cyrilzakka/clinical-trials huggingface dataset:
Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat

The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, 18 to 65 years old
* Stable Body weight
* Body Mass Index (BMI) of ≤40.0 kg/m\^2
* Acceptable volume of submental fat graded by clinician
* Dissatisfaction with the submental area expressed by the subject
* Signed informed consent form (ICF)
* SMF ratings of 1 or 4

Exclusion Criteria:

* No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic agents)
* Presence of clinically significant health problems
* History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
* Body mass index ≤40 kg/m\^2
Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating patients who have stage II or stage III prostate cancer.

OBJECTIVES: I. Determine the pathologic complete response rate to docetaxel in patients with high risk stage II or III prostate cancer. II. Determine the toxicity of this treatment in these patients. III. Correlate clinical measures of response (e.g., symptoms, physical exam, serum PSA, and endorectal MRI) with pathologic response to this treatment in these patients.

OUTLINE: Patients receive docetaxel IV over 30 minutes weekly for 4 weeks. Treatment continues for 2-6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 19-45 patients will be accrued for this study over 18 months.

Eligibility Criteria:
Eligibility Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Potential candidate for radical prostatectomy
* Any of the following:

  * Clinical stage T3 patients
  * Serum PSA at least 20 ng/mL
  * Gleason score 8-10
  * Clinical T2 disease and either of the following:

    * MRI evidence of seminal vesicle involvement
    * Gleason 4+3 cancer with either 5 or 6 biopsies positive
* CALGB 0-1
* WBC greater than 3,000/mm3
* Hematocrit greater than 30%
* Platelet count greater than 100,000/mm3
* SGOT, total bilirubin within normal limits
* Signed Informed consent

Exclusion Criteria:

* No prior hormones, radiation or chemotherapy for prostate cancer
* Evidence of serious active infection
Technology dRiven Enhancement to Engage & Connect

This study will investigate whether an intervention that includes remotely delivered therapy sessions and a digital mental health app, compared to only remotely delivered therapy reduces late-life depression

Depression in mid- and late-life is characterized with reduced functions of the reward system. The investigators designed a psychotherapy that aims to improve reward functions through engagement in pleasurable activities and in turn reduce depression. Prior work has shown that this therapy is acceptable and reduces depression. This study examines whether a hybrid intervention that combines clinician remotely-delivered psychotherapy, and a novel app named TREE-Connect, reduces late life depression. This TREE-Connect app uses a machine learning algorithm to promote adherence to therapy (completion of therapeutic homework) in late-life depression and increase cost-effectiveness and reach of treatment to older adults. This randomized controlled trials will test whether the hybrid intervention (clinician-delivered psychotherapy + app), compared to a condition that includes solely clinician-delivered therapy is acceptable and reduces late-life depression.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 50-80
* Capacity to provide consent for research assessment and treatment.
* Significant depression, i.e., PHQ-9 ≥10 (moderate severity of symptoms)
* Mini Mental Status Exam (MMSE) equal or greater than a score of 23.
* Off antidepressants or on stable dose for 8 weeks and do not intend to change the dose in the next 10 weeks, without individual psychotherapy services during the study period.

Exclusion Criteria:

* Intent or plan to commit suicide in the near future.
* Inability to communicate in English.
* History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, specific phobia, or antisocial or borderline personality disorder.
* Neurological disorders (dementias, amnestic and multidomain Mild Cognitive Impairment, Parkinson's disease, epilepsy, etc.).
* Acute or severe medical illness in the past 3 months (metastatic cancer, multiple sclerosis, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction, cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease, etc.) that may be the primary cause depressive symptoms, influence brain systems of interest, or impact ability to participate in the study.
* For MRI only: Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, insulin pump, cochlear implant, any other metallic biomedical implant contraindicating to MRI, and claustrophobia.
Neuromodulation Augmented Cognitive Training to Improve Cognitive Flexibility in Anorexia Nervosa

