cyrilzakka/clinical-trials huggingface dataset:
Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer

The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.

In this trial, all the patients will have weekly paclitaxel and cisplatin as neoadjuvant chemotherapy for 4 cycles. Patients with Her2 positive tumor will also receive the trastuzumab.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged ≥18years and ≤70 years
2. At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-2M0
3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER/PR positive is defined as \>1% stained cells and HER2-positive is defined as immuno-histochemistry (IHC) 3+ or FISH ratio ≥ 2.0
4. No prior systemic or loco-regional treatment of breast cancer
5. ECOG 0-2
6. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit （UNL）, creatinine≤1.5 UNL, bilirubin≤1.5UNL
7. No obvious main organs dysfunction

Exclusion Criteria:

1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug
2. Patient is pregnant or breast feeding
3. Inflammatory breast cancer and metastatic breast cancer
4. Any evidence of sense or motor nerve disorders
5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection
6. Any concurrent malignancy other than breast cancer
7. Know severe hypersensitivity to any drugs in this study
Addressing Intimate Partner Violence, Mental Health, and HIV in Antenatal Care

This quasi-experimental feasibility study recruit n=40 participants from each of two public antenatal clinics in Johannesburg, South Africa. Using the Bowen et al. approach, key feasibility study questions will be those around acceptability, implementation, and promising effects on intermediate variable. While this pilot trial is not powered to determine efficacy, it can help establish whether intervention targets the appropriate intermediate mechanisms (i.e. primary endpoints of IPV exposure and depressive symptoms) and moves intended outcomes in the right direction (i.e. towards better adherence as measured by self-reported adherence).

Prevention of mother-to-child transmission (PMTCT) programs are effective if women take medication regularly, yet many perinatal women in sub-Saharan Africa have sup-optimal adherence. Intimate partner violence (IPV) worsens women's ability to adhere to antiretroviral therapy (ART), and leads to higher rates of depression. In a quasi-experimental feasibility study in South Africa, 2 inner-city Johannesburg clinics will be assigned to intervention or enhanced standard of care conditions. Intervention consists of training health workers to deliver one-on-one sessions in pregnancy (4 sessions) and postpartum (2 sessions) using problem-solving therapy and safety planning. Following n=80 women in a prospective cohort will allow for preliminarily assessment of intervention effects on: perinatal depression, IPV exposure, and ART adherence at 6 months postpartum. Additional qualitative research with 10 providers and 15 beneficiaries will help us qualitatively assess acceptability of intervention content, measures, and study conditions. This pilot trial can establish acceptability of intervention and control conditions and provide preliminary point estimates to inform future trial design.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older (the age of research consent in South Africa)
* currently pregnant and less than 30 weeks gestation (from antenatal green card)
* speak a study language (English, isiZulu, Sesotho)
* living with HIV (self-reported and confirmed on green card)
* report past-year IPV (score of ≥1 on WHO multicountry study instrument)
* are willing to provide informed consent

Exclusion Criteria:

* fail to meet all of the inclusion criteria
* at risk of immediate danger (current suicidality, homicidality, or risk to child safety)
* planning to terminate the pregnancy
Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer

This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease progression, unacceptable toxicity or death from any cause occurs.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
* ECOG performance status of 0 or 1
* For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception
* For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization

Exclusion Criteria:

Disease-Specific Exclusions:

* HER2-positive status
* Prior chemotherapy for locally recurrent or metastatic disease
* Prior hormonal therapy \< 2 weeks prior to randomization
* Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization
* Investigational therapy within 28 days of randomization

General Medical Exclusions:

* Life expectancy of \< 12 weeks
* Inadequate organ function
* Uncontrolled serious medical or psychiatric illness
* Active infection requiring intravenous (IV) antibiotics at screening
* Pregnancy or lactation
* History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death
Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A\*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3 ) or MRCLS (Cohort 1) .


Eligibility Criteria:
Key Inclusion Criteria

* Age ≥16 (10 years at selected sites) and \<=75 years
* Diagnosis of advanced synovial sarcoma (Cohort 1, Cohort 2 and Cohort 3) or myxoid liposarcoma / myxoid round cell liposarcoma (Cohort 1 only) confirmed by cytogenetics.
* Previously received either an anthracycline or ifosfamide containing regimen.
* Measurable disease according to RECIST v1.1 prior to lymphodepletion
* HLA-A\*02:01, HLA-A\*02:02, HLA-A\*02:03 or HLA-A\*02:06 positive
* Tumor shows MAGE-A4 expression confirmed by central laboratory. North America Only (United States and Canada): Tumor (either an archival specimen or a fresh biopsy) shows MAGE-A4 expression of ≥1+ staining in ≥10% of the cells by immunohistochemistry.
* ECOG Performance Status of 0 or1. For subjects aged ≥10 to ≥16 years old:

Lansky Score ≥60%.

