cyrilzakka/clinical-trials huggingface dataset:
A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer

This is a first-in-human phase I/II study to examine the safety, tolerability and preliminary efficacy of VLS-1488 in subjects with advanced cancers.

This a first-in-human phase I/II study designed to assess the safety, tolerability and preliminary efficacy of VLS-1488 monotherapy and consists of two parts: Dose Escalation and Dose Expansion.

Dose Escalation will examine the safety and tolerability of VLS-1488 in different solid tumor types at various dose levels through a series of Dose Escalation and Backfill Cohorts to identify the Maximum Tolerated Dose (MTD) and to select dose levels for Dose Expansion. The criteria for dose (de-)escalation will be based on a Bayesian Optimal Interval (BOIN) design.

Dose Expansion will examine the safety, tolerability, Drug Drug Interaction (DDI) risk, Food Effect (FE) and preliminary efficacy of VLS-1488 in different tumor types and/or dose levels of interest through various expansion cohorts.

VLS-1488 will be given orally in 28-day cycles. Dosing will be continued until disease progression, unacceptable toxicity, withdrawal of consent, or other stopping criteria are met.

Eligibility Criteria:
Key Inclusion Criteria:

* All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site of measurable disease evaluable by CT scan or MRI per RECIST 1.1, able to take oral medication without alteration
* Dose Escalation: No available therapeutic options to provide clinically meaningful benefits in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non -Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction, Bladder (transitional cell), Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), Ovarian Carcinosarcoma, CN-high Endometrial/Uterine
* Dose Expansion: Must have been previously treated with several lines of standard of care treatment specified in the protocol in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non-Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), CN-high Endometrial/Uterine

Key Exclusion Criteria:

* MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype
* Previously received KIF18A inhibitor
* Current CNS metastases or leptomeningeal disease
* Cardiac parameters: MI or stroke ≤ 1 year, unstable angina/PE/DVT/CABG ≤ 6 months, NYHA Class ≥ II, LVEF \< 50%
* Inability to comply with concomitant medication restrictions with respect to strong inhibitors and inducers of CYP3A, and clinical inhibitors of MDR1 (P-gp) and BCRP
* Any clinically significant ascites or pleural effusions at time of enrollment, or any therapeutic paracentesis or thoracentesis within 28 days of planned first dose of study drug
* Bowel obstruction or GI perforation within 6 months of planned first dose of study drug
Strawberries, Cognition, and Vascular Health

The primary objective of this study is to investigate the effects of strawberries on cognitive responses, motor control function, and vascular and cardiometabolic risk markers in healthy older adults.

To achieve the objectives, 40 healthy men and women ≥65 years of age will consume 26 g of freeze-dried strawberries in the form of a drink-mix daily for 8 wk. Using a randomized crossover study design, the effects will be compared to the effects of 8 wk intake of a placebo drink-mix (with a 4 wk wash-out period between trials). Cognitive function measurements will be performed at baseline and 8 wk. Additionally, at each timepoint, flow-mediated vasodilation and blood pressure will be measured followed by collection of fasting blood samples to assess glucose, insulin, blood lipids (free fatty acids, triacylglycerol, total cholesterol, LDL cholesterol, and HDL cholesterol), inflammatory markers (interleukins 6 and 18), and markers of oxidative stress (oxidized LDL-C and malondialdehyde).

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women 65 years and older

Exclusion Criteria:

* stroke or myocardial infarction
* neurological disorders:
* epilepsy,
* multiple sclerosis,
* Parkinson's disease,
* stroke
* known metabolic disorders:
* liver,
* renal
* clinically diagnosed diabetes
* drug treatment for lipid reduction or hypertension,
* psychiatric medication use
Feasibility Study of Phase-contrast MRI for Flow in the External Carotid Branches Arteries

The phase-contrast MRI offers the advantage to combine precisely vascular flow measurements data with morphological images.

Even if the anatomy of the external carotid artery is well known, data obtained through Phase contrast MRI could permit to progress in several fields of cranio-maxillofacial surgery as for example arteriovenous malformations,radionecrosis, head and neck micro-reconstructive surgery.