The purpose of the study is to evaluate the use of a new brain stimulation tool called transcranial direct current stimulation (tDCS). tDCS is a new technique used to stimulate the brain. The investigators believe that it may help to change brain function in individuals with anorexia nervosa. The brain stimulation occurs outside the head. The tDCS procedure involves applying a small amount of electrical current across the scalp, for a short period of time. This small electrical current is able to change the electrical activity inside areas of the brain. In the current study, the investigators will ask participants to complete computer-based brain training sessions. While participants do the brain training exercises, they will receive either real tDCS for "sham" tDCS. "Sham" tDCS means that participants might feel sensations like tingling or vibrations from the tDCS machine, but will not actually receive the electrical current. Investigators will also ask participants to complete several tests to assess changes in brain function. The information gained from this study will help investigators to understand how tDCS could be used to improve brain function and learning in individuals with anorexia nervosa.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+ years
* Documented enrollment in residential-level treatment at The Emily Program and meeting criteria for AN (BMI \<18.5).
* Participant must be capable of giving informed consent, based on University of California San Diego (UCSD) Brief Assessment of Capacity to Consent (UBACC)39 risk assessment, which has been uploaded to ETHOS.
* Sufficient spoken English so as to be able to comprehend testing procedures.

Exclusion Criteria:

* Substance abuse in the participant
* Neurological condition or other developmental disorder
* Serious psychiatric disorder known to affect brain functioning and cognitive performance
* Medical instability, which will be evident based on required admittance status in the residential treatment facility from which participants will be recruited. (The Emily Program residential treatment patients are followed closely by a medical provider, who routinely assesses medical stability throughout the duration of each patient's stay in the treatment facility; therefore, if a participant is not currently a patient in this setting and/or has been recently discharged from residential treatment setting due to medical need to receive higher level of care/inpatient-level care, they will be excluded from enrollment in this study).
* MRI contraindication \[based on Center for Magnetic Resonance Research (CMRR) prescreening protocol\]
* tDCS contraindication (e.g., history of craniotomy, history of metallic cranial plates, screws, implanted devices).
Tibial Nerve Stimulation for Faecal Incontinence

The purpose of this study is to determine whether tibial nerve stimulation is an effective treatment for faecal incontinence.

Faecal incontinence is a common problem, affecting approximately 2% of the adult general population. Initial management involves dietary advice, anti-diarrhoeal medication, and behavioural therapy. In those who have not benefited from these conservative techniques sacral nerve stimulation is an established and effective treatment for faecal incontinence. This treatment involves using electrical pulses to stimulate the S3 nerve root - a nerve at the bottom of the back. These are the nerves which supply the lower end of the bowel, and the anal sphincter. It is believed that it is stimulation of the sensory fibres heading back towards the spinal cord at this level which is important for the therapeutic effect. To stimulate the sacral nerves however requires two operations under general anaesthetic, and surgical implantation of an expensive nerve stimulator.

The tibial nerve also contains fibres that arise from the S3 part of the spinal cord. Electrical stimulation of the tibial nerve will therefore send sensory information back to the same region of the spinal cord as sacral nerve stimulation. The tibial nerve is much more easily accessible on the inside of the ankle, and this allows stimulation to be carried out as an outpatient and without the need for surgery. It can be performed either percutaneously (with a fine needle placed through the skin to sit next to the nerve), or transcutaneously.

Tibial nerve stimulation has been successfully used for patients with urinary incontinence. There are small studies looking at tibial nerve stimulation for faecal incontinence which both show a benefit, but these studies are not controlled. We aim to determine in a randomised controlled trial whether either percutaneous or transcutaneous tibial nerve stimulation is an effective treatment for faecal incontinence.

