cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation

Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cell transplant (blood and marrow transplant) have very high chances of developing severe oral mucositis (between 95-100%). This mucositis not only causes significant morbidity but also hampers quality of life so much so that patients at times feel difficult to continue treatment.

No definite treatment exists for prevention or treatment of oral mucositis in this group of patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth factor) will reduce duration and severity. Palifermin is very expensive and not available in country. Recently the investigators have shown effectiveness of a probiotic Lactobacillus CD 2 in reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck squamous cell cancer patients. (Published online in European Journal of Cancer: http://dx.doi.org/10.1016/j.ejca.2011.06.010). No significant toxicity has been reported with its use.

Now, the investigators want to study the efficacy of this drug to reduce severity of mucositis in patients undergoing hematopoietic stem cell transplantation. The drug will be supplied by CD Pharma India Private Limited.

The investigators further give undertaking that study will be carried as per good clinical practices (GCP) and declaration of Helsinki.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 10 and 70 years.
2. Karnofsky Performance Score ≥ 70%.
3. Confirmed histological diagnosis of cancer/leukaemia for which haematopoietic stem cell transplantation is an approved modality of therapy.
4. Patients eligible to receive high-dose chemotherapy as part of conditioning regime.
5. Concomitant co morbid condition if present, controlled by medicines.
6. Serum creatinine 1.8mg/dl.
7. Total bilirubin 2mg/dl.
8. Liver enzymes within three times of normal limit.
9. Expected survival \> 6 months.

Exclusion Criteria:

1. Pregnant women and lactating mothers.
2. Patients with history of AIDS
3. Patients who have taken any other investigational product in last 4 weeks.
4. Patients having untreated symptomatic dental infection.
5. Patients with WHO Grade 3 or 4 oral Mucositis.
6. Other serious concurrent illness.
7. Inconclusive histological diagnosis.
8. Patients on anticancer antibiotics.
9. Patients with signs and symptoms of systemic infections.
10. Patient's/guardian's refusal to sign informed consent.
Measurement of the Distribution of Optical Properties in Adult Human Muscle

The researcher can use Diffuse Optical spectroscopy technique that uses harmless levels of near-infrared light to probe the concentrations and states of important physiological molecules such as hemoglobin water and lipids in human muscle,.

The researcher can monitor muscle physiology, for example during exercise or in response to external factors such as shock by Diffuse Optical spectroscopy technique.

The Diffuse Optical spectroscopy technique can determine significant changes in muscle, muscle structure, muscle tissues metabolism and hemodynamics.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female age 18 years and older
* Diagnosed of Cachexic condition
* Diagnosed of Cellulite adult female 18 years and older

Exclusion Criteria:

* Pregnant women
* Taking light sensitive drugs for use in photodynamic therapy
A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors

The purpose of this study was to determine the frequency of bleeding episodes in participants receiving fitusiran as prophylactic treatment of hemophilia compared to participants who were assigned to continue with their regular medication. In addition, the study assessed safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).

The duration of treatment with fitusiran was 9 months. The estimated total time on study, inclusive of screening, for each participant was up to 11 months for all participants who enroll in the extension study and participants in the on-demand arm who did not enroll in the extension study. The estimated total time on study was up to 17 months in fitusiran treatment arm participants who did not enroll in the extension study due to the requirement for up to an additional 6 months of follow-up monitoring for antithrombin levels.

Eligibility Criteria:
Inclusion Criteria:

* Males, greater than or equal to (\>=) 12 years of age.
* Severe hemophilia A or B with inhibitors.

  * (Severity confirmed by a central laboratory where coagulation factor VIII (FVIII) level was less than (\<)1% or factor IX (FIX) level was less than or equal to \[\<=\]2% at Screening; Inhibitors defined as inhibitor titer of \>=0.6 Bethesda units per milliliter \[BU/mL\] or as evidenced by medical records).
* A minimum of 6 bleeding episodes requiring BPA treatment within the last 6 months prior to screening.
* Willing and able to comply with the study requirements and to provide written informed consent and assent.

Exclusion Criteria:

* Known co-existing bleeding disorders other than hemophilia A or B.
* Antithrombin (AT) activity \<60% at Screening.
* Co-existing thrombophilic disorder.
* Clinically significant liver disease.
* Active hepatitis C virus infection.
* HIV positive with a cluster of differentiation-4 count of \<200 cells/microliter.
* History of arterial or venous thromboembolism.
* Inadequate renal function.
* History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-Acetylgalactosamine.
* History of intolerance to SC injection(s).
* Any other conditions or comorbidities that would make the participant unsuitable for enrollment or could interfere with participation in or completion of the study, per Investigator judgement.
Detection and Inflammatory Characterization of Deep Infection After Surgery for Locally Advanced Rectal Cancer With Microdialysis Catheters

The intention of the study is to explore metabolic and inflammatory parameters in the pelvis after abdominoperineal resection for locally advanced rectal cancer in patients that have received radiation therapy before surgery.

