cyrilzakka/clinical-trials huggingface dataset:
A Study of ABT-414 in Subjects With Solid Tumors

A study of ABT-414 in subjects with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have a solid tumor type likely to over-express Epidermal Growth Factor Receptor (EGFR) (Phase 1)
2. Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
3. Subjects have available tumor tissue
4. Subjects have adequate bone marrow, renal, and hepatic function as follows: Bone marrow: Absolute neutrophil count (ANC) \>/= 1,500/mm3 Platelets \>/= 100,000/mm3; Hemoglobin \>/= 9.0 g/dL Renal function: Serum creatinine \</= 1.5 times the upper limit of the institution's normal range Hepatic function: Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \</= 1.5 times the upper limit of the institution's normal range. Subjects with liver metastasis may have an AST and ALT of \</= 5.0 x the upper limit of normal.
5. Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer (NSCLC)
6. Eligibility is restricted to subjects with confirmed EGFR amplification in the EGFR amplified cohort

Exclusion Criteria:

1. The subject has uncontrolled metastases to the central nervous system (CNS). Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 28 days after definitive therapy and have not received prior whole brain radiation (Phase 1 only).
2. The subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 28 days prior to the first dose of ABT-414.
3. The subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
4. The subject had had major surgery within 28 days prior to the first dose of ABT-414.
5. The subject has a history of immunologic reaction to any Immunoglobulin G (IgG) containing agent.
6. Phase 2 portion only: The subject has previous or concurrent cancer that is distinct in primary site or histology from NSCLC, except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.
Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)

This study attempts to document the therapeutic value of combining loratadine antihistamine action (no sedative) with anti-inflammatory effects of betamethasone at low doses, which may facilitate treatment adherence by patients whereas providing an effective and rapid perennial allergic rhinitis (PAR) symptoms relief.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of perennial allergic rhinitis.
* Age \>= 6 years old and \<= 12 years old.
* Patients in good general conditions, without any other relevant clinical condition except for perennial allergic rhinitis.
* Symptoms total score at admission \>= 8 (out of 15 possible). Individual symptoms (score 0 to 3 points) were: Sneezing or nasal pruritus, eye reddening or pruritus, nasal congestion, wet nose or with secretion (sniffing), secretion sensation at pharynx (post-nasal dripping).
* Number of symptoms: At least three.

Exclusion Criteria:

* Age \< 6 years old or \> 12 years old.
* Co-existence of acute sinusitis or some chronic condition different from asthma or atopic dermatitis.
* Presence of systemic fungal infections.
* Conscience or behavioral disturbances.
* Current oral or parenteral steroid treatment.
* Concomitant use of Phenobarbital, rifampicin, diphenylhydantoin or ephedrine.
* Known hypersensitivity to any of the study pharmacological combination components.
Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen

The purpose of this study is to examine whether the transdermal testosterone system (TTS) is effective and safe in the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women who are on transdermal estrogen.

This is a randomised, double-blind, placebo-controlled, parallel-group, multicentre, 24 week study to be conducted in approximately 300 patients at approximately 14 clinical sites in the UK, 6 sites in Australia, 5 sites in Germany, and 2 sites in Canada. Women will be randomised 1:1 to receive 300 mcg/day TTS or placebo for a 24 week period. Consistent with previous phase III studies, efficacy will be assessed over 24 weeks using the Sexual Activity Log (SAL), and at 12 and 24 weeks using the Profile of Female Sexual Function (PFSF) and Personal Distress Scale (PDS). Safety will be assessed over the entire 24 weeks. Hormone data (free and total testosterone, total estradiol, and sex hormone binding globulin) will be collected at Weeks -4 and 24. The total duration of treatment for each patient is 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women will be screened for study participation according to the following inclusion criteria at Week -4. Eligible women must be a woman one year post menopausal, 40-70 years old in general good health on transdermal HRT and in a stable monogamous sexual relationship with low sexual desire causing distress.

Exclusion Criteria:

* Women will be screened for study participation according to the following exclusion criteria at Week -4 or as specified. Eligible women must not have any medical, physical, psychological, or pharmacological condition that could confound safety or efficacy.
A Phase II Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia

RATIONALE: Drugs used in chemotherapy, such as cytarabine and clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying clofarabine when given together with cytarabine to see how well they work in treating patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia.

OBJECTIVES:

* Determine the response rate in adult patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with high-dose cytarabine followed by clofarabine.