Eligibility Criteria:
Inclusion Criteria:

* Over 18
* Incontinence to solid or liquid faeces

Exclusion Criteria:

* Previous congenital or acquired spinal injury, spinal tumour or spinal surgery
* Neurological diseases, such as diabetic neuropathy, multiple sclerosis and Parkinson's disease
* Peripheral vascular disease
* Diabetes mellitus
* Congenital anorectal malformations
* Previous rectal surgery (rectopexy / resection) done \< 12 months ago (24 months for cancer)
* Present evidence of external full thickness rectal prolapse
* Chronic bowel diseases such as inflammatory bowel disease
* Chronic diarrhoea, uncontrolled by drugs or diet
* Anatomical limitations that would prevent successful placement of an electrode
* Previous use of transcutaneous electrical nerve stimulation Stoma in situ
PROject - Supportive and Palliative Care and INnOvation - Antwerp (Pro-Spinoza)

It is important to provide high quality palliative care to all patients with a non-curable and life-limiting condition. The Care Pathway for Primary Palliative Care (CPPPC) provides tools for health care professionals to help them delivering palliative care timely and accurately.This study investigates whether the implementation of the CPPPC really helps to improve patients' lifes.


Eligibility Criteria:
Inclusion Criteria:

* identified as a palliative care patient using the Surprise Question "Would you, as a family doctor, be surprised if this patient would die in the next 12 months?". If the answer is 'no', the patient is eligible for the study.

Exclusion Criteria:

* not having signed the informed consent.
Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects

Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate the safety and toleration of 2 different doses of lersivirine administered either fed or fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)

The aim of this study is to assess the efficacy and safety of endovascular treatment versus medical management in patients with acute basilar artery occlusion with extended time window of 24-72 hours from onset.

The ANGEL-BAO is a multicentered, prospective, randomized, open-label, blinded end-point clinical trial. A total of 224 patients with acute basilar artery occlusion with extended time window of 24-72 hours from onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups (endovascular treatment or medical management) after offering informed content.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years
2. Pre-stroke mRS of 0-2
3. NIHSS score ≥ 10 before randomization
4. Time interval from symptom onset (or last known well) to randomization within 24-72 hours
5. Diffusion-weighted imaging(DWI)-based pc-ASPECTS ≥ 6 and Pons-Midbrain Index (PMI) ≤3
6. Time from completion of DWI imaging to randomization is ≤3 hours
7. Each patient or their legal representative must provide written informed consent before enrolment

Exclusion Criteria:

1. Any sign of intracranial hemorrhage (except microbleeds) on brain imaging prior to randomization
2. Complete cerebellar infarct with significant mass effect, or bilateral thalamic infarction as evidenced by baseline neuroimaging
3. CT or MRI evidence of intracranial tumor (except small meningioma and cerebral aneurysm \< 3mm in diameter)
4. Known or highly suspected chronic occlusion of basilar artery
5. History of contraindication for contrast medium (except mild rash)
6. Current pregnant or breast-feeding
7. Known to have dementia or psychiatric disease unable to complete neurological assessment and follow-up
8. Life expectancy is less than 3 months
9. Enrolled in another drug or device trial or expected to participate in another drug or device treatment trial within the following 3 months.
10. Any other condition (in the opinion of the site investigator) that inappropriate to participate this study
Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus

The primary objective of this trial is to investigate the effect of multiple-dose faldaprevir (FDV) on the single-dose pharmacokinetics of cyclosporine or tacrolimus


Eligibility Criteria:
Inclusion criteria:

* Healthy males or females subjects
* Age 18 to 50 years (incl.)
* Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study

Exclusion criteria:

* Any finding in the medical examination (including blood pressure, pulse rate or ECG) deviating from normal and judged clinically relevant by the investigator.
* Systolic blood pressure (BP) less than 100 mmHg and more than 140 mmHg.
* Diastolic BP less than 60 mmHg and more than 90 mmHg.
* Pulse rate (PR) less than 50 bpm and more than 90 bpm.
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged clinically relevant by the investigator
* Positive QuantiFERON-TB Gold In-Tube
Randomized Trial Comparing Alfuzosin GITS 10 mg Daily With Placebo for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up

The purpose of the study is to compare alfuzosin GITS once daily versus placebo in achieving a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in delaying or avoiding a TURP.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50 or above
* Admitted for AUR due to BPH with PVR of 500 ml or more

Exclusion Criteria:

* Previous history of TURP
* Use of alpha blockers within recent 8 months
* Renal impairment (serum creatinine \>140 umol/l)
* Poor premorbid state
Phase 2 of HU-045 in Glabellar Lines

A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HU-045 and Xeomin® in Patients With Moderate to Severe Glabellar Lines


Eligibility Criteria:
Inclusion Criteria:

* 2(Moderate) and/or above of Facial Wrinkle Scale (FWS) score at frown in investigator's live assessment.
* Subject who signed voluntarily in informed consent form and fully understood about this clinical trial.