• Left ventricular ejection fraction (LVEF) ≥50%.

Note: other protocol defined Inclusion criteria may apply

Key Exclusion Criteria:

* HLA-A\*02:05 in either allele
* Received or plans to receive the following therapy/treatment prior to leukapheresis or lymphodepleting chemotherapy: Cytotoxic chemotherapy, Tyrosine kinase inhibitor (TKI) (e.g. pazopanib), Immune therapy (including monoclonal antibody therapy, checkpoint inhibitors,), Anti-cancer Vaccine, Gene therapy using an integrating vector (subjects who have received a gene therapy using a lentiviral vector may be eligible for the study), Corticosteroids or any other immunosuppressive therapy, Investigational treatment or interventional clinical trial, Allogeneic hematopoietic stem cell transplant, Radiotherapy to the target lesions, Major surgery
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study.
* History of autoimmune or immune mediated disease
* Symptomatic CNS metastases including leptomeningeal disease.
* Other prior malignancy that is not considered by the Investigator to be in complete remission
* Clinically significant cardiovascular disease
* Uncontrolled intercurrent illness
* Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
* Pregnant or breastfeeding

Note: other protocol defined Exclusion criteria may apply.
A Multicenter Randomized Controlled Study of Pulse Magnetotherapy Combined Medication in Anxiety Combined With Insomnia

The goal of this clinical trial is to explore the therapeutic effect of pulse magnetic therapy system combined with drug therapy on patients with anxiety and insomnia. The main questions it aims to answer are:

1. Whether the pulse magnetic therapy system is benefit on improving insomnia in anxiety patients.
2. This improvement is not due to the placement of the instrument。 Participants will accept pulse magnetic therapy (stimulation/sham stimulation) and accept scale evaluation before and after treatment.

Researchers will compare the pulse magnetic stimulation group, sham stimulation group and healthy controls to see if the pulse magnetic stimulation do effect on insomnia of anxiety patients.

Insomnia is the most common symptom of anxiety disorder, which has an important impact on the prognosis of anxiety. Pulse magnetic therapy system, with its advantages of compact, convenient, easy to carry, and not limited by the scene and time, has gradually become a common tool for sleep monitoring and treatment. This study is a multicenter randomized controlled design, including 150 cases in the pulse magnetic stimulation+drug treatment group, 150 cases in the sham pulse magnetic stimulation+drug treatment group and 100 healthy controls. Before and after treatment, the patients were comprehensively measured and evaluated with Insomnia Severity Index (ISI), Hamilton Depression Rating Scale 17 (HAMD), Hamilton Anxiety Rating Scale (HAMA), Pittsburgh Sleep Quality Index (PSQI), Self-Rating Sleep Scale (SSRS), Self-Rating Symptom Scale 90 (SCL-90), Quality of Life Scale (SF-36), and Treatment Adverse Reaction Scale (TESS), and sleep monitoring was conducted at the same time, To explore the therapeutic effect of pulse magnetic therapy system detector combined with drug therapy on patients with anxiety and insomnia.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who met the diagnostic criteria for anxiety disorder in the Diagnostic and Statistical Manual of Mental Disorders (Fifth edition; DSM-5) and were accompanied by insomnia with 14 \<HAMA\<21 , HAMD\<17 , and PSQI\>7 ;
2. Education level is unlimited;
3. Age: 18-55 years old.

Exclusion Criteria:

1. Have bipolar disorder, schizophrenia, depression and other mental diseases;
2. Have a clear history of head trauma, alcoholism, brain tumors, diabetes, hypertension, and serious primary heart, liver, kidney, and blood system diseases;
3. At present, patients with sleep disorders are being treated by other means besides drugs;
4. Pregnant and lactating women;
5. Have a history of seizures or strong positive family history of epilepsy;
6. Implantation of cardiac pacemaker;
7. Those receiving deep brain stimulation treatment;
8. There are metal or magnetic implants in the body (including but not limited to the brain);
9. Participated in clinical trials of other drugs and medical devices in recent 3 months;
10. Other researchers believe that they do not meet the conditions for inclusion.
A Study to Evaluate the Safety and Effect of CFZ533 on Patients With Graves' Disease

An open label study to evaluate the safety and efficacy of CFZ533 following 12 weeks treatment in patients with Graves' disease


Eligibility Criteria:
Key Inclusion Criteria:

