cyrilzakka/clinical-trials huggingface dataset:
Enhancing Cognitive Training Through Exercise After a First Schizophrenia Episode

This is a randomized controlled 6-month trial of the efficacy of a novel intervention combining neuroplasticity-based cognitive training with aerobic exercise, compared to the same systematic cognitive training alone. The primary treatment targets are overall cognitive deficit level and independent living skills. The investigators hypothesize that combining neuroplasticity-based computerized cognitive training and neurotrophin-enhancing physical exercise will produce large cognitive and functional improvements, even relative to cognitive training alone. Adding aerobic exercise to a cognitive training program will have the additional benefit of helping to ameliorate medication side effects, reduce the risk for developing metabolic syndrome, and help to prevent the deterioration in physical health that usually follows the onset of schizophrenia and its pharmacologic treatment. The investigators target the period shortly after a first episode of schizophrenia to maximize the generalization of cognitive improvement to functional outcome, before chronic disability is established.

The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder. A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.

Eligibility Criteria:
Inclusion Criteria:

1. a first episode of a psychotic illness that began within the past two years;
2. a diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia, schizoaffective disorder, mainly depressed type, or schizophreniform disorder;
3. between 18 and 45 years of age;
4. sufficient acculturation and fluency in the English language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities; and
5. residence within commuting distance of the Aftercare Research Program at the University of California, Los Angeles.

Exclusion Criteria:

1. evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
2. evidence of alcohol or substance use disorder within the six months prior to the first episode and evidence that substance abuse triggered the psychotic episode or makes the schizophrenia diagnosis ambiguous;
3. mental retardation, i.e. premorbid intelligence quotient less than 70.
Efficacy of OmegaBoost to Increase Omega-3 Levels in Healthy Individuals

The purpose of this study is to determine increases in the Omega Index test indicating optimal Omega-3s particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) levels for overall systemic benefits including healthy cardiovascular health and cholesterol levels as shown in the OmegaIndex (OmegaQuant) research.


Eligibility Criteria:
Inclusion Criteria:

* not currently taking Omega-3 supplements or fish oils
* able to swallow softgel or chew gummies nutritional supplement daily for a 12 week period
* able to make four (4) follow-up visits

Exclusion Criteria:

* allergy to fish or seafood
* h/o Atrial fibrillation, or at risk of Afib
* h/o congestive heart failure, heart disease, or prior myocardial infarction and/or cerebrovascular accident
* noncompliance with study requirements
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants

The purpose of this study will be to evaluate safety, tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants. Lots will be studied for consistency of the immune response, as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine.


Eligibility Criteria:
Inclusion criteria:

* Healthy 2 month old infants
* Available for the duration of the study and reachable by telephone
* Able to complete two blood drawing procedures during the study

Exclusion criteria:

* Previous vaccination, contraindication or history of allergic reaction to vaccines or vaccine components
* Bleeding disorder, immune deficiency or significant chronic or congenital disease
* Previous receipt of blood products or immune globulin
Efficacy of Lumbar Motor Control Training in Treatment Of Patients With Cervicogenic Headache

this study will be conducted to investigate the effect of lumbar motor control training exercise on headache frequency, duration, intensity and neck functional disability in cervicogenic headache patients

Cervicogenic Headache is a referred pain spreading from cervical structures supplied by the upper cervical spinal nerve roots (C1-C3), this referred pain that starts from the posterior aspect of the head and neck is usually found to be unilateral, and it also can spread to the frontal, temporal and orbital aspects of the head.The patient frequently reports having a terrible headache, having less neck range of motion, performing less well at work, and having trouble focusing, that may linger for hours. The convergence of primary sensory afferents from cervical nerve roots C1 to C3 with the afferents from the occiput and trigeminal nerve causes the underlying pathology. Because of this, the Suboccipital muscles particularly, which cervical roots C1 innervates to C3, are potential risk structures. Treatment options include posture correction, cervical and upper thoracic strengthening exercises, facet joint manipulation, ultrasound therapy, laser therapy, trigger release therapy, and cervical joint mobilization.famous exercise known as "Motor control exercise" attempts to improve the coordination and effectiveness of the muscles that support and govern the spine. It can also improve coordination between the deep neck flexors and superficial neck flexors and between core muscles of the lumbar region. fifty two patients will be randomly assigned to two equal groups; experimental group will receive lumbar motor control and cervical stabilization exercises and control group will receive cervical stabilization exercises only.

