cyrilzakka/clinical-trials huggingface dataset:
A Phase 2 Study of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease

The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 50-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. A DNA test will be used to identify the "LRRK2-driven" population with predicted elevation in the LRRK2 pathway.

Participants will:

• Take NEU-411 or placebo every day for 52 weeks

NEU-411-PD201 is a Phase 2, randomized, placebo-controlled, proof-of-concept study in participants with early Parkinson's Disease (PD) who have LRRK2-driven PD as measured by an investigational companion diagnostic genetic test (CDx). The study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NEU-411, an orally-administered, potent, selective, bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity as compared to placebo.

After participants are screened for inclusion in the study, approximately 150 participants will be randomized in a 1:1 allocation ratio to NEU-411 30 mg once per day or placebo for a 52-week treatment period. A safety follow-up visit will occur 2 weeks after the last treatment visit.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 50-80 years at time of screening, inclusive
2. Diagnosis of clinically established or clinically probable Parkinson's Disease (PD)
3. LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)
4. Modified Hoehn and Yahr (mH\&Y) of 1 to 2.5

Exclusion Criteria:

1. Secondary or atypical parkinsonian syndromes
2. Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) \>8%
3. Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)

Additional inclusion and exclusion criteria are outlined in the full study protocol.
Real-World Effectiveness of Bevacizumab Based on AURELIA in Platinum-resistant Recurrent Ovarian Cancer

This study will evaluate the efficacy and safety profile, response rate, progression free survival, overall survival of bevacizumab (Avastin) added to chemotherapy in patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with disease progression within 6 months of platinum treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have histologically or cytologically confirmed recurrent epithelial ovarian cancer, fallopian tube cancer, or peritoneal cancer.
2. Patients who have platinum-resistant disease (defined as having relapsed within 6 months of her last platinum-containing regimen)
3. Patients who have underwent chemotherapy of either weekly paclitaxel + bevacizumab, topotecan + bevacizumab, pegylated liposomal doxorubicin + bevacizumab in 2nd line or 3rd line chemotherapy.

Exclusion Criteria:

1. Patients with previous treatment with bevacizumab.
2. Patients who received bevacizumab combination therapy in 4th line or more chemotherapy.
Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France

The purpose of this study is to describe the way candesartan is used in heart failure treatment in France (treatment initiation and monitoring), treatment stops occurrence and reasons for and patients clinical evolution


Eligibility Criteria:
Inclusion Criteria:

* outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure

Exclusion Criteria:

* patients included in a clinical trial the last 30 days before consultation
* patients unable to answer the questions for linguistic or cognitive reasons
* patients who will be difficult to follow during the one year study
Short Term Growth in Children With Atopic Dermatitis

Main objective:to assess short term growth in children with atopic dermatitis during treatment with tacrolimus 0.1% and mometasone furoate 0.1%. A singl blind randomised cross over trial including 20 children. The study consists of 5 periods: run in, treatment(1),wash out, treatment(2) and run out. Each period 14 days where the children will use tacrolimus ointment tvice daily, mometasone furoate once daily or moisturizer (in run in wash out and run out)


Eligibility Criteria:
Inclusion Criteria: age 5-14, atopic dermatitis, normal current growth, Tanner 1, informed consent by the parent or guardian, willing and able to comply with study procedures

Exclusion Criteria: Tanner 2-5, treatment of atopic dermatitis with anti-inflammatory agent within 1 week before the first visit, current asthma or rhinoconjunctivitis that requires treatment with glucocorticoids, endocrine diseases, major surgery within 4 weeks prior to visit 1, fever \>39.5 for \>3 days
Efficacy And Safety Of Dysport In The Treatment Of Upper Limb Spasticity In Children

The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport used in the treatment of upper limb spasticity (altered skeletal muscle performance) in children with cerebral palsy (CP).


Eligibility Criteria:
Inclusion Criteria:

* Upper limb spasticity due to cerebral palsy
* Body weight 10 kg or over
* MAS score of 2 or more in affected elbow or wrist flexors

Exclusion Criteria:

* Fixed myocontracture
* Previous phenol or alcohol injection within 1 year
* Severe athetoid or dystonic movements
* Previous or planned surgery for spasticity in elbow or wrist flexors
* Neuromuscular disorders
* Previous Rhizotomy within 6 months
* Intrathecal baclofen within 30 days
Tigecycline for Treatment of Rapidly Growing Mycobacteria

To determine the safety, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus).

