cyrilzakka/clinical-trials huggingface dataset:
Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer

This study will evaluate the safety, tolerability and efficacy of anlotinib and trastuzumab deruxtecan in human epidermal growth factor receptor 2 (HER2)-low unresectable and/or metastatic breast cancer who had received ≤1 line of prior chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18 - 75 years; ECOG PS 0 or 1. 2. Pathologically documented breast cancer that:

  1. Is unresectable or metastatic.
  2. Has a history of low HER2 expression (IHC 1+\& IHC 2+/ISH- or 0\<IHC\<1+).
  3. Is HR-positive or HR-negative.
  4. Has progressed on, and would no longer benefit from, endocrine therapy.
  5. Has been treated with ≥1 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting.

     3. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1（Previously treated lesions with radiotherapy or focal therapy and no progression cannot be included as target lesion for assessment）.

     4. Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.

     5. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 6 months.

     Exclusion Criteria:
     1. Has previously been treated with anti-angiogenic targeted small molecule therapy.
     2. Prior treatment with antibody drug conjugate with a topoisomerase I inhibitor exatecan derivative.
     3. Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
     4. Has unresolved toxicities from previous anticancer therapy.
     5. Has uncontrolled or significant cardiovascular disease.
     6. Has any bleeding event, unhealed wounds, ulcerative or fractures.
     7. Has arterial or venous thromboembolic events occurred within 6 months.
     8. Has spinal cord compression or clinically active central nervous system metastases.
     9. Has any other condition that per protocol or in the opinion of the investigator is inappropriate for the study.
Drugs to Reduce the Side Effects of Chemotherapy

RATIONALE: Antiemetic drugs may help to reduce or prevent nausea and vomiting in patients treated with chemotherapy. It is not known whether receiving dexamethasone with granisetron is more effective than receiving dexamethasone with metoclopramide for reducing the side effects of chemotherapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of dexamethasone with either granisetron or metoclopramide in patients treated with chemotherapy.

OBJECTIVES: I. Compare the clinical efficacy and safety of Granisetron or Metoclopramide in combination with Dexamethasone in the prophylaxis of delayed nausea and vomiting induced by emetogenic cancer chemotherapy in patients with or without emesis in the acute phase.

OUTLINE: This is a randomized, double blind study. Patients are stratified by prior chemotherapy (yes vs no), regular alcohol consumption (yes vs no), and prior chemotherapy regimen (cisplatin/carboplatin vs others). Patients receive dexamethasone and granisetron by mouth bid on day 0. Patients are then randomized to receive either granisetron or metoclopramide with dexamethasone concurrently with chemotherapy. Arm I: Patients receive granisetron by mouth bid on days 1-5. Dexamethasone and a placebo are administered by mouth once daily on days 1-5. Arm II: Patients receive metoclopramide by mouth tid on days 1-5. Dexamethasone is administered by mouth once daily on days 1-5. Patients must complete a diary card daily for 6 days.

PROJECTED ACCRUAL: This study will accrue 360 patients.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Scheduled to receive a first course of highly emetogenic single day cancer chemotherapy regimens including: Cisplatin at least 50 mg/m2 Carboplatin at least 300 mg/m2 Dacarbazine at least 500 mg/m2 Doxorubicin at least 40 mg/m2 Epirubicin at least 60 mg/m2 Ifosfamide at least 1200 mg/m2 Cyclophosphamide at least 600 mg/m2

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Must be able to complete diary card (fluent in German, French, or Italian) No severe concurrent illness No other etiologies that cause vomiting, including: Gastrointestinal obstruction Hypercalcemia CNS metastases No active peptic ulceration No prior gastrointestinal bleeding due to peptic ulcer No moderate to severe nausea or any vomiting in the 24 hours prior to chemotherapy Not pregnant or lactating

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 months since prior chemotherapy Concurrent etoposide and fluorouracil allowed (days 1-5) No chemotherapy before day 0 of study Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent antiemetics No concurrent high dose benzodiazepines No concurrent psychotropic agents
Feasibility and Safety and Evaluation of the Potential Efficacy of Autologous Platelet-rich Plasma in the Treatment of Vascular Venous Ulcers

INTRODUCTION: Vascular ulcers are an important pathology in the daily medical practice in all the assistance levels, and they have big repercussion referring to individual, social and labour levels, supposing a big consumption of human and material resources.The cure with autologous platelet rich plasma (autologous PRP) has demonstrated in different studies a decrease in the cicatrization time comparing to conventional methods in hospital levels, which becomes interesting contrasting its efficacy in primary care.

AIM:Evaluate the practicability, security and potential of the autologous PRP in the treatment of vascular ulcers, comparing to the conventional treatment ( cure with humid environment), in primary care patients with chronic venous insufficiency in C-6 degree (CEAP classification).

