cyrilzakka/clinical-trials huggingface dataset:
Risk Reduction Program for Women Having High Risk of Breast Cancer

An intervention program involving education, guidance, counseling, case management and surveillance based on the Health Belief Model will be implemented on women with high risk of breast cancer. The impact of the breast cancer risk reduction program on participation in breast cancer screenings, health beliefs (health motivation, sensitivity, fear of breast cancer) and behaviors (physical activity, nutrition, health responsibility, genetic counseling) will be evaluated in the study.

In women with family history of breast cancer, cancer risk increases at least twice as compared to the population of the same age. The aim of this study is to evaluate the impact of the intervention program based on the Health Belief Model involving education, guidance, counseling, case management and surveillance, on participation in breast cancer screenings, health beliefs and behaviors in women with high risk of breast cancer.

This study protocol describes a randomized controlled trial with parallel group design. First degree biological relatives (mother, daughter, sister) of breast cancer patients who are diagnosed with breast cancer at or under the age of 50 and who apply to the Oncology Department will be randomly assigned to the intervention and control group.

The content of the Breast Cancer Risk Reduction Program created for the Intervention Group was planned according to the Health Belief Model (HBM) theoretical framework. The interventions based on HBM were carried out according to the OMAHA nursing interventions categories used in the field of Public Health Nursing (training, guidance, counseling, case management and surveillance). Breast Cancer Risk Reduction Program (BirCarrePro) is a 12-week program that includes six interviews. The first intervention in this group will begin with a 60-minute face-to-face individual training. After the first face-to-face interview, phone calls will be made in the second, third, sixth, ninth, and twelfth weeks. Pre-tests and post-tests will be completed by the participants via electronic questionnaires. Follow-up questionnaires will be applied by repeating the post-test at the 24th week. In the control group, post-test will be applied 12 weeks after the pre-test, and follow-up questionnaires will be applied 24 weeks after the pre-test.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being the first degree biological relative of a primary breast cancer patient diagnosed at or before the age of 50
* Aged 25 or older
* No mammography and/or MRI in the last 18 months
* Being literate

Exclusion Criteria:

* Having been diagnosed with breast cancer (first degree relative)
* Being pregnant or breastfeeding
Efficacy of Tacrolimus in Adults With Facial Non-segmental Vitiligo - VITAC

Multicentric French parallel double-blind randomized versus placebo study

Multicentric French parallel double-blind randomized versus placebo study, with duration of treatment of 6 months, and a post-treatment follow-up period of 6 months

Eligibility Criteria:
Inclusion Criteria:

1. Subject male or female with age over 18 years old
2. Diagnosis of non-segmental (symmetrical) vitiligo
3. Presence of at least one vitiligo target-plaque on the face, with:

   Area greater than 3cm² Local Vitiligo Area Severity Index (VASI) score ≥ 50% Stable (no change in pigmentation or size over the last 3 months) Recent onset (less than 2 years duration)
4. Subject affiliated to the French social security system

Exclusion Criteria:

1. Progressive vitiligo over the last 3 months
2. Spontaneous ongoing repigmentation (documented in the last 3 months)
3. Previous topical Tacrolimus treatment in the last 3 months
4. Previous topical or systemic treatment in the last month:

   Topical or oral corticosteroid Topical vitamin D Phototherapy or laser Other topical treatment specific to vitiligo Other immunosuppressant or immunomodulator
5. Underlying dermatological disease (i.e.: history of atopic dermatitis, eczema, psoriasis), which, according to the investigator, could interfere with the study assessments
6. Known sensitivity to study drug or macrolides
7. Past history of skin cancer or lymphoma
8. Congenital or acquired immunodeficiency
9. Pregnant or breastfeeding women
10. Women without contraception
11. Absence of signed informed consent
VitalThings Guardian Contactless Monitoring

This is a confirmatory study without any intervention. It is an uncontrolled, non-randomized and open-label study with measurements made with comparators, and it has a preset hypothesis for the primary endpoint. There are no similar devices to VitalThings Guardian M10 / M10 mobile on the market, consequently one or more different types of devices must be used as comparators.

