cyrilzakka/clinical-trials huggingface dataset:
Docetaxel in Treating Patients With Relapsed Prostate Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer.

OBJECTIVES:

Primary

* Determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel.

Secondary

* Determine the time to PSA recurrence in patients receiving this treatment.
* Determine the time to metastatic disease in patients receiving this treatment.
* Determine the time to androgen independent state in patients receiving this treatment.
* Determine the time to death from any cause in patients receiving this treatment.

OUTLINE: This is an open label study.

Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of unacceptable toxicity or disease progression.

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

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Eligibility Criteria:
Criteria for Patient eligibility

Inclusion criteria

1. Histologically confirmed adenocarcinoma of the prostate.
2. Prior primary therapy for prostate cancer, including radical prostatectomy, external beam radiation therapy, or brachytherapy.
3. Serum PSA \> 0.2 ng/dL following 8 months of androgen deprivation therapy or a nadir PSA \>0.2 ng/dL and at least 1 subsequent PSA values at the same or higher level, if prior to 8 months.
4. Serum testosterone \< 50 ng/ml.
5. No evidence of metastases on bone scan.
6. No evidence of metastases on CT scan of the abdomen and pelvis.
7. ECOG performance status \< 2.
8. Laboratory criteria for entry: absolute neutrophil count ≥ 1.2 K/cu mm, platelets ≥ 100 K/cu mm, serum bilirubin ≤ upper limit of normal (ULN), SGOT and SGPT ≤ 1.5 times institutional ULN if alkaline phosphatase ≤ ULN, alkaline phosphatase ≤ 5 times ULN if SGOT and SGPT are ≤ ULN, a serum creatinine ≤ 2 times institutional ULN.
9. Signed informed consent.

Exclusion Criteria

1. A second active malignancy during the last 5 years, except adequately treated non-melanoma skin cancer.
2. Life expectancy \< 3 months.
3. Grade 2 or higher peripheral neuropathy.
4. Prior investigational agent within the past 28 days.
5. Less than a 10% decrease (or continued rise) in PSA in response to initial androgen-deprivation therapy.
6. More than 12 months since initiation of androgen-deprivation therapy.
7. Prior docetaxel chemotherapy.
8. Patients recently (within 28 days) started on corticosteroids, with the exception of inhaled and topical steroids. Patients on stable doses of systemic corticosteroids will be eligible.
A Sports Injury Prevention Program to Reduce Subsequent Injuries After Concussion

The long-term goal of this research is to implement methods that healthcare providers can use across diverse clinical settings to (1) identify athletes at risk for (musculoskeletal) MSK injury when cleared to return to play (RTP) after a concussion and (2) develop practical ways to reduce MSK injury risk following concussion RTP. The rationale is that once post-concussion MSK injury risk factors are known and prevention strategies tested, concussion RTP protocols will evolve to include injury risk reduction programs.

Aims:

i. To determine the effect of a sports injury prevention program on MSK injuries initiated at concussion RTP and continued throughout the subsequent athletic season.

ii. To examine the effect of a neuromuscular training (NMT) program on clinical and instrumented postural control measures before and after the intervention.

The proposed study will use an intervention-based paradigm to further understand MSK injury risk after concussion RTP and to identify potential methods to reduce this risk. Common Data Element (CDE) and instrumented postural control data will be linked to objectively classify the clinical and functional underpinnings of concussion recovery and subsequent MSK injury among those engaged in an injury prevention program compared to those who are not. These are important elements to investigate because: 1) few studies have explored the mechanisms for MSK injury incidence after concussion using a multimodal and objective approach and 2) no investigations have examined interventions to improve long-term concussion outcomes initiated at RTP.

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants will be those diagnosed with a concussion, defined as a brain injury caused by a direct blow to the head, face, neck or elsewhere on the body, resulting in the rapid onset of impairment of neurological function and diagnosed by Children's Hospital Colorado sports medicine physicians.
* Being between 12-18 years of age
* The ability to complete initial testing within 14 days of the injury
* A post-concussion symptom scale (PCSS) score of greater than 9 at the time of enrollment.

Exclusion Criteria:

* Active lower extremity injury affecting balance
* Pre-existing neurological disorder (bipolar disorder, schizophrenia, etc.)
* Previous concussion sustained within the past year
* Prisoners, pregnant females, individuals with limited decision-making capacity
* Pre-existing learning disability
* Structural brain injury (confirmed with neuroimaging)
* A high velocity injury mechanism (e.g motor vehicle accident).
* Less than one month remaining in the current athletic season.
Improvement the Anti-migraine Treatment Efficacy by Tailoring the Drug to Individual's Pain Modulation Profile

* To delineate brain mechanisms that subserve endogenous analgesic (EA) in the healthy state.
* To identify alterations in mechanisms supporting EA in chronic pain (migraine) and their therapeutic relevance.

