cyrilzakka/clinical-trials huggingface dataset:
6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab

An open-label, randomized three-arm Phase II trial to explore the efficacy of BIBW 2992 as a single agent versus lapatinib versus trastuzumab in patients with HER2-positive treatment-naïve Stage IIIa locally advanced breast cancer. Additional information will be obtained on the safety profile and pharmacokinetics of BIBW 2992.


Eligibility Criteria:
Inclusion criteria:

1. Female, age 18 years or older.
2. Histologically proven breast cancer who have not received any prior therapy.
3. Locally advanced disease Stage IIIa with no evidence of distant metastatic disease other than anatomical site lymph nodes.
4. HER2-positive.

Exclusion criteria:

1. Absolute neutrophil count (ANC) less than 1500/mm3.
2. Platelet count less than 100 000/ mm3.
3. Hemoglobin level less than 9.0 g/dl.
4. Bilirubin greater than 1.5 mg/dI.
5. Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than twice the upper limit of normal.
6. Serum creatinine greater than 1.5 times of the upper normal limit.
7. Significant or recent acute gastrointestinal disorders with diarrhea
8. Pregnancy or breast-feeding.
9. Organ system dysfunction including cardiac (LVEF \< 50%).
10. Prior chemotherapy, radiotherapy or hormone therapy. Previous treatment with trastuzumab, EGFR, or EGFR/HER2-inhibitors.
11. Other malignancies diagnosed within the past five years.
12. Serious active infection. HIV, active hepatitis B or C.
Social Network Outcomes of a Livelihood Intervention for Impoverished Women in Rural Uganda

The objective of our study is to determine whether a livelihood intervention can change economic and psychosocial outcomes of social network ties and geographically proximate neighbors of impoverished women in rural Uganda.


Eligibility Criteria:
Inclusion Criteria:

* Eligibility will be limited to all adults living in Nyakabare Parish (i.e., aged 18 years and older), including emancipated minors. Emancipated minors will be defined as persons living below 18 years of age who are married, are pregnant, live with a biological child in the household, or are responsible for their own livelihood.

Exclusion Criteria:

* Persons under the age of 18 (other than emancipated minors as described above) and persons who do not live within Nyakabare Parish will not be permitted to participate.
Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy

The purpose of this study is to evaluate the retention in tumour and distribution behavior of \[Lu-177\]-Catalase after intratumoral injection,and preliminary evaluation the efficacy and safety of \[Lu-177\]-Catalase.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. At day1, patients who meet the eligibility requirements will be intratumoral injection the \[Lu-177\]-Catalase.The efficacy evaluation will be conducted at one month p.i., whether to continue intratumoral injection the \[Lu-177\]-Catalase, depending on the patient's efficacy and safety results.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients, aged 18-70 years; ECOG score 0 or 1;
2. Patients with advanced malignant tumors, such as liver cancer, ovarian cancer, prostate cancer, and so on, clearly diagnosed by pathology and/or cytology;
3. Patients with advanced solid tumors who have failed or cannot tolerate standard treatment;
4. Expected survival of more than 3 months;
5. According to the solid tumor efficacy evaluation criteria , the patient had at least one measurable or evaluable tumor lesion with the longest diameter ≥10 mm at baseline (in the case of lymph nodes, the short diameter ≥15 mm). This lesion is suitable for intratumoral injection (the length of the lesion is at least 1 cm or equal).
6. Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC≥4.0×109L or neutrophil ≥1.5×109L, PLT≥100×109/L, Hb≥90g/L; PT or APTT≤1.5ULN; Liver and kidney function: T-Bil≤1.5×ULT(upper limit of normal),ALT/AST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤ 4.5ULN if there is bone metastasis or liver metastasis); BUN≤1.5×ULT, SCr≤1.5×ULT;
7. Women must use effective contraception during the study period and for 6 months after the study (effective contraception means sterilization, intrauterine hormone devices, condoms, contraceptives/pills, abstinence or partner vasectomy, etc.); Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period;
8. Can understand and voluntarily sign informed consent, compliance is good