DESIGN:A pilot study will be executed, which will consist in a randomized clinical test, multicentred, in parallel groups and opened. 40 patients suffering of venous vascular ulcers will be studied, who will be between the age of 40-80 years old, and who will be attached to five health centers. Variables for the identification, following, result and patient profile have been defined. Emphasize the variables of "ulcer area decreasing", "CIVIQ index", "% one cure per week" .


Eligibility Criteria:
Inclusion Criteria:

* Patients resident in Barakaldo, who are seen in treatment rooms at the Zaballa outpatient clinic or one of the following health centres: Zaballa, La Paz, Urban, or San Vicente, in the Ezkerraldea-Enkarterri Health Region of the Basque Health Service - Osakidetza.
* Men or women of 40 to100 years of age
* Patients with stage C6 chronic venous insufficiency according to the CEAP classification
* Patients with vascular ulcers which have not responded to conventional treatment in 2 to 6 months
* Patients who present an analytical before entering the study with a normal range of number of platelets, red blood cells and hematocrit
* An ulcer of 3-5 cm in diameter
* An ABI of greater than or equal to 0.8 or less than or equal to 1.5.
* Independent patients or with sufficient family support
* Patients have given written informed consent

Exclusion Criteria:

* Patients with chronic treatment with immunosuppressive or retroviral drugs
* Coagulopathies
* Patients with chronic infectious diseases
* Patients under radiotherapy or chemotherapy
* Patients with a history of neoplasia
* Patients with more than two active ulcers
* Pregnant women
* Patients with active cellulitis or fever
* An ABI of less than 0.8 or more than 1.5.
Fish Oil Supplementation in Lactation

The main purpose of the study was to examine whether fish oil supplementation of lactating mothers affect infant development during first year of life, focusing on visual and mental development. A follow-up studies are conducted in order to see if early intake of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) have any long-term effects on health, primarily immun function and markers of cardiovascular risk.

Background:

Studies indicate that infants, who are fed formula without n-3 LCPUFA, have slower visual development than those, who receive n-3 LCPUFA in breast-milk. The mental development seems also to depend on whether infants are breast-fed or not. Long-term health has also been proposed to be affected (The infant origin of adult disease hypothesis). It is not clear whether these differences is due to dietary LCPUFA as comparison of breast-fed and formula-fed infants are complicated by the socio-demographic differences that exist between mother, who choose to breast-feed or not. Recent studies indicate that LCPUFA supplementation of formulas has beneficial effects on the visual acuity and mental abilities of infants. The LCPUFA content of breast-milk varies and this could potentially be of importance for infant development.

Methods:

211 pregnant women with a high (\>80 percentile) or low (\< mean) fish intake were recruited. After birth mother with low fish intake were randomized to receive 4 g/day of fish oil or olive oil for the first 4 months of the lactation period. 150 mother-infant pairs were followed for 1 year gathering information on maternal n-3 LCPUFA intake and infant development (growth, developmental milestones, visual acuity, cognitive functions and language acquisition). Milk samples were collected at 0, 2, 4 and 9 months and blood samples were taken from the mother and the infant at 4 months of age in order to determine the biochemical effect of the supplementation.

The children were followed-up at 2½ years of age and around 7 years of age. The study is performed in association to the National Birth Cohort.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with uncomplicated singleton pregnancy
* No metabolic disorders and prepregnancy BMI \< 30 kg/m2
* Intention to exclusively breast-feed for 4 mo
* Fish intake below the Danish mean or above 80th percentile (reference group)

Exclusion Criteria:

* Pre- or post term delivery (\< 37 or \> 43 wks of gestation)
* Abnormal weight for gestation (outside 10th-90th percentile range)
* Apgar score 5 min after delivery \< 8
* Infant admission to a neonatal department
* If supplementation did not begin within 2 wks after delivery
The Effect of the DASH Diet Containing Meat on Muscle and Metabolic Health in Older Adults