The aim of this study is to establish and develop Phase-contrast MRI sequences for vascular flow characterization branches of the external carotid artery in healthy patients and in pathological cases.


Eligibility Criteria:
Inclusion Criteria:

* group 1 : healthy volunteer
* group 2 : X-Ray treatment antecedent (at least 50 grays and older than one year)
* group 3 : antecedent of embolization of branches of external carotid artery
* group 4 : antecedent of muscular free flap surgery (older than one month)
* free and informed consent

Exclusion Criteria:

* group 1 : facial pathology, antecedent of facial injury, antecedent of X-Ray treatment in head and neck localisation, antecedent of head and neck cancer
* group 2 : antecedent of surgery for head and neck cancer or for vascular disease
* group 3 : antecedent of surgery for head and neck cancer or for vascular disease ; antecedent of X-Ray treatment.
* group 4 : antecedent of surgery for head and neck cancer or for vascular disease ; antecedent of X-Ray treatment or embolization
* patient with guardianship or trusteeship
* MRI cons-indications
* pregnancy and lactation
Long-term Follow-up (LTFU) of Patients Treated With Genome-edited Autologous Hematopoietic Stem and Progenitor Cells (HSPC)

CADPT03A12001 is a prospective, multi-center study that is designed to follow all enrolled patients who have received treatment with OTQ923 for long-term safety and efficacy.

This study is monitoring patients treated with OTQ923, an investigational drug product of ex vivo genome-edited autologous hematopoietic stem and progenitor cells (HSPCs) that induces fetal hemoglobin (HbF) production, for a total of 15 years following infusion to monitor long-term safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Accepted invitation to join based on prior treatment with gene therapy.
2. Patients must provide informed consent prior to their entry into this study.

Exclusion Criteria:

1. Completion of less than 1 year of safety follow-up in the treatment protocol (CADPT03A12101)
Chemotherapy or Chemotherapy Plus PD-1 Antibody in RET Fusion Positive Advanced NSCLC Patitnts: the POSEIDON Trial

This study aims to explore the efficacy and safety of chemotherapy or chemotherapy plus PD-1 antibody in RET Fusion Positive Advanced Non-small Cell Lung Cancer.

This study aims to explore the efficacy and safety of chemotherapy or chemotherapy plus the PD-1 antibody in RET Fusion Positive Advanced Non-small Cell Lung Cancer. We aim to enrolled 100 patients in this study, the primary endpoint was PFS.

Eligibility Criteria:
Inclusion Criteria:

* ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
* RET Fusion Positive
* First Diagnosis and Treatment
* Treatment Plan is Chemotherapy or Chemotherapy plus PD-1 antibody

Exclusion Criteria:

* - Patients received antitumor treatment before
* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women
Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis

RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.

PURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.

OBJECTIVES:

* Determine the ability of exisulind to inhibit growth and development of duodenal adenomas in patients with familial adenomatous polyposis.
* Determine the effect on apoptosis in polyp vs mucosal tissue in these patients when treated with this drug.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive oral exisulind 4 times daily.
* Arm II: Patients receive oral placebo 4 times daily. Treatment continues for 1 year.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* One of the following diagnosis:

  * Diagnosis of familial adenomatous polyposis

    * Prior total or subtotal colectomy
  * Attenuated adenomatous polyposis coli

    * May have colon intact
* 10-40 duodenal polyps from second portion to 10 cm distal to papilla of Vater

PATIENT CHARACTERISTICS:

Age:

* 18 to 80

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Hemoglobin at least 10 g/dL
* Platelet count at least 100,000/mm\^3
* No active hematologic disease

Hepatic:

* AST and ALT less than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase less than 1.5 times ULN
* No active hepatic disease

Renal:

* Creatinine less than 1.5 mg/dL
* No active renal disease

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active peptic ulcer disease
* No serious underlying medical or psychiatric illness that would preclude completion of the study or limit survival
* No prisoners or institutionalized patients
* No known allergy to sulindac or related compounds
* No active internal malignancy within the past 5 years
* No alcohol or drug abuse within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics

Other:

* No prior non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates more than 10 days a month for the past 3 months
* No concurrent NSAIDs (e.g., mesalamine, olsalazine, azodisalicylate, salsalate, sulfasalazine)
* Aspirin for cardiac reasons allowed (81 mg/day or 325 mg twice/week)
Comparative Study of the Analgesic Effect of Spinal Anesthesia or Infiltration Anesthesia for Hemorrhoidectomy

Background and Objectives: Postoperative analgesia and early recovery are relevant for hospital discharge after hemorrhoidectomy. This study investigated the postoperative analgesic effect with local infiltration compared with spinal block.

Methods: This randomized study included 40 patients aged 18 to 60 years old. Local group (LG) received local infiltration under general anaesthesia; spinal group (SG) received a subarachnoid block. LG received general anaesthesia with propofol, atracurium and propofol infusion as well as a local infiltration of 20 ml 0.75% ropivacaine. SG received 2 ml of 0.5% hyperbaric bupivacaine. Analgesic supplementation was with 50µg of fentanyl for LG and 1% lidocaine for SG. There were assessed: postoperative pain intensity, sphincter relaxation, motor blockade of lower limbs, time to discharge, analgesic dose over 1 week and adverse effects.

This is a prospective, randomized study, including 40 patients between 18 and 60 years, of both genders, ASA 1 or 2.

Patients in group 1( n= 19 ) will be submitted to spinal block and group 2 (n=21) to local infiltration. The spinal block will be performed with 10 mg of 0.5% bupivacaine. The infiltration will be performed with 10 ml of 0.75% ropivacaine on each side.

Will be evaluated: intensity of pain on a numerical scale from 0 to 10 every 30 minutes, relaxation of the sphincter muscles, intensity of pain after the operation every 30 minutes until reached the criteria for discharge, motor blocked of the lower limbs every 30 minutes, BP, HR, SO2, FR, other items that determine the conditions of discharge (urine output, nausea and vomiting), time to hospital discharge, and duration of analgesia.

Adverse effects and complications will be noted.

Eligibility Criteria:
Inclusion Criteria:

* Will be included 40 patients, ASA physical status 1 or 2 undergoing hemorrhoidectomy after approval by the Ethics Committee and signed Consent Form.

Exclusion Criteria:

* There will be excluded patients with associated diseases (fistula, fissure) infection at the puncture site, using anticoagulants or analgesics (up to 2 weeks before the procedure) and pregnant.
Completion and Acceptability of Treatment Across Primary Care and the commUnity for Latent Tuberculosis

This study investigates whether recent migrants to the United Kingdom are more likely to complete treatment for Latent Tuberculosis Infection (LTBI) if they are treated in the community (by General Practitioners/Family Doctors and pharmacists) than in a hospital TB clinic.

People with dormant/latent TB (LTBI) have TB bacteria in their bodies, but do not have any symptoms because the bacteria are not active. The investigators know that recent migrants with LTBI from countries where TB is very common (incidence greater than 150 per 100 000) are at risk of developing active TB (their dormant bacteria become active) after they arrive in the UK. Active TB can be both infectious and deadly. The treatment for LTBI is three-month course of antibiotics. This significantly reduces the risk of developing active TB. This treatment is currently arranged and supervised by hospital clinics, however, many migrants do not attend and numbers of people completing antibiotics is low. This leaves many at risk of developing active TB. This study investigates whether a community (primary care) based approach to the treatment of LTBI, coordinated by general practices and local pharmacists, will achieve higher rates of antibiotic completion. The London Borough of Newham, in the UK, has amongst the highest rates of active TB in Western Europe. As part of a strategy to tackle this disease burden, an innovative model of care has been implemented in the borough in which GPs and pharmacists screen and treat migrants with LTBI. Our trial will evaluate whether primary care based management of LTBI leads to higher rates of treatment completion amongst recent migrants when compared to hospital based care. This approach would save money (both for the health service and for patients in terms of travels costs) and reduce numbers of new cases of active TB.