The Exclusion Criteria:

1. Severe abnormal liver and kidney function;
2. Pregnant, pregnant and lactating women;
3. Can not lie flat for half an hour;
4. Refuse to join the clinical investigator;
5. Suffering from claustrophobia or other mental illness;
6. Other conditions deemed unsuitable for participation in the trial by the investigator
Randomized Controlled Trial of an Eczema Care Plan

The objectives of this project are to increase families' understanding of eczema and improve eczema management in the primary care setting. We have created an "Eczema Care Plan" similar to those used in the management of asthma. It gives specific instructions about medications, bathing and moisturizing, as well as when to seek further treatment. We will conduct a randomized controlled trial of the plan in Primary Care at Longwood for a 10 month period. Specifically, we aim to (1) decrease eczema severity (2) improve patient quality of life and (3) increase parental knowledge and confidence about eczema management. We also plan to track provider uptake and documentation of the plan and elicit feedback from parents and providers on the utility and feasibility of the plan.


Eligibility Criteria:
Inclusion Criteria:a) accompanying adult speaks English b) patient has a history of eczema c) patient is between the ages of 1 month and 16 years d) family is coming for an eczema visit or plans to discuss eczema e) accompanying adult is a primary caregiver f) child is not in foster care g) caregiver has not received an eczema care plan previously. -

Exclusion Criteria: a) accompanying adult does not speak English b) patient does not have a history of eczema c) patient is younger than 1 month or older than 16 years of age d) eczema will not be discussed at the visit e) accompanying adult is not the primary caregiver f) child is in foster care g) caregiver has received an eczema care plan previously.
Circulating Tumor DNA to Monitor Response to Neoadjuvant Chemotherapy in Breast Cancer

Investigators aim to investigate whether circulating tumor DNA is a sensitive marker to evaluate patients' response to neoadjuvant chemotherapy

Neoadjuvant chemotherapy(NAC) is traditionally for locally advanced disease, converting an inoperable to a resectable tumor.In recent years, it has become an option for patients of lower tumor stage to increase the possibility of breast conserving therapy. An effective method to monitor the response to NAC is important.

Eligibility Criteria:
Inclusion Criteria:

* Female patients undergoing NAC
* Age: 18-70 yrs
* Any menopausal status
* Any hormal receptor status

Exclusion Criteria:

* Metastasis discovered during NAC
* Lost more than 2 blood samples during NAC and surgery
Prospective, Monocentric, Interventional Study on Spontaneous Vaginal Clearance of Mycoplasma Genitalium

It is a prospective, monocentric, interventional study on spontaneous vaginal clearance of Mycoplasma genitalium.

The main objective is to evaluate the spontaneous vaginal clearance of M. genitalium in patients coming to perform a voluntary termination of pregnancy at the University Hospital of Bordeaux at 9 weeks after a vaginal sample positive for M. genitalium

Mycoplasma genitalium is a bacterium that colonizes female genital tract and can be responsible for sexually transmitted infection . M. genitalium can cause cervicitis and more rarely high genital infections.

In the vast majority of cases, presence of M. genitalium is not accompanied by any symptoms and women do not develop disease. Natural history of M. genitalium infection is not well documented. Some studies have shown a natural clearance of infection in women. The published work mainly concerns patients at very high risk of sexually transmitted disease, but we do not have French data.

We propose to study the natural clearance of M. genitalium infection in patients consulting at the Orthogeny Centre of the University Hospital of Bordeaux. Results of this work will allow us to have a better knowledge of the natural history of M. genitalium infection.

Eligibility Criteria:
Inclusion Criteria:

* Patient selected during the first consultation, pre-abortion, and having a vaginal swab positive to M. genitalium.
* Patient hospitalized for an abortion at the University Hospital of Bordeaux.
* An affiliated patient or beneficiary of a social security system.
* Signing free and informed consent.

