cyrilzakka/clinical-trials huggingface dataset:
Circulating Tumor DNA as Marker of Therapeutic Efficacy in Breast Cancer Patients

In nonmetastatic local advanced breast cancer patients, we are going to investigate whether circulating tumor DNA (ctDNA) detection can reflect the tumor response to neoadjuvant chemotherapy (NCT) and detect minimal residual disease after surgery.

Breast cancer is the most common malignant tumor in women worldwide, and chemotherapy is still the main method of breast cancer treatment. And for locally advanced breast cancer patients, neoadjuvant chemotherapy can further improve treatment efficacy, improve prognosis and increase the rate of breast conserving surgery. The persistence of a minimal residual disease at distant sites after the treatment of a localized breast cancer is a key parameter for posttreatment survival but cannot be reliably assessed by the current biological or radiological tools. Therefore, the prediction of the chemotherapy efficacy is very important. ctDNA, corresponds to fragmented DNA released into the blood stream by tumor masses, the detection and quantification of circulating tumor DNA (ctDNA) is a very promising tool that can assess tumor burden, response to therapy, and minimal residual disease. In this study, we wil collect breast cancer cases treated with neoadjuvant chemotherapy, draw blood and evaluate the efficacy each time before chemotherapy and after surgery, then measure the concentration of ctDNA in each sample. We will also analyze the demographic data,basic treatment and follow-up data including relapse, metastasis and survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients pre- or post-menopausal must have histologically confirmed early stage/locally advanced invasive breast cancer;
* Tumor size ≥ 0.5cm (clinical or radiographic measurements);
* Any nodal status allowed;
* Age \> 18 years old;
* Felt to be a possible candidate for neoadjuvant systemic therapy by their treating physician;
* ECOG score\<=2;

Exclusion Criteria:

* Known metastatic disease;
* With serious heart, lung, liver diseases;
* Poor cardiac function;
* Pregnant;
* Patients with other malignant tumor or treated before;
Social Behavior in Depression

In the project, investigators basically plan to test the difference in social behavior and social cognition between depressive patients and healthy individuals. To test this, investigators plan to use traditional or novel behavioral experiment paradigms to target various behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Age range between 18 and 60
* Education experience above high school
* Score for Hamilton's Depression Scale \>=17
* Diagnosis of depression through Scid

Exclusion Criteria:

* Undergoing electric shock treatment in 3 months
* Excluding those who with bipolar disorder
* Excluding those who with postpartum depression
* Excluding those who with hysteria
PMCF Study to Evaluate Safety of TIPMED TPM08 Total Knee Prosthesis Systems and TPM Revision Knee Prosthesis Systems

This is a observational multicenter study to assess the safety of TIPMED TPM08 Total Knee Prosthesis Systems and TPM Revision Knee Prosthesis Systems used for total knee arthroplasty or revision knee arthroplasty.

In this study, short term (12 months) safety data of TIPMED TPM08 Total Knee Prosthesis System and TPM Revision Knee Prosthesis System will be evaluated using Case Report Forms (CRF). A CRF should be completed at each control visit of the participants by investigator in order to assess safety of the TIPMED Knee Prosthesis Systems by success of operation, occurrence of adverse events during procedure or as the effects in 12 months period resulting from TIPMED Knee Prosthesis Systems. CRF will also include questions related to performance and effectiveness of TIPMED Knee Prosthesis Systems.

Participants should be treated according to instructions-for-use of the implants and accessories and according to clinical routine. The devices must have been used exclusively by physicians who are experienced in knee arthroplasty techniques and who are experienced in using the products in operations.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged older than 18 years of age,
* The subjects with appropriate indication for primary total or revision knee arthroplasty,
* The subjects who used TIPMED TPM08 Primary Total or Revision Knee Prosthesis System in their surgery,
* Subjects not under legal disability,
* Subjects or guardian who is willing and able to sign the informed consent form.

