cyrilzakka/clinical-trials huggingface dataset:
A Study of ARGX-110 in Participants With Advanced Malignancies

The purpose of this study is to determine the optimal dose of ARGX-110 in participants with advanced malignancies and to assess efficacy of ARGX-110 (exploratory efficacy cohort 5 only).

Phase I study conducted in participants whose tumors express the target of interest. Pharmacokinetics (PK), pharmacodynamics (PD), biomarkers will be determined to support dose selection.

Phase II study conducted in Cutaneous T-cell lymphoma (CTCL) participants who are CD70 positive. PK, PD, biomarkers and immunohistochemistry (IHC) will be determined to assess efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of malignancy refractory to, or relapsing after standard therapy
* Solid tumors or T-cell malignancies positive for the CD70 antigen by Immunohistochemistry/Fluorescence-activated cell sorting (IHC/FACS) within 56 days prior to administering the first dose of ARGX-110. IHC criterion: greater than \> 10 percent (%) of CD70 positive tumor cells
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or 2
* Serum albumin greater than or equal to (\>=) 20 gram per liter (g/L) (solid tumor only)
* Ability to comply with protocol-specified procedures/evaluations and scheduled visits. In particular, the ability of the patient to undergo a tumor biopsy (optional for safety expansion cohort 4)

Exclusion Criteria:

* History or clinical evidence of neoplastic central nervous system (CNS) involvement
* History of another primary malignancy that has not been in remission for at least 1 year
* Systemic glucocorticoid administration at doses greater than physiological replacement (prednisolone 20 milligram \[mg\] equivalent) within 28 days of ARGX-110 first dose administration (for T-cell malignancies higher systemic dose can be allowed following discussion with Sponsor)
* Major surgery within 28 days of ARGX-110 first dose administration
* Unresolved grade 3 or 4 toxicity from prior therapy, including experimental therapy
A web-and Mobile Phone-based Intervention in 4-year-olds: a Population-based Randomized Controlled Trial

This study aims to evaluate the effects of a mobile phone-based dietary and physical activity intervention on body fatness, dietary intake and physical activity of preschoolers

Childhood overweight and obesity is an increasing health problem globally, and can be established as early as 2-5 years of age. Mobile phone based (mHealth) interventions have been successful for weight management in adults; however, their potential in young children is yet to be established. Therefore, the ultimate goal of MINISTOP (Mobile-based INtervention Intended to STop Obesity in Preschoolers) trial is to help parents of four year old children to achieve a healthy weight and body fat via a smartphone app (MINISTOP). More specifically this trial aims to reduce body fat (primary outcome), increase the intake of fruits, vegetables as well as decrease the intake of candy, and sweetened beverages, and increase the amount of time spent in moderate-to-vigorous physical activity and decrease sedentary behaviors (secondary outcomes) in healthy preschool aged Swedish children. If the MINISTOP app is effective, it has the potential to be incorporated into the child health care to aid in counteracting overweight and obesity.

Eligibility Criteria:
Inclusion Criteria:

* parents having a four year old child and living in Östergötland; having the ability to have their child measured at baseline at 4.5 years ± 2 months of age
* at least one parent had to able to speak and read Swedish sufficiently well (i.e. be able to provide informed consent and understand the intervention content)

Exclusion Criteria:

* A child with a neurological or endocrine disease effecting weight
* A child with a parent suffering from a serious physical or psychological disease making the study too demanding for the family.
Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma

This clinical trial constructs and tests a novel multinuclear metabolic magnetic resonance imaging (MRI) sequence in patients with glioma (brain tumor) that is newly diagnosed or has come back (recurrent). This trial aims to develop new diagnostic imaging technology that may bridge gaps between early detection and diagnosis, prognosis, and treatment in brain cancer.

PRIMARY OBJECTIVES:

I. Construct and test a novel multinuclear Na+-H+ metabolic MRI sequence with sensitivity to Sodium (Na+) concentration, Potential of Hydrogen (pH), and oxygen (O2).

