However, on the other hand, there are studies that demonstrate the protective role of a moderate alcohol consumption. In this pilot study both options will be compared.

Methods: It is intended to recruit a total of 100 participants, including two observational cohorts of abstainers and drinkers. The intervention will be carried out in drinkers willing to change their alcohol consumption, divided into 2 groups of 50 participants, the abstention group and the Mediterranean alcohol-drinking pattern group. The Mediterranean alcohol-drinking pattern includes 5 aspects: moderate alcohol consumption (maximum of 1 drinks/day for women and 2 drinks/day for men), spread consumption throughout the week, drink with meals and never with an empty stomach, prefer wine and mainly red wine, as well as completely avoid episodes of binge-drinking. The main objective will be to compare the short and medium term effects on health of both patterns.

Eligibility Criteria:
Inclusion Criteria:

* Consuming more than 3 drinks a week (except for the abstention-control arm)

Exclusion Criteria:

* Sever chronic disease (cancer, cardiovascular disease, chronic hepatitis and mental illness)
* Pregnant women or breastfeeding
* Family or personal history of addiction, alcoholism or alcohol abuse
Personalized Information Before and After Total Knee Arthroplasty: PAK-study

Despite positive results following total knee arthroplasty (TKA), some patients are dissatisfied after recovery. Unfulfilled expectations is a key predictor of dissatisfaction. The aim of this study is to investigate if more patients fulfil or exceed their preoperative expectations one year after TKA when personal feedback on their PROs is given.


Eligibility Criteria:
Inclusion Criteria:

* Planned for primary TKA in Kliniek ViaSana
* Signed informed consent

Exclusion Criteria:

* Aged under 18 years
* Do not possess an own email adress,
* Do not have a thorough command of the Dutch language,
* Previously received contra-lateral primary TKA and/or unicompartmental KA.
Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh

Vaginal prolapse is a common condition that is treated with surgical correction. Recently surgeons have been using mesh to augment the repair of vaginal prolapse. Common complications of this surgery include vaginal pain, pain during sex, infection or erosion of the mesh in the vagina. There are different ways to close the vaginal wall over the mesh used in these procedures. Currently, there is no accepted standard method of closing the vaginal wall. The purpose of this study is to find out the best way to close the surgical wound in the vagina. We will compare interrupted closure (separate stitches) to continuous closure (one long, running stitch). We hope to show in our study that one method of closure is better than the other.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for surgery to correct anterior vaginal prolapse with mesh kit

Exclusion Criteria:

* Pregnant
Trial to Evaluate the Effectiveness of Angular Stable Locking System (ASLS) in Patients With Distal Tibial Fractures

In many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. The play between screw and nail can result in loss of reduction and the instability due to the interfragmentary movement can result in malunions or nonunions. Therefore, an Angular Stable Locking System for Intramedullary Nails (ASLS) was developed to enhance axial and angular fracture stability. ASLS provides angular-stable fixation between nails and screws with resorbable sleeves used as dowels in the nail locking holes. Preliminary results of a pre-study show a trend towards reduced time to pain-free full weight bearing in patients being treated with ASLS. This hypothesis will be tested in the present randomized controlled study.

The primary aim of the present study is to evaluate the effectiveness of the Angular Stable Locking System (ASLS) in patients with distal tibial fractures treated with Expert Tibial Nails (ETN). In many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. The play between screw and nail can result in loss of reduction and the instability due to the interfragmentary movement can result in malunions or nonunions. Therefore, an Angular Stable Locking System for Intramedullary Nails (ASLS) was developed to enhance axial and angular fracture stability. ASLS provides angular-stable fixation between nails and screws with resorbable sleeves used as dowels in the nail locking holes. Preliminary results of a pre-study show a trend towards reduced time to pain-free full weight bearing in patients being treated with ASLS. This hypothesis will be tested in the present randomized controlled study.

