cyrilzakka/clinical-trials huggingface dataset:
A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma

Primary Objective:

- To assess the safety, tolerability and plasma pharmacokinetics (PK) of SAR245408 given once daily as a tablet formulation of polymorph E in subjects with solid tumors or lymphoma.

Screening: 1 to 28 days Study treatment period: two 28-day cycles (56 days) End-of-treatment visit: no later than 7 days after the last study drug administration Subjects not eligible for treatment continuation after Cycle 2 will be followed up for safety; a follow-up visit will be performed within 30 ± 3 days after the last study drug administration Subjects eligible for treatment continuation after Cycle 2 will be offered the opportunity to enroll in the treatment-extension study TED12414.

Total duration of study participation for each patient: 58 to 118 days.

Eligibility Criteria:
Inclusion criteria :

* Solid tumor that is metastatic or unresectable, or relapsed or refractory lymphoma (including chronic lymphocytic leukemia/small lymphocytic lymphoma), for which standard therapies are no longer effective or there are no therapies known to prolong survival or patient cannot tolerate or has contra-indication for a standard therapy and there is no alternative therapies.
* Male or female patient \> or = 18 years old.
* Weight \> or = 40 kg.
* Eastern Cooperative Oncology Group performance status \< or = 1.
* Adequate white blood cells, platelets, and haemoglobin.
* Adequate liver and kidney functions.
* Fasting plasma glucose \< 8.9 mmol/L.
* Sexually active patients using adequate contraception.
* Women of child-bearing potential with negative pregnancy test.

Exclusion criteria:

* Lymphoma involving the gastrointestinal tract.
* Prior treatment with cytotoxic chemotherapy (including investigational agents) or biologic agents (antibodies, immune modulators, and cytokines) within 4 weeks, or nitrosoureas or mitomycin C within 6 weeks, before the first dose of study drug.
* Prior treatment with a small-molecule kinase inhibitor (including investigational agents) within 2 weeks, or 5 half lives of the drug or active metabolites, whichever is longer, before the first dose of study drug.
* Any other investigational therapy within 4 weeks before the first dose of study drug.
* Intolerance to prior treatment with a PI3K inhibitor.
* Prior anticancer hormonal therapy within 2 weeks before the first dose of study drug.
* Prior radiation therapy within 2 weeks before the first dose of study drug.
* Uncontrolled brain metastases or primary brain tumor.
* Hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection.
* Positive serologies for Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C virus (anti-HCV) antibodies.
* Patient is pregnant or breastfeeding.
* History of gastrointestinal surgery, or presence of gastrointestinal abnormality or disease, that may affect the pharmacokinetics of study drug.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Metabolic Studies- Interactions Between GH and Insulin in GHDA

The purpose og this study is to investigate the effects of growth hormon on insulin signalling pathways and the temporal association between administration of GH and developing of insulin resistance.

Insulin resistance is a pathophysiological component of type 2 diabetes, obesity and elevated blood pressure. Overall they are syndromes with multifactorial ethology and partly unclarified pathophysiology. Insulin resistance also occur in more seldom diseases with a more unified pathogenesis. Growth hormone deficiency (GHD) in adults with hypopituitarism is an example of one of those seldom diseases. Prolonged GHD is associated with abdominal overweight, dyslipidemia and increased cardiovascular morbidity. Besides, GHD-patients have decreased insulin sensitivity presumably secondary to the altered body composition. Long term effects of GH-substitution improves insulin sensitivity but it is well-known that subcutaneous administration of GH acute worsen insulin sensitivity in both muscles- and liver-tissue. Recently it has been reported that insulin resistance in patients with type 2 diabetes is associated with the induction of a signal protein called suppressor of cytokine signalling (SOCS). It´s interesting that GH also induces a stimulation of SOCS.

