cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo

A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

* Smoking history of at least 10 pack-years
* Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value
* Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria:

1. Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
2. Patients with concomitant pulmonary disease
3. Patients with a history of asthma
4. Any patient with lung cancer or a history of lung cancer
5. Patients with a history of certain cardiovascular comorbid conditions
6. Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
7. Patients in the active phase of a supervised pulmonary rehabilitation program
8. Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents Other protocol-defined inclusion/exclusion criteria may apply
Effect of Monitoring of Pulse Index Continuous Cardiac Output (PiCCO) on Shock Patients in Intensive Care Unit

PiCCO has become a widely used haemodynamic monitoring device in the management of shock patients in ICU patients nowadays. But the effects on outcome of use of Picco, such as hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical ventilation-free days and change of lactate and BNP in shock patients has not been determined. Patients will be randomly assigned to a Picco group or the control group, hospital mortality, vasoactive agents-free days, intensive care unit, and mechanical ventilation-free days and change of lactate and BNP will be observed. The conclusion will supply evidence for the clinical effectiveness of Picco in shock patients.


Eligibility Criteria:
Inclusion Criteria:

* critically ill patients with shock: Mean arterial pressure (MAP) \< 65 mmHg (\< 8,7 kPa) or systolic arterial pressure (SAP) \< 90 mmHg (\< 12 kPa) or the need for vasopressor (Norepinephrine \<0.05µg/kg/min) to support the MAP ≥ 65 mmHg (≥ 8,7 kPa) or the SAP ≥ 90 mmHg ≥ 12 kPa), when one of these criteria has lasted for 4 hours or longer

Exclusion Criteria:

* Age \< 18 years
* Age \> 85 years
* Pregnancy (positive pregnancy test in women of child bearing age)
Efficacy and Safety of Zenoctil in Reducing Body Weight

The intention of the study is to evaluate the safety and potential body weight and body fat loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind, placebo-controlled, parallel study conducted in Caucasian subjects.

This study will also include a diet plan for each subject, calculated based on gender, age, and energy requirements; and adjusted to be slightly hypocaloric.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian males and females, age 18 to 60 years
* 25 kg/m2 ≤ BMI ≤32 kg/m2
* Expressed desire for weight loss
* Accustomed to 3 main meals a day
* Consistent and stable body weight 3 months prior to study enrollment
* Commitment to avoid the use of other weight loss products/programs during the study
* Commitment to adhere to diet recommendation
* Females' agreement to use appropriate birth control methods during the active study period
* Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply

Exclusion Criteria:

* Known sensitivity to Garcinia cambogia, Lagerstroemia speciosa (other members of Lythraceae family), caffeine, tannins
* History of diabetes mellitus or other endocrine disorders
* Fasting blood glucose \>7 mmol/L
* Treatment with systemic corticosteroids within the last 12 months
* Current use of antidepressants
* Uncontrolled hypertension (\>160/110) or other uncontrolled cardiac, pulmonary, renal, or liver disease, determined to be clinically significant by the investigator
* Presence of acute or history of chronic gastrointestinal disease
* Schizophrenia or other diagnosed psychiatric disorders
* Any other acute or chronic disease or any other medical condition which, in the investigator's view, may preclude subject's inclusion (e.g., cancer, HIV)
* Bariatric surgery
* Abdominal surgery within the last 6 months
* History of eating disorders like bulimia, anorexia nervosa
* Changes in the dose of estrogen, contraceptives or thyroid hormone within the last 3 months
* Pregnancy or nursing
* Any medication or use of products for the treatment of obesity (e.g., fat binder, carbohydrate blocker/starch blocker, fat burner, satiety products etc.) within the last 6 weeks
* More than 3 hours strenuous sport activity per week
* History of abuse of drugs, alcohol or medication
* Smoking cessation within the 6 months prior to this study
* Incompliance due to language difficulties
* Participation in another study during the last 4 weeks
* Clinically relevant excursions of safety parameters
Rehabilitation Following Lumbar Disc Surgery