The proposed research will use psychophysics and multiparametric MRI to (i) delineate the brain mechanisms that subserve and regulate endogenous analgesia (EA)in the healthy state and (ii) to identify alterations in mechanisms supporting EA in chronic pain and their therapeutic relevance. In both healthy subjects and chronic pain patients, EA will be probed using the DNIC (diffuse noxious inhibitory controls) and offset analgesia paradigms. Functional MRI will examine activation of brainstem mechanisms important in EA, while both functional and structural connectivity analyses will assess the regulation of these brainstem mechanisms by cerebral cortical regions involved in attention and affect. One pathological painful condition, migraine, will be examined since it allows changes in EA associated with chronic pain to be investigated between episodes of pain. Finally, EA and EA associated structural and functional parameters will be used to predict the efficacy of one compound, amitriptyline, to treat migraine in individual patients. Taken together, the proposed research will provide substantial insights into basic mechanisms supporting and regulating EA and can provide a foundation for mechanism-based individualized choice of therapy that may benefit all chronic pain patients.

Eligibility Criteria:
Inclusion Criteria:

* healthy females
* migaine females
* ages 18-50
* for migraineurs: \>4 attacks/month

Exclusion Criteria:

* any migraine preventive treatment received during last 3 months or prior treatment with amytriptiline
* other chronic pain conditions
* psychiatric, other neurological diseases, language barrier or cognitive dysfunction
* Patients and controls will be asked to withdraw from any pain-relieving medications for 24 hours before the testing. The tests will be performed interictally atleast 2 days after the last attack.
Establish an Evaluation Scale for the Quality of Primary Care in Multi-professional Health Centres and Homes Integrating the Point of View of Patients in Complex Care Situations and Their Caregivers.

The prevalence of multimorbid patients and complex care is increasing in France and elsewhere in the world. It concerns 60% of the over 65 years old. Comprehensive care, the involvement of the patient and his caregivers appear as the solutions for the management of these new care situations. The structures of multi-professional grouping, developing a coordinated exercise (GECO), appear as the privileged place to take care of these patients. These structures become the main place of exercise in France (improved working conditions for professionals, financial incentives, public policy, etc.); they have shown their ability to formulate patient care protocols, to produce coordinated exercise, to better involve the patient and caregivers in their care. The question of improving the quality of care arises. To date, there is no data on the subject apart from some evaluations mainly medico-economic. The patient's place in the evaluation showed his interest with the existence of a proven correlation between patient satisfaction in particular and his compliance and health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age, followed in primary care centers, able to participate, speaking and understanding French,
* Patient in a complex care situation, benefiting from a multi-professional management (at least two different professionals from the center including the general practitioner),
* No opposition from the patient.

Exclusion Criteria:

* Patient not in a complex care situation
* Patient followed only by the the exercise coordinated group general practitioner
* Refusal to participate
* Patients who have already participated in phase 2 of the Qualsoprim project
* Adults under legal protection or unable to express their consent
* Persons deprived of their liberty by a judicial or administrative decision
Effects of Invisalign Palatal Expander System

The aim of this study is to evaluate the effectiveness of Invisalign Palatal Expander system ingrowing patients. This study compares the treatment outcomes of Invisalign Palatal Expander system to conventional treatments through randomized controlled trial.


Eligibility Criteria:
Inclusion criteria:

1. Mixed dentition phase with at least three nonmobile (stable) teeth which have more than 1/4 of primary molar root length left16 in either side
2. Early permanent dentition stage and early permanent dentition but second permanent molars not yet fully erupted in the arch
3. Unilateral or bilateral posterior cross bite patients; or Patients who have been diagnosed with transverse maxillary deficiency (Skeletal transverse discrepancy measured from the estimated center of resistances of the first molars17 ≤ - 3 mm);
4. Patients with Class I or Class II skeletal relationship
5. Subjects willing to consent to the trial

Exclusion Criteria:

1. Any general medical health problems which may influence treatment
2. Any craniofacial anomalies
3. Skeletal Class III patients
4. Mixed dentition patients with more than 2 heavily restored primary second or permanent first molars.
At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults

This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck.