Age-related changes in body composition, muscular fitness, and metabolic health resulting in the onset of obesity, sarcopenia, and chronic diseases are profound public health issues that are in need of immediate attention. Effective and feasible methods, such as dietary therapies, are needed to improve health in older adults that in turn lead to independence, enhanced quality of life and reduced hospitalizations. Diet quality and dietary protein intake are vital for maintaining body composition, muscle mass and improved physical performance. Malnutrition in dietary protein intake is a major cause of reduced muscle mass, strength, and function in older adults. The Dietary Approaches to Stop Hypertension (DASH) dietary pattern is a high-quality therapeutic diet known to improve health status in various diverse and at-risk populations resulting in improved heart health, maintained cognitive function and reductions in metabolic diseases such as diabetes, metabolic syndrome, and nonalcoholic fatty liver disease. The primary protein recommendations of the DASH diet are poultry and fish and it is recommended to decrease or exclude red meats from the diet. However, studies have demonstrated that lean red meat incorporated into a DASH-like diet doesn't exacerbate cardiovascular health indices in adults, indicating that lean red meat can be included in the DASH diet without negative effects on heart health. Although studies have reported on the DASH diet in older adults, no studies have investigated the effect of the DASH diet containing lean red meat on measures of body composition, muscle mass or metabolic health under controlled-feeding conditions. The purpose of this study was to determine the effect of the DASH diet containing daily intakes of lean red meat on indicators of body composition, muscular fitness and biomarkers of metabolic health in adults 65 and older using controlled-feeding and systems biology approaches.


Eligibility Criteria:
Inclusion Criteria:

* 65 and older
* Upward mobile ability

Exclusion Criteria:

* Under the age of 65
* Immobility
The Influence of Preoperative Cardiopulmonary Capacity on the Perioperative Lactate Level

The aim of this study is to identify if there exists a correlation between the preoperative cardiopulmonary capacity - measured in MET's - and the perioperative lactate serum level.

The determination of the cardiopulmonary (c/p) capacity is very important for the evaluation of every patient undergoing surgery. The ability to climb at least two flight of stairs is seen to be an acceptable c/p capacity for surgery. There are several ways to evaluate the fitness of patients. A common method to estimate the cardiopulmonary capacity is defining patients through the MET's (metabolic equivalents) scale. MET's can be defined relatively easy through a simple questionnaire. Patients with a reduced c/p capacity have less than 4 MET's, patients with a relatively good c/p capacity have 4-10 MET's and patients with a excellent c/p capacity have more than 10 MET's.

The lactate level in blood serum is a common parameter to asses anaerobic metabolism in patients. A high lactate level correlates with higher mortality rates and outcome.

To yet it is not clear if there exists a correlation between the preoperative cardiopulmonary capacity measured in MET's and the perioperative lactate level. We hypothysed that patients with a reduced cardiopulmonary capacity are associated with higher perioperative lactate levels, as these group of patients compensate the stressors operation/anesthesia less than patients with a good c/p capacity.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years

Exclusion Criteria:

* Cardiac surgery
Sugars-sweetened Commercial Beverages on Short-term Food Intake

The purpose of this experiment was to describe the effect of consuming 350 ml of 1% chocolate milk 60 minutes before a pizza meal on subjective appetite and short-term food intake when compared to cola, a fruit drink and a water control in normal weight and overweight/obese 9-14 year old boys and girls. It is hypothesized that 1% chocolate milk will increase meal time satiation to a greater extent than other sugars-sweetened commercially available beverages. Food intake will be measured 60 minutes after the consumption of 350 ml of water, fruit drink, cola or 1% chocolate milk.


Eligibility Criteria:
Inclusion Criteria:

* healthy boys and girls 9-14 years of age, stable weight, born at full term, normal birth weight

Exclusion Criteria:

* restricted diet, taking medications that affect food intake, significant learning, behavioral or emotional problems, food allergies to test treatments
Family Help Program: Nighttime Enuresis Treatment Program

The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate Enuresis diagnoses. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.

The purpose of the Family Help Program is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 46 children (5-12 years of age)suffering from pediatric enuresis (at least 2 times a week) will be randomized.

The intervention is delivered from a distance, using the urine alarm system accompanied by educational materials (manuals, video-tapes, audio-tapes) and telephone consultation with a trained paraprofessional "coach" who is supervised by a licensed health care professional. The telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team.

Fifty percent of the eligible participants will receive Family Help Program telephone-based treatment and 50% will be referred back to their family physician to receive standard care as determined by that physician. Those receiving standard care will be evaluated for outcome results and then compared to the Family Help treated participants. It is anticipated that Family Help treatment will be proven to be as or more effective than standard care.

Eligibility Criteria:
Inclusion Criteria:

* Is your child 3 to 12 years of age
* child wets the bed more than twice per week
* child dry during the day

Exclusion Criteria:

* child received any treatment for bedwetting in the past 6 months
* child at any time been dry for 6 months or longer
* child currently on Imipramine or Desmopressin
Hypertonic Saline as Therapy for Pediatric Concussion

This single center, blinded, randomized controlled trial evaluated the use of hypertonic saline versus normal saline as therapy for the symptoms of pediatric concussion post head injury.

The study hypothesis was that hypertonic saline would improve symptoms of pediatric concussion following head injury as measured on the self-reported Wong Baker Faces Pain Scale as compared to normal saline.