Eligibility Criteria:
Inclusion Criteria:

* Written consent before study start
* Growth Hormone substitution in stable dosis for at least 3 months prior to study start
* Other substitution in stable dosis for at least 3 months prior to study start

Exclusion Criteria:

* Medical treatment for diabetes
* Hypertension even with medical treatment
* BMI \> 30
* Excessive alcohol abuse
Studies of the Tumour Suppressor Gene PTEN - Endometrial Cancer

This project seeks to understand the role of the PTEN tumour suppressor gene in endometrial cancer (tumours of the uterine lining), the most common gynecologic cancer in the developed world. The studies in this program span the spectrum from fruit flies to humans, as part of a synergistic partnership that will significantly enhance our understanding of the molecular genetic events involved in the development and progression of endometrial cancer. The discovery of new targets for therapy, and the ability to evaluate these in subsequent clinical trials is a significant strength of this scientific interaction, which may result in cures for patients with primary and relapse endometrial cancer and prevention of this cancer in women who are at high risk.

PTEN is a critical module that regulates effects of sex hormones on the growth and apoptosis of endometrial cells; and plays an important role in the pathogenesis of subgroups of endometrial cancers, their biologic behaviour and responses to therapeutic agents. Furthermore, mutational inactivation of the PTEN gene can serve as an independent molecular marker that can predict relapse and survival in endometrial cancer. The prognostic effects of PTEN may also be modulated by other tumour suppressor gene losses including P53 mutations, by hormone receptor status, and microsatellite instability.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* patients who had a hysterectomy
* patient able to provide consent and complete questionnaire
The Nor-Hand Study

The Nor-Hand study is a hospital-based observational study including 300 patients with evidence of hand OA by ultrasound and/or clinical examination. The baseline examination (2016-17) consists of functional tests and joint assessment of the hands, medical assessment, pain sensitization tests, ultrasound (hands, acromioclavicular joint, hips, knees and feet), computer tomography (CT) and Magnetic Resonance Imaging (MRI) of the dominant hand, conventional radiographs of the hands and feet, fluorescence optical imaging of the hands, collection of blood and urine samples as well as self-reported demographic factors and OA-related questionnaires. Two follow-up examinations are planned after 3 (2019-20) and 8 years (2024-25), respectively. Cross-sectional analyses will be used to investigate agreements and associations between different relevant measures at the baseline examination, whereas the longitudinal data will be used for evaluation of predictors for clinical outcomes and disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40-70 years at screening
* Proven hand OA by clinical examination and/or ultrasound

  1. Clinical examination criteria: Heberden/Bouchards nodes and/or bony enlargement, squaring and/or deformity of the thumb base and no clinical signs of inflammatory arthritis (e.g. soft tissue swelling of two or less metacarpophalangeal (MCP) joints, and no soft tissue swelling of the wrist).
  2. Ultrasound criteria: Osteophytes in the interphalangeal joints and/or the thumb base, and no signs of inflammatory arthritis (e.g. synovitis with power Doppler activity in two or less MCP joints and no synovitis with power Doppler activity in the wrist).
* Capable of understanding and signing an informed consent form
* Provided a written informed consent to participate in the study

Exclusion Criteria:

* Diagnosis of inflammatory arthritic disease, e.g. seropositive or seronegative rheumatoid arthritis, psoriatic arthritis, reactive arthritis, spondyloarthritis or arthritis related to connective tissue disorders
* Diagnosis of psoriasis
* Erythrocyte sedimentation rate (ESR) \> 40 mm/hour and/or C-reactive protein (CRP) \>20 mg/L, without a known ongoing infection
* Anti Cyclic Citrullinated Protein (anti-CCP) and/or rheumatoid factor positivity
* Ferritin \>200 microgram/L for women and \>300 microgram/L for men and s-iron/s-total iron binding capacity (TIBC) above 50%
* Major co-morbidities (e.g. severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease or severe respiratory disease)
* Mental or psychiatric disorders, alcohol or drug abuse, language difficulties or other factors that make compliance to the study protocol difficult.
An Open-Label, Multicenter Study of the Safety and Anti Viral Activity of Brincidofovir (BCV, CMX001) for Ebola Virus Disease

The purpose of this study is to assess the safety and tolerability of Brincidofovir (BCV) when administered as an initial 200mg dose followed by 100mg twice weekly (BIW) for a total of 5 doses.