II. Correlate Na+-, pH-, and O2-weighted MR image measurements with sodium-proton exchanger isoform-1 (NHE1) immunohistochemistry (IHC), bioenergetics, and gene expression using stereotactic image-guided biopsies from human brain tumors.

III. Quantify changes in Na+-, pH-, and O2-weighted MR images after neoadjuvant anti-PD-1 immunotherapy in recurrent glioblastoma (GBM) and explore associated changes in tumor biology.

OUTLINE:

AIM 1: Previous scan data from healthy subjects is collected and analyzed.

AIM 2: Patients undergo MRI. Patients also undergo collection of tissue samples for IHC analysis.

AIM 3: Patients undergo multinuclear metabolic imaging before and after immunotherapy and prior to surgical resection.

Eligibility Criteria:
Inclusion Criteria:

* AIM 1: Healthy volunteers with no evidence of brain tumors or neurologic disease
* AIM 1: Age 18+
* AIM 2: Newly diagnosed or recurrent suspected or confirmed glioma (low or high grade)
* AIM 2: 10 IDH mutant and 10 IDH wild type gliomas
* AIM 2: Clinically indicated for resective surgery or biopsy
* AIM 2: Age 18+
* AIM 2: Tumor size \> 1x1x1 cm (measurable)
* AIM 3: Recurrent glioma enrolled in an immunotherapy trial or clinically indicated to receive immunotherapy including anti-PD1
* AIM 3: Age 18+

Exclusion Criteria:

* AIM 1: Cannot safely perform an MRI
* AIM 1: Age \< 18
* AIM 2: Cannot safely perform an MRI or use of MRI contrast agents
* AIM 2: Age \< 18
* AIM 3: Cannot safely perform an MRI or use of MRI contrast agents
* AIM 3: Age \< 18
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients

An observational cohort study will be conducted to non-invasively investigate central blood pressure and pulse wave velocity in children with kidney disease and controls. Using an oscillometric monitor, the investigators aim to non-invasively obtain the central blood pressure and pulse wave velocity (PWV), or arterial stiffness, of children with kidney disease. The investigators will also enroll age- and race-matched healthy controls and measure the same parameters for comparison. In addition, the investigators will measure PWV by standard arterial tonometry method in a subset of patients.

The specific aims of the study are as follows:

1. Using an oscillometric blood pressure monitor, the investigators aim to non-invasively obtain the central blood pressure and pulse wave velocity (PWV), or arterial stiffness, of children with kidney disease.
2. Measure oscillometric central blood pressure and PWV in age and race matched healthy children.
3. Measure PWV by standard arterial tonometry method in a subset of patients, and compare these measurements to the PWV measured using the oscillometric device.
4. Measure body composition of patients and controls (Body Mass Index, Waist-to-Height ratio, %body fat, and mid-arm muscle circumference) to see how this relates to central blood pressure and PWV.

Eligibility Criteria:
Inclusion Criteria:

* kidney transplant recipients who are at least 6 months post-transplant
* healthy children matched for age sex and race

Exclusion Criteria:

* age less than 3 years
Patient Perspectives in Mantle Cell Lymphoma Clinical Research

Clinical studies with a distinct emphasis on mantle cell lymphoma play a pivotal role in evaluating the safety and effectiveness of novel treatments for this disease. These trials are instrumental in ascertaining whether new medications surpass conventional therapies, providing substantial evidence to endorse their broad utilization.