Exclusion Criteria:

- Subjects in another interventional clinical trial will be excluded.
Efficacy of Rilpivirine-based Regimens as Switch Therapy From Nevirapine-based Regimens in HIV-infected Patients

Background: Nevirapine (NVP)-based antiretroviral therapy (ART) remains to be used in HIV-infected patients in resource limited countries despite its compliance and adverse effect concerns. Rilpivirine (RPV), a newer non-nucleoside reverse transcriptase inhibitor, could be used as an alternative to NVP in virologically suppressed patients. However, there has been limited experience with switching from NVP-based to RPV-based regimens. The investigators aimed to study efficacy and adverse events after ART switching from NVP-based to RPV-based regimens.

Methods: A randomized controlled non-inferiority trial was conducted in HIV-infected patients who received NVP-based regimens and had undetectable plasma HIV RNA for more than 6 months. Patients were randomized 1:1 to continuation arm (NVP-based regimens were continued) or switch arm (NVP-based regimens were switched to RPV-based regimens). Tenofovir disoproxil fumarate (TDF) plus lamivudine (3TC) or emtricitabine (FTC) remained as the backbone of the regimens. Primary endpoint was HIV RNA \<40 copies/mL at 48 weeks, with a non-inferiority margin of 12%. Changes of CD4 cell counts and lipid profiles from baseline were analyzed.

A single-center randomized controlled, non-inferiority trial to study 48-week treatment outcomes of RPV as a switch therapy was conducted at Ramathibodi Hospital, a tertiary care health center in Thailand from December 2016 to October 2017 Eligible patients who currently received TDF/3TC/NVP (group A) or TDF/FTC/NVP (group B) were block 4 randomly assigned (1:1) by computer-generated random numbers, to continue their current regimen of NVP 200 mg twice daily plus TDF/3TC (group A1) and plus TDF/FTC (groupB1), or to switch from NVP to RPV 25 mg once-daily plus TDF/3TC (group A2) and plus TDF/FTC (groupB2). Patients were advised to take RPV with a meal. Patients were scheduled trial visits at baseline, week 12, 24, 36 and week 48. The laboratory assessment was performed at baseline week 24 and week 48.

Eligibility Criteria:
Inclusion Criteria:

* Recent plasma HIV-1 RNA viral load within 6 months of the screening that was less than 40 copies/mL, and a CD4 cell count that was more than 200 cells/mm3
* Patient who treated with TDF/FTC/NVP or TDF/3TC/NVP for at least 6 month

Exclusion Criteria:

* patients with a history of HIV drug resistance, patients who used other drugs or drugs which interact with RPV (proton pump inhibitors, histamine H2-receptor antagonists, rifampin, antiepileptic drugs), female patients during pregnancy or breastfeeding, patients whose estimated glomerular filtration rate (eGFR)was \<60 mL/min/1.73m2 \[by The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) (12)\], and patients diagnosed with depressive or psychiatric disorders.
Efficacy and Safety of TAK-385 in the Treatment of Endometriosis

The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with endometriosis.

This Phase II, multicenter, double-blind, randomized, parallel-group, placebo-controlled study will evaluate the efficacy and safety of 3 dose levels (10, 20, and 40 mg) of TAK-385 following oral administration for 12 weeks in women with endometriosis.

Eligibility Criteria:
Inclusion Criteria:

1. Premenopausal women
2. The participants must have dysmenorrhea and pelvic pain associated with endometriosis.
3. The participant has experienced a regular menstrual cycle.
4. The participant has been diagnosed with endometriosis by method a), b), or c).