To assess the safety and efficacy of tigecycline in the treatment of drug resistant rapidly growing mycobacterial disease especially M. abscessus

Eligibility Criteria:
Inclusion Criteria:

* Positive cultures for rapidly growing mycobacteria
* Patients who have drug resistant isolates or are intolerant of macrolides or have serious infections unresponsive to currently available drugs
* Adults and children 10 years of age and older
* Pretreatment isolate of M. avium complex available for MIC determination
* Available for followup appointments

Exclusion Criteria:

* History of tetracycline allergy
* If a menstruating female, not pregnant and on adequate birth control
Patterns and Outcomes of Peripheral Vascular Complications Following Self-injection of Addictive Drugs.

Intravascular drug abuse is a common health problem with increasing prevalence throughout the world. The estimated number of IV drug abusers around the world is15.6 millions.

Intravascular drug abuse is a common health problem with increasing prevalence throughout the world. The estimated number of IV drug abusers around the world is15.6 millions.The prevalence of injected drug use is estimated between 0.09% and 1.3% depending on geographic location. There are various complications of IV drug abuse that are related to the toxicity of the substance, mode of consumption, and drug taking mode. These complications include skin and soft tissue infection (cellulitis, abscess, necrotizing fasciitis) (28%),infected(ranges from .03% to 1%)or non-infected pseudoaneurysm ,arterial ischemia( thrombosis , distal embolization), and venous thrombosis(29%).

The wide spectrum of complications due to IVDA mandates a wide range of treatment for each type starting from simple medical treatment such as antibiotics or anticoagulation to the most extensive surgical treatment options in cases such as PA that may require ligation of the arterial supply without revascularization. This may lead to gravid complications such as limb amputation.

Eligibility Criteria:
Inclusion Criteria:

* Current IV drug abuser
* (Age from 18 to 80 )
* Presented with peripheral vascular complications (pseudoaneurysm, limb ischemia, venous thrombosis, skin infection.)

Exclusion Criteria:

* Drug intake other than IV
* ( less than 18 or more than 80 )
* Presented with overdose
* Malignancy or serious illness
* Causes of vascular complications other than IV drug abuse
Comparison Between Pre and Intraoperative ERCP in Treatment of Common Bile Duct Stones

ERCP plays an important role in management of common bile duct stones. Herein the investigators compare preoperative against intraoperative ERCP.

210 were included but only 198 patients were randomly divided into two groups; PES/LC (100 patients) and LC/IOES (98 patients).

The total hospital stay were significantly shorter in the group of LC/IOES


Eligibility Criteria:
Inclusion Criteria:

* patients with gallstones and common bile duct stones

Exclusion Criteria:

* contraindications to ercp

contraindication to laparoscopy

biliary pancreatitis

refusal to participate
Transcranial Direct Current Stimulation for Freezing of Gait

This study will evaluate the effects of transcranial direct current stimulation (tDCS) in combination with locomotor training in patients with Parkinson's disease (PD) and freezing of gait (FOG).


Eligibility Criteria:
Inclusion Criteria:

1. age 18- 80
2. Parkinson's disease stages 2-3 Hoehn and Yahr.
3. Presence of Freezing of Gait
4. Stable medication regimen
5. Time to complete TUG \>12 seconds

Exclusion Criteria:

1. medical condition that would interfere with walking and training for 30 minutes
2. unable to perform timed up and go in the off condition
3. history of seizures
4. implanted deep brain stimulator, pacemaker or any other electronic device.
5. dementia
6. Adults unable to consent, individuals who are not yet adults (infants, children, teenagers) pregnant women, prisoners will not be considered for participation
Voice Analysis Using the LPC (Linear Predictive Coding)Method for the Prediction of Aspiration

It was well known that aspiration is the primary cause of an aspiration pneumonia among the dysphagia patients.

In order to predict the degree of an aspitation,video-fluoroscopic-swallowing study and fiberoptic-endoscopic swallowing evaluation have been developed, but those evaluations are invasive and allowed only in a limited condition.

In this study, as a precedent study for the non-linear analysis, voice analysis using LPC method will be evaluated. The superiority of LPC method will be compared with a spectral analysis using Jitter and Simmer as a positive control.

This clinical study will be performed prospective, positive-controlled, single-blind (i.e. assessor-blind),and single cohort clinical trial for efficacy


Eligibility Criteria:
Inclusion Criteria:

* Patients who were referred for VFSS

Exclusion Criteria:

* Patients cannot phonate d/t tracheostomy
* Preexisting oro-laryngo-pharyngeal disease
* Patients cannot follow 1 step command
* Patients cannot maintain a phonation for 3 seconds
* Refusal of participation
* Patients who were not classified for the candidate by physicians
* Patients who coughs following drinking of 5ml normal saline
A Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RBD7022

This is a randomized, single blind, placebo controlled, single center phase I study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of subcutaneously administered RBD7022 in participants with normal or elevated LDL-c cholesterol. The study will be performed in 2 phases: single ascending dose (SAD) phase and multiple ascending doses (MAD) phase in participants. The decision to escalate to subsequent dose levels will be made by the SRC based on the review of all available safety information in each cohort.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, aged 18 to 65 years, inclusive
* Body mass index between 17 and 28 kg/m2 , inclusive
* LDL-C normal or elevated at screening and baseline.
* Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent.
* The clinical laboratory examination of the subjects was within the normal range, or abnormal but had no clinical significance as judged by the investigators, and did not affect the study results;
* Vital signs, physical examination, ECG, ultrasound showed normal or abnormal but no clinically significant as determined by the investigator.