Locally advanced rectal cancers (LARC) threaten the normal surgical margins and therefore needs neoadjuvant (chemo-) radiotherapy to down-stage the tumor before surgery. The Norwegian Radium Hospital Oslo University Hospital is a regional center for treatment of LARC in the south-eastern part of Norway and treat approximately 80-100 patients in this category annually. About 50 of these patients receive abdominoperineal resection (APR) as the main surgical treatment. A very high rate of deep surgical site infections is reported in the APR group internationally, particularly in the patients that have received chemo-radiotherapy. The knowledge of why these patients have such a high rate of infections is scarce.

Microdialysis is a technique which enables close to real-time monitoring of the tissues and organs of interest.

The investigators want to utilize the microdialysis method to describe and monitor metabolic and inflammatory parameters, after extensive oncological surgery for LARC in patients that have undergone chemoradiotherapy before surgery. With the knowledge of how the normal biology is, the investigators hypothesize that infection can be readily detected by the biomarkers retrieved by microdialysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary rectal adenocarcinoma that have received radiation ≥25 Gy to the pelvis.
* operation with APR.
* have accepted and signed the consent form.

Exclusion Criteria:

* APR for other reasons
Prevalence of Alzheimer's Disease Pathology in the Community

The goal of this observational study is to (I) study the proportion of people with Alzheimer's disease pathology in a large Norwegian population-based cohort of people aged 70 years or older and to (II) study longitudinal changes of Alzheimer's disease pathology in the same population over a 14 year period.

The main aims are:

* What is the proportion of people with Alzheimer's disease pathology, defined by elevated plasma p-tau217, in a large Norwegian population-based cohort of people aged 70 years or older.
* What is the proportion of people with Alzheimer's disease pathology, defined by elevated plasma p-tau217, among those with normal cognition, mild cognitive impairment and dementia in a large Norwegian population-based cohort of people aged 70 years or older.
* What is the association between plasma p-tau217 concentration and mild cognitive impairment or dementia 4, 10 and 14 years later, respectively.
* What is the association between plasma NfL concentration and mild cognitive impairment or dementia 4, 10 and 14 years later, respectively.

Data is used from The Nord-Trøndelag Health Study (HUNT) wave 3 (2006-2008) and 4 (2017 - 2019, also including HUNT AiT 2021-2023).


Eligibility Criteria:
Inclusion Criteria:

* Living in the area of Nord-Trøndelag, where the HUNT study is carried out.
* Age 70 or older when participating in HUNT4
* Available blood sample from HUNT3, HUNT4 70+ or HUNT4 70+ AiT

Exclusion Criteria:

* None
Study of a COX-2 Inhibitor for Prevention of Ovulation

In this study the investigators propose to evaluate a COX-2 inhibitor(meloxicam) to assess its effect on follicular development and find out if this regimen delays or blocks ovulation while maintaining ovarian cyclicity. The investigators intend to administer 15 mg or 30 mg of meloxicam per day for 18 days starting on day 5 after onset of menses during 3 continuous cycles. The 3 treatment cycles will be preceded and followed by control cycles with no treatment. Ovulation or lack there of will be monitored by transvaginal ultrasound examinations (TVUs), estradiol, luteinizing hormone (LH), and progesterone levels in multiple blood samples in each cycle. The investigators will recruit a total of 56 women. Each woman will be randomly assigned to 1 of the 2 dose regimens of meloxicam, with 28 women assigned to each of the 2 dose regimens. Participating women will demonstrate an ovulatory cycle before starting meloxicam treatment and will be protected from pregnancy by prior sterilization.

In a recent study, following follicular development by daily ultrasound examinations in 22 women, meloxicam was administered when the dominant follicle reached a diameter of 18 mm (Jesam, Salvatierra et al. 2010). Results from this study indicate that meloxicam 30 mg given for five days in late follicular phase was more effective at delaying follicular rupture than 15 mg. Follicular rupture was delayed more than 48 hours in 11/22 (50%) volunteers in the group treated with 15 mg/day and in 20/22 (91%) volunteers in the group treated with 30 mg/day.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Proven fertility in the past
* 18- 40 years old
* Regular menstrual cycles in the past 3 months (24-35 days)
* Surgically sterilized
* Non-lactating
* Hemoglobin of at least 11 g/dl
* Willing to give informed consent in writing

Exclusion Criteria:

