cyrilzakka/clinical-trials huggingface dataset:
Safety of Single Intravenous Administration of S95010 in Human Healthy Volunteers

The purpose of the study is to assess, the safety and tolerability of single ascending doses of S 95010 and to assess the pharmacokinetics (PK) of S 95010.


Eligibility Criteria:
Inclusion Criteria:

* Young healthy male subjects aged between 18 and 45 years (both inclusive)

Exclusion Criteria:

* Any acute or chronic illness or clinically relevant findings such as livers,kidney, spleen, cardiovascular disease, eye disease in the selection/ inclusion visit examinations
* Any abnormal laboratory result on blood and urine samples taken during screening, judged clinically relevant by the investigator
* History of liver dysfunction or total bilirubin or ALT or AST or ALP or γGT \> ULN at selection
* History of renal dysfunction or GFR \< 75mL/min/1.73 m2 (MDRD equation) at selection
VR for Surgical Prehabilitation and Rehabilitation

This randomized controlled trial aims to determine feasibility and acceptability of of VR-physical therapy modules for surgical patients undergoing breast or axilla surgery in order to prepare for and recover from surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age
* English speaking
* Will undergo breast or axilla surgery at Stanford
* Have access to internet and stable Wifi at home
* Have access to a space with stable chair at home
* Ability to sit-to-stand without significant balance issues
* Absence of chronic vertigo or nausea/vomiting
* Agreeable to up to 4 weeks of prehab prior to surgery and up to 8 weeks of post-operative rehab

Exclusion Criteria:

* Inability to engage in PT due to physical limitations identified by the participant and/or care team
* Inability to complete a brief online survey at three time points during the duration of the study
* Inability to consent
Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.

The clinical signs presented by a patient with a mild head injury are highly variable but remain strongly predictive of brain damage. The reference examination for the diagnosis of post-traumatic intracranial hemorrhage is currently the cerebral scanner without injection of contrast medium. Magnetic resonance imaging (MRI) tends to surpass CT in equipped centers, except for suspected bone lesions. The time required to perform brain imaging depends on the patient's clinical condition, comorbidities and treatments.

The responsibility of antiplatelet agents in post-traumatic intracranial hemorrhage is currently discussed, particularly with aspirin.

The hypothesis is that there is no significant difference in the proportion of intracranial hemorrhage in patients on antiplatelet agents after mild head trauma, in the absence of other factors favoring the occurrence of intracranial hemorrhage.


Eligibility Criteria:
Inclusion criteria

* Adult patient (≥18 years old)
* Visit to the emergency room of the Strasbourg University Hospital during 2017
* Victim of mild head trauma
* Patient who has given their consent to the reuse of their data for the purposes of this research.

Non-inclusion criteria

* Patient who expressed their opposition to participating in the study
* Subject under safeguard of justice
* Subject under guardianship or curatorship
* Patient on anticoagulant
* Non-isolated head trauma (AVP, fall greater than 6 meters, etc.)
Positive Psychology Intervention for Spanish-speaking Hispanic/Latino Adults at Risk for Cardiovascular Disease

The largest epidemiologic study of Hispanic/Latino participants thus far, i.e., the Hispanic Community Health Study/Study of Latinos (HCHS/SOL) documented that 80% of men and 71% of women have at least one major cardiovascular disease (CVD) risk factor. The American Heart Association emphasizes that current CVD prevention efforts are sparse and ineffectual in minority populations and acknowledges the need for new and more effective disease prevention strategies. This observational study and pilot cluster-randomized clinical trial seeks to implement and evaluate a novel 8-week Positive Psychology (PP) Intervention (compared to an attention control condition) in Hispanic/Latino adults with uncontrolled hypertension, i.e., elevated 24-hour ambulatory blood pressure, with primary interest in testing efficacy for clinically meaningful improvements in cardiovascular function.

The study features piloting of a cluster-randomized trial to determine whether a positive psychology (PP) intervention is associated with greater improvements in blood pressure compared to an attention control condition. The pilot trial additionally evaluates the efficacy of the PP intervention with respect to psychological well-being, hypertension-related health behaviors, autonomic cardiac control, and high-sensitivity C-reactive protein. Serum blood assays will facilitate exploration of mechanistic indicators linking psychological well-being to cardiac functioning.

Eligibility Criteria:
Inclusion Criteria:

* Hispanics/Latinos recruited from Catholic church sites in Chicago-land area
* aged ≥18
* fluent in English or Spanish with ≥8th grade education
* elevated 24-hour ambulatory blood pressure levels (systolic BP\> 140 mmHg and \>90 mmHg for diastolic BP).

