cyrilzakka/clinical-trials huggingface dataset:
A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation

To evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.

This is a multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation who received treatment with either PN40082 or Restylane Silk in prior Protocol PRO 2018-02 (NCT04032977). Subjects meeting the inclusion/exclusion criteria will receive a single additional treatment with PN40082

Eligibility Criteria:
Inclusion Criteria:

1. In Protocol PRO 2018-02, the subject was in the per-protocol population, i.e., met all inclusion/exclusion criteria; received study device, completed Visit 5 within the specified window; had LFGS score by the Blinded Evaluating Investigator at Visit 3/Month 2, and had no significant protocol violations that would affect the treatment evaluation.
2. If female and of childbearing potential, a negative urine pregnancy test at Visit 1/Day 1 and the subject agrees to use adequate contraception during the study period
3. Willing to give written informed consent

Exclusion Criteria:

1. Women who are pregnant, lactating, or planning a pregnancy
90% Effective Dose of Norepinephrine Infusions Under Intensive and Standard Treatment

The objective of this study is to investigate the 90% effective dose of norepinephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment during cesarean section

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the 90% effective dose of norepinephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment during cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
Evaluation of the Efficacy and Safety of Advantage® Strips in Women Stress Urinary Incontinence (SUI )

This is a single-center retrospective study that evaluates the effectiveness and long-term safety of the TVT tape ( advantage Boston Scientific) in the treatment of stress urinary incontinence in women on a population of 500 patients with a mean follow-up of 6 years.


Eligibility Criteria:
Inclusion Criteria:

* patient who received the laying of a strip ADVANTAGE between 1/1/2015 and 1/6/2012

Exclusion Criteria:

* no
Impact of a Telephone-based Support Intervention on the Long-term Well-being of Women Undergoing Termination of Pregnancy for Fetal Anomaly

This study focuses on women undergoing termination of pregnancy for fetal anomalies (TOPFA). Psychological consequences of such terminations may be even greater than those associated with spontaneous losses of pregnancy because of shame and guilt which can result in social isolation. Currently, there is little support for women after they have left hospital. In this study, 50 TOPFA women will be randomly assigned to an intervention group and 50 to a control group. By completing four questionnaires at the time of induction of labour, total sample will be assessed for depression, stress and "hardiness"; they will be reassessed at 3, 6, and 12 months. Total sample will be interviewed by phone at 6 and 12 months. We hope to determine whether a telephone-based intervention (a biweekly supportive call) can decrease the emotional distress experienced by women undergoing termination of pregnancy.

We hypothesize that: 1)women in the intervention group will show lower rates of depression and stress and a significant increase in hardiness over time at 6 and 12 months post-termination compared with the control group; 2) women who score low on hardiness initially will experience more psychological distress at 6 and 12 months than subjects who score higher initially, irrespective of group; 3) women who have anxious/avoidant attachment styles will not show an improvement in psychological distress over time, irrespective of group.

Eligibility Criteria:
Inclusion Criteria:

* women over 18 years of age undergoing termination of pregnancy for fetal anomaly at Mount Sinai Hospital, Toronto
* fluent in oral and written English
* able to understand the nature of the study
* can provide informed consent
* can be reached by telephone

Exclusion Criteria:

-women who are currently seeing a therapist or undergoing psychiatric care, and women who do not meet all of the inclusion criteria
The Effects of Home-Based Rehabilitation Treatments Among Persons With Symptomatic Knee Osteoarthritis

Knee Osteoarthritis (OA) is one of the most frequent causes of physical disability and pain among adults. Recent evidence suggests that shorter exercise programs that incorporate kinesthesia, balance and agility (KBA) techniques may result in more rapid symptom relief and functional improvements in comparison to traditional therapeutic exercise. KBA techniques are designed to improve dynamic joint stability by using a series of activities which challenge balance and coordination. To determine the independent effects of KBA training on functional abilities, it is necessary to test it as a training program unto itself. The proposed clinical trial is designed to do this by using three training groups: KBA only; lower extremity strength training only; and a combination of the two. The total exercise time and intensity of each condition will be approximately equal. A non-exercise group will control for any effects related to the testing procedures and the passage of time. Community volunteer men and women age 50 and over with physician diagnosed symptomatic knee OA will participate.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50 years or over of either gender
* Self-reported knee pain
* Physician diagnosed tibiofemoral OA, unilateral or bilateral, per ACR guidelines
* Demonstrated minimal knee OA related dysfunction per WOMAC score
* Not engaged in a regular leg exercise program for minimum of 6 months