Eligibility Criteria:
Inclusion Criteria:

* The patient is ≥ 18 years old
* The patient suffers from an acute distal third tibial fracture classified as:

AO 42 A1-A3, AO 42 B1-B3, AO 42 C1-C3, AO 43 A1-A3

* The fracture is fixed with an Expert Tibia Nail (ETN)
* The patient was able to walk without walking aid prior to the accident
* The patient is able to understand and read local language at elementary level
* The patient is willing and able to give written informed consent to participate in the study according to the CIP

Exclusion Criteria:

* The patient is legally incompetent
* Preexistent malunion or nonunion of the fracture under investigation
* Osteotomies
* The patient suffers from additional fractures of the lower extremities (Exception: ipsilateral fibular fracture)
* The patient suffers from a pathologic fracture
* The patient suffers from active malignancy
* The patient is pregnant, breast feeding or planning to get pregnant during the study period
* The patient suffers from a life-threatening condition
* The patient is affected by drug or alcohol abuse
* The patient has participated in any device related clinical trial affecting the lower extremities within the previous month
* The patient has participated in any drug related clinical trial affecting bone healing within the previous month
Determination of Fraction Size Equivalent Dose (FED) Levels for Intracranial Conformal Avoidance Radiotherapy

The primary objective is to evaluate and quantify the reproducibility of functional magnetic resonance imaging (fMRI) maps of the eloquent brain areas corresponding to specific neurological functions based on activation maps obtained with different thresholds in patients with benign and biopsy proven low-grade brain neoplasms. Another objective is to access the impairment in neurological function in image guided intracranial radiotherapy using neurocognitive assessment tools and to derive dose response curves relating the impairment in a particular neurological function to the FED received by the area of eloquent brain corresponding to it.


Eligibility Criteria:
Inclusion Criteria:

* Indication for brain radiotherapy.
* Ability to undergo MRI scans and time to participate in neurocognitive testing.
Knowledge, Attitude and Perception of Pregnant Women Regarding Medications

The goal of this observational study is to learn about the pregnant women's knowledge, attitude, and perception regarding the use of medications in pregnancy. The main question it aims to answer is:

What is the present knowledge, attitude, and perception of pregnant women regarding medication use?

Participants (pregnant women) already attending the antenatal clinic for routine follow-up will answer survey questions about their knowledge, attitude, and beliefs about medication use and restriction during pregnancy, as well as the source of their information.

This is a descriptive cross-sectional study (survey) that will be held at Ain shams University Maternity Hospital.

The protocol approval will be sought from the ethical committee of department of Obstetrics and Gynecology, Ain Shams University.

• Data collection (the questionnaire): The study will use anonymous questionnaire; based upon previous similar studies.

The questionnaire comprises closed-ended questions categorized into four sections, along with fifth section consisting of statements pertaining to respondents' beliefs:

A. Section A (10 items) will contain information about the participant's socio-demographic and health related characteristics.

B. Section B (7 items) will assess their knowledge about medication use and restriction, during pregnancy.

C. Section C (4 items) will assess their attitude about medication. D. Section D (4 items) will assess the source of their information. E. Section E (9 statements) will assess their beliefs about medications use during pregnancy.

This questionnaire will be presented in its Arabic version and pre-tested on 15 pregnant women to evaluate the construct and content validity, as well as to determine if any modifications to wording are necessary. These participants will not be included in the final analysis.

The questionnaire will be distributed to pregnant women who attend the hospital for their routine antenatal check-up visits. In instances where women are unable to read or write, the principal investigator and attending house officer in the unit will provide assistance in reading and explaining the questions to facilitate the completion of the questionnaire.

* Data will be collected and recorded.
* Statistical analysis will be done accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women attending the Ain shams University Maternity Hospital

Exclusion Criteria:

* Pregnant ladies refusing to participate in study.
* Pregnant ladies needing immediate transport to emergency department.
* Pregnant ladies needing immediate intervention.
CONNEQT Pulse Validation Study

The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard, auscultatory sphygmomanometer in a pregnant population.

Clinical staff will review patient's medical record to determine eligibility. Following informed consent, a brief medical history will be collected. Serial blood pressure measurements will be collected to compare an auscultatory sphygmomanometer to blood pressure measurements of the CONNEQT Pulse blood pressure monitoring system in a pregnant population according to ISO protocol 81060-2.