* Allergy to meloxicam, aspirin, or other NSAIDs
* Currently pregnant or breast feeding
* History of gastrointestinal problems like stomach ulcer, bleeding or bowel problems
* History of heart attack, stroke, or blood clot
* Hemorrhagic or coagulation disorders
* Known liver and renal disorder
* History of or signs and symptoms of cancer, hyperprolactinemia, bloody breast discharge, diabetes, or any endocrine disturbance
* History of asthma, skin or mucosal allergies
* Hypertension: systolic blood pressure \> 135 mm Hg or diastolic blood pressure \>85 mmHg
* History of mental illness including depression or epilepsy
* Cigarette smoker
* Habitual user of anti-inflammatory drugs
* Alcoholism or any drug abuse
* Use of anticoagulants or steroids
Convection Enhanced Delivery of CSF in DBS for Parkinson's

This study will evaluate safety foremost but also the distribution and initial effectiveness of infusion-enhanced, MRI-guided DBS for patients with medication-refractory, Parkinson's disease

This is an open-label, single-arm, pilot study investigating the safety and feasibility of infusion-enhanced, MRI-guided DBS electrode placement. The investigators intend to enroll patients with Parkinson's disease and medically-refractory motor symptoms, who are already planned for MRI-guided DBS electrodes under general anesthesia. The hypothesis of the study is that a convective micro-infusion of autologous CSF will enhance the T2-weighted MRI visualization of the targeted nucleus during image-guided DBS surgery for Parkinson's disease. The investigators will record standard clinical measures of PD at baseline and 6 months following DBS surgery. The study will recruit patients at a rate of approximately one a month and will take less than two years to complete.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, age 30 years and older
2. Subjects with advanced PD who are scheduled for MRI-guided DBS surgery under general anesthesia
3. Subjects who are able and willing to give informed consent and able to attend clinic visits through 6 months
4. The target nucleus, GPi or STN, is visible on MRI so that it can be targeted for the study infusion and then for MRI-guided DBS

Exclusion Criteria:

1. DBS surgery planned in the awake condition with microelectrode recordings and clinical testing
2. Spinal pathology not amenable to lumbar puncture
3. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
4. Legal incapacity or limited legal capacity as determined by the neuropsychologist
5. Are participating or have participated in another clinical trial in the last 30 days
6. Any illness that in the investigator's opinion preclude participation in this study.
Vestibular Schwannoma and Psychological Factors

The surgery of a vestibular schwannoma induces balance disorders which have a an impact on the patient's daily life and disrupt their quality of life.

But the balance disorders don't seem to be the only ones factors that impaired the patient's quality of life. It has been alrealdy shown that emotional and psychological factors are also related to patient's quality of life.

This study evaluates the relationship between the balance control compensation and these factors (i.e. emotional and psychological) in the vestibular schwannoma resection process.

The research protocol is based on 5 evaluation: 3 days before surgery, 8 days, 30 days, 90 days and 360 days after surgery including posturographic tests, videonystagmography and psychological questionnaires at each evaluation.

Eligibility Criteria:
Inclusion Criteria:

* patients with unilateral vestibular schwannoma (stage I to IV according to the Koos classification) with an indication for surgery.
* age between 18 and 75 years
* patients with written informed consent
* patients with Social Security affiliation

Exclusion Criteria:

* patients with psychiatrics pathologies
* ear pathology different from vestibular schwannoma (cholesteatoma of the middle ear, tympanic membrane perforation)
A Clinical Study Evaluating the Efficacy and Safety of Retinoic Acid in Patients With 15q11-q13 Duplication Syndrome

Autism Spectrum Disorders (ASD), with its core symptoms of communication and repetitive behaviors, is a serious neurodevelopmental disorder common in childhood and affects about 1% of children. So far, autism remains a clinical dilemma with no effective therapy.

The most common chromsomal ability among ASD patients is 15q11-13q duplication syndrome(dup15q syndrome).Clinical phenotypes of dup15q syndrome include autism, mental retardation, epilepsy (usually refractory epilepsy, often manifested as infantile spasm), congenital heart disease, mild facial abnormalities, etc.

UBE3A is one of the most important genes in the 15q11-q13 region.Biochemistry and molecular biology of the Chinese Academy of Sciences Hu Ronggui group found a new kind of autism in mechanisms and potential therapeutic targets - describe the ubiquitin ligase UBE3A protein and retinoic acid.Previous studies have shown that the basis of the relevant treatment measures can effectively relieve the mouse model of autism characteristics. Therefore, retinoic acid supplementation in the treatment of dup15q syndrome is a potential therapeutic target.