The purpose of the clinician investigation is to validate a claim made for the investigational device performance. The objective is to confirm that the device performs at +/- 1.2 respirations per minute (RPM) accuracy against the identified comparator device, and compare performance to the standard of care as documented in the literature. The study will be conducted with patients admitted to the emergency ward after the initial treatment and examination.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to the Emergency Ward (EW)

Exclusion Criteria:

* Under age (below 18 years) and subjects not able to provide informed consent themselves. Subjects dismissed from the EW rooms within 30 minutes from first registration are removed from the study.
A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P02 monotherapy in adult patients with selected squamous solid tumors.

This Study has a Phase I ALE.P02 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P02 as monotherapy at RP2D in adult patients with selected advanced or metastatic Claudin-1 positive (CLDN1+) cancers.

Eligibility Criteria:
Inclusion Criteria:

* Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC.
* Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment.
* Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment.
* Have provided tissue for CLDN1 analysis in a central laboratory.
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
* Demonstrate adequate bone marrow and organ function.
* Patients must have recovered from all toxicities led by prior treatment.
* Have measurable disease based on RECIST 1.1 as determined by the site.

Exclusion Criteria:

* Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma.
* Has received antineoplastic therapies prior to study intervention within specified time frame.
* Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain).
* Patients with uncontrolled diabetes.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate.
* Concomitant use of drugs that are known to prolong or shorten QT and/or have known risk of Torsades de Pointes.
The Role of Neuromodulators in Refractory Functional Dyspepsia

The study was designed to investigate the effect of central neuromodulators on refractory functional dyspepsia

Functional dyspepsia (FD) is a prevalent disease combined with emotional disorders. Antidepressants are beneficial in the treatment of refractory FD, while for the long-term use of antidepressants, it could lead to withdrawal syndrome or other adverse events.

Refractory FD patients were unsatisfied with the regular first-line anti-acid treatment. However, many patients were worried about taking antidiepressants, even though guideline has recommended antidepressant use in FD. In our study, we would use low-dose and short-term antidepressant in refractory FD patients, and investigate whether short-term antidepressants application would improve therapeutic efficacy and minimize antidepressant withdrawal of FD patients.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old;
* education level higher than middle school;
* met the Rome IV criteria for FD; absence of abnormalities on physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), and abdominal imaging and GI endoscopy within 6 months;
* absence of Helicobacter pylori infection;
* signed written informed consent for participation in the study.

Exclusion Criteria:

* evidence of organic digestive diseases;
* diabetes, cancer and other diseases might affect GI function;
* pregnancy, lactation or breastfeeding;
* a history of allergic reaction to any of the drugs used in the study;
* participation in other clinical trials in the previous 3 months.
Body Mass Index and Post-dural Puncture Headache

Post-dural puncture headache (PDPH) is seen more frequently in pregnant women due to stress, dehydration, intra-abdominal pressure, and insufficient fluid replacement after delivery. Obesity protects against PDPH in pregnant women; increased intra-abdominal fat tissue reduced cerebrospinal fluid leakage by increasing the pressure in the epidural space. Therefore, this study investigated the influence of body mass index (BMI) on PDPH in elective caesarean section patients in whom 27G spinal needles were used.

The study included 420 women with American Society of Anesthesiology physical status I-II who underwent elective caesarean section under spinal anesthesia. The patients with a BMI less than 30 were accepted as normal weight (Group I) and those with a BMI above 30 were accepted as obese (Group II). Dural puncture performed with a 27G Quincke spinal needle at the L3-4 or L4-5 intervertebral space and given 12.5 mg hyperbaric bupivacaine intrathecally. The patients were questioned regarding headache and low back pain 6, 12, 24, and 48 hours after the procedure, and by phone calls on days 3 and 7.

Eligibility Criteria:
Inclusion Criteria:

(ASA) physical status I-II who underwent elective caesarean section under SA. Women age 18-40 years.

Exclusion Criteria:

* Who had undergone lumbar disc or vertebra surgery, had chronic low back pain or headache, had contraindications for neuro-axial block, and emergency patients.
Iodine Status of the Indigenous Peoples (Karen) Living in Thailand

In describing the iodine status involving health conditions of the minority groups, this observational study aims to learn about the iodine status of the Indigenous Peoples (Karen) in a subdistrict in western Thailand. The Participants will be collected their urine to determine urinary iodine concentrations At the same time, their household salt will be also collected to determine iodine content.