OUTLINE: This is an open-label phase II study. Patients are stratified according to diagnosis (acute myeloid leukemia vs acute lymphoblastic leukemia Phase II: Patients receive high-dose cytarabine followed by clofarabine (at the dose determined in phase I) on days 1-3.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 39 patients were accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Pathologic confirmation of acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL)

  * No M3 AML
* Meets 1 of the following criteria:

  * In first relapse
  * In second relapse after a second complete remission (CR) that lasted ≥ 3 months
  * Refractory to initial induction therapy
* No symptomatic CNS involvement

PATIENT CHARACTERISTICS:

* ECOG performance status ≤ 2
* Creatinine \< 2 mg/dL
* Bilirubin ≤ 2 mg/dL
* AST and ALT ≤ 4 times upper limit of normal
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 weeks after completing study treatment
* Ejection fraction ≥ 45% by echocardiogram
* No active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant
* No psychiatric disorders that would interfere with giving consent, study participation, or follow-up procedures
* No other severe concurrent disease that would preclude study treatment

PRIOR CONCURRENT THERAPY:

* At least 1 week since prior therapy and recovered
* No other concurrent chemotherapy

  * Hydroxyurea to control WBC count before starting study treatment allowed
* No concurrent corticosteroids unless used for diseases other than leukemia
* No concurrent palliative radiotherapy
* No concurrent growth factors (e.g., epoetin alfa, filgrastim \[G-CSF\], or sargramostim \[GM-CSF\]) in patients with AML
Clinical Validation Study of the Eximis CS (Contained Segmentation) System

The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System.

This is a prospective, multi-center, single-arm study to confirm device safety and effectiveness when utilized for containment, segmentation, and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.

Eligible subjects who have signed an informed consent form (ICF) will be enrolled. Subjects will be sequentially enrolled and assigned a study identification number. Surgeons will also be assigned a unique number.

Subjects will undergo the standard of care regarding all aspects of the pre-operative, surgical, and follow-up procedures. The aspect unique to this study is the capture, segmentation, and extraction of the target tissue will utilize one integrated device, the Eximis CS System, which segments tissue via segmenting wires using RF energy. The device is not intended to provide any therapeutic effect.

All subjects will be followed for safety through a post-procedure follow-up visit that will occur at minimum 30 days and maximum 45 days post-operatively through the post-procedure follow-up visit.

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Eligibility Criteria:
Inclusion Criteria:

Planned laparoscopic hysterectomy or myomectomy. Tissue specimen size is greater than 6 cm in diameter, less than 13 cm in the longest dimension, and at most 10 cm in the second longest dimension, based on preoperative assessment.

Pre-operative evaluation, which may include imaging, cervical cancer screening, and endometrial biopsy has been completed.

Signed informed consent. Willing to adhere to protocol requirements and complete follow-up.

Exclusion Criteria:

Subject is post-menopausal, defined as amenorrhea \>12 months in the absence of ovulation suppression.

Known or suspected malignancy of gynecological origin as determined by standard clinical practice.

Candidate for en bloc tissue removal, for example through the vagina or via a mini-laparotomy incision.

Hemoglobin \< 8 g/dl within 30 days prior to surgery. Subject has a current history of undiagnosed genital bleeding Subject has an implanted electronic device where use of radiofrequency (RF) energy would be contraindicated (e.g., pacemaker, internal defibrillator).

Medical condition, surgical history, or intra-operative findings, which in the option of the investigator, precludes utilization of the Eximis CS System.

Known allergy to polyurethane, polyethylene, thermoplastic fluoropolymer and/or chlorinated polyvinyl chloride.

Concurrent participation in another therapeutic or interventional clinical trial with investigational pharmaceutical agent(s) or medical device(s) that could impact evaluation of this study as determined by the Investigator.

Inability to comply with the study procedures or follow-up in the opinion of the investigator.

Subject is pregnant.

Intraoperative Exclusion: Abdominal wall thickness at the umbilicus incision site exceeds 6 cm.
Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs

A recent study has shown that certain drug allergies were actually related to an immune system against certain viruses. The aim of the study is to evaluate, in patients taking antiepileptic drugs, if this treatment induces proliferation of these viruses and secondarily an immune response that would promote the development of a rash. In particular, will be studied whether these drugs can induce virus reactivation "dormant" in the immune system. This study will not affect the usual follow-up proposed by investigators, with the exception of some additional blood samples.