Exclusion Criteria:

* With a clear history of primary diseases of major organs, the subject is not suitable to participate in this study considered by the investigator;
* Diagnosis of diabetes mellitus;
* Pregnant or breastfeeding women;
* Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.
Anxiety and Distress Levels in Women With Suspected Endometrial Cancer

Patients attending the rapid access gynaecology clinic with a suspicion of endometrial cancer are understandably nervous. Few studies have quantified anxiety and distress of patients in this group.

This study surveys anxiety and stress levels of women attending clinic (by filling in an anonymous questionnaire). Additionally, in women who need a tissue biopsy, women are asked to rate their pain scores.

Aims:

Quantify the anxiety and stress levels of women attending the Rapid access gynaecology clinic with a suspicion of cancer

Background:

Endometrial cancer is a tumour originating in the endometrium (womb lining); it is the most common gynaecological cancer in the United Kingdom (UK). In 2012, there were almost 100,000 new cases diagnosed in Europe. Endometrial cancer classically presents with postmenopausal bleeding (bleeding after the menopause), or intermenstrual bleeding (bleeding in between periods).

Although routine management for these women does vary, in general a screening test is performed, typically a pelvic (internal) ultrasound to assess the endometrium (womb lining). In cases where the endometrial thickness is above the threshold for investigation -an endometrial biopsy (sampling cells from the womb lining) is indicated. Whilst well tolerated, this can be quite painful.

Once the endometrial biopsy is performed, it is sent to the histologist for further examination. Histological analysis may take several days and patients are either brought back to clinic for discussion of the results or are given a telephone appointment. The patient often will not know the result of the test for up to 2 weeks; thus causing a lot of unnecessary anxiety and distress.

The study:

Patients attending the Rapid Access Gynaecology Clinic will be invited to participate in the study by filling in a short anonymous survey.

Additionally, patients undergoing a tissue biopsy sample will be asked to provide a pain score, followed by a brief interview to ascertain if they would undergo the procedure again if it was needed and how they tolerated the procedure. Additionally, the time taken to perform the procedure will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* All women presenting to rapid access gynaecology clinic with suspected gynaecological cancer

Exclusion Criteria:

* Anyone lacking capacity.
* \<18years old.
* Pregnant.
* Anyone unable to understand English (in absence of translator)
A Study to Assess Adverse Events and Change of Masseter Muscle Prominence Using BOTOX Injections in Adult Participants

The masseter muscle is one of the muscles in the lower face used for chewing. Prominence of the masseter muscle can appear as a widened and square lower face shape, which is an aesthetic concern for individuals who prefer a narrower and more ovoid lower face shape. Treatments are available for masseter muscle prominence (MMP), but researchers are looking for new non-surgical treatments. This study will assess adverse events and effectiveness of BOTOX in adult participants with MMP.

BOTOX is being investigated for the treatment of MMP. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. There is 1 in 5 chance that participants will be assigned to placebo. Around 250 adult participants with MMP will be enrolled in the study at approximately 20 sites in Japan.

Participants will receive either BOTOX or Placebo administered as 6 intramuscular injections to each masseter muscle on Day 1. Participants who are eligible for retreatment will be given BOTOX on either Day 180, 210, 240, or 270 and will be followed until approximately Day 360.

There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, facial photography, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Adult Japanese individuals.
* Participant with marked or very marked masseter muscle prominence (MMP).