Exclusion Criteria:

* High risk health status per (e.g.) ACSM guidelines
* Inability to obtain physician release for exercise
* Unresolved balance disorder
* Unresolved neurological disorder
* History of knee surgery or major knee trauma injury
* Hip or ankle instability, excessive weakness, surgery or major trauma injury
* Hip or knee replacement
* Intra-articular joint injection within 4 weeks of the study
Masitinib in Primary Progressive Multiple Sclerosis or Relapse-free Secondary Progressive Multiple Sclerosis

The purpose of this study is to evaluate the activity of oral AB1010, administered at two dose levels during 3 years to patients with primary or secondary progressive multiple sclerosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 60 years, from both sex, and suffering from multiple sclerosis either primary progressive or secondary progressive without relapse within 2 years before inclusion.
2. Patients with EDSS score in the range of 2 to 6.5, inclusive
3. EDSS progression ≥ 1 point within 2 years before inclusion

Exclusion Criteria:

1. Disease other than MS responsible for clinical signs and/or MRI lesions
2. Secondary progressive MS with relapse in the 2 years before inclusion
3. Treatment with interferon or glatiramer acetate within four weeks prior to treatment allocation
4. Treatment with oral or systemic corticosteroids or ACTH within four weeks prior to treatment allocation.
5. Active current bacterial, viral (including hepatitis B and C, HIV, EBV, CMV, herpes zoster, herpes simplex), fungal, mycobacterium, protozoan, or other infection
A Phase IV, Multi-Center, Open-Label Trial of Sibutramine in Combination With a Hypocaloric Diet in Obese and Overweight Thai Subjects.

The purpose of the study is to determine the safety and weight loss when sibutramine is used in overweight and obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject has nutritional obesity and BMI \>30 kg/m

Exclusion Criteria:

* Type 1 or type 2 diabetes mellitus
* Inadequately controlled hypertension
* History of Gilles de la Tourette's Syndrome.
* Use of any MAOIs, SSRIs, amino acids, antimigraine drugs, opioids
* Hypothyroidism or hyperthyroidism.
* History of:

  * benign prostatic hyperplasia
  * neurological disorders
  * psychiatric illness
  * severe renal or hepatic impairments
  * narrow-angle glaucoma
* History of cardiovascular disease or cerebrovascular disease
* Persistent tachycardia at rest
* Pulmonary hypertension
* Phaeochromocytoma
Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

A multicenter, open labeled randomized, phase II trial comparing mFOLFIRINOX and mFOLFOX6 as adjuvant treatment for high risk stage III (pT4N1/2 or pTanyN2) colon cancer

After inclusion and exclusion criteria have been fulfilled and the patient consent has been obtained, the patient will be included and randomized to mFOLFIRINOX or mFOLFOX 6 with a 1:1 ratio.

Arm A: mFOLFIRINOX Arm B: mFOLFOX

Eligibility Criteria:
Inclusion Criteria:

1. Age of 20-70 years with an ECOG ≤ 2
2. Age of 71-75 years with an ECOG = 0
3. Pathologically confirmed high-risk stage III colon adenocarcinoma (pT4N1 or pTanyN2)
4. Curative radical resection (successful R0 resection) within 60 days before randomization
5. Adequate organ functions

   * ANC ≥ 2×106 cells/mL
   * Hemoglobin ≥ 9.0 g/dL
   * Platelets ≥ 100×106 cells/mL
   * Alanine aminotransferase/aspartate aminotransferase ≤2.5 × times the upper limit of normal (ULN)
   * Serum total bilirubin ≤ 1.5 ULN
   * Alkaline phosphatase ≤ 2.5 × ULN
   * Serum creatinine ≤1.5 × ULN or creatinine clearance \> 50 mL/min (Cockcroft-Gault formula)
6. Able to understand and willing to sign and date written voluntary informed consent form
7. Life expectancy ≥ 5 years

Exclusion Criteria:

1. Distant metastasis
2. Middle or lower rectal cancer of need for radiotherapy
3. Postoperative complication of 3 or more grades of Clavien-Dindo classification
4. Underlying disease or postoperative condition which is contraindication for chemotherapy
5. Known hypersensitivity reaction to any study treatment component
6. Familial adenomatosis polyposis or hereditary non-polyposis colorectal cancer
7. Inflammatory bowel disease
8. Previous other malignancy which cannot be curatively treated
9. Pregnancy or breast feeding
10. Any other situation would exclude the patient from study based on the investigator's opinion
A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD)