Eligibility Criteria:
Inclusion Criteria:

* Patients age over 18 years
* Patient for whom treatment of antiepileptic class will be started or was set for less than 48 hours and including one of the following molecules (as princeps or generic equivalent form): sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine eslicarbazepine acetate.
* Patient or patient's representative who was informed and signed the consent form
* Effective contraception in women of childbearing age
* Affiliation to health insurance

Exclusion Criteria:

* Immunosuppressive therapy in progress or acquired immunodeficiency
* Patient with meningitis or meningoencephalitis
* Patient with known contraindications to any molecules indicated in the study
* Major Patient protection (guardianship) or deprived of liberty by judicial or administrative decision.
* Patient participating in another clinical trial or participated in another trial in the month before.
* Pregnant or breastfeeding women.
Metacognitive Training in the Older Adults With Depressive Symptoms (MCT-Silver)

Depression is one of the most common mental disorders in older adults and a major cause of years lived with disability. Depression does not always respond to antidepressants, and non-pharmacological interventions are recommended by international guidelines. The Metacognitive Training for Depression in Later Life (MCT-Silver) is a creative and innovative group intervention that aims to reduce depressive symptoms by challenging the cognitive and metacognitive beliefs characteristic of this disorder, that intends to enable participants to recognize and correct their automatic and dysfunctional thinking patterns and behavior. It was developed by the partner institution's team, and has already demonstrated positive results. This project aims to extend the research study to Portugal, through cultural adaptation, pilot study, and a Randomized Controlled Trial (RCT). To this end, we defined the following aims: To plan and conduct a pilot study to assess the efficacy of the MCT-Silver in the Portuguese population; To conduct a multicenter randomized controlled trial (RCT).


Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* Age: 60 years or older
* Sufficient command of the Portuguese language
* Willingness to participate in the intervention for a period of 4 to 8 weeks (participants who do not participate in the intervention will also be included in the analysis)
* Adequate visual and hearing acuity for neuropsychological testing and participation in the group sessions
* Values above 10 on the Hamilton Depression Scale

Exclusion Criteria:

* Active psychotic symptoms (i.e., hallucinations, delusions, or manias)
* Acute suicidal ideation
* Cognitive impairment
* Dementia or other neurological disease
Online Suicide Prevention Campaign Aimed at Men

This study aims to examine whether the online suicide prevention campaign for men could increase openness about emotions and help-seeking behavior, and decrease hopelessness and adherence to traditional gender norms concerning self-reliance among men. The effectiveness of the campaign will be evaluated in adult men using a pre-post questionnaire study design.


Eligibility Criteria:
Inclusion Criteria:

* Gender identity: male
* ≥ 18 years old
* Have access to internet and a computer/tablet/smartphone
* Speak Dutch

Exclusion Criteria:

* Gender identity: female or other
* \< 18 years old
* No acces to internet and a computer/tablet/smartphone
* Non-Dutch speaking
Application of CLCVP Technique in Early Intervention of CSA-AKI

The goal of this clinical trial is to learn about in postoperative acute kidney injury in cardiac surgery. The main questions it aims to answer are:

1. Controlled low central venous pressure (CLCVP) technique can reduce the occurrence of cardiac surgery-associated acute kidney injury (CSA-AKI) by reducing venous congestion and increasing renal perfusion pressure.
2. CLCVP technique does not increase the risk of postoperative cognitive dysfunction (POCD) during cardiac surgery.

Participants who are assigned to the intervention group will receive CLCVP technique. Specific methods are as follows: First,20min after the end of cardiopulmonary bypass, on the basis of ensuring that the mean arterial pressure (MAP) ≥ 60mmHg, the patients will accept dorsal elevated position. After that, if the patient's central venous pressure (CVP) is less than 10mmHg, nitroglycerin will be pumped at 0.2ug/ (kg \* min). If the patient's CVP is still greater than or equal 10mmHg, we increase the dose by 0.2ug/ (kg \* min) and pump again for 5min, and the like. Until the patient's CVP is less than 10mmHg or the dose of nitroglycerin increases to 1ug/ (kg \* min), the current dose is maintained until the end of surgery.

If participants are assigned to the control group, no intervention measures will be taken.

The researchers will compare the intervention group with the control group to see the occurrence of CSA-AKI and POCD after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older, who underwent cardiac surgery (coronary artery bypass grafting (CABG), heart valve surgery, heart transplant or surgical excision of intracardiac myxoma) were eligible for analyses.

Exclusion Criteria:

* pre-existing renal insufficiency defined by presence of abnormal preoperative serum creatinine ≥ 133 μmol/L and/or preoperative diagnosis of renal insufficiency within 6 months' preoperative period.
* patients with preoperative dialysis dependence within 60 days before surgery, off-pump heart surgery, prior kidney transplantation, pregnancy, as well as those under drug therapy with nitroglycerin were excluded.
Amoxicillin-clavulanate Alone or in Combination With Ciprofloxacin in Low-Risk Febrile Neutropenic Adult Patients: A Prospective, Double-blind, Randomized, Non-Inferiority Multicenter, Phase III Clinical Trial.