This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck. The refraction measurements that users obtain from the VisionCheck are from testing at-home and without additional guidance other than that normally provided to those purchasing the device.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Ages 30+
3. Had purchased an EyeQue refraction device.
4. Obtained EGN's from the EyeQue refraction device.
5. Ordered Try-On glasses based on EyeQue EyeGlass Numbers.
6. Allow use for this study the VisionCheck refraction and try-on glasses measurements, taken prior to study participation.

Subject Exclusion Criteria, Subjects that by self-report:

1. Do not have a command of the English language.
2. Lack the ability to follow instructions.
3. Lack binocular vision.
4. Are Color-blind.
Phamacokinetics and Safety Profiles of DA-5210 10/1000mg in Healthy Subjects at Fasting State

Phamacokinetics and safety profiles of DA-5210 10/1000mg in Healthy subjects at Fasting State


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* BMI between 18 and 30 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History
Iron Deficiency Anemia, Iron Supplementation and Genomic Stability in Infants

This study compares weekly versus daily administration of iron for prevention of anemia in 6 months old infants. One third of the infants that are exclusively breast fed will not receive iron, the second third will receive iron weekly and the last third will receive iron daily. Half of the infants that take infant formula will receive iron weekly and the other half will receive iron daily.

Iron deficiency is the most prevalent nutritional deficiency and the main cause of anemia. It's estimated that 43% of pre-school children worldwide are anemic, in Argentina a national survey carried out in 2007 (last survey), showed that 34.5% of children less than 2 years old were anemic and that 50.8% of children 6 to 9 months old were anemic. Although there is a consensus on iron supplementation as a preventive strategy for anemia in infants, there is a poor adherence due mainly to mild gastrointestinal adverse effects and low prescription rates from pediatricians. On the other hand, the excess of iron can lead to genomic instability with structural and functional alterations on proteins, lipids and DNA. Weekly administration of iron has been proposed as an alternative of similar efficacy and higher effectiveness in older children and pregnant women, but sufficient evidence for infants is lacking.

Eligibility Criteria:
Inclusion Criteria:

* 3 months old infants, clinically healthy, born to term (\>37 weeks), that weighted at birth between 2500 and 4000 g, that have normal prenatal records.

Exclusion Criteria:

* anemic or iron deficient infants, or that have a chronic pathology, or that have undergone an acute pathology in the previous 15 days. Children that are receiving antibiotics or vitamin supplements.
Curosurf/Budesonide for Infants With Respiratory Distress Syndrome

Infants showing high local pulmonary inflammation diagnosted by respiratory distress syndrome usually need the second or more pulmonary surfactant and is easier to developing to Brochopulmonary. Cursurf is used worldwide in infants with respiratory distress syndrome, Budesonide is a glucocorticoid with a high local anti-inflammatory effect.Our hypothesis is Cursurf combined with Budesonide could reduced the need of Cursurf and incidence of Brochopulmonary dysplasia.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of respiratory distress syndrome

Exclusion Criteria:

* pneumothorax
* surgical disease
* major congenical defects
Pedometer and Exercise Study in Prostate Cancer Patients With Hormonal Therapy

A randomized clinical trial evaluating the use of a pedometer and brief exercise coaching in prostate cancer patients treated with androgen deprivation therapy. The investigators want to demonstrate if there are less side effects of hormonal therapy and better quality of life in patients who made regular exercise.

To evaluate effectiveness of regular exercise and well-being all patients will complete questionnaires about sexual function (IIEF-15) and quality of life. We will also perform at each visits anthropometrics measurement of waist, leg and arm, weight and vital signs. Biochemical analysis and prostatic specific antigen will be done periodically.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Histologically proven prostate cancer
* Treatment plan is to administer long term ADT (androgen deprivation therapy).
* Patient must currently be treated with ADT for at least 2 weeks before enrollment in trial, and for no more than 6 months. Patient treated with a maximum androgen blockade strategy, combining an anti-androgen agent with a LHRH analog agent are admissible to this protocol, but not patients treated only with an anti-androgen agent alone.
* Written informed consent to participate in the trial.

Exclusion Criteria:

* Known hypersensitivity to Zoladex, Casodex (if applicable), or any component of these product, or to other similar agents
* Severe cardiac disease (New York Heart Association class III or greater)
* Severe lung disease
* Uncontrollable pain
* Unstable bone lesion
* Any co-morbidity restraining the patient's ability to walk alone or to modify his walking habits (eg Parkinson's disease, advanced multiple sclerosis, leg amputation, ...)
* Any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.
* Any contraindication to undertake the 6-minutes walk test (unstable angina or myocardial infarction during the previous month, a resting heart rate of more than 180, systolic blood pressure of more than 180, and a diastolic pressure of more than 100). The patient must have his cardiovascular conditions stabilized and controlled before enrollment in the trial.
* Unwillingness or incapacity to consent to trial participation.
A Study to Explore the Association Between Blood Pressure, HIV and Antiretroviral Therapy

The purpose of this study is to explore the association between blood pressure, HIV and/or its treatment in a cross sectional observational study.