Exclusion Criteria:

* Subject who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
* Infection, dermatological condition or scar at the treatment injection sites
* Subject who has marked facial asymmetry
* History of facial nerve palsy or eyebrow/eyelid ptosis
* History of surgical procedures affecting on the lines of forehead and/or middle of the forehead areas
* History of malignant tumor within 5 years (except for basal cell carcinoma
* Any disease and condition that, in the view of the investigator, would interfere with study participation
* Subject who has been treated with any botulinum toxin drug within 6 months
* Subject who takes skeletal muscle relaxants,
* Subject who takes a anticoagulant, antiplatelet, NSAIDs, Vitamin E of over 1,000IU/day (except for low dose aspirin)
* From screening,
* Subject who have positive results of HIV, Syphilis, HBV, HCV
* Drug Hypersensitivity
* Subjects who have hypersensitivity reaction to investigational drug or local anesthetics
* History of Anaphylaxis or severe combined allergy disease
* Subject who has physically untreatable glabellar lines like that can't be spread out even if someone forces it to spread out
* Pregnant and lactating women
* Fertile women and men who have plans to pregnancy and who do not agree to appropriate contraception.
* Participant who has been treated with any investigational drug within 30 days from screening
* Subject who are not eligible for this study based on investigator's judgement.
Nifedipine Compared to Atosiban for Treating Preterm Labor

The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor.


Eligibility Criteria:
Inclusion Criteria:

1. Gestational age between 24 to 34 weeks which had been documented by a definite LMP and sonography up to 20 weeks.
2. All women fulfilled the criteria of preterm labor. The diagnosis of preterm labor required the presence of 4 uterine contractions or more over 30 minutes, each lasting at least 30 seconds, and documented cervical change. The cervical criteria were met when either of the following was present:

   1. Nulliparous women: a single cervical examination demonstrating dilatation of 0 cm to 4 cm and effacement of at least 50%
   2. Multiparous women: a single cervical examination demonstrating dilatation of 1 cm to 4 cm and effacement of at least 50%.
3. Provision of written informed consent

Exclusion Criteria:

1. Chorioamnionitis
2. Preterm rupture of membranes
3. Vaginal bleeding
4. Major fetal malformations
5. Severe hypertensive disorders
6. Intrauterine growth restriction (\< 5th percentile).
7. Non-reassuring fetal heart rate
8. Maternal contraindications

   1. Chronic hypertension
   2. Systolic blood pressure \< 90 mmHg
   3. Cardiovascular disease
   4. Elevated hepatic enzymes
9. Congenital or acquired uterine malformation
Suprachoroidal Administration in Subjects With Choroidal Metastasis From Breast or Lung Primary Tumors

The primary objective is to assess the safety and tolerability of bel-sar treatment in subjects with choroidal metastasis from breast or lung primary tumors.

This is an open-label, dose escalation trial designed to assess safety and tolerability of 4 dose strengths and 1-2 cycles of bel-sar treatment in subjects with choroidal metastasis from breast or lung primary tumors.

Eligibility Criteria:
Inclusion Criteria:

* Have a clinical diagnosis of Choroidal Metastasis, from a histopathologically or cytologically confirmed breast or lung primary tumor.
* Have a single Choroidal Metastasis in only 1 eye, and no Choroidal Metastasis in the other eye (i.e., unilateral, unifocal Choroidal Metastasis).

Exclusion Criteria:

* Active ocular infection or disease.
* Must not have evidence of a primary tumor or metastatic lesion in the brain requiring treatment with radiation therapy per the primary treating oncologist's assessment.