The proposed study will be a randomized clinical trial designed to determine the most effective physical therapy program for individuals who have undergone lumbar discectomy surgery. The study will compare two different post-operative physical therapy programs (general strengthening or general + specific strengthening). Both groups will begin treatment 2 weeks post-surgery. Subjects in both groups will receive weekly treatment sessions for 8 weeks with a treatment program emphasizing exercises shown to activate the large trunk muscles without imposing potentially harmful compression or shear forces. The general + specific strengthening group will also receive exercises shown to isolate activation of the deep trunk muscles, in particular the multifidus, with training augmented by the use of diagnostic ultrasound biofeedback. Patient assessments will be conducted pre- and post-surgery, as well as 10 (post-treatment) and 26 weeks after surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old
* Diagnosis of LDH based on imaging (MRI or CT scan) of the lumbar spine with concurring clinical examination findings (based on the judgment of the attending neurosurgeon)
* Appropriate surgical candidate based on the opinion of the attending spine surgeon, and scheduled for single-level lumbar discectomy (open or micro-discectomy).
* Able to attend weekly treatment sessions.

Exclusion Criteria:

* Prior surgery to the lumbar spine
* Spondylolytic or degenerative spondylolisthesis present on pre-surgical imaging
* Unable to speak and understand English
* Peri- or post-operative complication (infection, nerve injury, dural tear, vascular injury, etc.) that would limit or delay the ability to participate in post-operative rehabilitation.
* Multi-level surgery or the use of instrumentation during surgery (i.e., lumbar fusion)
The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).

To determine the anti-tumour activity and biological effects of cediranib (AZD2171) at a dose of 45mg, primarily in Gastrointestinal Stromal Tumour (GIST) patients who are resistant to imatinib mesylate (current standard therapy) and also in patients with metastatic Soft Tissue Sarcoma (STS) resistant to standard therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological confirmation of GIST which is resistant or intolerant to imatinib mesylate, or metastatic STS, which is refractory to standard therapies or for which no standard therapy exists

Exclusion Criteria:

* Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes.
* Patients with a history of poorly controlled high blood pressure
Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge)

The purpose of this pragmatic cluster randomized control trial is to test the effectiveness of cervical cancer screening follow-up completion using two implementation approaches for self-collected HPV testing in a rural, low-resource setting: 1) community health workers recruiting women door-to-door and 2) community health workers recruiting women at community health meetings.

This study will also help to further understand how current patient referral systems are working between health facilities, patient and provider preferences for integrated care and health system related barriers to integrated cervical cancer screening.

Hypothesis: More women will receive screening via the community health meeting but the engagement to care (i.e., visual inspection with acetic acid-our main outcome) will be greater in the door-to-door arm.

A cluster randomized control trial will be conducted with the objective of understanding differences in the effectiveness of cervical cancer screening models using self-collected HPV testing on engagement in care. In 31 villages, women will be recruited for self-collected cervical cancer and sexually transmitted infection (STI) screening by: 1) Community health worker recruitment for self-collection (door-to-door), 2) community health meetings. Visual inspection with acetic acid (VIA), cryotherapy and thermocoagulation will be offered in local health facilities for all women who test positive for high-risk (HR)-HPV types. Women needing advanced cancer care will be referred to the Uganda Cancer Institute in Kampala.

The unit of randomization (2 arms) will be villages and the analysis will also account for clustering within this unit or randomization. All participants will receive an integrated package of cervical cancer screening and education and will participate in a survey at baseline. Samples will be tested using GeneXpert (XpertHPV) point of care testing at the Kigandalo health facility for HPV and high risk HPV (HR-HPV). Intervention arms will be implemented in phases by year to avoid temporal contamination.

Eligibility Criteria:
Inclusion Criteria:

* Women with no previous history of hysterectomy
* aged 25-49 years old
* no previous history of treatment for cervical cancer
* provided written informed consent.

Exclusion Criteria:

* Women who are under 25 or over 49 years of age,
* who have previously had a hysterectomy or been treated for cervical cancer
* unable to provided informed consent.
Treatment of Fibrotic Scars With Rapid Acoustic Pulse (RAP) Device

A multi-treatment proof of concept clinical study is to evaluate the safety, and efficacy of multiple treatments with Soliton's Rapid Acoustic Pulse (RAP) device for the improvement in the appearance of fibrotic scars

Soliton's Rapid Acoustic Pulse(RAP) device is an electrohydraulic (EH) device using Soliton's Rapid Acoustic Pulse (RAP) technology developed to minimize the appearance of scars through both micro-disruption of the scar matrix leading to scar remodeling and down regulation of the 'fibrotic fibroblasts'

Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 years of age or older at the screening visit.
2. The participant is healthy, as determined by the investigator based on a medical evaluation including medical history.
3. The participant has a fibrotic scar (keloid or hypertrophic scar) that is easily delineated photographically located on the chest, back, trunk, upper arms or upper legs.
4. Scar must be located an essentially planar surface.
5. Scar size preferably between 2.5 cm2 and 5 cm2.
6. Preferably, the scar length is greater than 25 mm; and height greater than 2.5 mm.
7. Scar less than 5 years old.
8. Participant is willing to forego any other scar treatments until complete with study participation.
9. Participant is willing to participate in study and adhere to follow-up schedule.
10. Participant is able to read and comprehend English.

Regardless of the above, the final decision on scar inclusion will rest with the PI.

Exclusion Criteria:

1. Participant is sensitive to loud sounds
2. Participant had treatments, including topical steroids, to the scar being treated in the study in the prior 12 months.
3. Participant is unwilling to have research photos taken of treatment areas in the presence of Sponsor's researchers.
4. Participant is unwilling to have RAP treatment provided in the presence of Sponsor's researchers.
5. Participant is pregnant or planning to become pregnant during the duration of the study.
6. Metal or plastic implants near the area of the treatment (vascular stent, plates and screws, chest wires, hips, knees, elbows, etc.).
7. Active electronic implants such as pacemakers, defibrillators, cochlear implants, nerve/brain stimulators, drug pump, etc.
8. Medical disorder that would hinder the wound healing or immune response (no blood disorder, etc.).
9. History of coagulopathy(ies) and/or on anticoagulant medication.
10. Skin disorders (skin infections or rashes, extensive scarring, psoriasis, etc.) in the treatment area.
11. Current smoker.
12. Any surgical procedure in the prior 3 months, or planned during the duration of the study.
13. Any issue that, at the discretion of the Investigator, would interfere with assessment of safety or efficacy or compromise the participant's ability to fulfill study obligations
14. Treatment with another investigational device or agent within 30 days before treatment or during the study period
Analysis of Biomechanical Parameters and Return to Sport After Total Hip Replacement

This prospective study aims to evaluate the dynamic biomechanical parameters of gait in active patients who have undergone total hip replacement (THR), focusing on movements critical for return to sport.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for total hip replacement surgery
* Active patient with low to high level of physical activity prior to surgery
* Informed consent
* Complete medical file

Exclusion Criteria:

* Contralateral hip surgery
* Neurological disorder affecting movement (e.g. Parkinson's disease, stroke)
* Spinal pathology affecting movement or posture
* Dementia or inability to complete questionnaires and assessments
* Pregnant or breast-feeding patient
* Patient under protective supervision
* Patient not covered by a social security scheme
Flupentixol and Melitracen Tablets in the Treatment of Emotional Disorder

To evaluate the efficacy and safety of Flupentixol melitracen tablets in the treatment of different types of non random emotional disorders

Involuntary emotional expression disorder (ieed) is a kind of disorder of emotion control. Its main clinical feature is frequent short and violent uncontrollable crying and (or) laughing, which is different from mood disorder and self emotional expression.

The mixture of Flupentixol and melitracen is used for antidepressant. Melitracen is a tricyclic antidepressant, while Flupentixol is a neurodepressant in structure, but its dose in Deanxit has antidepressant properties.

The active components of Deanxit are Flupentixol dihydrochloride (Flupentixol) and melitracen (melitracen). Flupentixol is a thiazolyl (thioanthracene) antipsychotic, and melitracen is a tricyclic antidepressant. Low dose Flupentixol (0.5mg-3mg) has antidepressant and antianxiety effects, while melitracen has antidepressant effect. The mixture of the two components is used to treat mild to moderate mental disorders.

The purpose of this study was to evaluate the efficacy and safety of Flupentixol melitracen tablets in the treatment of different types of non random emotional disorders.

Eligibility Criteria:
Inclusion Criteria:

1. men and women aged 18-70;
2. Patients with nervous system diseases (such as stroke, amyotrophic lateral sclerosis, brain trauma, multiple sclerosis, Alzheimer's disease, etc.) accompanied by non random emotional expression disorder;
3. The informed consent form signed by the subject indicates that the subject has been informed of all the contents related to the study;
4. The subjects are willing and able to comply with the study visit schedule, treatment plan, laboratory examination and other study procedures.