Eligibility Criteria:
Inclusion Criteria:

* The age of the subjects ranged from 20-40 years old, both genders.
* Patients with chronic mechanical neck pain with frequent cervicogenic headaches persisting for more than 3 months.
* Positive flexion rotation test.
* Unilateral head pain without side shift or bilateral head pain with dominant side headache associated with neck pain and aggravated by neck movement and/or sustained awkward head positioning
* Joint tenderness in at least one of the upper three cervical joints or the occipital region as detected by manual palpation.
* Intensity of headache is moderate to severe.
* Abnormal performance in CCFT \< = 26 mmHg
* Body mass index range from 18 to 25 km/m2

Exclusion Criteria:

* Fracture or previous surgery on the vertebral column.
* Spinal stenosis.
* Disc prolapsed.
* TMJ dysfunction.
* Headache with autonomic involvement, dizziness, or visual disturbance.
* Congenital condition of the cervical spine.
* Neck pain of less than three months
Clavipectoral Fascia Plane Block for Clavicle Surgery

The pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block and recently clavipectoral fascia plane block (CPB). CPB was defined by Valdes in 2017 firstly. It may be used for postoperative analgesia after clavicle surgery. CPB may be an alternative to interscalene brachial plexus block.

The aim of this study is to evaluate the efficacy of the US-guided CPB for postoperative analgesia management compare to no intervention control group after clavicle surgery. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Clavicle fracture is common in men and children after a direct fall on shoulder during sport activity such as cycling or an injury during a traffic accident. The pain after clavicle fracture surgery may be managed with combined superficial cervical plexus-interscalene block and recently clavipectoral fascia plane block (CPB). CPB was defined by Valdes in 2017 firstly. It may be used for postoperative analgesia after clavicle surgery. The clavipectoral fascia covers the clavicular site of the pectoralis major muscle. It provides the potential interfascial space between the clavicle and the pectoralis major muscle. CPB provide effective analgesia after clavicle surgery. It is also easy to perform. With this advantage and its analgesic effectiveness for clavicle surgery, CPB may be an alternative to interscalene brachial plexus block. However, randomized clinical efficacy trials are needed to investigate the effectiveness of CPB for clavicle fractures. In the literature, data about CPB is so limited, however it seems a good alternative to brachial plexus block for pain management after clavicle fracture The aim of this study is to evaluate the efficacy of the US-guided CPB for postoperative analgesia management compare to no intervention control group after clavicle surgery. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II
* Scheduled for clavicle surgery under general anesthesia

Exclusion Criteria:

* history of bleeding diathesis,
* receiving anticoagulant treatment,
* known local anesthetics and opioid allergy,
* infection of the skin at the site of the needle puncture,
* pregnancy or lactation,
* patients who do not accept the procedure
Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients

The purpose of this study is to assess the PK of AP-CD/LD given at dose of 50/500mg three times daily compared to CD/LD immediate release (Sinemet) 1.5 tablets of dose of 25/100 given 5 times per day in Parkinson's Disease patients.

An open label, non randomized crossover phase 2 study to assess the PK of AP-CD/LD given at dose of 50/500mg three times daily compared to CD/LD immediate release (Sinemet) 1.5 tablets of dose of 25/100 given 5 times per day in Parkinson's Disease patients. The study will have a screening period followed by an overnight stay in clinic where Immediate release CD/LD (Sinemet) will be administered five times, approximately every three hours. At specified intervals, blood will be drawn for PK testing. On Days 2-7, subjects will be treated at home with AP CD/LD three times/day, approximately every five hours. Day 8 will be overnight stay in clinic for PK study. AP CD/LD 500mg TID will be dispensed to subjects with specified timelines for PK assessment. Each subject will return to clinic on day 15 for a safety followup visit.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of PD consistent with UK Brain Bank Criteria
2. Stable dose of levodopa/carbidopa IR for at least 4 weeks prior to entry; taking at least 4 doses of IR levodopa during waking hours, and total daily dose of at least 400mg prior to initial screening
3. Stable on all anti-PD medications for 30 days prior to screening. COMT inhibitors are held prior to PK studies on day 1 through day 8

Exclusion Criteria:

1. Atypical or secondary parkinsonism
2. clinically significant cardiac, pulmonary, hepatic, or renal disease or other condition which contraindicates participation in judgement of investigator
3. severe dyskinesia as assessed by PI
4. significant cognitive impairment
5. Clinically significant psychiatric illness in opinion of PI
6. history of small bowel or gastric surgery (including PEG-J placement for Duopa/Duodopa) or bowel obstruction, diagnosis of small bowel narrowing, diagnosis of Crohn's disease, frequent nausea or emesis regardless of etiology, and symptomatic gastroparesis.
7. History of GI pathology of clinical significance as determined by PI
8. Allergy to study drug or Yellow Dye #5 (tartrazine)
9. Unable to swallow large pills
10. Active GERD and regular use of PPIs
11. Women who are pregnant or nursing or are of childbearing potential who are not willing to use a medically acceptable method of contraception
Observational Retrospective Trial on Sequential Hormonal Therapy in Patients With Prostate Cancer

Observational Retrospective trial on sequential hormonal therapy in patients with Prostate Cancer


Eligibility Criteria:
Inclusion Criteria:

* non metastatic Prostate Cancer
* previous treatment with bicalutamide 150mg
* biochemical relapse/progression

Exclusion Criteria:

* use of other treatments for Prostate Cancer
Pharmacokinetics of Anidulafungin on Intensive Care Unit (ICU)

The objective of this study is to determine whether pharmacokinetic parameters of anidulafungin correlate with disease severity and plasma protein levels in critically ill patients.