Exclusion Criteria:

* Unavailable for study period; have cognitive impairment denoting dementia
* have severely reduced life expectancy
* are currently enrolled in psychotherapy or take prescribed antidepressants
* history or current diagnosis of bipolar disorder, dissociative disorder, psychosis, or substance abuse
* have severe depression.
Goals of Care Discussion for Patients with Advanced Lung and Gastrointestinal Cancer in the Emergency Department of a Comprehensive Cancer Center

To improve quality of life for participants with advanced cancer, support their families, and lower overall cost of care.

Primary Objective:

To compare overall percentage of days spent in an acute care setting over the 30-day period from time of the index emergency department (ED), referred to as Acute Cancer Care Center (ACCC), visit for patients who receive the emergency department-based GOC intervention and those who do not.

Secondary Objective:

To obtain data on rates of admission to the ICU, death in the hospital setting, symptom improvement for participants hospitalized, hospice referral, survival, and 30-day care costs for participants who receive the GOC intervention in the ACCC and those who do not.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is at least 18 years old presenting to the triage area of the MDACC ACCC for treatment
2. Participant has advanced lung or GI cancer. Advanced cancer patient defined as: locally recurrent or metastatic for which there is no curative treatment available.
3. Participant screens positive for at least 2 of 3 triple threat conditions (dyspnea, altered mental status, or poor performance status)
4. Participant has the ability to speak and write in English
5. Participant has the ability to provide consent OR is accompanied by a LAR able to provide consent

Exclusion Criteria:

1. Participant is already enrolled in hospice
2. Participant is comatose
3. Participant has severe intellectual disability
4. Participant has a history of dementia documented in the medical records
5. Participant has baseline communication barriers such as aphasia or deafness
6. Participant is new to MDACC, without established oncology care at our institution at time of ACCC arrival
7. Participant is 18 years or older, currently cared for by pediatrics service
8. Pregnant women
9. Prisoners
Combination Chemotherapy, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Newly Diagnosed Large B-Cell Lymphoma

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vincristine, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Steroid therapy, such as prednisone, may be effective in treating cancer and blocking the body's immune response. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with prednisone and monoclonal antibody therapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving doxorubicin together with vincristine, cyclophosphamide, prednisone, and rituximab followed by rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with newly diagnosed large B-cell lymphoma.

OBJECTIVES:

Primary

* Determine event-free survival of patients with large B-cell lymphoma treated with CHOP-R followed by consolidation therapy.

Secondary

* Determine overall survival.
* Evaluate relapse-free survival for patients achieving complete or partial response.
* Determine the rate of disease progression.
* Determine response rate at the end of study therapy.
* Assess the toxicities of this regimen.

OUTLINE: This is a multicenter study.

* Induction therapy: Patients receive the CHOP-R regimen comprising doxorubicin hydrochloride IV, vincristine IV, cyclophosphamide IV, and rituximab IV on day 1 and prednisone IV on days 1-5. Treatment repeats every 2 weeks for 2 courses.

Patients who achieve complete or partial response, as assessed by PET/CT scan, receive a third course of induction therapy.

* Consolidation therapy: Patients receive rituximab IV on days -8 to 0 and yttrium Y 90 ibritumomab tiuxetan IV on day 0.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed large B-cell lymphoma

  * Stage I, II, III, or IV disease
  * Bone marrow or lymph node involvement by small cell lymphoma allowed
  * No serious, progressive pathology (at investigator's discretion)
* CD20-positive disease
* Measurable disease
* No prior indolent lymphoma, treated or not
* No meningeal or CNS lymphoma

PATIENT CHARACTERISTICS:

* International prognostic index \< 2 (adjusted for age)
* Life expectancy \> 3 months
* ALT and AST ≤ 2.5 times upper limit of normal
* Bilirubin ≤ 30 mmol/L
* Creatinine ≤ 150 μmol/L
* HIV, hepatitis B virus, and hepatitis C virus negative (unless after vaccine)
* No contraindication to chemotherapy or immunotherapy
* No cancer in the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
* No contraindication to a venous catheter

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 30 days since prior and no other concurrent investigational treatment
* No prior therapy
* No concurrent participation in another clinical study
Infertility and Pregnancy Outcomes of Fertility Spared Gynecological Oncology Patients

FSS which aims to preserve a woman's fertility while still effectively treating the cancer, has become an increasingly popular option for young women diagnosed with these types of cancers. It is important to assess how FSS affects a woman's reproductive health, sexual function, psychological well-being, and overall quality of life. This research aims to provide valuable insights into the long-term effects of FSS on a woman's life, and can help healthcare providers make informed decisions about the best treatment options for their patients.