The treatment for Latent Tuberculosis Infection will be 3 months of combined oral Rifampicin and Isoniazid with Pyridoxine. The dosage is weight dependent.

Eligibility Criteria:
Inclusion Criteria:

* Patients with LTBI aged 16-35 and who have entered the UK less than 5 years ago from a country with a TB incidence of greater than 150/100,000.
* Latent Tuberculosis is defined as a positive IGRA test without any symptoms or physical signs of active Tuberculosis and no evidence of active Tuberculosis on Chest X-ray.

Exclusion Criteria:

1. Pregnant or breastfeeding women
2. Patients requiring medications that cannot be safely taken with Rifinah
3. HIV infection.
4. Individuals with known liver disease, or abnormal liver function tests (LFTs)
5. Diagnosis of cirrhosis (jaundice, haematemesis, ascites or previous episodes of liver encephalopathy)
6. Chronic or active hepatitis B or hepatitis C virus infection
7. Previous treatment for TB or LTBI.
8. Individuals who are unable to consent or who would usually be offered LTBI treatment under DOT because of their mental or social disabilities or those with drug or alcohol abuse
9. Evidence of active TB
Idiopathic Scoliosis and Orthodontic Treatment

Scoliotic pathology remains to this day little known, on the one hand in its etiologies but also in its various implications and possible associations. One of the notable questions found in the literature is concerned with the link between idiopathic scoliosis and the stomatognathic system. This question arises from the study of the anatomy and function of its two entities.

The aim of the study is to determine the frequency of orthodontic treatment in adolescents with idiopathic scoliosis, and to compare it with that of adolescents without spinal dysmorphism.


Eligibility Criteria:
Inclusion criteria:

* Adult and child (age ≥ 12 years)
* Be carriers of idiopathic scoliosis confirmed by X-ray.
* Have reached bone maturity (Risser 4 and more)
* Adult who has not expressed, after information, the reuse of his data for the purposes of this research
* - Child and Holders of parental authority who have not expressed, after information, the reuse of their data for the purposes of this research

Exclusion criteria:

* Refusal to participate in the study
* Association with another orthopedic pathology
* Adult patients under guardianship or crater or under the protection of justice
Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex

Study aimed to evaluate the efficacy and tolerance of Lazolex®, an emollient gel, to treat mucocutaneous lesions caused by herpes simplex virus.

A single-center, single-arm, open-label, phase II clinical trial was conducted with 30 patients divided into two groups: 15 patients with herpes simplex virus type 1 (HSV-1) infections and 15 with herpes simplex virus type 2 (HSV-2) infections. All received topical treatment with Lazolex® Gel four times daily for 10 days. The efficacy and tolerance of the treatment were evaluated on day 10 and day 20 after the study started. In addition, recurrence rates were evaluated before treatment with Lazolex® and after a 4-year follow-up period after treatment.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of acute or chronic herpes simplex mucocutaneous infection,
* mild course of disease (defined as body temperature \<37.2°C and without signs of general infirmity),
* application of last treatment for herpes simplex infection \>3 months,
* available to cooperate during the study,
* provision of written informed consent.

Exclusion Criteria:

* abnormal laboratory results,
* hypersensitivity to the product or its components,
* pregnancy or breastfeeding,
* acute/ chronic renal or liver failure,
* history of migraine,
* organic brain lesion,
* generalized anxiety disorder,
* blood supply disturbance in the vertebrobasilar pool,
* stage 3 essential hypertension,
* concomitant acute or decompensated disease that could affect the study results,
* intake of acyclovir, antibiotics, immunosuppressants, antimetabolites, or glucocorticosteroids during 3-month period prior to the study,
* concomitant participation in another clinical trial.
Advanced Pelvic Floor Training Program for Prostate Cancer Surgery