Eligibility Criteria:
Inclusion Criteria:

* Positive for Ebola virus RNA in plasma
* Subject must be able to ingest, absorb, and tolerate oral medication
* Subject must be willing to use adequate contraception during their participation

Exclusion Criteria:

-
A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab

This is a single arm, pilot multicenter prospective study in up to 22 participants with relapsing multiple sclerosis. Patients screened for the study can either be scheduled for vaccine, have received a single vaccine with a scheduled second dose, or already completed full course (two dose) vaccination. Fully vaccinated participants must be able to complete immune assay No.1 ≥ 14 days after the second dose of vaccine


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study
2. Age 18-55 years old inclusive at Screening
3. Diagnosis of relapsing MS by 2017 revised McDonald criteria
4. Must be willing to comply with the study schedule
5. Have received/scheduled vaccination with a FDA approved for emergency use COVID-19 mRNA vaccine (either Pfizer or Moderna) (i) either been scheduled for vaccine, (ii) received a single vaccine with a scheduled second dose, or (iii) already completed full course (two dose) vaccination.
6. Currently receiving ofatumumab for the treatment of RMS (Preoftumumab serology with Hepatitis B testing showing no active or latent infection, as well as serum IgG results to be recorded in the database if available)

Exclusion Criteria:

1. Known clinical diagnosis of COVID-19 prior to screening based on investigator's or patient's personal physician's judgement
2. Has a contraindication to receiving an mRNA COVID-19 vaccine
3. Has an immediate allergic reaction to past vaccine or injection
4. Any safety finding including low IgG and/or low IgM levels requiring an ofatumumab treatment interruption within the 12 weeks immediately prior to vaccination as determined by the HCP
5. Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks prior to the screening visit
6. Prior treatment with S1P agent within 2 months of study enrollment
7. Prior treatment with natalizumab within 6 months of study enrollment
8. Contraindications to ofatumumab treatment as per the USPI will be adhered to which include active infection hepatitis B infection, progressive multifocal leukoencephalopathy and pregnancy.
9. Participation in another interventional clinical trial within 14 days before enrollment.
10. Have been treated with any of the medications as described in the full protocol
11. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 6 months after stopping medication
Propranolol Versus Propranolol and Clonidine in Sympathetic Hyperactivity After Moderate Traumatic Brain Injury

evaluation of the effect of Propranolol versus propranolol and clonidine on decreasing sympathetic hyperactivity after moderate traumatic brain injury

measuring catecholamine levels after moderate traumatic brain injury after giving propranolol and clonidine

Eligibility Criteria:
Inclusion Criteria:

* GCS on admission between 9 and 12 age 18 up to 60 years both sexes

Exclusion Criteria:

* history of heart disease, cardiac arrhythmia and myocardial infarction diagnosis ofpreexisting brain dysfunction. impending brain herniation and craniotomy diagnosis of spinal cord injuries. diagnisis of severe liver and renal disease current use of beta blocker and or alpha agonist current using of intravenous vasopressor contraindication to enteral feeding and can not swallow pregnancy
The NutriNet-Santé Study

The NutriNet-Santé study was set up to investigate nutrition and health relationships. Specifically, it was the first web-based cohort worldwide on such a large scale (n=171 000 as of 2021) focused on the complex link between nutrition and health status. It is characterized by a very detailed assessment of nutritional exposure and dietary behavior.