This is a prospective cohort study that aims to evaluate the infertility and pregnancy outcomes, as well as the quality of life of women who underwent fertility-sparing surgery for gynecological malignancies. The study included a comprehensive evaluation of the participants' medical history, surgical procedures, oncological treatment, and fertility preservation methods. Participants recruited from a tertiary care hospital, and women diagnosed with gynecological malignancies (e.g. cervical, ovarian, endometrial cancer) who underwent fertility-sparing surgery between 2010 and 2022. Women who have undergone total hysterectomy, bilateral salpingo-oophorectomy, or adjuvant oncological treatment were excluded from the study. Participants were contacted by phone and asked to complete questionnaires to assess their quality of life using the WHOQoL-BREF and FertiQoL scales.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gynecologic cancer, and being fertile in the meantime
* Applying directly to gynecologic oncology department
* Demand of preserving the fertility

Exclusion Criteria:

* Having hysterectomy prior to the diagnosis
* Having bilateral ooferectomy prior to the diagnosis
* Being in menopause
* Not accepting to fill the survey
* High stage disease which is not able to have FSS
Modified Consent Form Utility

Subjects enrolling into a nutrition study of the effects of tea on fat absorption will be randomized to receive either a standard informed consent document or a modified document that is shorter and more easily understood than the standard document. The hypothesis is that using a shorter form that is more easily understood and more visually simple will lead to greater subject satisfaction in the consent process and will not compromise subject comprehension of key study aspects. Consent for study inclusion has been waived by the IRB because informing subjects of the nature and process of the study would likely affect the findings, and both the standard and modified consent forms were approved for use in the nutrition study.


Eligibility Criteria:
Inclusion Criteria:

* participation in parent study, English speaking

Exclusion Criteria:

* none
Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy

Since the introduction of the Jamshidi needle in 1971, new advances in bone marrow sampling have not been seen. In 2007, a new battery-powered bone marrow biopsy system was developed. This technology, using a battery-powered drill to operate the needle accessing the posterior iliac bone, was approved by the Food and Drug Administration (FDA) and is currently commercially available.

Few randomized controlled trials (RCTs) have compared the use of the battery-powered bone marrow biopsy system to the Jamshidi needle (the traditional manual) method of bone marrow sampling. This research study is designed to evaluate the effectiveness of the Jamshidi needle compared to the battery-powered bone marrow biopsy system.

100 participants will be enrolled in this study at Emory University.

PRIMARY OBJECTIVE:

I. Assessing the quality and quantity of bone marrow core biopsies.

SECONDARY OBJECTIVES:

I. Assessing the nature of pain by established visual analogue scale (VAS) questionnaires.

II. Timing of the actual procedure.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo bone marrow biopsy using the power drill.

ARM II: Patients undergo bone marrow biopsy using the traditional Jamshidi needle.

All patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7.

After completion of study treatment, patients are followed up periodically.

Eligibility Criteria:
Inclusion Criteria:

* All patients with existing plasma cell disorders and no history of psychiatric disorders who can receive conscious sedation are eligible to participate in the trial

Exclusion Criteria:

* Pregnant women are excluded from participating in this study
Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients.

Multiple Sclerosis (MS) is often characterized by the presence of balance and cognitive impairments. Cognitive functions play a key role in balance control. Simultaneously performing cognitive tasks decreases walking and balance ability (Dual-Task cost). Rehabilitative treatment of patients with MS does not have to consider separately the motor and cognitive aspects. Video-Game Therapy (VGT) is a novel tool that allows a multimodal training approach. VGT typically provides augmented feedback during training that can contribute to learning motor skills. The main objective of this exploratory study will be to test the effects of a commercially available VGT on balance and cognitive function in ambulatory MS patients compared to a standardized balance platform training (BPT). Secondary, we will explore the effects of VGT and BPT on other domains that are usually impaired in MS population and that can be improved by motor rehabilitation, such as psychological well-being, fatigue and Quality of Life.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of MS (primary or secondary progressive, relapsing-remitting), without relapses in the preceding 3 months
* mild to moderate balance impairments with increased fall risk, defined as TUG \> 8.4s
* disability rate definited by Kurtzke Expanded Disability Status Scale (EDSS) score from 4 to 5.5,

Exclusion Criteria:

* other conditions that may affect motor function
* impaired cognitive functioning (Mini Mental Status Examination score less than 24)
* visual impairments (daltonism and visual acuity deficit)
* medical conditions that might interfere with the ability to complete the study protocol safely.

A group of healthy subjects matched for age and sex will be involved for a comparison on the instrumental data (force platforms).
Efficacy Of Oral Trehalose In Spinocerebellar Ataxia 3

This study evaluates the effectiveness of oral trehalose in alleviating the neuropathological and motor behaviour deficits among patients with SCA3. A total of 40 participants with SCA3 will be recruited, with 20 participants to be administered with trehalose while another 20 participants to be administered with a maltose placebo.