   * Laparotomy
   * Laparoscopy
   * Chocolate cyst of the ovary confirmed by MRI

Exclusion Criteria:

1. Participants diagnosed with measurable uterine fibroids with the longest diameter of 3 cm or larger
2. Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
3. Participants with a previous or current history of thyroid dysfunction
4. Participants with current or previous history of pelvic inflammatory disease
5. Participants with positive PAP smear test result conducted
6. Participants with a history of panhysterectomy or bilateral oophorectomy
7. Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
8. Participants with a previous or current history of a malignant tumor
9. Participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (SERM), activated vitamin D, other vitamin D, calcitonin, ipriflavone, steroid hormone, vitamin K, teriparatide,or denosumab
10. Participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (GnRH) analogue, dienogest, danazol, or aromatase inhibitor
11. Participants who have been treated with bisphosphonate preparation
12. Participants with a previous or current history of hypersensitivity or allergy to Leuplin, synthetic LH-RH, LH-RH derivatives, gelatin-containing formulations or food containing gelatin, or have a previous or current history of severe hypersensitivity or severe allergy to other drugs
13. Participants with non-diagnosable abnormal genital bleeding
14. Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
15. Participants with clinically significant cardiovascular disease or uncontrollable hypertension
16. Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
17. Participants with active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \> 1.5 times the upper limit of normal (ULN) in the clinical laboratory tests
Erythropoietin Treatment in Extremely Low Birth Weight Infants

Objective: To investigate whether recombinant EPO reduces the need for transfusion in extremely low birth weight (ELBW) infants and to determine the optimal time for treatment.

The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too.

Study population: 219 patient randomized into 3 groups

Methods: Blinded , multicenter trial, ELBW infants were randomized on day 3 to one of 3 groups: early EPO group (rhEPO from the first week for 9 weeks , n= 74), late rhEPO group (rhWEPO from the fourth week for 6 weeks, n=74), or control group (no rhEPO, n= 71). All infants received enteral iron (3-9 mg/kg/day) from the first week. The rhEPO ß dose was 750 IU/kg/week. Success was defined as no transfusion and hematocrit levels never below 30%.

The concentrations of trace elements and of antioxidant enzymes were investigated in all patients, too. Clinical and nutritional data were recorded prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Extremely low birth weight infants

Exclusion Criteria:

* Cyanotic heart disease
* Major congenital malformation requiring surgery
* Gestational age \> 30 weeks
* Administration of an investigational drug during pregnancy
* Lack of parental consent
Fit Moms- an Internet-based Postpartum Weight Loss Program

The purpose of this study is to provide weight loss interventions for Mothers participating in the WIC program, using the internet to deliver weight loss materials.

Develop recruitment methods and determine feasibility of recruiting WIC postpartum women who meet inclusion criteria. We will collect data on number of individuals screened and reasons for exclusions. Establish and examine feasibility and effectiveness of protocol for WIC counselors reinforcing adherence to web based program. We will assess frequency with which WIC counselors adhere to protocol of reinforcing adherence to web-based program and extent to which any "treatment contamination" occurs between WIC counselors and Standard Care participants.In those randomized to Enhanced WIC + Internet-based postpartum program, examine acceptability, burden, ease of use, frequency of technical problems, and adherence to web-based program (number of logins, message board postings)Explore whether the Enhanced WIC plus Internet postpartum weight loss program will produce significantly greater weight losses than Standard WIC at 2 months. Explore whether Enhanced WIC plus Internet postpartum weight loss program will result in greater improvements in eating and exercise behaviors (examined at 0, and 2 months) and psychosocial parameters (i.e., depression, social support, self-efficacy, body image) than standard care.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years.
* Delivery within 6-52 weeks
* Exceed pre-pregnancy weight by at least 6.8 kg (15 pounds)
* Current BMI \> 22
* English speaking
* Has computer with internet access
* Literacy of at least 5th grade reading level

Exclusion Criteria:

* Pregnant or planning to become pregnant
* Relocating in the next year
* Serious medical problem (i.e. heart disease, cancer, renal disease and diabetes), for which physician supervision of diet and exercise prescription is needed.
Comparison of Eccentric Muscle Training and Proprioceptive Neuromuscular Facilitation Techniques in Neck Pain

It was aimed to compare the eccentric exercise training given to the neck muscles of people with non-specific neck pain and the proprioceptive neuromuscular facilitation (PNF) technique on pain, endurance and functionality.