https://etude-nutrinet-sante.fr/ https://info.etude-nutrinet-sante.fr/en

NutriNet-Santé is a large-scale (n=171,000) web-based cohort coordinated by EREN, launched in France in 2009 to investigate nutrition and health relationships. All required ethics authorisations have been obtained (listed here). NutriNet-Santé participants regularly fill questionnaires through a dedicated and secure website, providing extensive, high-quality nutritional and non-nutritional data, including repeated data on socio-demographics and lifestyle (yearly), anthropometrics (every 6 months), dietary intake (every 6 months), physical activity (IPAQ questionnaire, yearly)5 and health status (every 6 months). NutriNet-Santé is characterised by a very detailed and up-to-date assessment of nutritional exposure and dietary behaviours. Usual dietary intakes are assessed at baseline and every 6 months thereafter through a series of 3 non-consecutive randomly assigned 24h dietary records. Daily energy, alcohol, micro- and macronutrient intakes are calculated using the published NutriNet-Santé food composition database (\>3,500 generic items). All major health events (e.g., cancers, cardio- and cerebrovascular diseases) are reported by the participants and validated by an expert committee of physicians based on medical records, and/or retrieved from the French National Health Insurance medico-administrative databases to limit potential reporting bias. In turn, mortality data are obtained from the exhaustive French National Mortality Registry (CépiDC). The number of incident events already registered is as follows: 4,200 cancers and 1,240 deaths. A sub-sample of the cohort (n=20,000) provided blood and urine samples, currently stored at -80°C in EREN's biobank.

Eligibility Criteria:
Inclusion Criteria:

* aged over 15 years
* access to internet

Exclusion Criteria:

* aged under 15 years
Brain/Neural Hand Exoskeleton Control for Restoration of Bimanual Tasks

This study investigates whether spinal cord injury and stroke survivors (n=10) are able to operate a brain/neural hand exoskeleton (B/NHE) based on electroencephalography (EEG) and electrooculography (EOG) for restoration of bimanual activities of daily living (ADLs). To assess bimanual ADLs, the Berlin Bimanual Task Assessment (BEBITA) will be applied. Improvements in BEBITA will be evaluated with and without B/NHE use.


Eligibility Criteria:
Inclusion Criteria (Stroke):

* single ischemic or hemorrhagic insult with subcortical lesion (medullary canal, internal capsula, pedunculi cerebri)
* interval since stroke at least 6 months
* substantial motor deficit with:
* Medical Research Council (MRC) -score of less than 2 out of 6 possible points (0=no activity; 1=visible contraction without motor effect; 2=movements with elimination of gravity; 3=movements against gravity; 4=movements against weak resistance; 5=normal force)
* Fugl-Meyer Test (upper extremity) of less than 31 points, "no to little mobility"

Inclusion Criteria (Spinal Cord Injury):

* cervical spinal cord injury, height C5-C6
* interval after spinal cord injury at least 6 months
* substantial motor deficit with American Spinal Cord Association (ASIA) -Classification B or C (A=no muscle function/sensitivity below the spinal cord injury; B=no muscle function, limited sensitivity present; C=low non-relevant muscle function, sensitivity present; D=functionally relevant muscle functions present; E=fully preserved or restored functions)

Exclusion Criteria (Stroke and Spinal Cord Injury):

* Alcohol or drug problem (regular consumption of more than 2 alcoholic beverages per day, or taking illegal drugs)
* currently undergoing neurological or psychiatric treatment based on a secondary diagnosis
* Severe and uncontrollable medical problems:
* Non-adjusted malignant high blood pressure, World Health Organization (WHO) Hypertension Grade II
* non-adjustable diabetes mellitus, HbA1c \> 58 mmol/mol
* renal failure, from KDIGO glomerular filtration rate (GFR) category G3b (moderate to severe impairment)
* Liver failure, Child-Pugh stages B and C
* Heart failure New York Heart Association (NYHA) grade III-IV
* malignant tumor disease
* severe arrhythmia in need of treatment
* severe oedemas
* severe arthritis
* serious cognitive impairment (minimum status below 23 points)
* Severe spasticity (Ashworth grade ≥ 4)
* Pregnancy
* Bilateral motor deficit (in stroke patients)
The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy

As the duration of the interval between the time of last preparation-agent dose and the start of the colonoscopy is increasing, the quality of bowel preparation will be worse.