Exclusion Criteria:

* Asymmetry of left and right sides of the face that could prevent identical Masseter Muscle Prominence Scale (MMPS) or MMPS-P grading on both sides of the face, as determined by the investigator.
* History of permanent soft tissue fillers in the jawline.
Role of Low-Molecular-Weight Heparin in Unexplained Recurrent Pregnancy Loss

Using low-molecular-weight heparin (LMWH), outcomes such as live birth rate and the occurrence of pregnancy complications are some of the variables reported in some studies, with varying degrees of success. The present study aimed to compare the role of LMWH in unexplained recurrent pregnancy loss.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant females between 18 and 44 years of age
* Gestational age above 8 weeks
* A history of ≥3 consecutive first trimester pregnancy losses

Exclusion Criteria:

* Patients with systemic lupus erythematosus
* Positive IgG and IgM anticardiolipin antibodies
* Positive for thrombophilia screening
* Any platelet function abnormality or a previous thromboembolic event requiring anticoagulant therapy (including heparin, aspirin or warfarin)
* Sensitive to acetylsalicylic acid, heparin, or warfarin
* Patients with any genetic, anatomical, or hormonal cause of recurrent pregnancy loss
Validation of a Score That Predicts Residual Disease in Incidental Gallbladder Cancer

An incidental gallbladder carcinoma is detected in approximately 0.2% of the cholecystectomy specimens removed for presumed benign disease. In patients that meet specific criteria, a surgical re-operation is recommended to treat possible residual tumor disease not treated with the initial cholecystectomy. The presence of residual disease in the re-intervention specimen worsens the prognosis of patient survival, according to several published series. Patients with known or high-risk of residual disease may benefit from a specific strategy that would improve patient selection before attempting re-resection. A pathology-based score has been developed but has not been yet validated in an external series of patients. The use of pathological data from the initial cholecystectomy specimen could identify patients at risk of residual disease and aid in selecting a specific therapeutic strategy prior to attempting surgical re-exploration.

* Sample size: 30 (minimum).
* Statistical analysis: populations will be compared with chi-square test or Fisher's exact test (categorical variables) and Student's t test or Mann-Whitney U test (continuous variables). A univariate and multivariate logistic regression analysis will be performed to evaluate the predictive factors of residual disease. The Kaplan-Meier method will be applied for survival analysis and curves will be compared using log-rank test. Univariate and multivariate Cox proportional hazards ratio will be applied to determine the predictive factors of survival. Variables with p values inferior to 0.1 in the univariate analysis will be used to perform the multivariate analysis. Statistical significance is defined when p \< 0.5. The statistical program used will be SPSS version 23.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with a diagnosis of incidental gallbladder cancer requesting therapeutic evaluation in the participating hospital centers.

Exclusion Criteria:

* All patients with non-incidental gallbladder cancer.
* All patients with incomplete or deficient data collection.
* Patients without a signed informed consent.
Improving Health Outcomes of Diabetic Veterans: A Diabetic Self-Management Program

Control of the blood sugar prevents complications and results in extra years of life in patients with diabetes. Practice Guidelines delineating specific ways physicians manage diabetes have been outlined. Missing are guidelines for health care providers to encourage patients to take responsibility for their diabetes. Traditional patient education models have been ineffective in managing diabetic persons because they have relied upon information given alone and are disease centered rather than patient centered. This study will explore the role of self-efficacy in helping veterans move toward healthy behaviors.

Background:

Control of the blood sugar prevents complications and results in extra years of life in patients with diabetes. Practice Guidelines delineating specific ways physicians manage diabetes have been outlined. Missing are guidelines for health care providers to encourage patients to take responsibility for their diabetes. Traditional patient education models have been ineffective in managing diabetic persons because they have relied upon information given alone and are disease centered rather than patient centered. This study will explore the role of self-efficacy in helping veterans move toward healthy behaviors.

Objectives:

The long-term objectives are to: 1) increase recognition of veteran�s responsibility for health; 2) develop more effective skills in managing chronic conditions; and 3) explore the role of self-efficacy in facilitating improvements in health behaviors and health care utilization.

Methods:

This is a prospective, randomized controlled clinical trial of 2,068 cognitively intact, diabetic veterans. The outcome measures (health behaviors, self-efficacy, health status and health care utilization) will be measured using self-rated scales developed and tested by Lorig and colleagues from Stanford University. Glucose levels and BMI changes will be evaluated using information documented in the medical record.

Status:

Enrollment (a total of 326 patients) is closed. All necessary data have been received and are being analyzed.

Eligibility Criteria:
Inclusion Criteria:

Cognitively intact diabetic veterans.

Exclusion Criteria:
OEIS Outcome Data Registry

This registry is created under the sponsorship of the Outpatient Endovascular and Interventional Society (OEIS) to monitor the clinical course and treatment outcomes of patients undergoing office-based endovascular procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or older;
* Patient is identified as having undergone a percutaneous transluminal vascular intervention or attempted intervention, in an ambulatory (outpatient) facility, for the treatment of peripheral vascular disease within native arteries or bypass grafts, from the infrarenal aorta distally to the feet.

Exclusion Criteria:

* Patient treated for a non-eligible condition or procedure
* Diagnostic procedures without intervention or attempted interventions
* Serious mental illness that might preclude subject's ability to comply with follow up
* Life expectancy of less than 6 months