Exclusion criteria:

* Patient with vaginal co-infection with C. trachomatis.
* Patient with symptoms of high genital infection.
* Taking fluoroquinolones, macrolides or tetracyclines within 21 days of inclusion.
* Patient under legal protection.
Creatine to Augment Bioenergetics in Alzheimer's

By doing this study, researchers hope to see if creatine monohydrate is a helpful treatment for people with Alzheimer's disease.

Alzheimer's disease is a progressive brain disorder that causes memory and thinking problems. Current medications may temporarily help with symptoms but cannot stop the disease from getting worse. As such, new treatments that slow or stop the disease from progressing are needed.

There is some evidence from animal studies that taking creatine monohydrate may improve thinking in Alzheimer's disease and be good for brain health. However, no studies have looked at creatine monohydrate supplementation in humans with Alzheimer's.

Creatine monohydrate is a dietary supplement regulated by the FDA. This is a study that will test if taking creatine monohydrate may be a helpful treatment for people with Alzheimer's disease. In this study, investigators will will evaluate:

1. Whether persons with Alzheimer's disease are able to easily take creatine monohydrate for 8 weeks.
2. Whether creatine monohydrate affects thinking function in people with Alzheimer's Disease.
3. Whether creatine monohydrate affects certain biochemicals in the brain and body.
4. Whether creatine monohydrate improves muscle size and strength.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cognitive impairment due to Alzheimer's disease
* Agreed cooperation from a study partner
* Speaks English as primary language
* Age 60 to 90
* Stable medication for ≥30 days
* BMI ≥ 20.0kg/m2

Exclusion Criteria:

* Insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or recent cardiac event (i.e., heart attack, etc.)
* Other neurodegenerative disease
* Ongoing renal disorder or abnormal renal or liver function
* Unable to undergo MRI
* Clinical trial or investigational drug or therapy participation within 30 days of the screening visit
* Non-English speakers
* Inability to perform strength testing
* Weight \> 350 lbs.
Sipuleucel-T and Ipilimumab for Advanced Prostate Cancer

This is a clinical trial designed to quantify the immune response and determine the tolerability and side effects of sipuleucel-T when given in combination with ipilimumab for patients with advanced prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with advanced prostate cancer who are eligible to receive sipuleucel-T in accordance with FDA approved labeling of sipuleucel-T
* Subjects must understand and sign an informed consent form

Exclusion Criteria:

* Subjects who are not eligible to receive sipuleucel-T
Exploring Clinical Study Experiences of People With Depression

The study seeks to delve into the firsthand experiences of patients diagnosed with depression who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.

By joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future depression patients and play an active role in advancing medical research.


Eligibility Criteria:
Inclusion Criteria:

* Patient has self-identified as planning to enroll in a clinical trial
* Patient has been diagnosed with depression
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant
Comparison of Transversalis Fascia Plane Block and Erector Spinae Plane Blocks in Cesarean Section

Cesarean section is one of the most common major surgical procedures performed worldwide,, Post-cesarean analgesia should provide adequate pain control while allowing the mother to remain active to meet the needs of the baby. Insufficient analgesia after cesarean section may be associated with acute postoperative pain, chronic pain, higher opioid consumption, delayed functional capacity, and postpartum depression. Techniques such as neuraxial techniques, oral and intravenous agents, wound infiltration, and behavioral therapy can be used in the treatment of post-cesarean pain pain. In addition, Transversus abdominis plane block (TAP), Quadratus Lumborum block (QLB), Erector Spina block (ESP), Transversalis Fascia plane block (TFP) are used safely under ultrasound guidance. In this study, it was aimed primarily to examine the effects of TFP and ESP blocks on pain scores, and secondarily to evaluate analgesic consumption.