The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor \[SSRI\] or serotonin and norepinephrine reuptake inhibitor \[SNRI\]) in all participants with major depressive disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

Transferred-entry participants:

-Participants must have completed the double blind (DB) (expand DB) Treatment Phase of Study 67953964MDD3001 or Study 67953964MDD3002 without early treatment discontinuation or switch in the oral selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in the parent study

Direct-entry participants:

* Have a Hamilton Depression Rating Scale (HDRS)-17 total score of 20 or higher at the first and second screening interviews and must not demonstrate a clinically significant improvement (that is, an improvement of more than 20 percent (%) on their HDRS-17 total score) between the first and the second independent HDRS-17 assessments
* Have had an inadequate response to at least 1 oral antidepressant treatment, administered at an adequate dose (at or above the minimum therapeutic dose per Massachusetts general hospital antidepressant treatment response questionnaire \[MGH ATRQ\]) and duration (at least 6 weeks) in the current episode of depression
* Must be an outpatient at open-label treatment phase baseline
* Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Structured Clinical Interview for DSM-5 Axis I Disorders-Clinical Trials Version (SCID-CT)

Direct-entry and Transferred-entry Participants:

-Participants should not take any prohibited medication or food supplements

Exclusion Criteria:

Transferred-entry Participants:

* Participant has been non-compliant with the study intervention administration in the DB Treatment Phase in either of Studies 67953964MDD3001 or 67953964MDD3002 (that is, have missed either 4 or more consecutive doses of study intervention or a total of 8 or more doses during the DB Treatment Phase)
* Participant has any condition or situation/circumstance for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments

Direct-entry Participants:

* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
* Has a history or evidence of clinically meaningful noncompliance with current antidepressant therapy
* Known allergies, hypersensitivity, or intolerance to aticaprant or any of its excipients
Prostate Cancer Evaluation of TaRgets in Genito Urinary Screening Program

Toward personalised treatment in early metastatic prostate cancer based on the assessment of biomarkers in cancer tissue samples and circulating tumour cells.


Eligibility Criteria:
Inclusion Criteria:

* Prostate Cancer patients
* Castration Resistant
* Prostatic tissue available
* Metastasis which may be biopsied

Exclusion Criteria:
Use of Pedometer Following Radical Cystectomy

This is a study to evaluate whether use of a pedometer following radical cystectomy decreases post-operative narcotic use and time to return of bowel function.

This is a randomized controlled prospective study looking at the effect of using a pedometer with graduated step-count goals following radical cystectomy on rate of ileus, return of bowel function and post-operative narcotic use. Subjects will be randomized into a control group or study group. The control group will receive standard of care, with information provided regarding the importance of ambulation following surgery. The study group will receive a pedometer with graduated step-count goals from post-operative day 0 to post-operative day 21. Both groups will be given a standardized post-operative narcotic regimen, and will be asked to record initial passage of flatus and first bowel movement. Subjects will remain on the study until post-operative day 21.

Eligibility Criteria:
Inclusion Criteria:

This study will include men and women age18-75 undergoing radical cystectomy for bladder cancer at Virginia Mason Medical Center. This includes both open and robot-assisted radical cystectomy, and all types of urinary diversion will be included in the trial. Subjects both with and without neo-adjuvant chemotherapy will be included in the study.

Exclusion Criteria:

* Long-term opioid use, defined by CDC as use of opioids on most days for \>3 months
* History of inflammatory bowel disease
* Prior abdominopelvic radiation
* Travel to Europe during study period
* Concurrent surgery during radical cystectomy
* Inability to ambulate
* Gastroparesis or other baseline bowel dysmotility issues
* Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
A Mobile Tai Chi Platform for Fall Prevention and Cognition in Older Adults

The investigators will assess feasibility and acceptability of the Tele-Tai Chi (TC) intervention; explore changes in clinically relevant outcome measures including: physical activity, self-efficacy, quality of life, cognitive function, balance, gait, and evaluate changes in TC proficiency. To achieve this, the investigators are running a single-arm study for older adults that involves a 12-week home-based Tai Chi intervention. Study participation includes four remote and/or in-person (at Spaulding Rehabilitation Hospital) visits to evaluate study participants (mobility tests and questionnaires).

The overall goal of the study is to test the delivery of a novel Tele-Tai Chi (TC) intervention in a single-arm feasibility study for community-dwelling TC-naïve older adults. The investigators will assess feasibility and acceptability of the Tele-TC intervention and its specific components through both qualitative and quantitative feedback, as well as the systematic tracking of adherence data to inform future trials and potential clinical use of the Tele-TC system. The investigators will also explore changes in outcome measures including physical activity, self-efficacy, quality of life, cognition, balance and gait, and evaluate changes in TC proficiency.