This particular study stands out as it centers on the firsthand experiences of individuals battling mantle cell lymphoma who are actively engaged in a clinical trial featuring medicinal interventions. The primary objective is to meticulously scrutinize trial completion rates and voluntary withdrawals within this patient group.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of mantle cell lymphoma
* No serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Concurrent participation in another therapeutic clinical trial.
* Subject has an uncontrolled infection
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Clinical Study on the Efficacy and Safety of Hetropapa Ethanolamine Tablets in the Treatment of Thrombocytopenia Caused by Concurrent Radiotherapy and Chemotherapy in Cervical Cancer

This study is a single arm, single center and exploratory clinical study, which aims to explore the efficacy and safety of hetropapa ethanolamine tablets in the treatment of thrombocytopenia caused by concurrent radiotherapy and chemotherapy of cervical cancer. The primary end point was the proportion of subjects who were effective after treatment with hetropapa in the first cycle after treatment, that is, the platelet value recovered to ≥ 100 x 109 / L after treatment. The main inclusion criteria were: voluntary participation in the trial and signing informed consent; Age ≥ 18 years old, regardless of gender; Cervical cancer was diagnosed by histopathology or cytology; Platelet \< 75 × 109/L； At the time of screening, the expected survival time is ≥ 12 weeks, and can be treated with the current chemotherapy regimen for at least 1 cycle.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate in the trial and sign the informed consent form; Age ≥ 18 years old, regardless of gender; Cervical cancer was diagnosed by histopathology or cytology; Platelet \< 75 × 109/L At the time of screening, the expected survival time is ≥ 12 weeks, and can be treated with the current chemotherapy regimen for at least 1 cycle

Exclusion Criteria:

* Screening or baseline platelet value \< 30 × 109/L Suffering from the following hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, bone marrow proliferative diseases, multiple myeloma and myelodysplastic syndrome; Thrombocytopenia caused by causes other than CIT occurred within 6 months before screening, including but not limited to chronic liver disease, hypersplenism, infection and bleeding; Clinical manifestations of severe bleeding within 2 weeks before screening, such as gastrointestinal tract or central nervous system bleeding; Neutrophil absolute value \< 1.0 × 109 / L, hemoglobin \< 80g / L; It is allowed to use granulocyte colony stimulating factor, erythrocyte and EPO infusion in line with clinical routine; The researcher believes that participating in the trial has a great risk to the subject's health or safety, or other situations that may affect the efficacy evaluation.
Assessment of the Impact of Intestinal Gas Emission Quality on the Postoperative Course After Abdominal Surgery

The recovery of transit after surgery is an important parameter in postoperative evaluation. It generally reflects simple postoperative outcomes and allows the patient to return home.

The quality of gas recovery after surgery has not been studied to our knowledge, but it is not uncommon for an operated patient to emit some gas considered as a recovery of transit when it is ultimately a false transit preceding a postoperative ileus. Furthermore, intestinal gases and their composition reflect the intestinal microbiota. This microbiota has been shown to be predictive of the appearance of an operative complication. As the analysis of this microbiota cannot be carried out routinely, it is important to be able to use a reflection of this microbiota in routine practice and to correlate it with the surgical outcomes. Intestinal gas therefore seems to be the tool of choice.

The main objective is to evaluate the association between the appearance of an operative complication and the resumption of gas transit qualified according to its quantity and quality.

The secondary objectives are to compare the quantity and quality of gases pre- and post-operatively and to define a predictive score for surgical complications, based on the number and quality of post-surgical gases.

Data regarding gas transit are collected by the patient in a questionnaire the two days before the surgery and until the patient leaves hospital (or until day 15 post-operative if the patient is still hospitalized).

Data regarding possible complications ((defined according to Dindo-Clavien as any deviation from the expected postoperative outcomes within 90 days following surgery) are collected throughout the hospital stay (day 0 : surgery to day 15 post-operatively), during the post-operative consultation (day 30) and during a telephone call to the patient (day 90).

The expected results are to highlight a correlation between the quality/quantity of gases and post-operative outcomes. A predictive score for complications could then be proposed and validated during this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old
* Indication for open or laparoscopic abdominal surgery
* Whose expected length of stay is ≥ 2 days

Non Inclusion Criteria:

* Patients requiring a stomy on the initial surgery
* Need for immediate postoperative intensive care
* Emergency surgery
* Patient not knowing how to read or write
* Poor understanding of the French language
* Person deprived of liberty by judicial or administrative decision
* Person subject to psychiatric care under duress
* Person subject to a legal protection measure
* Person unable to express consent
* Person objecting to participating in research