In low risk neutropenic fever in cancer, standard of care is the association of amoxicillin clavulanate and ciprofloxacin. But in this population, the rate of fever related to infection is very low, leading to a overtreatment of the patients. The aim of this study is to validate a descalation of the antibiotherapy with safety concerns.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Treated for a solid cancer or a hematological malignancy
* Presented with low-risk\* febrile neutropenia due to chemotherapy with an expected duration of neutropenia ≤ 7 days
* Neutropenia is defined by an absolute neutrophil count ≤ 500/mm3.
* Fever is defined by temperature ≥ 38.3° or ≥ 38° twice during a 1-hour interval.
* Signing informed consent \*Low risk is defined by MASCC score ≥ 21

Exclusion Criteria:

* Hypersensitivity to the active substances: amoxicillin-clavulanic, ciprofloxacin, penicillins, to other quinolones or to one of the excipient
* History of severe immediate hypersensitivity reaction to another beta-lactam
* History of jaunditis/hepatic impairment related to amoxicillin/clavulanic
* Concomitant administration of ciprofloxacin and tizanidine.
* Clinical signs of focal infection including history of untreated dental abscess.
* Signs of sepsis or organ failure.
* Severe immune deficiency other than the current cancer, except controlled-HIV infection
* Gastrointestinal symptoms requiring intravenous treatment (mucositis, vomiting, severe diarrhea...).
* Known aminotransferase serum levels \> 5 x normal values.
* Known renal insufficiency defined as creatinine clearance of \< 30 mL/min (MDRD).
* Antibiotherapy within 24h before enrollment. Prophylactic use of amoxicillin is an exclusion criterium whereas prophylactic use of trimethoprim-sulfamethoxazole (cotrimoxazole) and penicillin G (Oracilline®) are not and will be considered in the analysis.
* History of infection or colonization due to bacteria resistant to experimental drugs in the previous year
* Can be enrolled in the study only once.
* Patients not benefiting from a Social Security scheme or not benefiting from it through a third party.
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies
* Pregnant or breastfeeding women, women at age to procreate and not using effective contraception (either hormonal / mechanical : oral, injection, subcutaneous, implantable, intrauterine device, or surgical : tubal ligation, hysterectomy, total ovariectomy).
Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)

In women at 26 to 30 weeks gestation and who are risk for threatened early birth, who have not had their baby by 14 or more days after being given a single course of antenatal corticosteroids (ACS), do repeated courses of ACS every 14 days until 33 weeks' gestational age lower the risk of illness or death in babies compared to repeated courses of placebo. Children are assessed at 2 years and 5 years for neurodevelopmental impairment.

In women at 26 to 30 weeks gestation, who are at increased risk for preterm birth and remain undelivered 14 or more days following a single course of antenatal corticosteroids (ACS), are multiple course of ACS every 14 days until 33 weeks effective in reducing the risk of perinatal or neonatal mortality or significant neonatal morbidity, compared to placebo.

18-24 Month Follow-up: Children (18-24 months corrected gestational age) are assessed with the Bayley Scales of Infant Development (Second Edition) to determine neurodevelopmental impairment.

5 Year Follow-up (MACS-5): Children are assessed using the Child Behaviour Checklist (1 1/2 - 5) and the Behaviour Rating Inventory of Executive Function (Preschool version) to determine neurocognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Women who have previously received one completed course of ACS, at least 14 days ago and continue to be at increased risk of preterm birth
* Gestational age greater ≥ 26 weeks and gestational age \< 31 weeks

Exclusion Criteria:

* Women requiring chronic doses of corticosteroids secondary to medical conditions
* Women with a contraindication to corticosteroids
* Women with clinical evidence of chorioamnionitis (temperature ≥ 38°c)
* Known lethal congenital anomaly (e.g. anencephaly)
Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

The objective of this PMS study is the evaluation of depressive symptoms measured with Unified Parkinson's Disease Rating Scale (UPDRS) Part I (mentation, behavior and mood) and with Hospital Anxiety and Depression Scale Depression Subscore (HADS-D) under pramipexole treatment in early and advanced PD patients. In addition it will be investigated whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III). 250 patients diagnosed with Parkinson's disease (PD) will be investigated by 80 specialists (neurologists or neurologists/psychiatrists) across Austria. Pramipexole will be taken orally at an initial dosage of 0.375 mg/day (using a three times daily schedule independently of food intake) and can be titrated upwards, as required, at weekly intervals to a maximum total daily dose of 4,5 mg (TID) as per Summary of Product Characteristics (SPC).


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic PD with or without fluctuations
* Indication for treatment with Pramipexole
* Presence of at least mild depressive symptoms (as judged by the treating physician)
* Ability to reliably complete a self-rating scale (Hospital Anxiety and Depression Scale (HADS))

Exclusion Criteria:

* Any contraindications according to the Summary of Product Characteristics (SPC), hypersensitivity to pramipexole or to any of the excipients
* Ongoing treatment with pramipexole