Eligibility Criteria:
Inclusion Criteria:

1. Between 6 and 18 years old
2. Clinical diagnosis + scale diagnosis of autism (1) Clinical diagnosis: clinical diagnosis was made by 2 experienced doctors according to the medical history provided by the caregivers and the diagnostic criteria of ASD in DSM-V; (2) Scale diagnosis: The diagnostic assessment was conducted by highly qualified practitioners taking the ADOS-2 score, Restricted Behabior (RRB) and Social Affect (SA) scores. The scores were converted to standardized severity scores (CSS) for three diagnoses of non-spectrum disorders, autism and autism spectrum disorders.
3. Genetics: 15q11-13 duplicates diagnosed by SNP-Array or A-CGH microarray, including UBE3A gene

Exclusion Criteria:

1. A history of acute or chronic infection within the last 3 months
2. There are still active seizures within the past 1 year
3. Have taken vitamin and/or mineral supplements within the last 6 months
4. A history of chronic diseases, including abnormal liver function, abnormal kidney function, and abnormal thyroid function;
Endodontic Post-operative Pain Evaluation of Patients After Using Endomethasone N or Endomethasone SP (EndoPOP)

The study is a post-marketing performance and safety study, designed as a comparative, prospective, multicenter, simple-blind, randomized clinical trial. 300 subjects requiring a primary or a secondary root canal treatment will be enrolled in 2 groups (150 in each group). The aim of the study is to demonstrate the superiority of the hydrocortisone-containing root canal sealer Endomethasone N RCS, compared to the hydrocortisone-free root canal sealer Endomethasone SP RCS, with regard to reduction of the maximum post-operative spontaneous pain during the 7 days following the root canal treatment.

Root canal treatment procedures will be in accordance with the allocation by randomisation of Endomethasone N RCS or Endomethasone SP RCS. The spontaneous and the Masticatory pain will be record at predefined times, a phone call will be done at 48h and a visit will be realized at day 7 (max Day 14).


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female (age ≥ 18 years);
* Patient requiring root canal treatment or retreatment;
* Patient who will need a single visit for the root canal therapy, for a mature molar or second premolar, with or without pre-operative pain
* Patient who received information and gave written consent (signed informed consent form);
* Subject affiliated to a health insurance system, or is a beneficiary (art. L.1121-11, Code of Public Health, France).

Exclusion Criteria:

* Pulpotomy or pulpectomy performed at a prior visit;
* Tooth with apical calcification (sealer unable to reach the root apex);
* Tooth with suspected root perforation;
* Immature tooth (too wide root apex requiring an apexification);
* Other dental treatment ongoing or scheduled within the study period;
* At least one symptomatic tooth among those that are not included in this study
* Known hypersensitivity to steroids, local anesthetics, or any component of study medical devices;
* Subject using long term anti-inflammatory drugs;
* Use of illicit substances during the 48h before the first visit (cannabis, cocaine...);
* Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator;
* Subject who cannot be contacted in case of emergency (phone number);
* Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial;
* Vulnerable subjects (art. L.1121-5 and L.1122-1-2, Code of Public Health, France; art. 66 of the Regulation (EU) 2017/745 on medical devices)
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid Tumors

This is an open-label, multicenter, Phase I dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0623 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) followed by an expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0623 administered orally on a 21 day on/7-day off dosing schedule.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable
* Evaluable disease or disease measurable per RECIST
* Life expectancy \>= 12 weeks
* Adequate hematologic and end organ function
* Agreement to use effective form of contraception for the duration of the study
* Consent to provide archival tissue
* For the cohort expansion stage (Stage II): Patients in this cohort must have had no more than four prior systemic therapies for cancer and must have KRAS mutant CRC (Stage II A and B), pancreatic cancer (Stage IIC, or KRAS mutant NSCLC \[Stage IID\])

Exclusion Criteria:

* History of prior significant toxicity from a MEK pathway inhibitor requiring discontinuation of treatment
* History of parathyroid disorder or history of malignancy-associated hypercalcemia requiring therapy in the last 6 months
* History of retinal vein occlusion (RVO) or predisposing factors to RVO, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy
* Evidence of visible retinal pathology considered a risk factor for retinal vein thrombosis
* History of glaucoma
* Palliative radiotherapy, experimental therapy, or anti-cancer therapy or major surgical procedure within a specified timeframe prior to first dose of study drug
* Current severe, uncontrolled systemic disease
* History of clinically significant cardiac dysfunction
* History of active gastrointestinal bleeding within 6 months prior to screening
* Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, or hepatitis B or C virus
* Active autoimmune disease
* Uncontrolled ascites
* Pregnancy, lactation, or breastfeeding
* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
* For the Exploratory PK Cohorts (Stage IB and Stage IC): Patients who have a history of or ongoing gastro-esophageal reflux disease or peptic ulcer, or who have gastric pathology or history of gastric surgery which could affect absorption of GDC-0623 from the stomach, will be excluded from these cohorts