Iodine deficiency (ID) is a global public health problem, and it is estimated that almost 240 million school-aged children (SAC) worldwide have an insufficient iodine intake. Currently, severe ID is uncommon, but mild-to-moderate ID is still widespread on a global level, especially in the Asia region. Iodine deficiency causes multiple adverse effects on growth and development in all age groups. Salt iodization is recommended as the most cost-effective way of delivering iodine to the target population to combat iodine deficiency. In addition, the cyclic monitoring of urinary iodine concentration (UIC) in vulnerable groups is recommended by the World Health Organization (WHO).

However, some minority communities such as indigenous peoples living in remote rural areas are not included in IDD surveillance programs. Indigenous peoples in many developing countries, including Thailand, are largely ignored in development efforts, as they are disadvantaged minority groups in those societies. These indigenous peoples may therefore be at risk of many adverse health and nutrition consequences, resulting in their quality of life. In order to promote nutrition and health, and to ensure adequate iodine intake among indigenous peoples in Thailand, it is essential to understand the urinary iodine concentration of the populations and the iodine content in their household salt. The results from this study could then be considered and potentially strengthen the Universal Salt Iodization (USI) program in Thailand, to reach indigenous peoples in border areas.

This study will conduct in Karen communities in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand. The participants will be divided into 2 groups, school-aged children, males and females (6-12 years), and women of reproductive age (15-49 years). The Participants will be collected their urine to determine urinary iodine concentrations At the same time, their household salt will be also collected to determine iodine content.

Eligibility Criteria:
Inclusion Criteria:

* Karen ethnic population living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand
* Healthy school-aged children, male and female, aged 6 -12 years old (n=300)
* Healthy reproductive-aged women, aged 15 - 49 years old (n=300)
* Can follow the steps of this study

Exclusion Criteria:

* NO
the Serum Metabolite Based PrecogColo Dx Test for Advanced Colorectal Neoplasia Screening

This study is to Evaluate the diagnostic sensitivity of the serum metabolite based PrecogColo Dx test for advanced colorectal neoplasia Screening, including advanced adenoma and colorectal cancer. There are two steps in this study. Firstly, the diagnostic model is established based on tumor-specific and gut-microbiome related serum metabolites. Secondly, the sensitivity, specificity and accuracy of the diagnostic model is evaluated in detecting advanced adenoma and colorectal cancer stages in an independent multi-centered cohort.

Subjects aged \>45 at average risk for development of CRC will be enrolled. Subjects will complete the PrecogColo Dx test, followed by completion of a screening colonoscopy. . Results from PrecogColo Dx test were compared to the results of an optical colonoscopic examination, and histopathological diagnosis of all significant lesions discovered during the colonoscopy, in order to determine the sensitivity for CRC and advanced adenoma, respectively, as well as determining specificity of non-advanced neoplasia individuals. Histopathological results from biopsied tissue or excised lesions were categorized based on the most clinically significant lesion present by a central pathologist.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 45 years of age at the time of enrollment.
2. Subject presents for a screening colonoscopy.
3. Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
4. Subject is able and willing to sign informed consent.

Exclusion Criteria:

1. Patients received tumor treatment prior to the drawn of blood sample, including surgical resection, neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy and targeted therapy.
2. Patients received antibiotics within 2 weeks.
3. Patients with indications of emergency surgery, including bleeding, obstruction and perforation.
4. Patients who are positive for Human Immunodeficiency Virus (HIV).
5. Patients with abnormal liver and kidney function.
6. Patients with the history of inflammatory bowel disease.
7. Patients who had history of other malignancies.
8. Subject has a diagnosis or medical history of any of the following conditions:

   1. Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome)
   2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
Therapeutic Efficiency of Mandibular Advancement Device Using Smartphone Sleep Applications and Pulse Oximeter

An observational clinical trial in a single centre. The objective of this study was to determine the efficacy of mandibular advancement device (MAD) therapy on snoring intensity, frequency, and oxygen desaturation periods in mild-moderate obstructive sleep apnea (OSA) patients with snoring problems. Totally, 18 mild-moderate OSA patients (8 females and 10 males) with subjective snoring complaint were selected. Each patient's diagnostic polysomnographic analysis (PSG) was accepted as initial PSG values. Each patient was subjected simple pulse oximeter (SPO) and smartphone sleep application (SSA) at 3 different nights at home. Diagnostic mean values of oxygen desaturation index (obtained by using SPO), snoring intensity score (obtained by using SSA), and snoring percentage (obtained by using SSA) were recorded. Non-titratable-customized MAD with 60-75% of maximal mandibular protrusion were fabricated. The patients were instructed to wear their MAD every night. SPO and SSA measurement were repeated at the 1st, 4th, 12th, and 24th week of the treatment process. At the 24th week of treatment, The PSG were repeated and all PSG, SPO, and SSA values were compared with initial diagnostic values.