Exclusion Criteria:

-Immediate post-operative intensive care
Diesel Exhaust and Vascular Function

Double-blind, sham- and placebo-controlled randomized study of effects of freshly-generated diluted diesel exhaust inhalation on vascular function. To examine role of adrenergic system a trial of alpha-blocker terazosin is also used. Each participant completes four study sessions, separated by at least three weeks: 1) Diesel exhaust inhalation (DE, controlled at 300 micrograms/cubic meter for two hours) and terazosin (2 mg prior to inhalation exposure); 2) DE plus placebo (matched for terazosin); 3) filtered air plus terazosin; and 4) filter air plus placebo. The investigators assess outcomes of blood pressure, forearm brachial artery ultrasound, and plasma measures of endothelial activation. The investigators hypothesize that DE exposure will be associated with increased blood pressure, decreased brachial artery diameter, and increased circulating endothelins, and that these effects will be attenuated by terazosin administration.


Eligibility Criteria:
Inclusion Criteria:

* healthy without chronic illness
* Body Mass Index 18.5 - 26.0
* tolerates 2 mg terazosin dose without unacceptable symptoms
* able to return for four exposure sessions

Exclusion Criteria:

* any chronic disease
* tobacco user
* asthma
* elevated cholesterol
* obesity
* hypertension
* diabetes
* any chronic cardiovascular or pulmonary disease
* pregnancy or unwillingness to use effective contraception, if female
Development of a Software Correlating Simultaneously fMRI, EEG and Peripheral Physiological Activity

The study aim to improve the quality of EEG recordings during simultaneous fMRI acquisitions. The second aim is to validate the correspondence between cerebral areas activated in fMRI and cortical areas identified with high density EEG during the listening of emotional musical pieces.


Eligibility Criteria:
Inclusion Criteria:

* Right handed healthy people
* Sensitive to "music chill" (Barcelona Reward music Questionnaire\>50)
* Having given their participation agreement
* Individual with health insurance coverage.

Exclusion Criteria:

* Pregnant women
* Individuals in "exclusion period" of another study
* No inclusion criteria of fMRI acquisition
* Subjects with auditory deficits.
Jail-Based Impact of Crime Intervention

The purpose of this study is to evaluate whether the Impact of Crime (IOC) group intervention with jail inmates reduces post-release recidivism, substance abuse, and HIV risk behavior.

This project imports social-personality theory and research on moral emotions and cognitions to the applied problems of crime, substance abuse, and HIV risk behavior. The primary aim of this study, a Phase 2 Randomized Clinical Trial (RCT) of the restorative justice-inspired Impact of Crime (IOC) group intervention, is to examine the efficacy of treatment and to determine if changes in moral emotions and cognitions serve as mechanisms of action, explaining the impact of treatment involvement on reductions in post-release recidivism, substance abuse, and HIV risk behavior.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years or older
* Must be male
* Must be currently incarcerated jail inmate
* Must be sentenced
* Sentence must be short enough to serve out sentence at ADC
* Release date must follow projected final session of treatment
* Must speak, read, and write in English with sufficient proficiency to use workbook and participate in group sessions
* Must be assigned to the jail's "general population"

Exclusion Criteria:

* Actively psychotic
* Assigned "keep separate" from other group members
Understanding the Effects of Water-related Appetite Expectancies on Caloric Intake in College Students

