cyrilzakka/clinical-trials huggingface dataset:
Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment

The main objective of the study is to assess whether the performance of type 2 quadratus lumborum block produces an improvement in the quality of life of the patient with osteoarthritis of the hip.

The quadratus lumborum block is an interfascial block of the posterior wall of the abdomen, initially described for the management of postoperative pain in abdominal surgery due to its suggested effect on the T7-11 roots. The analgesic efficacy of type 1 quadratus lumborum block (QL1) in hip surgery was subsequently published. Regarding chronic pain, QL2 has been successfully performed in posttherniorrhaphy pain or pancreatic cancer.

This quadratus lumborum type 2 or posterior, is performed in the patients with hip joint based on the innervation of the hip and taking the role of thoraco-lumbar fascia in the analgesia of these patients as a reference. The good results obtained in the first 5 patients have led us to evaluate whether this blockade can indeed be an analgesic alternative in patients with coxarthrosis.

Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent (Annex 2)
* Age 18-85 years
* Cartilage injury (coxarthrosis) hip
* Illness \<1 year of evolution
* Patients with pain after treatment with physical therapy, exercises, NSAIDs.
* EVN\> 5

Exclusion Criteria:

* Refusal of the patient
* Allergy to the drugs used
* Contraindication for performing the technique
* Intraarticular treatment in the previous 3 months
* Pregnancy
Randomized Double Blinding Controlled Study on" Jia Wei Xiao Yao Jiaonang" Treating Mild to Moderate Major Depressive Disorder

This is a randomized, double-blind multi centric clinic study. Both of therapist and patient are blind. There are 180 patients from 3 hospitals included, who meet DSM-IV criteria for major depressive disorder, the score of HAMD-item\>20，\<35；and meet the criteria for TCM syndrome of "Liver Qi stagnation and Transformation of Stagnant Qi into Fire". Patients are randomized to JWXY and sertraline treatment groups, receiving oral sertraline (start with 50 mg/day for one week then continue with 50 mg/day) plus placebo of JWXYJN; or oral JWXYJN plus placebo of sertraline daily for 2 months. The symptoms of depression and anxiety are measured with HAMD and HAMA tests at baseline and at 2，4，8 weeks; and LFT, BUN, Cr are assessed at baseline and end of program. Then data will be analyzed with SPSS software to determine the efficacy and safety of JWXYJN comparing to sertraline in the treatment of mild to moderate major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older.
* A diagnosis of MDD, single episode or recurrent, according to DSM-IV
* Meets DSM-IV criteria for Major Depressive Disorder.
* factor score from the 24-item Hamilton Depression Rating Scale (HAM-D) \>20,\<35
* Patients must be able to provide written informed consent

Exclusion Criteria:

* Patients with a current (or within 6 months prior to the Screening Visit) Axis I disorder of Post Traumatic Stress Disorder, Eating Disorder, Obsessive Compulsive Disorder.
* Patients with a history of schizophrenia, schizoaffective disorder or bipolar I or II disorder (with a history of hypomanic or manic episodes).
* Patients who meet DSM-IV criteria for substance abuse (alcohol or drugs) within 3 months prior to Screening Visit or substance dependence within 6 months prior to the Screening Visit.
* Patients who meet criteria for any of the following DSM-IV MDD Specifiers: \[a\] With Catatonic Features; \[b\] With Postpartum Onset; \[c\] With Seasonal Pattern \[d\] with Psychotic Features.
* Patients who are receiving formal psychotherapy or have had psychotherapy within the 12 weeks prior to the Screening Visit.
Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids

Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.

Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
* Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
* Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
* Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits

Exclusion Criteria:

* Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:

  * Six months or more (immediately prior to Screening Visit) without a menstrual period, or
  * Prior hysterectomy, or
  * Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);
* Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
* Documented endometriosis or active pelvic inflammatory disease (PID);
* Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
* Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;
* Use of prohibited concomitant medications:

  1. Depo-Provera use must cease ten months prior to first dose of study drug, or
  2. GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
  3. Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study
Study of the Causal Link Between Rheumatoid Arthritis and Periodontitis Using Mendelian Randomization

This study aims to investigate the causal relationship between rheumatoid arthritis and periodontitis using Mendelian randomization. Data will be sourced from genome-wide association studies (GWAS) to explore genetic associations and assess potential risk factors in an East Asian population.

The purpose of this study is to explore the causal association between rheumatoid arthritis (RA) and periodontitis using Mendelian randomization (MR). RA and periodontitis share similar inflammatory pathways and immune responses, but their causal relationship remains unclear. This study will utilize genome-wide association studies (GWAS) data from an East Asian population to identify single nucleotide polymorphisms (SNPs) associated with RA and assess their potential impact on the risk of developing periodontitis. Statistical methods such as inverse-variance weighting, MR-Egger regression, and weighted median analysis will be employed to analyze the data. The findings may provide insights into the shared genetic basis and causal relationships between these two conditions, offering potential targets for preventive strategies.