Deaths from AIDS have declined dramatically since the introduction of highly active antiretroviral therapy in HIV infected patients. However the incidence of heart disease has increased four-fold and is now one of the major causes of death in HIV infected patients. While HIV drugs are known to adversely affect serum lipids, the evidence concerning the association between raised blood pressure (a major risk for cardiovascular disease) HIV and/or its treatment is limited and conflicting. The researchers believe it of interest to study heart disease risk factors in patients with HIV infection to avoid one premature cause of death (AIDS) being replaced with another potentially preventable cause of death and disability (heart disease). In this cross sectional observational study the researchers will systematically measure blood pressure and other cardiovascular risk factors in HIV positive patients on and off antiretroviral therapy. These individuals will be matched for age, sex and ethnic group with HIV negative individuals.

Eligibility Criteria:
Inclusion Criteria:

* Attending St. Mary's sexual health outpatient department
* Patients willing to give written informed consent
* Ability to communicate in English

Exclusion Criteria:

* Failure to give written informed consent in English
Effects of ISIS 113715 on Insulin Sensitivity, Glucose, and Lipid Metabolism and Energy Expenditure in Type 2 Diabetics

The aim of this study is to examine the effects of ISIS 113715 monotherapy on insulin sensitivity, glucose and lipid metabolism and energy expenditure in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (post menopausal and/or surgically sterile)
* Aged 18 to 70 years
* Treatment naïve subjects with fasting blood glucose levels of 150-220 mg/dL, hematocrit of \>/= 35% and HbA1c levels of \>/= 7% and \</= 10.0%
* Subjects on antidiabetic therapy with fasting blood glucose levels of 100-200 mg/dL, hematocrit of \>/= 35%, and HbA1c levels of \>/= 6.5% and \</= 9.0%

Exclusion Criteria:

* Greater than 3 severe hypoglycemic episodes within six months of screen
* Pregnant, breastfeeding, or intends to become pregnant
* Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT greater than 1.5 times the upper limit of normal
* History of hepatitis B surface antigen, hepatitis C antibody, or HIV
* Complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
* Clinically significant and currently active diseases
* Clinically significant abnormalities in medical history, physical examination, or laboratory examination
Feasibility, Acceptability, and Effectiveness of an Individualized Plant-based (iPLANT) Diet Plan in Colorectal Cancer: Mixed Method Embedded Design

The goal of this intervention study is to investigate the effectiveness of individualized plant-based diet plan on nutritional indices and clinical outcomes in colorectal cancer patients receiving chemotherapy. The main questions to answer are:

1. What are the current eating trends in colorectal cancer patients?
2. What are the common perceptions of adopting a plant-based diet in colorectal cancer?
3. Does iPLANT diet plan improve nutritional indices of colorectal cancer patients?
4. Does iPLANT diet plan improve patients' gastrointestinal side effects and quality of life without compromising their nutritional status?

Participants will be randomly assigned into two arms (intervention and control) using opaque envelop system. Intervention group will receive individualized plant-based diet plan and diet counselling, whereas the control group will receive usual diet counselling.

The researcher will compare the differences in nutritional outcomes and quality of life between intervention and control groups before and after intervention.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with colorectal cancer, including the sites of caecum, appendix, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, and rectum
* TNM stage II to IV
* Receiving chemotherapy
* Able to take food orally

Exclusion Criteria:

* Have cognitive impairments or mental disorders
* Diagnosed with severe illness, such as chronic kidney disease and chronic obstructive pulmonary disease
* Within 4 weeks of bowel resection
* Terminally ill or receive hospice care
* Receiving enteral or total parenteral nutrition
* Having inflammatory bowel diseases
* Having gastrointestinal bleeding or obstruction
* Pregnancy or breastfeeding
* Severe anemia (\<0.8g/dL)
* ECOG performance score \>2
* High stoma output (\>1500ml per day)
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind, placebo-controlled setting


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite allergens

Exclusion Criteria:

* Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments
* Use of any concomitant medication that could affect the patient's study treatment response or assessment results