The study was planned as a quantitative study. Volunteer individuals with nonspecific neck pain between the ages of 18-65 will be included in the study, and the participants will be randomly distributed into 3 groups. Control group (n=15), proprioceptive neuromuscular facilitation technique application group (n=15), eccentric muscle training technique application group (n=15). People included in the study will be explained in detail and will be asked to sign a voluntary consent form approved by the ethics committee. Demographic information of individuals in all three groups will be recorded first. Participants in all three groups will be evaluated at the beginning and end of the applications. In our study, participants were evaluated with the McGill Pain Questionnaire to evaluate the character and character of pain, their physical fitness with the Deep Neck Flexor Endurance Test (DBFET), their functionality related to daily living activities with the Neck Disability Index (NEI), and their quality of life with the World Health Organization Short Form of Quality of Life (WHOYKA-CF). ) Tampa Kinesiophobia Scale (TKÖ) and a goniometer for Cervical Region Joint Range of Motion Measurement will be used to evaluate kinesiophobia, which is the fear of pain and re-injury, as well as anxiety towards activity and physical movement. This study will be planned five times a week for six weeks. Stretching and stabilization exercises will be applied to the control group in 3 sets of 10 repetitions.

Eligibility Criteria:
INCLUSION CRITERIA

* Being between the ages of 18-65
* History of neck pain that has persisted for at least 7 days
* Agreeing to participate in the study
* Having the ability to read and write Turkish. EXCLUSION CRITERIA
* Radiculopathy and structural disorder in the cervical region,
* Surgery to the cervical region,
* Inflammatory disease,
* Severe psychological illness,
* Presence of infection in the bone and soft tissue in the cervical spine,
* Malignancy,
* Advanced osteoporosis,
* Those with upper extremity pathologies,
* Having a neurological disease that will prevent treatment
* Having previously undergone cervical region and spine surgery
* Having been included in a physiotherapy program for the neck and back area in the last 6 months,
* It was defined as the administration of drugs such as NSAIDs (Nonsteroidal Anti-Inflammatory Drugs) and opioids in the last 24 hours.
Rehabilitative Training for Older People With Schizophrenia

This study will evaluate the effectiveness of a rehabilitation program called Functional Adaptation Skills Training (FAST) in treating older patients with schizophrenia.

People with schizophrenia often have problems functioning in everyday life. As people with schizophrenia get older, resources for effective health care and social services may become more limited. There is a need to develop effective rehabilitation programs that are sensitive to the special needs of older persons with schizophrenia.

Patients are randomly assigned to either 1 of 2 groups. The FAST group will involve 24 sessions of group intervention designed to enhance daily functioning of older patients with schizophrenia. The placebo group will involve participation in a psychosocial support group for an equivalent amount of time. Treatment is followed by 6 monthly maintenance sessions. Patients will be assessed at 6, 12, and 18 months after the study start. Assessments include clinical and functional measures.

Eligibility Criteria:
Inclusion Criteria:

* Have schizophrenia or schizoaffective disorder
Stable Angina Observational Registry

The purpose of this study is to describe the clinical profile and current status of the diagnosis and management of stable angina in India by non-interventional consulting physicians (CP) through a large multicenter observational registry.

An observational registry on diagnosis and management of stable angina in India Purpose To describe the clinical profile and current status of the diagnosis and management of stable angina in India by non-interventional consulting physicians (CP) through a large multicenter observational registry.

Design A prospective, multi-center, observational registry. Subject Population Adult, male or female subjects with symptomatic stable angina visiting non-interventional consulting physicians for treatment and who meet the study inclusion/exclusion criteria.