Eligibility Criteria:
Inclusion Criteria:

* Between 18-50 years
* Cesarean Section

Exclusion Criteria:

* Cesarean Section under general anesthesia
* emergency cases
* those with a body mass index greater than 35 kg/m2
* coagulopathy
* local infection
Local Assessment of Ventilatory Management During General Anesthesia for Surgery

Objectives

1. To characterize mechanical ventilation practices during general anesthesia for surgery
2. To assess the dependence of intra-operative and post-operative pulmonary complications on intra-operative Mechanical Ventilation (MV) settings

Research questions

* What MV-settings are used during general anesthesia for surgery?
* Do MV-settings vary in and/or between centers?
* Do MV-settings vary internationally?
* Are MV-settings associated with incidence of intra-operative pulmonary complications?
* Are MV-settings associated with incidence of post-operative pulmonary complications?

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* All surgical procedures requiring invasive mechanical ventilation (MV)during general anesthesia for laparoscopic or non-laparoscopic surgery.
* This includes MV performed with supra-glottic devices (e.g. laryngeal mask)
* This includes patients receiving MV at the onset of the procedure (e.g. Intensive Care Unit patients)
* This includes patients who will receive one-lung ventilation during the procedure

Exclusion Criteria:

* Obstetric surgical procedures or any procedure during pregnancy
* Surgical procedures outside the operating room
* Surgical procedures involving extra-corporal circulation
A Cohort of Maternal Vascular Malperfusion-related FGR (CoMVMFGR)

Based on a precise diagnostic standard process, through a multicenter study, we will establish a cohort focusing on placenta-mediated fetal growth restriction (FGR). Long-term follow-up will be conducted to seek predictive indicators for short-term and long-term adverse outcomes of maternal vascular malperfusion-related FGR (MVM-FGR).

Fetal Growth Restriction (FGR) denotes the inability of fetal growth to attain its inherent genetic potential due to diverse pathological influences. It stands as a significant determinant of morbidity and mortality during the perinatal phase, intricately linked with adverse long-term consequences. The etiology of FGR is complex, involving maternal, placental/umbilical, and fetal factors. Among these, maternal vascular malperfusion-related FGR (MVM-FGR) emerges as the prevalent subtype, which is considered to have potential for early intervention and prevention.

To address this, we will establish a cohort dedicated to MVM-FGR, guided by a stringent diagnostic standard process tailored for FGR. Our objective is to compile a comprehensive dataset of singleton pregnancies diagnosed with MVM-FGR cases through multicenter collaboration. The definition of FGR aligns with the FIGO consensus criteria. We conduct thorough prenatal screenings for fetal factors, including genetic abnormalities, infections, and structural anomalies, subsequently enrolling MVM-FGR cases into our cohort.

Techniques including Doppler ultrasound, magnetic resonance imaging (MRI), and electronic fetal heart monitoring will be employed to assess fetal conditions. Follow-up continues until the child reaches the age of two years postpartum. Pathological examination of the placenta is performed after delivery, with additional placental genetic testing if necessary.

Eligibility Criteria:
Inclusion Criteria:

1.Singleton pregnancy 2. diagnosed as FGR according the delphi consensus:

1. Early-onset FGR(\<32 weeks) Estimated fetal weight (EFW) or abdominal circumference (AC) \< 3rd; or EFW or AC \< 10th, combined with abnormal doppler, including uterine artery pulsatility index(UtA PI) \>95th percentile, umbilical artery pulsatility index(UA PI) \>95th percentile； or umbilical artery absent end-diastolic flow (UA-AEDF) or umbilical artery reversed end-diastolic flow(UA-REDF).
2. Late-onset FGR(≥32 weeks) Estimated fetal weight (EFW) or abdominal circumference (AC) \< 3rd; or \>2 of the following 3 criteria:

   * EFW or AC \<10th percentile
   * EFW or AC crossing percentiles\>2 quartiles on growth percentiles
   * CPR \<5th percentile or UA-Pl\>95th percentile 3.provision of signed written informed consent.

