cyrilzakka/clinical-trials huggingface dataset:
Thalidomide Plus Chemotherapy Versus Chemotherapy Alone for Advanced Breast Cancer

Sixty advanced breast cancer patients are planed to enrolled in this clinical trial. Forty patients are enrolled into thalidomide plus chemotherapy group. Twenty patients are enrolled into chemotherapy alone group. There is no restriction on chemotherapy regimen and lines.

The study compares the combination of thalidomide and chemotherapy with chemotherapy alone for the treatment of stage IV breast cancer. Efficacy and safety of the chemotherapy-thalidomide combination will be evaluated. Assessing the isolated effects of thalidomide in a setting where pre and post treatment serum specimens can be obtained will provide essential information about the mechanisms by which vascular endothelial growth factor(VEGF) inhibition affects tumor growth, and represents an ideal opportunity to evaluate the molecular effects of thalidomide on breast tumor.

Eligibility Criteria:
1. inclusion criteria:

   * Women \>/= 18 and \< 65 years of age .
   * Histologically or cytologically confirmed breast cancer with evidence of metastatic disease. (Note: the participant must be recovered from any clinically significant toxicity thereof last therapy.)
   * ECOG performance status 0-2.
   * Adequate bone marrow, kidney and liver function.
   * ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
2. exclusion criteria:

   * Prior treatment with thalidomide.
   * Patients with HER2 positive disease.
   * Untreated and/or uncontrolled brain metastases.
   * Prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed.
   * Known HIV (Human Immunodeficiency Virus) infection.
   * Pregnant or breast-feeding women.
   * Bilateral invasive breast cancer.
   * Cardiac and thrombotic disease or risk for same as judged by Investigator.
   * Other serious illness or medical conditions such as (partial list- review with Investigator) history of significant neurologic or psychiatric disorders that would prohibit the understanding and giving of informed consent, active uncontrolled infection, active peptic ulcer, unstable diabetes mellitus or subjects with symptomatic, intrinsic lung disease resulting in dyspnea at rest.
Clinical Utility of Neuromodulation on Tinnitus

The aim of the present narrative review is to one of the first to critically evaluate the clinical effectiveness of neuromodulation as a therapeutic option for patients with tinnitus. Our method involves conducting a systemic review and the findings reported following PRISMA statement. Pubmed, Cochrane database and Google Scholar databases literature search was conducted for articles reporting the use of neuromodulatory interventions on tinnitus patients. Each article was evaluated using the Cochrane risk of bias tool.


Eligibility Criteria:
Inclusion Criteria:

* Tinnitus patients
* At least one of the neurofeedback methods
* Single and multi-center
* Randomized control trials and observational studies

Exclusion Criteria:

* Non-peer-reviewed papers, letters, editorials
* Not English language
Study of CB-839 (Telaglenastat) in Combination With Talazoparib in Patients With Solid Tumors

This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor CB-839 with the poly adenosine diphosphate ribose polymerase (PARP) inhibitor talazoparib in participants with advanced/metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

(Part 1)

-Documented incurable/locally advanced or metastatic solid tumors that have either relapsed or are refractory or intolerant to standard therapies of proven clinical benefit.

(Part 2) Meets 1 of the 3 defined cohorts:

* Cohort 1: Documented incurable/locally advanced or metastatic ccRCC
* Cohort 2: Documented incurable/locally advanced or metastatic defined as ER, PR negative (\<1%) and HER2 negative (immunohistochemistry 0 to 1+ or fluorescence in situ hybridization \[FISH\] negative)
* Cohort 3: incurable/locally advanced or metastatic CRC

For both Parts 1 \& 2:

* Recovery to baseline or ≤ Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 from toxicities related to the prior therapy
* Adequate renal, hepatic, and hematological function
* Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 evaluable disease (Part 1) or measurable disease (Part 2)
* Ability to provide written consent in accordance with federal, local and institutional guidelines
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

Exclusion Criteria for both Parts 1 \& 2:

* Prior treatment with CB-839 or a PARP inhibitor
* Unable to received oral medications
* Active and/or untreated central nervous system metastasis. Patients with treated brain metastases must have (1) documented radiographic stability of at least 4 weeks duration demonstrated on baseline central nervous system (CNS) imaging prior to study treatment and (2) be symptomatically stable and off steroids for at least 2 weeks before administration of any study treatment.
* Major surgery within 28 days prior to first dose of study drug
* Receipt of any anticancer therapy within the following windows: small molecule tyrosine kinase inhibitor therapy (including investigational) within the prior 2 weeks or 5 half-lives prior to C1D1, whichever is longer; any type of anti-cancer antibody or cytotoxic chemotherapy within 4 weeks prior to C1D1; radiation therapy for bone metastasis within 2 weeks prior or any other external radiation therapy within 4 weeks prior to C1D1; patients with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Development of a Decision Support System to Prevent and Treat Disease-related Malnutrition

The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. There is a lack of tools to follow up the nutritional treatment of these patients. The investigators develop the decision support system "MyFood" which can be used to assess patients' dietary intake, evaluate intake against individual needs, and propose nutrition related measures and an individual nutrition plan for each patient. The investigators will study the clinical effects of using MyFood among hospitalized patients. In addition the implementation of the tool among healthcare workers will be studied.