Participants will be assessed at 4 timepoints over the course of the 12-week Tele-TC intervention: at baseline, at 4 weeks, at 8 weeks, and at 12 weeks.

Study participants will be instructed to train on their own at least three times a week and to participate in one-on-one live sessions with TC instructors two or more times during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 60 and 85 years old
* Naïve to Tai-Chi practice (never practiced TC)
* Montreal Cognitive Assessment (MoCA) score between 17 and 13.
* Self-reported ability to walk continuously for 15 minutes without an assistive device
* Working email address
* Prior experience with and current access to a computer, smart phone or tablet device

Exclusion Criteria:

* Chronic neuromuscular conditions (e.g. Parkinson's disease, multiple sclerosis, stroke)
* Acute medical conditions requiring hospitalization within the past 6 months or that could interfere with safely participating in the study
* Active cancer
* Significant musculoskeletal conditions requiring chronic use of pain medication
* Significant cognitive impairment (Diagnosed with dementia (self-reported), or Montreal Cognitive Assessment (MoCA)-Blind score \< 13)
Neoadjuvant Adriamycin and Ifosfamide Plus High-Dose ICE in Patients With Soft Tissue Sarcoma (STS)

Complete resection is still the only curative treatment option in patients with soft tissue sarcoma (STS). Patients with a non-resectable STS have a dismal prognosis even without evidence of metastatic disease. The aim of this trial is to determine whether neoadjuvant dose-intensive chemo-radiotherapy is a feasible and effective approach in patients with non-resectable STS.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed STS with locally advanced non-resectable disease
* Metastatic disease is allowed in case of solitary resectable metastases
* Grading according to Coindre \> II°
* Measurable tumor lesions
* Age \> 18 through 65 years
* Karnofsky status \> 70 %
* Written informed consent

Exclusion Criteria:

* Prior chemotherapy
* Intercurrent disease interfering with the adequate administration of study medication including severe psychological disease
* Insufficient liver-, renal or bone marrow function
* Evidence of pregnancy
* Treatment within another clinical trial
* Uncontrolled viral Infections (HIV,HBV, HCV)
* other malignancies
Desensitising Celiac Disease Patients With the Human Hookworm

We have established that the hookworm Necator americanus (Na) dramatically alters the local and systemic immune landscape of the infected human host. Consistent with the principle of desensitisation, diet managed celiac disease subjects previously infected by us with Na will be invited to receive small incremental doses of gluten as pasta (3-25 mm straw of spaghetti) over 16 weeks. Each participant will then be carefully re-assessed to determine if it is appropriate to undertake a 12-week gluten challenge.

Hypothesis The adaptive Th2/regulatory profile imposed by Na will promote gluten tolerance following a micro-dose desensitising programme.

Primary Aim: To determine the safety and efficacy of Na as a tolerising agent in celiac subjects

Specific Aim 1. Undertake a therapeutic pilot study comparing mucosal histopathology before and after a gluten challenge, to be preceded by a programmed desensitising micro-challenge using Na as a tolerising agent.

Specific Aim 2. Assess systemic and mucosal immune responses to gluten micro-challenge, Na infection, and gluten re-challenge throughout the pilot study, to be referenced against hookworm-naive people with treated and untreated celiac disease.

Specific Aim 3. Utilising blood and tissue from hookworm-naive celiac disease volunteers, undertake in vitro studies focusing on the effects of Na-derived excretory/secretory (ES) products on gluten-stimulated gut mucosal cell apoptosis, cytokine and gene profiles.

Eligibility Criteria:
Inclusion Criteria:

* Previously enrolled adults who received an experimental hookworm infection with diet treated celiac disease.

Exclusion Criteria:

* Immune suppressive therapies
Pilonidal Excision Versus Endoscopic Surgery

Compare clinical outcomes of endoscopic pilonidal sinus treatment (EPSiT) with excision treatment with a randomised clinical trial.

Primary outcome: complication rate Secondary outcomes: Quality of life, recurrence rate, length of stay, post operative pain (NRS), return to work time, time to complete wound healing, resource use.

Allocation ratio 2:1

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II
* Pilonidal disease \<3 previous treatments
* Previous incision and drainage allowed
* Over 16 years

Exclusion Criteria:

* Co-morbidity \>ASA II
* Unable to consent themselves
* Under 16 years
* Vulnerable adults