cyrilzakka/clinical-trials huggingface dataset:
Safety and Tolerability of PRO-143 Ophthalmic Solution in Healthy Volunteers.

Study to evaluate the safety and tolerability of PRO-143 solution ophthalmic in healthy volunteers.

A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-143 ophthalmic solution in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female.
* Age ≥ 18 years old at screening visit.

Exclusion Criteria:

* Any ocular or systemic condition.
* Patient with one blind eye.
* Visual acuity of 20/40 in any eye.
* Use of ocular or systemics medications.
* Contraindications or sensitivity to any component of the study treatments.
* Contact lens users.
* Ocular surgery within the past 3 months..
* Women who were not using an effective means of contraception or who were pregnant or nursing.
* Participation in any studies of investigational drugs within 90 days previous to the inclusion.
Culturally-Informed Counseling in Latinas at High Risk for Hereditary Breast or Ovarian Cancer

This pilot clinical trial studies a culturally-informed counseling intervention in Latinas at high risk for hereditary breast or ovarian cancer. A culturally-informed counseling intervention may be an effective method to help people learn more about their cancer risk.

PRIMARY OBJECTIVES:

I. To conduct a randomized trial of a culturally-informed pre-genetic cancer risk assessment (GCRA) telephone intervention.

II. To evaluate the effect of the pre-GCRA intervention versus a time and attention control versus standard scheduling procedure alone (usual care) on levels of anxiety, perceived personal control and cancer genetics knowledge.

III. To explore patients' experiences with the pre-GCRA intervention through post-intervention telephone interviews.

SECONDARY OBJECTIVES:

I. To explore patients' perceived barriers to GCRA through no-show telephone interviews.

OUTLINE:

Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive a culturally-informed adapted motivational interviewing telephone call.

ARM II: Patients participate in a controlled condition comprising a health habits intervention group.

ARM III: Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process. All patients are mailed standard new patient packets containing questionnaires on demographics and personal health history, and a family history form. All patients then undergo genetic cancer risk assessment.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have a personal history of hereditary breast or ovarian cancer; a subset of 60 women without a personal history of hereditary or ovarian cancer will be included in an exploratory subset analysis
* Meet NCCN criteria for consideration of genetic testing for hereditary breast cancer
* Willing to sign consent
* Pregnant women and women of child-bearing potential are eligible for participation in this study
* Women who report themselves to be of Latino or Hispanic ethnic background (defined as Spanish, Mexican, Central or South American, Cuban, Puerto Rican, Dominican, or other Hispanic origin)
* Women who are under- or uninsured and come from low-income communities
* Ability to understand English or Spanish

Exclusion Criteria:

* Previous participation in GCRA
The Cohort Study for Chronic Obstructive Pulmonary Disease (COPD) in China

The purpose of this study is to establish the large COPD cohort and biological database in China, aiming for precision medicine to optimize diagnosis and treatment choices and to monitor and improve clinical outcomes in this disease.

This is a 5-year multi-center observational prospective longitudinal cohort study to to establish the large COPD cohort and biological database in China, including COPD subjects( n= 3000) and GOLD 0 subjects (n= 800).Sites Investigators will be respiratory physicians working in the respiratory department of our sites, which must be tier 2 or tier 3 hospitals in China, with the equipment and ability to conduct pulmonary function test, HRCT.Patients must meet all the inclusion criteria and none of the exclusion criteria.No additional investigational drugs will be applied to the patients. Full analysis set will be used for all analyses. Missing data will be analysed as it is. Statistical analysis will be conducted by epidemiology \& statistics work group from Chinese Academy of Sciences, using SAS and SUDAAN software. An electronic data capture system will be used in this study. Paper-based questionnaire administration will also be used.Questionnaire variables will be checked before data entry.During the study, PI will be in charge of the monitoring of the whole procedure. Two working group will do the data cleaning and data analysing.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40-75 years
* COPD group: baseline post-bronchodilator FEV1/FVC \< 0.7
* GOLD 0 group: individuals with chronic respiratory symptoms and/or high risk factors
* Signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years

Exclusion Criteria:

* Acute exacerbation in the past 3 months
* Having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc
* The usual criteria of serious uncontrolled diseases
* thoracic or abdominal surgery in the last 3 months
* eye surgery in the last three months
* retinal detachment
* myocardial infarction in the last 3 months
* admission to hospital for any cardiac condition in the last month
* heart rate over 120 beats per minute
* antibacterial chemotherapy for tuberculosis
* pregnant or breast feeding
Local Infiltration Analgesia With Ropivacaine Versus Placebo in Bilateral Hip Arthroplasty