* Male and female patients 18 to 65 years of age included.
* Women of child-bearing potential must be willing to use highly effective methods of contraception during the study treatment epoch and for 12 weeks after the last study treatment.
* Graves' hyperthyroidism, with the following labs measured at screening:
* TSH\<LLN and either FT3\>ULN or FT4\> ULN and
* TRAb ≥ 2.5 IU/L
* Patients must weigh at least 40 kg to participate in the study

Key Exclusion Criteria:

* History of treatment of Graves' disease with radio-iodine ablation or thyroidectomy and/or current treatment with anti-thyroid drugs (methimazole or propylthiouracil) within one week of starting the study treatment
* History of hyperthyroidism not caused by Graves' disease (e.g. toxic multinodular goiter, autonomous thyroid nodule, or acute inflammatory thyroiditis) and/or history or presence of thyroid storm (fever, profuse sweating, vomiting, diarrhea, delirium, severe weakness, seizures, markedly irregular heartbeat, yellow skin and eyes (jaundice), severe low blood pressure, and coma).
* Previous treatment with a B cell-depleting biologic agent or any other immune-modulatory biologic agent within 5 half-lives (experimental or approved).
* History of recurrent clinically significant infection or of recurrent bacterial infections with encapsulated organisms.
* History of primary or secondary immunodeficiency, including a positive HIV (ELISA and Western blot) test result.
* History or evidence of tuberculosis by either of the following tests:
* Positive PPD skin test (size of induration measured after 48-72 hours, and a positive result is defined as an induration of ≥ 5mm or according to local practice/guidelines) OR
* Positive QuantiFERON TB-Gold test
* Plans for immunization with a live vaccine within a 2-month period before enrollment or during the study period.
* Treatment with immunomodulatory drugs, such as cyclosporine A, methotrexate, and/or cyclophosphamide within 3 months from baseline. Glucocorticosteroid therapy with prednisolone up to 10 mg daily is permitted if patients are on stable dose for more than 3 months before enrollment in the study.
* Pregnant, breastfeeding females, and women of child bearing potential unless they are using highly effective contraception
Indications for Breast Reduction in the Public Health Care System

The overall purpose of the project is to create a scientific basis for which patients should be offered breast reduction in the public sector. More specifically , the project aims to:

* To examine the evidence for current national guidelines for breast reduction. The hypothesis is that BMI, breast volume, resection weight, and mental and physical symptoms affect the outcome of breast reconstruction, both in terms of complication risks, patient satisfaction and quality of life .
* To investigate which patients benefit the most from a breast reduction, in a health economic perspective. The starting point is that resources are limited and the purpose is to maximize the health effects for the patient at as low cost as possible. The hypothesis is that the health benefits, for the individual and society, are different depending on how big the breasts are and how much symptoms a patient has preoperatively.
* To examine back function and objective problems in women, with both natural and augmented breasts, with different body constitutions and volumes. The hypothesis is that a certain breast volume give rise to different physical symptoms in different women, depending on their other physical factors.
* To develop preferences for benign breast conditions that are treated in plastic surgery and for complications that the treatment can cause. Preferences are used to calculate QALY (quality-adjusted life years). Knowledge of preferences is essential for an analysis of healthcare needs.
* To examine women's experiences of how their breast hypertrophy affects them and their expectations of a breast reduction. The hypothesis is that the experience breast hypertrophy affects patients differently, and that expectations on a breast reduction can vary between different individuals.


Eligibility Criteria:
Inclusion Criteria:

* Breast volume \> 800 ml
* BMI\< 25 if under 50 years of age and BMI\<2 if over the age of 50
* Symptoms of breast hypertrophy
* Non-smokers

Un-operad controls:

-Symptoms of breast hypertrophy, but do not comply with the criteria above.

Augmented controls:

* Augmented breast volume \> 800 ml
* BMI\< 25 if under 50 years of age and BMI\<2 if over the age of 50

Exclusion Criteria:

* Inability to provide informed consent
* Inability to understand the Swedish language
* Age under 18 years
Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.

Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease patients. Volume overload is a predictor of mortality in PD patients. In this Randomized controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency bioimpedance device, to measure the level of overhydration in PD patients and explore its value in fluid management in peritoneal dialysis patients as well as their prognosis.

Optimal fluid management is one of the primary objectives of dialysis treatment, and there is significant concern that peritoneal dialysis (PD) patients can become progressively fluid-loaded with time on treatment, especially as residual kidney function declines. Body Composition Monitor (BCM) has the potential to enable better management of fluid balance. The investigators undertake a prospective, randomized, open-label, controlled trial to determine whether availability of longitudinal BCM measures help clinicians maintain stable fluid status over 24 months in 300 peritoneal dialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older but no older than 80 years.
* who had been on chronic peritoneal dialysis for more than 3 months.
* All of them have signed the informed consent.