The prevalence of disease-related malnutrition among hospitalized patients is 30-50%. Disease-related malnutrition increase the morbidity and mortality among patients and leads to longer length of stay. There is a lack of tools to follow up the nutritional treatment of patients at nutritional risk. The decision support system "MyFood" is developed in the project with the purpose to prevent and treat disease-related malnutrition. MyFood includes 4 modules: 1) A function to register patient needs and symptoms, 2) Dietary assessment function, 3) Automatic evaluation of dietary intake compared to individual needs, 4) Feedback, including a report on intake of energy, protein, and liquids compared to individual needs, and recommendations for nutritional measures and an individual nutrition plan.

Clinical effects of using MyFood among hospitalized patients will be studied in a randomized controlled trial. In addition, the implementation of the tool among nurses and other healthcare workers will be explored.

Eligibility Criteria:
Exclusion Criteria:

* \<72 hours expected hospital stay
* Terminal patients
* Pregnant
* Psychiatric patients
* Patients who cannot read the Norwegian Language
* Patients diagnosed with: sickle cell anemia, haemophilia, or deep vein thrombosis
Screening in Trauma for Opioid Misuse Prevention

The current study seeks to begin the crucial work of creating effective protocols to prevent opioid misuse, addiction, and related complications by developing and pilot testing an opioid risk screening protocol at Wisconsin trauma centers.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient victim of traumatic injury
* Expected need for post-discharge outpatient opioid analgesia
* English speaking
* Disposition to short-term rehabilitation facility is allowed

Exclusion Criteria:

* Disposition to a skilled nursing or long-term acute care facility
* Current active opioid use disorder or current active participation in a program of recovery for another substance use disorder
Innovation of Custom-made Silicon Insoles for Diabetic Patient

"Diabetic foot ulcers, caused by diabetes-related nerve and blood vessel damage, can lead to amputations. Silicone insoles help prevent ulcers but are often expensive. Affordable, customized insoles are available, making prevention more accessible.

This research aims to create affordable, locally manufactured silicone insoles for diabetic foot ulcers, reducing costs and improving accessibility. six-month study at the Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged patients,
* Both genders will be included
* Diagnosed with diabetic ulcers/diabetes
* Reporting pain and mild ulcers on foot,

Exclusion Criteria:

* Recent history of foot injuries
* Presence of other musculoskeletal conditions affecting the foot
* Inflammatory conditions such as rheumatoid arthritis or gout
* Neurological conditions affecting foot or leg functions
KOPPeling: Help From Your Own Circle

The goal of this randomized clinical trial is to test the effectiveness of the KOPPeling intervention that aims at unburdening COPMI (Children Of Parents with a Mental Illness). COPMI are at risk of overtaking the tasks of their parents when their parents are unable to fulfil such due to their psychiatric condition. By overtaking tasks and the urge to always take care of their parents, COPMI often do not participate in outdoor activities, which are necessary for their socio-emotional development. Moreover, insufficient socio-emotional development and parentification are risk factors for the development of psychiatric conditions.

KOPPeling is an intervention for COPMI families that focuses on activating the social networks of the families. Within KOPPeling, a strategic plan will be developed and carried out with the goal of receiving support from the social network that will overtake tasks of the family to unburden COPMI.

This study aims to answer the following questions:

1. To what extent does KOPPeling lead to an increase in Quality of Life (QoL) among COPMI?
2. To what extent does KOPPeling lead to an increase in mental health among COPMI?
3. To what extent does KOPPeling lead to a reduction of parenting stress among COPMI parents?
4. To what extent does KOPPeling lead to an increase in outdoor activities among COPMI?
5. How does KOPPeling affect the feelings of guilt of COPMI when engaging in outdoor activities?
6. What pre-conditions are needed to make KOPPeling widely applicable?
7. What are the long-term effects of KOPPeling on the QoL and psychological problems among COPMI and parental stress among COPMI parents?