One of the risk factors for mortality of patients with candidemia is inadequate antifungal therapy. The first days in the intensive care unit (ICU), patients are unstable and it can be questioned whether therapeutic levels of anidulafungin are reached after a standard loading scheme. At this moment there are several clues that the PK of anidulafungin in critically ill patients is different, but an overall picture is lacking.

For the investigation of the correlation of the pharmacokinetics of anidulafungin and the disease severity a full pharmacokinetic profile will be obtained. Predictive scoring systems will be used to assess disease severity.

Eligibility Criteria:
Inclusion Criteria:

* treatment with anidulafungin
* at least 18 years of age
* invasive candidiasis
* admitted to an intensive care unit

Exclusion Criteria:

* allergic to anidulafungin or its excipients
* contra-indication stated in SPC
* neutropenia
AIDMA: A Psycho-educational Program Designed to Support and Train Carers of Alzheimer's Disease (AD) Patients

The aim of the project is to demonstrate that a psycho-educational programme designed to support and train carers of Alzheimer's disease (AD) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment. This training programme focuses on the explanation/description of behavioral, cognitive and functional disorders induced by the disease, as well as principles of cognitive and psycho-social stimulation of the patients in daily life.

Context: Research showing the benefit of a combined approach including specific antidementia drugs and psycho-educational programmes for caregivers in the caring of Alzheimer's disease patients is still lacking. We venture the hypothesis that combined treatment including a specific antidementia drug for the AD patient and a psycho-educational programme for the caregivers has a larger benefit for both the patient and the caregiver on psychological, behavioural, and cognitive parameters.

Main objective: to demonstrate that a psycho-educational programme designed to support and train carers of Alzheimer's disease (AD) patients induces a significantly higher benefit than anticholinesterase drug treatment alone or associated to memantine treatment.

Secondary objective: identify patterns of responders and non-responders (taking into account cognitive, psychological parameters).

Methodology: national multicentric, randomized trial, single blinded, with 2 parallel groups of 120 patients and 120 caregivers trained for a 3 month period with 3 assessments: before, just after and 3 months after the training period. Patients and caregivers are recruited (according to exclusion and inclusion criteria) and followed up in memory centers participating in the trial.

Evaluation criteria:

Primary criteria for the patient: DAD scale (Disability Assessment for Dementia).

Secondary evaluation criteria - for the patient: NPI and ADAS-Cog; for the caregiver: ZARIT scale, Questionnaire of feeling of competency, Montgomery and Asberg Depression Rating Scale (MADRS), Geriatric Depression Scale (GDS).

Statistical analysis by the department of biostatistics and medical computing of the Hospital Cochin will be performed.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* AD outpatients
* Stable pharmacological treatment
* Mini-Mental State Examination (MMSE) \[10 -28\]
* Age \[60-90\]
* Informed consent

Caregivers:

* Reliability
* Motivation
* Psychological disorder related to patient's disease
* Need for information or help
* Informed consent

Exclusion Criteria:

Patients:

* Other dementia
* Severe general disease
* No reliable caregiver

Caregivers:

* Physical or mental disease incompatible with patient's management
* Impossibility to participate in the educational program
* Absence of anxiety-depression
* Psychotherapy
Long-term Outcomes of Superficial Esophageal Squamous Cell Carcinoma

Tumor is the primary public health problem and the incidence of esophageal cancer showed the increasing trend in the past thirty years. According to the statistics in 2015, the new onset of esophageal cancer is about 477,900 yearly. The mainly pathologic type of esophageal cancer in China is esophageal squamous cell carcinomas, which accounts for more than 90% of patients in China. With the development of endoscopic technics, more and more patients choose to receive the endoscopic procedure rather than traditional surgery. However, the long-term efficacy and outcomes of patients with superficial esophageal squamous cell carcinoma received different interventions remained unclear. Thus, investigators aim to conduct a multi-center retrospective study to investigate the long term outcomes of superficial esophageal squamous cell carcinoma patients receiving endoscopic treatment and surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients received endoscopic treatment because of the superficial esophageal disease and had the pathologic diagnosis of squamous cell carcinoma.