The null hypothesis was that there would be no difference in change of reported pain in either group.


Eligibility Criteria:
Inclusion Criteria:

* 4-17 years old
* consent obtained
* pain as a symptom of concussion
* head CT negative for intracranial pathology

Exclusion Criteria:

* younger than 4 years or older than 17 years
* multi trauma
* cardiac, neuro, renal history of disease
* seizure
* narcotic, drug use
* pregnancy
* head CT with traumatic intracranial pathology
* no consent
Use of Positron Emission Tomography/Computed Tomography (PET/CT) to Assess Tumor Response to Neoadjuvant Treatment for Distal Rectal Cancer

Preoperative chemoradiation therapy is the preferred initial treatment option for distal rectal cancers. However, assessing tumor response to preoperative chemoradiation therapy remains a challenge to the colorectal surgeon, especially when determining if there is a complete response, observed in more than 10% of cases. The purpose of this study is to evaluate the use of the PET/CT in assessing distal rectal tumor response to preoperative chemoradiation therapy.

Patients with distal rectal adenocarcinoma will be submitted to an initial whole body PET/CT prior to the preoperative chemoradiation therapy with 5-fluorouracil and 5040 cGy. Six weeks and 12 weeks after the preoperative treatment is finished the PET/CT will be repeated. At 1 and at 2 years after preoperative treatment is concluded another PET/CT will be performed. The colorectal surgeon evaluating the response to chemoradiation therapy will be blinded to the results of the PET/CT, as the radiologist will be blinded to the response assessment. PET/CT results will not be used to determine treatment strategy, unless metastatic disease or other disease is diagnosed. Patients with a complete clinical response at 8 weeks will be rigorously followed while patients with an incomplete clinical response at 8 weeks will be submitted to radical surgery. PET/CT results will be compared to current radiological studies and final pathological reports.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Rectal Adenocarcinoma
* Location of Tumor less than 7cm from Anal Verge

Exclusion Criteria:

* Pregnancy or Nursing
* Metastatic Disease (Stage IV disease)
* Previous treatment for any cancer
* Patients clinically unable to receive neoadjuvant chemoradiotherapy
* Hypersensitivity to 18FDG
Frequency of Pompe's Disease and Neuromuscular Etiologies in Patients With Restrictive Respiratory Failure Associated With Signs of Muscle Weakness

A breach of respiratory function may be one of the elements more or less early or predominant clinical picture of neuromuscular diseases. It is considered that the obstructive syndromes represent 64% and restrictive or mixed syndromes 36% of chronic respiratory insufficiency, approximately 7% due to a neuromuscular disease. The frequency and type of impairment are dependent on the underlying pathology.

The neuromuscular restrictive respiratory failure (IRR) remains partially unknown pulmonologists, especially because the signs of muscle weakness are sometimes difficult to detect. However, respiratory diseases are a major concern in neuromuscular diseases because they can have an impact both on sleep (not sleep, ...) on the daily activities (breathlessness on exertion, dyspnea) and thereby alter the quality of life of patients. Moreover, they represent a significant morbidity and mortality factor. Chest tightness may in some cases reveal the disease and thus constitute the chief complaint of a patient with a neuromuscular disease. In late-onset Pompe disease, lung disease is the predominant clinical symptoms in about 30% of patients.

An algorithm was developed to guide practitioners and help them in their diagnostic approach to the cause of the IRR (diagnostic algorithm ATS / ERS 2005). However, this algorithm does not allow precise identification of the neuromuscular causes.

At the patient level, this can have an impact by extending the time before placing a diagnosis. In Pompe disease, the average time to diagnosis reached 7.9 years. However, there are for this disease a simple and rapid diagnostic test. Therefore, a greater awareness of practitioners with regard to the particular Pompe disease and neuromuscular diseases in general may be beneficial to patients.

This study aims to:

i) awareness pulmonologists to the possibility of neuromuscular an IRR.

ii) characterize the frequency of neuromuscular origin of IRR in a broad population of patients with concomitant signs muscle weakness.

iii) reduce the time to diagnosis by directing patients to neuromuscular reference center early.


Eligibility Criteria:
Inclusion Criteria:

* Presence of a CV \<80% of predicted and / or \<LIN
* Presence spirometry a report Tiffeneau (FEV / CV) equal to or higher than normal
* Signature of informed consent
* Men and women age ≥ 18 years
* Production of a medical examination
* Affiliated to social security

Exclusion Criteria:

* restrictive breath traumatic
* restrictive respiratory failure associated with parenchymal disorder, whether localized or diffuse
* known neuromuscular disease associated with a restrictive lung disease
* Patient under guardianship, curatorship, protected by law
* Inability to cooperate
* Morbid obesity with a BMI ≥40