The aim of the present studies is to determine how the duration of the interval of the time of last preparation dose and the start of colonoscopy affects the quality of the bowel preparation and when the proper timing of the colonoscopy is after completion of last preparation regimen

Eligibility Criteria:
Inclusion Criteria:

* Adult outpatients(18-85 years of age) who undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms, other symptoms

Exclusion Criteria:

* age under 18 years, pregnancy, breast feeding, prior history of surgical large bowel resection, severe renal failure (creatinine ≥ 3.0mg/dL (normal 0.8-1.4)), drug addiction or major psychiatric illness; allergy to PEG, refusal of consent to participate in the study.
Avatar-based Therapy for Female Orgasmic Disorder

A randomized controlled trial was conducted for testing the efficacy of a novel avatar-based intervention (IG), that was compared with a control group (CG) for women with female orgasmic disorder (FOD). Participants were 31 women who were randomly assigned to the intervention or the control conditions. Intervention was based on the cognitive behavioral therapy approach (treatment with the most empirical evidence) and previous literature about FOD. It consisted of 12 weekly online individual sessions and aimed at improving the FOD diagnosis, sexual variables, and variables that are known to affect orgasm consecution. Control group was based on minimum therapeutic contact. Changes over time in the assessed variables were analyzed using linear mixed models, considering treatment group, measurement time point, and group-by-time interactions as fixed effects. Effect sizes were computed (Cohen's d; number needed to treat - NNT; reliable change index - RCI).


Eligibility Criteria:
Inclusion Criteria:

* Present the characteristics to diagnose female orgasm disorder after a clinic assessment (considering natural characteristics of the women's sexual response cycle (Conn \&amp; Hodges, 2022) based on the DSM-5 criteria.
* Provide a medical check to prove the absence of physical factors that may be the cause of the orgasm dysfunction, as this is the first part to diagnose FOD.
* Be at least 18 years old (adult).
* Have access to a computer with the characteristics to run Second Life and internet connection.

Exclusion Criteria:

* Present a diagnosis of a physical condition that may be the cause of the orgasm dysfunction (e.g., genital lesions, systemic and hormonal factors, vulvovaginal atrophy).
* Presence of other psychological pathology (e.g., depression, trauma) that may be the cause of the orgasm dysfunction.
* Have alcohol dependence (i.e., evaluated during the clinical assessment, according to the diagnostic criteria from the DSM-5, to determine if the individual meets the criteria for an alcohol use disorder diagnosis).
* Drug use, including medication that is known to cause sexual difficulties (e.g., selective serotonin reuptake inhibitors (SSRIs), that are a particularly common drug cause of sexual dysfunction.
* Have participated in a previous psychological intervention in the last year.
Chronic Subdural Hematoma Treatment With Intra-Arterial Bevacizumab Injection

The goal of this clinical trial is to test whether infusing bevacizumab into the middle meningeal arteries can be used to treat chronic subdural hematomas (cSDH).

The main questions it aims to answer are:

* Is bevacizumab infusion safe in cSDH patients?
* Is bevacizumab infusion effective in treating cSDH?


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years)
* Radiographic evidence of chronic subdural hematoma, including

  1. Persistence of subdural blood more than 10 days after index traumatic injury or event
  2. Presence of mixed density blood
  3. Presence of subdural membranes
* Can obtain informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.

Exclusion Criteria:

* Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study.
* Patients with concomitant intracranial pathology other than subdural hematoma (e.g., intracranial malignancy).
* Patients with known hypersensitivity to bevacizumab.
* Patients with radiographic evidence of mass effect.
* Patients have focal neurological deficits attributed to subdural hematoma.
* Patient had craniotomy or burr hole operative procedures performed in preceding two weeks prior to onset of subdural hematoma.
* Secondary causes apart from trauma for the chronic subdural hematoma, such as underlying vascular abnormality or tumor.
* Emergent surgical evacuation is required for the patient.
* Non-convexity chronic subdural hematoma, as the middle meningeal artery will not supply this area.
* Coagulation abnormalities, including platelet count \<100,000 and/or international normalized ratio of \<1.5 despite attempts for correction.
* Patients with known contraindications for angiography. Patients with contrast allergy will be premedicated with diphenhydramine and steroids.
* Patient has known active systemic infection or sepsis.
* Patient has contradiction to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC).
* Patient has life expectancy of less than six months due to comorbid terminal conditions.
* Patient has a premorbid modified Rankin score (mRS) of 5 or greater.
* Concurrent participation in another research protocol for investigation of an experimental therapy.