Participants will participate in the ten-to-twelve-week long KOPPeling intervention. Researchers will compare the intervention group with a waiting list control group to test the effect of KOPPeling on the QoL and mental health of COPMI and parental stress of parents.


Eligibility Criteria:
Inclusion Criteria:

* The family has children aged 0-18 living at home
* The parental disorder influences the parent's (or parents') ability to carry out several important parental tasks, placing their offspring at risk of taking over these tasks

Exclusion Criteria:

- The family has no existing social network
Prediction of Outcome of Non Invasive Ventilation COPD Patients by Assessment of Diaphragmatic Performance

Transthoracic ultrasonographic assessment of the diaphragmatic performance as a predictor for the outcome of NIV in critically ill COPD patients with acute exacerbation.

Chronic obstructive pulmonary disease (COPD) is considered a common disease worldwide, and it poses a major health and economic problem.

COPD was the fifth leading cause for death in 2022 and will rank third by 2030. So, it's considered a devastating disease for patients and their loved ones .

Patients presented with acute exacerbations of COPD may need respiratory intensive care unit (RICU) admission. Non invasive ventilation (NIV) is considered a cornerstone management option in patients with acute exacerbation of COPD (AECOPD). Therefore, early prediction of NIV failure may help in decision making regarding escalation to invasive mechanical ventilation To date, the diaphragm is the main respiratory muscle, and derangement of it's function is an important factor in the pathophysiology of COPD COPD patients have increased airway resistance and airflow limitation, which in turn increases the mechanical load of breathing exerted on the diaphragm Diaphragmatic weakness in COPD patients results from decreased muscle strength and mobility . Although, diaphragmatic performance is a key determinant of dyspnea in COPD patients, it is rarely assessed in clinical practice In practice, only vital sign such as respiratory rate and arterial blood gases parameters (ABG) such as PH, PaO2, PaCO2, SPO2, and fiO2/paO2 are considered predictors of NIV outcome.

Assessment of diaphragmatic function transthoracic ultrasound (TUS) is a reliable, safe and bed side method for prediction of NIV outcome . Several tools commonly applied to determine diaphragmatic function such as; fluoroscopy, Computed tomography (CT), transdiaphragmatic pressure measurement, phrenic nerve stimulation, and electromyography can't be routinely used in intensive care units due to technical challenges and limitations

Eligibility Criteria:
Inclusion Criteria:

* One Hundred fifty five critically ill COPD patients admitted to respiratory intensive care unit
* Diagnosis of COPD and COPD exacerbation is fulfilled according to GOLD 2022 criteria
* Age\>40years

Exclusion Criteria:

* Age ˂ 40 years.
* Refusal to participate in the study.
* Patients with morbid obesity (BMI\>40).
* Absolute indication for intubation like coma ,hemodynamic instability, or life threatening arrhythmia.
* Contraindication to NIV like untreated pneumothorax, pneumothorax with air leak, widespread facial burn or trauma, tracheotomy, or active upper gastrointestinal bleeding.
Safety and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Subjects Co-Infected With Hepatitis C Virus (HCV) and HIV

The purpose of this study is to determine whether the combination of telaprevir, peginterferon alfa-2a, and ribavirin is safe and effective in treating hepatitis C virus (HCV) infection in subjects who are infected with both HCV and human immunodeficiency virus (HIV).


Eligibility Criteria:
Inclusion Criteria:

* Chronic, genotype 1, hepatitis C with detectable HCV RNA
* HIV-1 infection for \>6 months
* Documentation of a liver biopsy within 1 year before the screening visit showing evidence of hepatitis (demonstrated by inflammation and/or fibrosis)

Exclusion Criteria:

* Previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
* Previous treatment with interferon or ribavirin
* Evidence of hepatic decompensation in cirrhotic subjects
* Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months
* Part A only: subjects who have been on a HAART regimen within 12 weeks before study start
Impact Study of Community Based Treatment of Neonatal Infection by Health Extension Workers on Neonatal Mortality

The purpose of the study is to determine whether community based management of infections with antibiotics administered by health extension workers reduce all cause mortality in neonates after the first day of life compared to current MOH IMNCI model of referral to hospital

Although 44% of neonatal deaths in Ethiopia are due to infection, access to treatment for neonatal infections is very low for most families. Even though the newly adapted Integrated Management of Newborn and Childhood Illness (IMNCI) package includes assessment of newborns, if a baby has any danger signs that may be suggestive of infection and is taken to health posts, the baby is to be referred to hospital for treatment. Given that only about 5% of neonatal deaths occur in hospitals and the distance to hospital is often far and the costs prohibitive, very few babies are likely to receive essential lifesaving antibiotics. Evidence from India, Bangladesh, and Nepal demonstrates that community health workers can effectively manage neonatal infections at home. However it is not known whether and community-based management of neonatal infections is effective, feasible and acceptable in the Ethiopian context. Local evidence regarding lives saved and cost is required in order to inform health policy and programming regarding community-based treatment of neonatal infections.