Spinocerebellar ataxia 3 (SCA3) is a rare form of inherited neurodegenerative disease involving progressive degeneration of spinocerebellar tract. SCA3 is characterised by increasingly worsening cerebellar function leading to gait abnormalities and poor coordination, dysarthria, and abnormal eye movements. Non-ataxia features include pyramidal and extrapyramidal manifestations, sensorimotor, neuropsychological and psychiatric symptoms. This is attributed to the role of cerebellum in motor, cognitive and affective processing (i.e. cerebellar cognitive and affective syndrome; CCAS), as well as its extensive connection with cerebral structures.

Trehalose is an omnipotent disaccharide molecule found in lower and higher life forms except in vertebrates. It has an amorphous (i.e. non-reducing) property, which is shown in its high hydrophilicity, chemical stability and strong resistance to denaturation / breakdown by heat, acid or enzyme. It is also shown to help refold partially denatured protein, thereby stabilizes protein aggregates, including those of polyglutamine, in vivo as well as in vitro. This has provided an avenue in which trehalose as a therapeutic agent for neurodegenerative disorders with pathological changes of protein aggregates.

In this study, a double-blinded randomised controlled trial (RCT) will be employed. A total of 40 patients with SCA3 will be randomly allocated to oral trehalose group and a placebo group (20 participants for each arm). With regards to clinical outcomes, motor and cognitive performances will be assessed to infer the efficacy of trehalose. Likewise, structural, resting-state fMRI (i.e. functional connectivity), and MR spectroscopy (i.e. metabolism), will be used as imaging biomarkers in this study.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years old.
* Genetically confirmed SCA 3 diagnosis.
* Presence of progressive cerebellar syndrome (i.e. symptomatic) and genetic confirmation of SCA 3 in one of the immediate family members with similar clinical syndrome.
* Able to read, speak, and understand English or Malay.

Exclusion Criteria:

* Diagnosis of Diabetes Mellitus Type 1 or Type 2
* Presence of any concomitant neurological condition that might interfere with clinical measures used in this study.
* Presence of contraindication or hypersensitivity to trehalose.
* Use of stimulant / medication, caffeine, and tobacco within less than 24 hours washout period prior to assessment and / or scan.
* Presence of severe visual and / or auditory perceptual deficits.
* MRI contra-indications: claustrophobia, pregnancy, electronic implants (e.g. pacemaker) in the body, aneurysm clip, and current or past employment as machinists, welders or metal workers.
Carbetocin and Oxytocin in Elective Caesarean Section With High Risk of Postpartum Hemorrhage

Double blinded randomized controlled study

Women will be randomized into two groups using COMPUTER-GENERATED RANDOM NUMBER LIST.

264 dark colored envelops will be serially numbered containing the corresponding letter of the corresponding drug that will be used.

Group C: 132 women in the carbetocin group will receive a bolus of 100 μg intravenous injection at delivery of the anterior shoulder.

Group O: 132 women in the oxytocin group will receive 5 IU of oxytocin by slow intravenous injection at delivery of the anterior shoulder.

* All patients will receive general anaesthesia.
* Operation will be carried out by a three year registrar (at least).
* Uterus will be repaired in situ. Primary endpoint: is the amount of blood loss.
* Blood loss will be estimated using the change in Hb% and hematocrit, the actual blood loss will be calculated using the following equation:
* The actual blood loss equals the estimated blood volume X difference between the initial hematocrit and the final hematocrit / the initial hematocrit

Secondary endpoints include:

1. The need for additional uterotonic medication after carbetocin or oxytocin administration.

   - Uterine tone and Uterine fundus level (with respect to the umbilical point, UP) will be monitored during CS, at the end of CS, 2 hours, 12 hours and 24 hours after delivery

   - Additional uterotonic drugs, needed if sufficient uterine tone is not achieved within 5 minutes of oxytocin or carbetocin administration, will include: i. Ergometrine 0.5 mg by slow intravenous injection. ii. Misopristol 1000 micrograms rectally.
2. The need for blood transfusion or operative interventions related to PPH

   - The need for blood transfusion or operative intervention (B-Lynch sutures, uterine artery ligation, internal iliac artery ligation, Hysterectomy) will be considered.
3. The change in hemoglobin and hematocrit post versus pre CS

   - The drop in hemoglobin level and hematocrit will be evaluated by comparing the hemoglobin concentration on admission and 24 hours after delivery.
4. The hemodynamic adverse effects and the cost-benefit of both drugs.

Eligibility Criteria:
Inclusion Criteria:

* Multiple pregnancy
* Presence of uterine fibroid
* Previous Myomectomy
* Presence of placenta previa
* Past History of PPH
* Fetal Macrosomia
* Polyhydramnios

Exclusion Criteria:

* Hypertension
* Preeclampsia
* Cardiac, Renal, Liver diseases
* Epilepsy
* History of hypersensitivity to Carbetocin