Enrollment:

The study is expected to enroll 1000 to 1500 subjects by 150 - 250 non-interventional consulting physicians. The enrollment period will be around 4 months.

Inclusion criteria

Subject must meet all of the following criteria to be eligible for inclusion in the trial:

1. Subject has been provisionally diagnosed with stable angina by the CP (consulting physician) during the current visit or within 3 months preceding the current visit
2. Subject agrees to sign a data release form

Exclusion criteria

Subjects will be excluded from the trial if any of the following criteria are met:

1. Subject has a history of Acute Coronary Syndrome
2. Subject has a history of prior revascularization
3. Subject has a history of previous MI
4. Subject has new onset angina with symptoms less than one month

Objectives:

1. Describe the demographic and medical profile of subjects diagnosed with stable angina by non-interventional consulting physicians in India
2. Describe the diagnostic pathway prescribed by non-interventional consulting physicians and adopted by stable angina subjects in India
3. Describe the management of stable angina by non-interventional consulting physicians and undertaken by subjects in India

Eligibility Criteria:
Inclusion criteria

Subject must meet all of the following criteria to be eligible for inclusion in the trial:

1. Subject has been provisionally diagnosed with stable angina by the CP (consulting physician) during the current visit or within 3 months preceding the current visit
2. Subject agrees to sign a data release form

Exclusion criteria

Subjects will be excluded from the trial if any of the following criteria are met:

1. Subject has a history of Acute Coronary Syndrome
2. Subject has a history of prior revascularization
3. Subject has a history of previous MI
4. Subject has new onset angina with symptoms less than one month
A Long-Term Study Continuing on From Study 04-001-01 of an Experimental Medication in Adults With Anxiety Disorder

The purpose of the study is to assess the safety and effectiveness of the experimental drug, a benzodiazepine drug, in long-term use and the effects on quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with anxiety disorder.

This trial is a long-term, open label, safety and efficacy study of an experimental medication in adults with Generalized Anxiety Disorder (GAD). To enroll in this study, investigators and patients must have first participated in Jazz Pharmaceuticals, Inc. Protocol 04-001-01. The study is designed for four stages that should last a total of 37 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Complete Study 04-001-01
* Able to take the medication for 9 months
* Understand and sign the Informed Consent
* Comply with all study-related procedures
* Women of child bearing potential must have a confirmed negative urine pregnancy test
* Lack of clinically significant abnormalities in health

Exclusion Criteria:

* Experienced any SAEs (serious adverse events) that were related or possibly related to study drug during participation in Study 04-001-01
* Early termination from study 04-001-01
* Any new condition that could interfere with the evaluation of the subject, interpretation of safety data, or compliance with the protocol requirements
* Experiencing AEs (adverse events) such that in the opinion of the investigator, per protocol, study drug administration or safe participation in this study would be precluded.
* Taken any disallowed medications noted in Study 04-001-01 between the completion of Study 04-001-01 and entry into this trial
Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome

The purpose of this study is to evaluate the safety and effectiveness of intravitreal ranibizumab (Lucentis) in patients with fluid and blood leakage in their eyes due to ocular histoplasmosis.

Patients will be evaluated monthly for one year.

Participants will be assigned to one of two groups:

Group A will receive 3 monthly injections of ranibizumab followed by an as needed injection throughout the remainder of the study Group B will receive injections of ranibizumab on an as needed basis throughout the study

You cannot take part in this study if:

1. You are pregnant or intending to become pregnant in the next 12 months or are nursing an infant
2. You are under the age of 18

Eligibility Criteria:
Inclusion Criteria:

* age 18 or over
* active choroidal neovascularization secondary to ocular histoplasmosis
* Visual acuity between 20/25 and 20/400

Exclusion Criteria:

* pregnancy or intent to become pregnant within the next 12 months
* nursing an infant
* premenopausal women not using contraception
* prior treatment with subfoveal thermal laser
* allergy to sodium fluorescein simultaneous participation in another investigation or trial