Exclusion Criteria:

1. patients with acute infection, acute trauma, perioperative period and acute attack of chronic diseases;
2. Patients in critical condition or dying can not participate in this study;
3. Pregnant or lactating women;
4. Substance abuse patients;
5. Allergic to Deanxit;
6. Mental disorder; Coma;
7. Untreated angle closure glaucoma;
8. In the early recovery of myocardial infarction, patients with different degrees of heart block or arrhythmia and coronary artery ischemia;
9. Monoamine oxidase inhibitors were used;
10. Participated in any other studies involving studies or post marketing drugs within 30 days prior to screening;
11. According to the judgment of the researcher, there are other serious acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risks associated with participating in the trial or using the research products, or may affect the interpretation of the research results, which may make the subjects unsuitable for participating in the trial;
12. Inability and / or unwillingness to understand and / or comply with the protocol.
Non-Myeloablative Allogeneic Transplant for Myelodysplastic Syndromes and Myeloproliferative Disorders

To improve survival outcomes for patients with MDS and MPD with a nonmyeloablative allogeneic hematopoietic cell transplant.

Non-Myeloablative Allogeneic Hematopoietic Cell Transplantation for Treatment of Myelodysplastic Syndromes and Myeloproliferative Disorders (Except CML)

Eligibility Criteria:
Inclusion Criteria:- Myelodysplastic Syndromes

* Myeloproliferative Disorders
* HLA matched donor available Exclusion Criteria:- organ dysfunction
* HIV positive
Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score

Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as cT1 or T2, N0-1, and M0.
* Disease must be ER+ and HER2-.
* Ki67 score/proliferative index ≤ 30% or low to intermediate mitotic index
* Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram.
* 70 years of age or older.
* ECOG performance status ≤ 3
* Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

* Prior surgery for this cancer
* A history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer.
* Currently receiving any other investigational agents.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.
* Uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements.
* Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with endocrine therapies. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer

This study will compare the safety and efficacy of sunitinib in combination with FOLFOX versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic colorectal cancer who have not been treated before.

The study was terminated on April 26, 2010 due to lack of efficacy, as determined during the interim analysis of data in April 2010, showing that the study did not meet its primary endpoint to demonstrate a statistically significant improvement in PFS. The decision to terminate the trial was not based on any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of the colon or rectum with locally advanced or metastatic disease
* Evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
* Eastern Cooperative Oncology Group (ECOG) 0 or 1

Exclusion Criteria:

* Previous treatment with Sutent, Avastin, or any other systemic therapy for locally advanced or metastatic colorectal cancer
* Less than 6 months since completion of adjuvant chemotherapy to documentation of recurrent disease
* History of cardiac disease
* Brain mets
Sleep, Nutrition and Psychological Functioning in Kindergarten Children

The proposed study has the following aims: (a) to assess the concomitant and longitudinal links between sleep and cognitive, behavioral and emotional functioning in kindergarten children; (b) to assess the immediate and the long-term effects of an intervention to promote healthy sleep habits (HSI) on the child's evolving sleep patterns, as well as on related cognitive, behavioral and health domains; (c) to assess the immediate and the long-term effects of an intervention deigned to promote healthy nutrition (HNI) on the eating habits of children, their weight and BMI measures (the comparison/control group) and (d) to assess the links between eating habits and sleep in kindergarten children.

The main hypotheses of the proposed study are: (a) Shorter and more disrupted sleep would be concomitantly and longitudinally associated with compromised cognitive, emotional and behavioral functioning in kindergarten children; (b) In comparison to the HNI group, children in the HSI group will extend their total sleep time, improve their sleep quality and their sleep schedule will be more stable following the intervention; (c) improvement in sleep habits will be associated with improvement in cognitive, emotional and behavioral functioning; (d) in comparison to the HIS group, children in the HNI group will improve their eating habits, engage in more physical activities and better manage to achieve and maintain an age-appropriate body weight.


Eligibility Criteria:
Inclusion Criteria:

* Preschool children (aged 3-6 years) and their parents

Exclusion Criteria:

* (a) significant health or neurological-developmental problems; (b) severe psychological problems, psychiatric diagnosis or treatment; (c) concurrent psychotherapy or similar interventions; (d) medical sleep problems (e.g., sleep apnea); (e) lack of mastery in Hebrew.