Eligibility Criteria:
Inclusion Criteria:

* Participants included in the genome-wide association study (GWAS) database.
* Subjects with available genotypic data relevant to rheumatoid arthritis and periodontitis.

Exclusion Criteria:

* Individuals without complete genotypic data or those with missing critical phenotypic information.
RehabNytte - A Study of Rehabilitation Processes in Specialized Care in Norway

The main objective of the study is to describe function and health related to quality of life during the first year after rehabilitation, to measure the degree and impact of user involvement in the rehabilitation process, assess factors associated with change in work -ability and -participation, and to test measurement properties of a new core set of outcome measures for rehabilitation launched by the Norwegian Directorate of Health.

This is a large multicentre cohort study including patients receiving rehabilitation at 17 rehabilitation centres from Norway, \*the RehabNytte Consortium. Invitation and registration of participants will be conducted by local project coordinators in the period between 01.01.2019 and 31.03.2020.

All participants will receive rehabilitation as usual at each centre, and report HRQoL, health and function (by PROMS) through a digital self-reporting system at admission, discharge and after 3, 6 and 12 months.

This study seeks to answer several research questions related to the overarching areas:

1. Patient reported change of function, health and quality of life during the first year after rehabilitation
2. Degree of user involvement in rehabilitation
3. Change in work -ability and -participation
4. Quality assessment (use of Quality indicator set)
5. Measurement characteristics (feasibility and responsiveness) of recommended PROMS in rehabilitation

Eligibility Criteria:
Inclusion Criteria:

* Patients that participates in inpatient or outpatient rehabilitation programs at one of the participating centers.
* Age over 18 years
* Access to internet at home
* Access to personal secure login with BANK ID.

Exclusion Criteria:

* Severely reduced cognitive function
* severe mental illness with inadequate consent competence ability to participate
* Insufficient understanding of Norwegian written language.
Masitinib in Patients With Mild to Moderate Alzheimer's Disease

The purpose of this study is to assess the safety and efficacy of masitinib for the treatment of mild to moderate Alzheimer's Disease. Masitinib will be administered as add-on therapy in patients who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine.

Actual standard treatment for mild to moderately severe Alzheimer's dementia includes acetylcholinesterase inhibitors (donepezil, rivastigmine and galantamine) and a NMDA receptor antagonist (memantine for moderate to severe Alzheimer's disease). These medications have shown to have an effect on some cognitive and non cognitive symptoms of the pathology. However, their efficacy remains limited and may decrease with time. There is an unmet medical need in this pathology. Masitinib is a selective tyrosine kinase inhibitor that is thought to exert a neuroprotective effect through its activity on mast cells and other non-neuronal cells of the central nervous system, with subsequent modulation of inflammatory and neurodegenerative processes, as well as possibly disruption of the Aβ signaling cascade via inhibition of the Fyn signaling pathway. This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study of oral masitinib. The objective of this study is to compare the efficacy and safety of masitinib at various doses versus matched placebo in the treatment of patients with mild to moderate Alzheimer's Disease. Masitinib will be administered as add-on therapy in patients who have been treated for a minimum of 6 months with a stable dose of cholinesterase inhibitor (donepezil, rivastigmine or galantamine) and/or memantine. Approximately 675 patients will be randomized into 5 treatment groups. The co-primary outcome measures are the Alzheimer's Disease Cooperative Study Activities of Daily Living score (ADCS-ADL), and Alzheimer's Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog) after 24 weeks of treatment.

Eligibility Criteria:
Inclusion criteria include:

1. Patient with dementia of Alzheimer's type, according to the Diagnostic and Statistical Manual of Mental Disorders criteria (DSM-IV)
2. Patient with probable Alzheimer' disease according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association criteria (NINCDS-ADRDA)
3. Patient with MMSE ≥ 12 and ≤ 25 at baseline
4. Patient treated for a minimum of 6 months with a stable dose of cholinesterase inhibitors (donepezil, rivastigmine or galantamine) at baseline, and/or a stable dose of memantine for a minimum of 6 months at baseline, with no changes foreseen in therapy throughout the study.

Exclusion criteria include:

1. Patient with any other cause of dementia not due to Alzheimer's disease.
2. Patient with Alzheimer disease with severe forms of delusions or delirium (patients with light and mild forms of delusions and delirium will be allowed in the study).
Development of a Cell Culture Process for the Production of Human T-lymphocyte Precursors

The purpose of this study is to finalise the development of a process for the production of T-cell progenitor cells.