Eligibility Criteria:
All Groups:

1. Able to provide informed consent
2. Pregnant patient, beyond the first trimester (greater than 12 weeks of gestation)
3. 18 years of age, or older

Normotensive:

1. Systolic blood pressure \<140 mmHg (18,66 kPa) and diastolic blood pressure \<90 mmHg (12 kPa)

Hypertensive:

1. Without proteinuria \>300 mg in 24 h; and
2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12 kPa)

Pre-Eclampsia:

1. With proteinuria \>300 mg in 24 h; and
2. With systolic blood pressure ≥140 mmHg (18,66 kPa) or diastolic blood pressure ≥ 90 mmHg (12,00 kPa)
Multicentric Retrospective Study of Perinatal Mortality

Background: Perinatal mortality ranges mortality from 22 gestational weeks up to the first 7 days of life and extended mortality goes up to 28 days of life. The perinatal mortality rate is the most sensitive index of the health status of women and their offspring and of the quality of maternal and child health services. Per our knowledge, there is no study that evaluates perinatal mortality in Catalonia, although household data are available from each hospital. Moreover, the official records usually do not match with the household surveys due to lack of clarity on the definitions. Aim: the aim of the study is to compare the WHO perinatal mortality classification following the ICD-PM in comparison with the used classification. Methodology: Multicentric retrospective study. Data from Sant Joan de Déu, Maternitat Clinic and Parc Taulí hospitals.


Eligibility Criteria:
Inclusion Criteria:

* stillbirths more than 22 weeks of gestation
* neonatal deaths up to 28 days of life

Exclusion Criteria:

- avortions more than 22 weeks of gestation
Efficacy Study of MCS110 Given With Carboplatin and Gemcitabine in Advanced Triple Negative Breast Cancer (TNBC)

To determine whether MCS110 antibody therapy improves the efficacy of carboplatin and gemcitabine (carbo/gem) in advanced TNBC patients


Eligibility Criteria:
Inclusion Criteria:

* Adult women (≥ 18 years of age) with advanced TNBC.
* Histological or cytological evidence of estrogen-receptor negative (ER-), progesterone receptor negative (PgR-) and human epidermal growth factor-2 receptor negative (HER2-) Breast Cancer by local laboratory testing, based on last available tumor tissue.
* ER/PgR negativity to follow local guidelines
* If IHC HER2 2+, a negative FISH test is required
* A pre-treatment tumor biopsy demonstrating high TAM content as assessed per the central laboratory
* Patients must have:

At least one measurable lesion per RECIST 1.1. (Note: Measurable lesions include lytic or mixed (lytic + blastic) bone lesions, with an identifiable soft tissue component that meets the measurability criteria)

Exclusion Criteria:

* Prior chemotherapy for advanced BC. Previous adjuvant/neoadjuvant chemotherapy is allowed (carboplatin, cisplatin or gemcitabine only if \> 12 months has passed since last administration).
* Therapy for underlying malignancy within 2 weeks prior to start of study treatment:
* Chemotherapy, biologic therapy (antibodies and biologically targeted small molecules)
* Radiotherapy
* Major surgery
* Patients receiving concomitant immunosuppressive agents or chronic corticosteroids (≥10 mg of prednisone or equivalent) at the time of first study dose.
* Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.
* Known history of human immunodeficiency virus or active infection with hepatitis virus or any uncontrolled active systemic infection.
* Patients with the following laboratory values during screening and on Day 1 predose:
* Absolute Neutrophil Count (ANC) \< 1.5x109/L
* Hemoglobin \< 9 g/dL
* Platelets \< 100x109/L
* Serum creatinine \> 1.5 x ULN
* Serum total bilirubin \> 1.5 x ULN
* AST/SGOT and ALT/SGPT \> 3.0 x ULN
Clinical Trial to Investigate the Pharmacokinetics of Second-Line Anti-Tuberculosis Agents

This study aims to investigate the pharmacokinetic characteristics of second-line anti-tuberculosis agents after oral/intramuscular administration in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* healthy male subject aged 20 to 50 at screening
* a body weight in the range of 55 kg (inclusive) to 90 kg (inclusive) with ideal body weight range of 19.0 to 26.0 subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

* subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* subject judged not eligible for study participation by investigator.
Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome

Polycystic ovary syndrome (PCOS) is a common reproductive disease associated with endocrine and metabolic disorders. Some studies have shown that Chinese herbal medicine is beneficial for PCOS, but the efficacy of Chinese herbal medicine in the treatment of PCOS is not clear, because the quantity of pre-clinical data was limited and the quality of clinical evidence was variable. Therefore, this randomized double-blind placebo-controlled trial aim to evaluate the efficacy of Chinese herbal medicine (Bushen Huatan Decoction) in women with PCOS.


Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of PCOS is based on the Rotterdam criteria.
2. Meet the syndrome differentiation standard of kidney-yang deficiency with phlegm-dampness and blood stasis in TCM theory.
3. women aged 18-40 years without fertility requirements.
4. A willingness to undergo this treatment plan.

Exclusion Criteria:

1. Hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one week apart).
2. Diminished ovarian reserve, FSH (follicle-stimulating hormone) level more than 10 IU/L.
3. Abnormal thyroid function, TSH (thyroid stimulating hormone) level less than 0.2 mIU/mL or more than 5.5 mIU/mL.
4. Suspected Cushing's syndrome.
5. Adrenal or ovarian tumors secreting androgen.
6. Poorly controlled type II diabetes.
7. Pregnancy or lactation.
8. Hypertensive patients with poorly controlled blood pressure (a systolic blood pressure more than 160 mmHg or a diastolic blood pressure more than 100 mmHg).
9. Those who had taken hormones or other drugs during the previous 3 months.
10. Acute heart, liver, kidney or blood diseases.
Effects of Self-Compassion Practice on Stress Reactivity Among Sexual Minority Women

This project will test the ability of brief self-compassion training to attenuate physiological and subjective responses to induced stress among sexual minority women, transgender people, and nonbinary people.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older
* Be fluent in English (i.e., speak and read English)
* Have Internet access
* Have a working email address
* Self-identify sexual identity as LGBQ+ or another non-heterosexual identity AND gender identity as cisgender woman, transgender, nonbinary, or other gender minority identity
* Currently live in Central NY

Exclusion Criteria:

* Failing an inclusion criterion
* Report having been hospitalized at an inpatient facility for psychiatric support within the past 6 months
* Report being currently pregnant
* Report a history of heart attack, unstable angina pectoris, heart failure, coronary heart disease, vascular, heart problems, stroke, or brain hemorrhage
* Report being on blood pressure medication
* Have resting systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 100 mmHg
Validation of the Italian Version of the Forgotten Joint Score (FJS-12) in Total Ankle Replacement

The arthritic pathology of the tibio-tarsal joint has a prevalence of approximately 1% in the general population, and its incidence has been increasing over the years. Advanced-stage arthritis causes pain, impairs mobility, and has an extremely negative impact on patients' quality of life, resulting in significant social and economic costs. Unlike hip and knee arthritis, ankle arthritis is often secondary to traumatic events, affecting younger patients. An emerging treatment for severe ankle arthritis is ankle prosthetic replacement, and patient-reported outcome measures (PROMs) are increasingly used to assess patient outcomes. The study focuses on the validity and reproducibility of the Italian versione of the Forgotten Joint Score (FJS) in ankle prostheses, obtained through the translation-back-translation method, with a sample size of 120 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either gender, aged between 25 and 80 years;
* Patients who have undergone total ankle replacement surgery for tibio-tarsal joint pathology starting from 2018, as well as new patients on the waiting list.
* Signed informed consent for participation in the study;
* Patients who are prepared and motivated to attend the scheduled follow-up visits and complete the study questionnaires.

Exclusion Criteria:

* Patients unable to understand or consent;
* BMI \> 40.
* Refusal to complete the study consent form.
* Substance abuse or psychological disorders that could interfere with the ability to comply with rehabilitation programs and postoperative assessments.
* Known sensitivity to device materials.
* Presence of an active or suspected latent infection in or around the affected ankle joint.