Eligibility Criteria:
Inclusion Criteria:

* mild-moderate OSA patients with subjective snoring complaints

Exclusion Criteria:

* Severe OSA
* Undergone previous surgical therapy for SS or OSA
* High-risk of cardiovascular, respiratory, neurological, or psychiatric disorders
* Inadequate dental anchor for MAD treatment
* Temporomandibular joint dysfunction
* Angle Class III maxillomandibular relation
Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial

The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration and to explore women's experiences with and attitudes towards contraceptive and breastfeeding counseling in the peripartum time period

Immediate postpartum initiation of the etonogestrel contraceptive implant has been proven to decrease rates of rapid, repeat pregnancies. Evidence supports that in healthy women with term infants initiation of the contraceptive implant 1-3 days postpartum does not appear to have any adverse effects on lactogenesis or breastfeeding continuation. However, no high quality study to date has examined the effects of progestin-only contraception in women known to be at risk for low milk supply, including women with a premature delivery, obesity, polycystic ovarian syndrome, diabetes, or a prior history of low milk supply.

The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration. This will be a three-armed randomized non-inferiority study of women who plan to breastfeed, have known risk factors for low milk supply, and who intend to use the contraceptive implant postpartum. Women will be randomized to one of three groups for the timing of contraceptive implant placement: within 30 minutes of placental delivery, 24-72 hours postpartum, or 6 or more weeks postpartum. Women will be assessed at 6 weeks, 3 months and 6 months postpartum. Outcomes will include time to Lactogenesis Stage II, duration and exclusivity of breastfeeding, continuation of and satisfaction with the contraceptive implant, and side effects, including bleeding patterns, associated with the implant.

Findings from this trial will be used by clinicians, hospital systems, and policy makers working to expand access to immediate postpartum implants while supporting women in meeting their breastfeeding goals.

Eligibility Criteria:
Inclusion Criteria:

* Live pregnancy of at least 24 weeks gestation
* Intention to use a contraceptive implant postpartum
* 17 years of age or older
* English or Spanish speaking
* Admission to Labor and Delivery with a plan for delivery (women in both latent and active labor will be eligible)
* The presence of at least one of the following conditions known to be a risk factor for low milk supply:

  * Expected delivery prior to 34 weeks
  * Obesity (pre-pregnancy BMI \>35)
  * Polycystic Ovarian Syndrome
  * Diabetes (gestational or pre-gestational)
  * Self-reported difficulty with low milk supply in past

Exclusion Criteria:

* Not English or Spanish speaking
* Allergy or Contraindication to contraceptive implant
Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant

Open label single center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

The study objective is to determine if the administration of direct acting antivirals for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Donor meets MGH transplant center criteria and already listed for isolated kidney transplant
* No available living kidney donor
* Recipient has ≤ 730 days of accrued transplant waiting time
* Recipient chronic hemodialysis or peritoneal dialysis
* Recipient must agree to birth control.

  °.Weigh ≥ 50kg
* Serum ALT within normal limits
* Subject's Insurance company approves payment for DAA therapy post-kidney transplant

Exclusion Criteria:

* AB Blood type
* HCV genotype 1
* BMI \> 35
* Any liver disease in recipient
* Pregnant or nursing (lactating) women
* Known allergy or intolerance to tacrolimus that would require administration of cyclosporine
* Albumin \< 3g/dl or
* Platelet count \< 75 x 103/mL
* Positive crossmatch or positive donor specific antibodies
* HCV RNA positive
* Hepatitis B surface antigen positive
* Patients with primary focal segmental glomerulosclerosis (FSGS)
* Any contra-indication to kidney transplantation per our center protocol