High-volume infiltration analgesia may be effective in postoperative pain management following total hip arthroplasty. In this randomized, double-blind trial patients undergoing bilateral hip arthoplasty are randomized to receive high-volume local anesthetic infiltration in one hip and similar infiltration with saline (placebo) in the other hip.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for bilateral total hip arthroplasty
* able to speak and understand Danish

Exclusion Criteria:

* treatment with opioids or steroids
Adaptive DBS to Offset STN Dysregulation During Exercise in PD

The investigators conduct a prospective study to evaluate the effects of exercise on Parkinson's Disease brain biomarkers detected with the PerceptTM PC neurostimulator.

The investigators will conduct a prospective study to evaluate the effects of exercise on Local Field Potential biomarkers detected from the subthalmic nuclues in Parkinson's Disease with the PerceptTM PC neurostimulator. Subsequently, adaptive Deep Brain Stimulation applied in response to low beta peak (L-beta; 13-20Hz) will be performed to evaluate feasibility of whether aDBS can offset the effects of exacerbation of parkinsonism during exercise performance and recovery.

Eligibility Criteria:
Inclusion Criteria:

Persons with PD who have a Medtronic DBS Sensight implant and a Percept IPG.

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Exclusion Criteria:

Persons not meeting the above listed implant criteria Persons not meeting the age limit criteria Persons who are not able to complete the study exercise Persons not able to comprehend and consent to study participation.
Establishing the Diagnosis Standard and Analysis the Risk Factors of POI in Chinese Women

The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women.

Premature ovarian insufficiency (POI) is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. The POI guideline development group of ESHRE recommends the following diagnostic criteria: oligo/amenorrhea for at least 4 months and an elevated follicle stimulating hormone (FSH) level \>25 mIU/mL on two occasion \>4 weeks apart. But there still no diagnosis standard of POI in Chinese.The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women.

Eligibility Criteria:
Inclusion Criteria:

* Infertility
* The length of menstrual cycle longer than 35 days or shorter than/amenorrhea
* Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤7, on at least two occasion \>4 weeks apart

Exclusion Criteria:

* Polycystic Ovarian Syndrome
* other causes of amenorrhea
Evaluation of a Gatekeeper Training Program

The main objective of the proposed study is to evaluate the efficacy of a gatekeeper training suicide intervention program, Applied Suicide Intervention Skills Training (ASIST), in improving medical students' knowledge about suicide intervention, impact of attitudes on someone at risk for suicide and competent use of intervention skills to recognize risk and intervene effectively compared to medical education as usual. This research project will be undertaken using a randomized-controlled trial design. Questionnaires and objective structured clinical examinations using simulated patients will be completed at three time points: 1) before training, 2) after training, and 3) at one year following the training. Medical students' clinical skills in recognizing risk and intervening with simulated patients, as well as knowledge about suicide intervention and the impact of attitudes on someone at risk for suicide will be evaluated.

The current proposal plans to implement and evaluate a secondary suicide intervention skills training program (gatekeeper training) in medical school students in Winnipeg, Manitoba, Canada. The main objective of the current proposal is to evaluate the effectiveness of a gatekeeper training program, Applied Suicide Intervention Skills Training (ASIST), in improving medical students' intervention skills with suicidal patients compared to training as usual. Secondary aims include comparisons of changes in knowledge, perceived competence and attitudes around suicide.

Findings from previous studies have demonstrated a significant positive effect of gatekeeper training on suicide prevention attitudes, skills and knowledge. As well, general studies in medical education reveal that students who have been able to practice, observe, and receive feedback in small groups showed an improvement in skills and confidence over those who were given didactic teaching only. Therefore, the investigators anticipate that the ASIST training program will significantly improve medical students' knowledge about suicide intervention, and will increase their recognition and response to suicide risk compared to education as usual. The investigators also expect that ASIST training will help them to understand the impact of attitudes on suicide prevention, and will increase their perceived competence and ability to recognize and treat a suicidal individual compare over training as usual. It is hypothesized that medical students trained in ASIST will differ significantly in their ability to correctly recognize and intervene with suicidal individuals based on their use of a standardized suicide intervention model and objective assessment using standardized patients.

Eligibility Criteria:
Inclusion Criteria:

* all medical students at University of Manitoba

Exclusion Criteria:

* those who choose not to participate
* those who have already taken ASIST training or related SafeTALK training
An In-vitro Standardization of B Cell Elispot Assays

This study is being done because the study doctor is trying to develop a new test which will help transplant doctors monitor patients with high panel reactive antibodies (PRA). The test would be used to monitor patients' PRA when doctors are trying to lower it through a process known as desensitization. Desensitization lowers high PRA levels and allows patients to receive transplants. This is a single center study to evaluate and optimize the use of a new laboratory test to detect and measure the immune system's functioning.