Exclusion Criteria:

* Combined with other severe disease
* With a history of esophageal surgery
* Combined with other malignant disease
Study of the Platelet Function During the Last Month of Pregnancy

The objective is to compare women's platelet answer in the last month of pregnancy to women old enough to procreate, no pregnancy and without hormonal treatment.

The hypothesis of research is that the decrease of platelet answer in pregnant women could not only limit the occurence of embolic accidents but also explain the lowest incidence of the arterial thrombosis in comparison with the venous thrombosis.

This is a monocentric study comparing a group of pregnant women and a group of "no pregnancy" women.

The goal of the present study is to determine the impact of pregnancy on platelet function. For this, the study propose to explore, in women in the last month of pregnancy, the ability of platelets to aggregate after activation by strong agonists but also their ability to adhere to a matrix and form thrombies.

The study will include 30 pregnant and 30 "no pregnancy" control women, of childbearing age and not taking hormone therapy. From a blood sample, two types of examination will be implemented:

A) In whole blood, we will evaluate the percentage of platelet adhesion to collagen matrix or fibrinogen and the volume of thrombies formed.

B) In washed platelets and whole blood, we shall determine the percentage of aggregation after activation by different agonists and the amount of certain membrane markers of platelet activation. Furthermore, an assay of estradiol plasma will be made.

Eligibility Criteria:
Inclusion Criteria:

* Signature of the form of consent
* Absence of any physical or psychic pathology which can interfere with the normal realization of the study

  * Group1 : Women in the last month of pregnancy
  * Group 2 : Women old enough to procreate, no pregnancy and without hormonal treatment

Exclusion Criteria:

* Thrombopenia (platelet numeration \< 120 000 / mm3),
* Gestational diabet,
* Hormonal treatment : oestrogen-progestagen, progestagen, Selective Estrogen Receptor Modulator (SERM), inductors of ovulation,
* Anticoagulant and any medication which can intervene on the platelet function (AINS, antidepressants)
* Personal history of thromboembolic accident venous or arterial,
* Personal history of haemostasis disease
* Personal history of hepatic or renal disease
* Personal history of autoimmune disease.
Study to Assess the Efficacy and Safety of CJM112 in Patients With Inadequately Controlled Severe Asthma

An unmet medical need exists for patients with moderate and severe asthma who continue to demonstrate symptoms despite being on standard of care medications, and are not eligible for other biologic therapies developed or in development for T2-high(allergic/eosinophilic) asthma. The purpose of this study was to determine if CJM112, an anti-IL-17A antibody, displayed the clinical efficacy and safety profile to support further development in patients with inadequately controlled moderate to severe asthma with low IgE and low circulating eosinophil levels.

After an initial screening visit, run-in period and baseline assessments, the eligible subjects entered the treatment period and were randomized in a 3:2 ratio to one of the two treatment groups:

* 300 mg CJM112 s.c. injection received once per week for the first 4 weeks, followed by once every two weeks up to Week 12 (Day 85) + standard of care treatment.
* Matching placebo + standard of care treatment. After completion of the last dose on Day 85 of treatment period, subjects returned for the final efficacy assessment on Day 92. Following the treatment period, all subjects entered a 13-week safety follow-up period, including the End of Study (EoS) visit on Day 176.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a physician-diagnosed history of moderate to severe asthma for a period of at least one year prior to screening.
2. Patients on a stable therapy regimen of asthma for at least 3 months prior to screening with at least medium dose inhaled glucocorticoid and at least one additional asthma controller medication (such as inhaled long-acting bronchodilator, leukotriene antagonist, theophylline, stable low dose glucocorticoid, etc).
3. Acceptable and reproducible spirometry with FEV1 ≥ 40 and ≤ 90% of predicted at screening and baseline (re-testing is allowed once).
4. ACQ score ≥ 1.5 at screening and baseline (re-testing is allowed once).
5. Total serum IgE \< 150 IU/mL
6. Peripheral blood eosinophils \<300/μL

Exclusion Criteria:

1. Previous use of biologics or other concomitant medications within the time periods specified in the SOM/protocol.
2. History of ongoing, chronic, or recurrent moderate or severe infectious disease.
3. Patients who have smoked or inhaled nicotine or tobacco products within the 6 month period prior to Visit 1 or who have a smoking history of greater than 10 pack years.
4. Patients who have had an asthma attack/exacerbation requiring systemic corticosteroids for at least 3 continuous days within 4 weeks prior to screening.
5. Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Visit 1 or during the screening period.
6. Women of child-bearing potential unless they use highly effective methods of contraception during dosing and for 13 weeks after stopping of investigational drug.