Eligibility Criteria:
Inclusion Criteria:

* Participants who give consent to be treated at Health Post by Health extension worker

Exclusion Criteria:

* If Newborn is Critically sick
Neurodegeneration in Newborns After Anesthetics

The purpose of the study is to quantify biomarkers of neural damage in neonates exposed to varying levels of volatile anesthetic in utero.

This study will enroll 130 pregnant patients undergoing C-section or fetal surgery with EXIT (Ex Utero Intrapartum Treatment) procedures under epidural or general anesthesia with low (0.75 MAC) or high (2.5 MAC) concentrations of desflurane. Patients will be recruited from both the Hospital of the University of Pennsylvania (100 C Section) and Children's Hospital of Philadelphia (30 EXIT procedure).

The standard of care protocol for patients undergoing anesthesia for these cases will be followed throughout the surgery. These include monitoring and management of blood pressure, heart rate and rhythm, ventilation, oxygenation, temperature, and fluid status. Management of these parameters will be at the discretion of the clinical team. The choice of the anesthetic technique will also be at the discretion of the clinical team. Typical anesthetic management includes the following:

C-section under epidural anesthesia: induction and maintenance with 1.5% lidocaine, sodium bicarbonate and 1:200,000 epinephrine

C-section under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 4.5-5%

EXIT procedure under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 15-18%

1. After the baby is delivered, and the umbilicus is cut, two ml of blood will be taken from the umbilical vein and artery on the placenta side. A portion of the blood will be used for the blood gas and the remainder will be used for the S100B study assay.
2. 5 ml of blood will be taken from the mother via the existing intravenous catheter.
3. 5 ml of amniotic fluid will be obtained at hysterotomy and will be used for the S100B study assay.

All subjects will receive standard of care post operative clinical care and monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. Women delivering a child via cesarean section or EXIT procedure
2. Informed consent

Exclusion Criteria:

1. Known fetal neurologic defect
2. Known maternal neurologic abnormality
3. Sensitivity or allergy to medications used in the study

   1. C-section under epidural anesthesia: induction and maintenance with 1.5% lidocaine, sodium bicarbonate and 1:200,000 epinephrine
   2. C-section under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 4.5-5%
   3. EXIT procedure under general anesthesia: induction with propofol 2 mg/kg and succinylcholine 2 mg/kg intravenously; maintenance with desflurane 15-18%
Bioavailability of Folate From a Mixed Diet Using a Stable Isotope Method

The main objectives of this project are:

1. to determine the relative bioavailability of dietary folate from a total diet, compared with synthetic folic acid and
2. to determine the bioavailability with a higher precision than previous methods.

The hypothesis is that the bioavailability of dietary folate within a confidence interval of +/-20% can be estimated.

Folate plays a role in the prevention of certain birth defects and possibly also in prevention of neurocognitive diseases, cancer and cardiovascular disease. The proportion of dietary folate that is absorbed and becomes available for metabolic processes in the body has been estimated between 30 and 98%, but an accurate figure is lacking. Since subjects generally differ a lot in their folate or homocysteine response upon a change in dietary folate intake, the between-person variability in these responses is high. Therefore, bioavailability estimates derived from these responses have large confidence intervals. With this trial the researchers want to determine folate bioavailability with a higher precision than previous trials. A good estimate of folate bioavailability from the general diet is necessary to construct reliable dietary reference intakes for folate.

Eligibility Criteria:
Inclusion Criteria:

* Serum B12 \>118pmol/L;
* Serum creatinine \<125micromol/L;
* Plasma total homocysteine \<26micromol/L.

Exclusion Criteria:

* Cardiovascular disease, cancer, rheumatoid arthritis, epilepsy, gastro-intestinal disorders;
* Use of drugs interfering with folate metabolism;
* Use of B vitamins within the period three months prior to the study.
* Body Mass Index (BMI) \> 30
A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children

The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female asthmatic children with mild to moderate persistent asthma.
* 12 months to 8 years of age.
* For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
* For infants age 12 to \<48 months old: 2 or more wheezing episodes in past 12 months which lasted \> 1 day and affected sleep.
* AND with at least one major or two minor risk factors.

Exclusion Criteria:

* Any other significant childhood illness/abnormality or chronic lung disease
* Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
* Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
* Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
* Any use of oral corticosteroids within 30 days of screening or prolonged use (\>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.