Sensitization to HLA antigens is the main barrier to solid organ transplantation. Currently, HLA sensitization is monitored by testing patients' serum against a panel of HLA antigens (whether those will be presented on cell surface or on solid phase matrixes) and calculating the % of positive responses. Such result give indication of the relative breadth of sensitization but not on it "depth" - the relative strength of specific antibodies, nor does it provide any information regarding the memory B cells / plasma cells that can manufacture a specific HLA directed antibody.

This is a single center study to evaluate and optimize the use of in-vitro assay to enumerate B cells producing human leukocyte antigens (HLA)-specific antibodies. The proposed assay is based on principles used for enumeration of specific cytokine producing memory T cells - an ELISPOT assay. The investigators are currently using the T cell ELISPOT assay in our laboratory.

The investigators believe that the proposed assay will provide biologically relevant immune measures that are crucial for the long term outcome of transplantation in highly sensitized patients.

Highly sensitized patients encompass a high risk patient group among transplant recipients. The proposed assay is designed to predict the fate of DSA producing (or capable of producing) memory and plasma cells. Thus, it should allow prediction and early detection of activation of the humoral arm of the immune system, specifically against the donor. This, in turn, may prompt early intervention and preservation of the allograft. Three tubes of blood will be drawn twice, 8-12 weeks apart, during clinic or standard of care dialysis visits following optimization. Subjects undergoing desensitization will have three tubes of blood drawn seven times over the course of two years for the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Subjects should be listed for solid organ transplant at NU/NMH
* Subjects should be \> or = to 18 years of age, either gender
* Subjects should have history of prior sensitization of HLA antigens
* Subjects should have documented antibody specificity previously tested at the transplant immunology lab at NU
* Subjects should be capable of understanding the study, consents, HIPAA process and be able to give informed consent.

Exclusion Criteria:

* Subjects younger than 18 years of age
* Subjects with no sensitization history
Safety and Efficacy of Cariprazine As Adjunctive Therapy In Major Depressive Disorder

This is an outpatient study to evaluate the safety, and efficacy of RGH-188 as an add-on therapy to standard antidepressants in patients who did not respond to previous antidepressant therapy.


Eligibility Criteria:
Inclusion Criteria:

* Men and women, 18-65 years old
* Currently meet the DSM-IV-TR criteria for moderate to severe MDD without psychotic features.
* Previous failure to respond to adequate trials of one or two ADTs with less than 50% reduction in depressive symptoms during the present episode.

Exclusion Criteria:

* DSM-IV-TR based diagnosis of an axis I disorder, other than MDD, or any axis I disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
Shock Wave Therapy: Do the External Appearance of the Device Influence Clinical Outcomes?

To check in patients suffering from chronic plantar fasciitis treated with shock wave therapy, if the outward appearance of the device affects clinical outcomes.

Study Design: a controlled, randomized, parallel assessor-blinded clinical trial.

Patients suffering from chronic plantar fasciitis (duration more than 6 months) will be assigned to three different groups:

* Group I: Treatment applied by standard shock waves device.
* Group II: Shock wave therapy applied by a modified standard device to offer more attractive, more technical, smarter, better appearance, larger and with an expansion of external information devices more sophisticated.
* Group III: Shock wave therapy applied by a modified standard device to offer a more austere, disfigured, unattractive, modest and smaller external appearance.

The shock waves emitted to the 3 devices will be identical; the only difference will be the external image of the device.

The main outcome will be the function of the foot by the FFI (Foot Function Index) questionnaire.

As secondary variables: pain by VAS (Visual Analogical Scale) in different situations, the plantar fascia thickness measured by ultrasound, and the perception of patient recovery measured with the Likert scale. Adverse effects, painkillers consumption and pain experienced during the treatment of shock waves were also assessed.

The patients will be followed and monitored for a month, two months and four months after treatment finished.

For the statistical analysis of clinical variables, ANOVA (analysis of variance) will be performed to check whether the evolution of patients over time was different depending on the device applied.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years.
2. Being able to understand the explanations about the potential benefits and risks of study participation.
3. Diagnosis of chronic plantar fasciitis. Proven by clinical examination: Meeting at least 2 of the following criteria:

   * Tenderness in the proximal insertion of the plantar fascia (area of the medial calcaneal tuberosity).
   * Pain during the first steps to get out of bed in the morning and / or after a period of rest time.
4. With a duration of symptoms ≥ 6 months at the time of study entry.
5. Having received conservative therapy without success, at least two treatments. Treatments may have been made isolated, combined or consecutively.