Radical prostatectomy is a common and effective treatment for prostate cancer but is associated with urinary incontinence that can persist for several months after surgery and significantly reduce quality of life. Studies have shown that routine performance of pelvic floor exercises after radical prostatectomy can aid in the recovery of urinary control; however, conventional pelvic floor exercises do not produce consistent results. Research indicates that incorporating other deep abdominal muscles can further activate the pelvic floor making it stronger than by activating the pelvic floor alone. Specifically, 'Pfilates' and 'Hypopressives' are two new techniques that combine traditional pelvic floor exercises with activation of supportive muscles. Our proposed study will be the first to test the effect of an advanced pelvic floor exercise training program that includes Pfilates and Hypopressives to treat urinary incontinence following radical prostatectomy. Our primary aim of this study is to assess the feasibility of conducting a full-scale RCT of an advanced pelvic floor exercise training program, including standard pelvic floor exercises, Pfilates, and Hypopressives techniques on urinary incontinence. Feasibility will be determined by measuring recruitment success, retention, outcome capture, and intervention adherence, tolerance, and safety. We hypothesize men under going radical prostatectomy for prostate cancer in the advance pelvic floor training program will report greater improvement in urinary incontinence and health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Men with localized prostate cancer (stage cT1-cT2) who have consented for radical prostatectomy (open retropubic, laparoscopic, robot-assisted laparoscopic)
* Between the the ages of 40 and 80 years
* Proficient in English

Exclusion Criteria:

* i) Diagnosed with a known neurological disease, autoimmune connective tissue disorder;
* ii) Have prior experience with pelvic floor training by a healthcare provider;
* iii) Have uncontrolled hypertension;
* iv) Have diagnosed COPD (Chronic Obstructive Pulmonary Disease) and/or chronic restrictive respiratory disease; or
* v) Have a history of inguinal herniation
First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)

The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing decompression and single level instrumented posterolateral lumber autograft fusion surgery.

This will be a first in human Phase I, ascending dose, multi-center, randomized patient study evaluating the efficacy, safety, PK of AK1320 MS. The study will enroll up to 4 dose escalating cohorts with each cohort having 2 treatment groups. Cohort 1 and Cohort 2 (AK1320 MS group (n=3-7); Control group (n=0-3)) and Cohort 3 and Cohort 4 (AK1320 MS group (n=6-7); Control group (n=0-3)).

Eligibility Criteria:
Inclusion Criteria:

1. Involved level L1 to S1
2. Use of local autologous bone only.
3. Degenerative spondylolisthesis up to Meyerding's Classification Grade 1 or 2.
4. Moderate or higher disability as assessed by Oswestry Disability Index.
5. Neurogenic claudication and/or radiculopathy with or without back pain.
6. Male or female over 22 years of age and less than 81 years of age.

Exclusion Criteria:

1. Prior lumbar decompression or spine fusion attempt (any level).
2. Undergoing concurrent interbody fusion.
3. Requires spinal fusion at more than one lumbar level.
4. Degenerative scoliosis.
5. BMI \> 40.
6. Radiographically confirmed significant spinal instability.
7. Active or recent (within the past two (2) years) worker's compensation litigation.
AC-1204 Long-term Efficacy Response Trial (ALERT Protocol)

The study will evaluate the safety \& efficacy of AC-1204, a ketogenic compound, administered orally on a daily basis for 6 months. Following the 6 month double-blind phase of the study, subjects may enroll in an optional 6 month open-label extension phase. Efficacy will be evaluated by standard tests of memory and cognition, along with other measurements of activities of daily living and quality of life. Safety will be assessed by frequency of adverse events and changes in laboratory test results. Subjects will be stratified and outcomes will be separately analyzed based on apolipoprotein E4 genotype (APOE4).

Two primary outcome measures will be assessed in APOE4(-) patients:

1. differences from baseline between AC-1204 and placebo groups' ADAS-cog scores at 6 months
2. differences from baseline between AC-1204 and placebo groups' CIBIC+ scores at 6 months Secondary endpoints will include differences between AC-1204 \& placebo groups' scores for these same instruments at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Males/females between age of 55 -85 years
* MMSE scores between 16-26
* Probable mild to moderate AD

Exclusion Criteria:

* Presence of other CNS disorders as alternative causes of dementia
* Type 1 or Type 2 diabetes
* Significant renal/hepatic disease