Consuming large volumes of water has recently been identified as a common weight loss strategy among U.S. adults. It is a widespread belief that drinking water increases feelings of satiety and reduces food intake, which could contribute to long-term weight maintenance. Many studies have shown support for this, demonstrating water's ability to reduce hunger and energy intake. In some cases, increased water consumption was associated with weight loss. However, the mechanisms of how water affects food intake have been minimally explored. There is potential that the effect of water on reduced food intake and increased satiety is due to individuals' belief that water will reduce their appetite and food intake. The question remains if water expectancy has a meaningful influence on water's ability to reduce food intake. The investigators hypothesize that participants will report less hunger and consume fewer calories when given water and an expectancy that water will affect appetite, compared to a condition when given water and do not expect water to have an effect on appetite. We further hypothesize that calorie intake will not meaningfully differ when participants are given water with no expectancies compared to when given no water. During this experiment, the investigators will vary the presence of water and manipulate expectancies about water's effects on appetite across three conditions: (1) an expectancy and water condition; (2) an expectancy and no water condition; and (3) a no expectancy and water condition. In each condition, participants will engage in a bogus taste test and complete two short cognitive tasks for distraction purposes. In an effort to prevent demand characteristics, this study involves deception. Participants will be told that the research team is interested in testing the effects of three different mint herb variations on attention, coordination, and taste perceptions. After completing the cognitive tasks and taste test, participants will have a 10 minute period to eat as much of the remaining food as they'd like. Food will be weighed before and after this period (without the participant's knowledge) in order to determine caloric intake.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years of age
* rating at least two foods from each category (chips/crackers and sweets/candies) on the food options list for the taste test as a 7 ("like moderately") or higher on a 9-point hedonic scale
* willing/able to come to the lab for three sessions

Exclusion Criteria:

* current smoker
* self-report of a current or past eating disorder diagnosis
* taking an appetite suppressant or stimulant medication
* currently engaged in a weight loss program
* currently pregnant, breastfeeding, or planning to become pregnant
* allergy to mint
Imaging the Effects of Bihemispheric Transcranial Stimulation and Motor Training After Stroke.

Functional and structural magnetic resonance imaging (MRI) will be used to investigate neural correlates of bihemispheric transcranial direct current stimulation (tDCS) associated with upper limb rehabilitation in chronic stroke patients. For this purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric tDCS associated with intensive and individualized rehabilitation. Neuroimage will be employed before and after the intervention to investigate neural correlates of expected changes in motor function.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Stroke (\> 12 months)
* Upper limb sensorimotor sequelae due to stroke affecting only one cerebral hemisphere
* The structural integrity of the corpus callosum sensorimotor
* Showing ability to perform some movement with the paretic upper limb: at least minimal active mobility of the wrist and two fingers of the paretic hand.
* Score ≥ 18 at Folstein Mini-Mental State Examination

Exclusion Criteria:

* Score ≥ 4 at Ashworth Scale
* MRI or tDCS contraindications (cardiac pacemakers; implanted medication pumps; cochlear, or eye implants; craniotomy, skin lesions at the site of stimulation; surgical clips in or near the brain; claustrophobia, history of seizures, permanent makeup or tattoos with metallic dyes...)
* Prior neurological diseases
* Hemodynamic instability
* Pregnancy
* Traumatic or orthopedic lesion limiting the range of upper limb motion
* Severe comprehension deficits, apraxia or neglect that would interfere with performing the study tasks
* Score \> 59 at the Fugl-Meyer Assessment of Motor Recovery after Stroke
Operative Difficulty Grading Scale for Laparoscopic Cholecystectomy in BPKIHS

The main purpose of this study is to utilize operative grading scale to predict conversion to open,complication and reintervention and validate Nassar Scale.

Laparoscopic cholecystectomy is the commonly performed procedure in our institute. Laparosopic cholecystectomy is high variable surgery ranging from simple routine operation to difficult surgery leading to increased morbidity and mortality. The majority of previous scores use a combination of pre-operative and operative data and were produced in studies that were limited by retrospective data, small sample sizes and lack of external validation.

Very few intraoperative difficulty grading scale was published and none are widely used in clinical practice. So operative grading scale will have advantages of assisting in intra-operative strategy and planning, allowing comparison across different research studies, facilitating risk adjustment for surgical outcomes and providing an aid in training surgeons and monitoring of training progression.

The main purpose of this study is to utilize operative grading scale to predict conversion to open,complication and reintervention.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing laparoscopic cholecystectomy

Exclusion Criteria:

* CBD Stone
* Malignancy of Extrahepatic biliary tree
* Cholecystectomy as a part of other surgery