Eligibility Criteria:
Inclusion Criteria:

* Healthy donors, men aged 18 to 40 years.
* Body weight ≥ 65 kg with a body mass index (BMI) calculated by weight in kg/(height in m)² of 20 to 30 kg/m² at screening.
* Informed consent form signed and dated prior to any study-specific screening procedure.
* Health status judged by the investigator to be compatible with participation in the study based on medical history, results of physical examination, results of biological laboratory tests (cell blood count including RBC, hematocrit, hemoglobin, reticulocytes, WBC, platelet, PT, aPTT, CRP, fasting blood glucose, ionogram (Na+, K+, Cl-, HCO3-), creatinine, creatinine clearance by Cockcroft, albumin, total protein, total bilirubin, AST, ALT, ALP, GGT), vital signs measurements and 12-lead ECG. All results should be normal or, if out of range, clinically insignificant in the judgement of the investigator.
* Venous capital compatible with leukapheresis
* Have a high probability of complying with and completing the study.
* Be affiliated with a Social Security scheme

Exclusion Criteria:

* Any cardiovascular (e.g. heart failure), hepatic, renal, respiratory (e.g. asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunological, dermatological, haematological (including hemoglobinopathy), neurological, psychiatric disorder or any history of allergy to a drug.
* State of acute illness (e.g., vomiting, fever, diarrhea) within 7 days prior to the first day of the study.
* History of drug abuse in the year preceding the first day of the study.
* History of alcoholism in the year prior to day 1 defined as consumption of more than 3 standard drinks/day (30 g/day) or 15 standard drinks/week (150 g/week) or less than two non-alcoholic days each week, or more than 5 standard drinks (50 g) on a single occasion.
* Any contra-indication to filgrastim
* Positive serological results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, syphilis and/or human T-lymphotropic virus (HTLV).
* Positive urine drug tests (methadone, barbiturates, benzodiazepines, tricyclic antidepressants, cocaine, cannabinoids, morphine, amphetamines and methamphetamines, including 3,4-methylenedioxy-N-methylamphetamine \[MDMA\]).
* Laboratory workup including blood count, fasting blood glucose, blood ionogram, creatinine, AST, ALT, gamma GT, alkaline phosphatase, total bilirubin, CRP, PT, aPTT incompatible with leukapheresis protocol.
* Use of any experimental drug within 30 days prior to inclusion.
* Use of any prescription or over-the-counter medication within 5 times the elimination half-life prior to inclusion. However, any prescribed medication that may interfere with the study objectives must be discontinued for at least 30 days.
Mitochondrial Metabolism and Hepatic Complications of Obesity

The study aims to characterize mitochondrial metabolism in the liver of obesity surgery patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis.

The study aims to characterize mitochondrial metabolism in the liver of obesity surgery patients and to study its relationships with hepatic steatosis, inflammation, and fibrosis. The protocols involves a per-operative hepatic needle biopsy for mitochondria characterization and histological scoring of steatosis, inflammation, and fibrosis

Eligibility Criteria:
Inclusion Criteria:

* adult men and women
* affiliated to a social security
* candidate for laparoscopic obesity surgery

Exclusion Criteria:

* Excessive alcohol consumption:\> 20 g / day (woman),\> 30 g / day (male)
* Chronic viral hepatitis B or C
* Genetic hemochromatosis
* Taking the following drugs for at least 3 months up to 6 months before the scheduled date of obesity surgery: systemic corticosteroids, amiodarone, methotrexate
* Wilson's disease
* autoimmune hepatitis
* alpha 1-antitrypsin deficiency
* abetalipoproteinemia
* Contraindications to liver biopsy
Can Waveform and Flow Traces From Mechanical Insuflattion:Exsufflation (MI:E) be Used to Identify Laryngeal Responses to MI:E and Thus Optimise Treatment Algorithms?

Objectives:

* To establish if physiotherapists can use the waveform traces from the cough assist machine to work out when patients are having an abnormal airway response to cough assist
* To establish how cough assist device settings, particularly in breath and cough pressures affect a patient's response to using the cough assist device
* To provide some clinical guidance to physiotherapists on methods for assessing and treating abnormal airway responses to cough assist devices

Methodology:

Subjects will complete breathing tests; spirometry, peak cough flow (PCF) and sniff nasal inspiratory pressure (SNIP) to establish baseline breathing function and rule out anyone with breathing conditions. A nasal camera will be used to look at the voice box at rest.

Cough assist will be delivered via a face mask which will allow for simultaneous use of the nasal camera and cough assist carried out in the same way as another research team have done previously. The nasal camera will be attached to a video camera to allow recording, analysis and documentation of the observations. The cough assist protocol will be delivered by a physiotherapist experienced in delivering cough assist. Cough assist waveforms will be downloaded into Care Orchestrator software (Philips Respironics, Murraysville, USA) and reviewed at the same time as the nose camera recordings to establish if voice box responses can be identified from the waveform patterns. For confirmation of Care Orchestrator software waveforms, a device that records airflow during breathing (spirometer) will be connected (Alpha touch, Vitalograph, Ennis, Ireland) into the cough assist circuit in the same way another research team has before.