Exclusion Criteria:

* Fetus with definitive genetic disorders related to FGR, fetus with confirmed intrauterine infection (CMV, syphilis and etc.), fetus with structural anomalies
* Incomplete information or absence of informed consent
Progesterone Levels During Ovulation and Luteal Phase

Natural cycles are evaluated during fertility treatments for different therapeutic options, like insemination (IUI), time intercourse (TI) or frozen-thawed embryo transfers (FET). Two possible protocols can be used for natural cycles, with or without hCG trigger. Usually, studies including natural cycles consider both options as equivalent, not considering the possible bias that the exogenous hCG (human chorionic gonadotrophin) might have. In this prospective study, Investigators aim to evaluate the differences in the hormonal profile during the ovulation when it occurs spontaneously vs triggered with a bolus of hCG.

For the pure natural cycle (PNC), ovulation will be detected by a combination of ultrasound monitoring the follicular growth and serial measurement of luteinizing hormone (LH), estradiol (E2) and progesterone (P4) levels, which is recognised to be the most accurate method of correctly identifying ovulation.

For the modified natural cycle (MNC), a bolus of rhCG 6500 IU subcutaneous (sc) will be administered when 1 dominant follicle reaches 17mm or above, after excluding previous LH surge. This is the first prospective study where the differences on the hormonal profile for ovulation will be studied.

HYPOTHESIS:

H0: The hormonal profile is not different between the PNC and the MNC H1: The hormonal profile is different between the PNC and MNC

Administration of hCG is a popular method for triggering ovulation since it may avoid the need to perform IUI or FET at weekends. However, it is an intervention compared with the detection of the spontaneous LH rise. Moreover, due to the presence of hCG receptors in the human endometrium, administration of hCG might interfere with endometrial receptivity. Previous publications evaluating pregnancy rates demonstrated that the use of hCG injection during the natural cycle reduces the pregnancy rates, in FET and IUI. It remains unclear what might be the mechanism to explain the lower pregnancy rates: a possible direct effect of hCG on the hCG receptors of the endometrium or a modification of the hormonal profile after the administration of the hCG, affecting the window of implantation (WOI).

Eligibility Criteria:
Inclusion Criteria:

* Healthy women below 40 years
* Regular and Ovulatory cycles

Exclusion Criteria:

* Previous adnexal surgery
* Endometriosis
* PCOs
* Using hormonal contraception during the previous 2 months: OCP, progesterone IUD
Elucidating the Molecular and Biochemical Basis of the Human AhR-mutation Disease

In a previous study, we have identified a consanguineous family from Northern Israel with three children affected by idiopathic infantile nystagmus (IIN) and foveal hypoplasia, which follow an autosomal recessive mode of inheritance of AhR gene. in this study we will determine whether the disease phenotype is the consequence of a decrease in or absence of AHR-induced AHH activity

In a previous study, we have identified a consanguineous family from Northern Israel with three children affected by idiopathic infantile nystagmus (IIN) and foveal hypoplasia, which follow an autosomal recessive mode of inheritance of AhR gene. in this study we will:

1. To determine whether the disease phenotype is the consequence of a decrease in or absence of AHR-induced AHH activity. To this end, basal and ligand-mediated AHH enzyme activity will be compared in heterozygotic and homozygotic family members versus healthy volunteers.
2. To examine steady state protein levels of the AHR protein in cells of homo- and heterozygotic patients versus those of healthy volunteers. If no mutant protein is detected, we will determine the effect of the mutation on mRNA stability.
3. To analyze steady state levels of related partner proteins (such as ANRT) and proteins levels of transcriptional targets (AHH) in heterozygotic and homozygotic family members versus healthy volunteers.
4. To investigate the ability of the mutant allele to induce transcriptional activation in an engineered yeast test system. We will use a yeast strain engineered to contain human AHR and AHR nuclear translocator together with a reporter gene to investigate whether the mutation interferes with transcription activation.

Eligibility Criteria:
Inclusion Criteria:

* patients with mutation in AhR gene

Exclusion Criteria:

* None