Exclusion Criteria:

1. Bilateral plantar fasciitis.
2. Hiper/ hypothyroidism.
3. Diabetes mellitus.
4. Treatment with anticoagulants
5. Inflammatory diseases.
Study to Determine Tolerability After Intravenous Administration of BIBN 4096 BS in Healthy Male and Female Volunteers

The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single intravenous administration of increasing doses in healthy male and female volunteers


Eligibility Criteria:
Inclusion Criteria:

* Participants should be healthy males and females
* Age range from 21 to 50 years
* Within +- 20% of their normal weight (Broca-Index)
* All female volunteers must use a safe contraception (i.e. oral contraceptive, spiral; sterilized) and must have a negative pregnancy test
* In accordance with Good Clinical Practice (GCP) and local legislation each volunteers are supposed to give their written informed consent prior to admission to the study
* Each subject will have his medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as a 12-lead Electrocardiogram (ECG) within 14 days before the first administration of the test substance.
* Haematopoietic, hepatic and renal function test will be carried out in the laboratory
* The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations

Exclusion Criteria:

* Volunteers will be excluded from the study if the results of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from normal clinical values
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (\>= 24 hours) within ten half-lives of the respective drug before enrolment in the study
* Use of any other drugs which might influence the results of the trial during the week previous to the start of the study
* Participation in another study with an investigational drug within the last two months preceding this study
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 40g/day)
* Drug abuse
* Blood donation ( \>= 100 ml) within the last 4 weeks
* Excessive physical activities (e.g. competitive sports) within the last week before the study
* Pregnant and/or lactating volunteers
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Carbon Monoxide Poisoning

That SPECT brain imaging tracks and is consistent with clinical history and physical exam as well as cognitive testing.

The study is a retrospective review of the PI's experience using SPECT brain imaging and hyperbaric oxygen therapy in the diagnosis and treatment of non-acute phases of carbon monoxide poisoning. The purpose is to see if the SPECT brain imaging is consistent with the clinical condition and cognitive testing on the patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults and children with non-acute carbon monoxide poisoning who underwent SPECT brain imaging as part of their evaluation and treatment

Exclusion Criteria:

* None.
EBUS-TBNA-RTE VS Radiography in Staging of NSCLC

The purpose of this study is to make a qualitative and quantitative analysis of the intrathoracic lymph nodes by CP-EBUS elastography for the first time, and to make a benign and malignant diagnosis.

The newly developed convex array can be used to identify the hardness of the lymph nodes and estimate the benign and malignant lymph nodes indirectly through the quantitative and visualized analysis of the elastic coefficient of the bronchus through the CP-EBUS elastography mode.

The purpose of this study is to make a qualitative and quantitative analysis of the intrathoracic lymph nodes by CP-EBUS elastography for the first time, and to make a benign and malignant diagnosis.

120cases will be enrolled.Compared with the commonly used methods to evaluate intrathoracic lymph node metastasis, the accuracy of chest CT and PET-CT were compared. The lymph node staging method and the final pathological gold standard of the three groups were compared, so as to verify the accuracy and clinical popularization of the bronchial ultrasound elastography mode.

Eligibility Criteria:
Inclusion Criteria:

1. Intrathoracic lymph node enlargement
2. EBUS-TBNA operation can be performed

Exclusion Criteria:

1. Unable to cooperate with the experiment
Autogenous Dentin Derived Barrier Membrane Versus Collagen Membrane

Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane

Autogenous Dentin Derived Barrier Membrane versus Collagen Membrane for Guided Bone Regeneration in Immediate Implant

Eligibility Criteria:
Inclusion Criteria:

1. Patient's age ranges from 18-50 years.
2. Adequate inter-arch relation and inter-occlusal space that could accommodate the implant abutment and the future restoration
3. Non-restorable tooth that needs dental extraction \&amp; guided bone regeneration for immediate implant.
4. Presence of alveolar bone defect with vertical loss of buccal bone more than a third implant thread.
5. Co-operative patients willing to complete the follow-up periods.

Exclusion Criteria:

1. Any pathological condition at site of surgery.
2. Patients with systemic diseases that contra-indicate the surgical procedure.
3. Heavy smoking.
4. Parafunctional habits such as bruxism and clenching.
5. Pregnant patients. -