Eligibility Criteria:
Inclusion Criteria:

* Patients with neuromuscular disease(NMD) including but not limited to Motor Neurone Disease (MND), Multiple Sclerosis (MS) and Muscular Dystrophy
* Age ≥18

Exclusion Criteria:

* Unable to comply with protocol
* Unable to give informed consent
* Evidence of obstructive airways disease FEV1:FVC \<0.7
* Patients with a history of:
* Un-drained pneumothorax
* Severe bronchospasm
* Head injury with ICP \> 25mmHg
* Severe arterial hypotension
* Trache-oesophageal fistula
* Significant haemoptysis
* Facial fractures
* Vomiting
* Flail segment
* Epistaxis within two weeks
Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents

This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment of children and adolescents with obsessive-compulsive disorder


Eligibility Criteria:
Inclusion Criteria Have a minimum total score of 16 on the JCY-BOCS, Weight is within the standard weight ± 2S.D. based on the standard weight for each age in the School Health Statistical Survey Exclusion Criteria Have the following predominant psychiatric diagnosis -Schizophrenia Have previously been treated with fluvoxamine maleate
Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)

The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.

Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the patient, are evaluated using questionnaire.

Local recurrence is evaluated under the same imaging protocol used for Whole breast radiation.

Eligibility Criteria:
Inclusion Criteria:

* Patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer
* Patient agrees to evaluation of the axilla with sentinel lymph node biopsy
* Peri or post-menopausal women age \> 50, defined as women who have experienced no menstrual period in the past 6 months or more
* BRCA1 and 2 gene mutation negative, if tested. \[genetic testing is NOT required based upon personal or family history\]
* Unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) \< 2.0 cm in diameter, primary T-stage of Tis or T1 (AJCC criteria)
* Grade 1, 2, or 3 acceptable
* Associated LCIS is allowed
* Pure DCIS allowed if \<2.5 cm, low to intermediate nuclear grade and resected margins negative at \> 3 mm (per ASTRO criteria)
* Estrogen receptor (ER) status of positive
* Patient has clear margins \>2 mm on gross pathologic examination
* Patient is node-negative, defined as N0 (i-) or N0 (i+)
* Patient must be deemed functionally and mentally competent to understand and sign the informed consent
* Neoadjuvant hormonal therapy is allowed if all other ASTRO suitable criteria have been met prior to onset of hormonal therapy

Exclusion Criteria:

* Prior breast malignancy or other malignancy if metastatic, or with expected survival of \< 5 years
* Immunocompromised status
* Pregnancy
* Women with an active connective tissue disorder (i.e. scleroderma, lupus and others)
* Breast cancer that involves the skin or chest wall, locally advanced breast cancer
* Invasive lobular carcinoma
* Evidence of lymphovascular invasion (LVI)
* Invasive carcinoma with extensive intraductal component (EIC)
* Neoadjuvant chemotherapy
* Patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection
* Someone who is not a candidate for breast conserving management, i.e., prior whole breast radiation therapy
Decolonization to Reduce After-Surgery Events of Surgical Site Infection

The DECREASE SSI Trial (Decolonization to Reduce After-Surgery Events of Surgical Site Infection) is a two-arm multi-center individual placebo-controlled randomized (2,700 participants randomized 1:1) clinical trial to reduce post-discharge surgical site infection following open colon or small bowel surgery by comparing chlorhexidine bathing plus nasal mupirocin in the 30 days following discharge to soap without antiseptic properties (placebo) and placebo nasal ointment. This trial seeks to enhance the care of the 675,000 patients annually who undergo colon and small bowel surgery by finding simple and efficacious interventions to reduce SSI.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Recent open (not solely laparoscopic) surgery involving an abdominal incision within the past 14 days. For cesarean section, recruitment restricted to BMI ≥ 40.
* Able to communicate regularly by phone
* Able to bathe, shower or have this task performed by a caregiver

Exclusion Criteria:

* Transfer to an acute care hospital
* Discharged to receive end-of-life hospice measures
* Discharged more than 14 days after surgery
* Allergic to mupirocin and/or chlorhexidine
* Active infection at enrollment\*

  \*Refers to
  1. Infections requiring systemic antibacterial agents, so viral illness (e.g., COVID, flu) is not an exclusion.
  2. Topical antibacterial agents do not count toward exclusion (e.g., topical products for acne)
  3. Prophylactic antibacterial agents do not count toward exclusion
* Surgical incision not closed at discharge