Exclusion Criteria:

* were expected to stop PD treatment in 6 months;
* were amputees;
* had a cardiac pacemaker or metallic implants;
* had peritonitis one month before recruitment;
* treated together with hemodialysis;
* were during pregnancy or lactation;
* were positive with HIV;
* had serious diseases, including cancer, infection and liver cirrhosis, which were not suitable for the study.
Velcade (Bortezomib, PS-341) and Rituximab in Relapsed/Refractory Mantle Cell and Follicular Non-Hodgkin's Lymphoma

This study will determine the overall response rate and toxicity of rituximab and Velcade in combination in patients with relapsed or refractory mantle cell non-Hodgkin's lymphoma.

Rationale: Previous studies testing bortezomib and rituximab separately indicate these agents have some efficacy against mantle cell lymphoma (MCL). Bortezomib is a targeted cancer drug that blocks proteasomes. The proteasome is an enzyme complex existing in all cells that influences proteins controlling cellular processes. By blocking the proteasome, bortezomib disrupts biologic pathways such as those related to the growth and survival of cancer cells. Rituximab is a monoclonal antibody that attaches to a protein called the CD20 antigen that is found almost exclusively on the surface of B-cells with leukemia. Once rituximab attaches to the protein, the immune system activates to kill the malignant B-cells. The current study combines bortezomib and rituximab in patients with relapsed or refractory MCL.

Purpose: This study will evaluate the safety and efficacy of bortezomib and rituximab in patients with relapsed or refractory MCL. Blood, molecular, and tumor analysis will be conducted to provide researchers with information about areas such as rituximab resistance, the effects of bortezomib on cells associated with immune function, and protein alterations related to the cellular growth and death of MCL. In addition, the role of maintenance therapy and timing of administration in MCL will be assessed.

Treatment: Patients in this study will receive bortezomib and rituximab. Both drugs will be administered through intravenous infusions. There are two treatment periods in this study. The first is considered induction therapy where patients will receive bortezomib and rituximab intermittently over an eighteen week period. Lower dosages of rituximab will be given to patients at the beginning of the study to ensure no severe toxicity occurs. Those patients without disease growth after the eighteen weeks of treatments will continue with maintenance therapy. During this time period, patients will be given bortezomib and rituximab for up to one year and a half. Several tests and exams will be conducted throughout the study to closely monitor patients. Treatments will be discontinued due to disease growth or unacceptable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed mantle cell or follicular lymphoma
* Relapsed or refractory disease
* ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, 2 or 3

Exclusion Criteria:

* Pre-existing sensory or motor peripheral neuropathy
* No active or untreated CNS (Central Nervous System) lymphoma
* History of severe, life-threatening hypersensitivity or infusion reactions prior rituximab treatment.
Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins

Some of the fat (triglyceride) from the food humans eat gets stored in the bowel. This triglyceride can then be released into the blood when another meal is consumed or in response to hormones. How the gut hormone glucagon-like peptide-2 (GLP-2) and glucose release the triglyceride from the gut is not known. The research team in this study is interested in finding out how teduglutide (a degradation resistant form of GLP-2) ang glucose, given together, release stored triglyceride from the gut by evaluating how blood lipoproteins respond to teduglutide in healthy individuals.

The lipoprotein response will be performed in 15 healthy individuals recruited by newspaper advertisements. A member of the study team will explain the study in detail on visit 1, and if the individual is interested in participating, informed consent will be obtained and preliminary screening will occur. On visit 2 participants will receive a high fat liquid meal after an overnight fast. Hourly blood samples will be taken for 5 hours, followed by a subcutaneous teduglutide injection and simultaneous glucose drink. Following the injection and drink, blood samples will be taken every 15 minutes for the first hour and every 30 minutes for the subsequent 3 hours.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, aged 18 to 60 years.
* Body mass index 20 to 27 kg/m2

Exclusion Criteria:

1. Patients with active inflammatory bowel disease
2. Patients with pre-existing Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption
3. Patients with active bowel malignancy
4. Patients with diabetes mellitus or known/ suspected motility disorders of the gut
5. Patients with decompensated liver disease
6. Patients on ezetimibe or bile acid sequestrants
7. Patients who are pregnant or breastfeeding.
8. Patients with renal disease.
9. Patients on benzodiazepine.
10. Unstable cardiac or respiratory disease
11. Any changes to medication in the preceding month
12. Patients with hypersensitive to Revestive or any ingredient, active or a history of the drug within the last 5 years
13. Patients with GI malignancy (GI tract, hepatobiliary, pancreatic)