cyrilzakka/clinical-trials huggingface dataset:
The TOBY Children Study

The aim of this study is to determine the efficacy of therapeutic hypothermia following perinatal asphyxia on neurological and neuropsychological outcomes and also to assess academic attainment and any additional health, societal or educational costs associated with changes in outcome as a result of the intervention. This study will determine whether the apparent initial benefits of cooling are maintained in the longer term.

Perinatal asphyxia (a lack of oxygen occurring around the time of birth) may have long term consequences on brain functioning, which may be altered by treatment with hypothermia (cooling). Currently, there is no information on the effect of cooling on outcome beyond 18 months of age. We intend to assess at 6 - 7 years of age, the children that participated in the TOBY trial of whole body cooling following perinatal asphyxia and compare between the children that had received the cooling treatment soon after birth and those that were not treated with cooling, the number that survived with an intelligence quotient (IQ) greater than 84, the presence and severity of disabilities, educational attainment and the economic impact on families and service providers. If possible, children will be assessed in their school, with the option of alternative venues such as home or clinic if required.

During the assessment a paediatrician will conduct a neurological examination. A psychologist will administer psychometric tests to evaluate cognitive, behavioural and motor development. Questionnaires completed by parents and teachers will complete the data collection. Economic factors will also be assessed in the parent questionnaire.

Each child will have contact with the assessors during one school day with appropriate breaks. Assessments will take place over a period of 3 years.

* Assessment tools used:

  * Wechsler Preschool and Primary Scale of Intelligence Third Edition (WPPSI-III; 2004) or Wechsler Intelligence Scales for Children
  * NEPSY Second Edition
  * Working Memory Test Battery for Children
* Neurological examination by paediatrician
* Questionnaire data from parents/guardians and teachers

Eligibility Criteria:
Inclusion Criteria:

* participant in the TOBY Study

Exclusion Criteria:

* previously documented instruction not to approach for inclusion in further TOBY projects
Alzheimer Disease : Rehabilitation's Intervention at Home

Alzheimer's disease (AD) is the most common cause of dementia among elderly patients. By its prevalence and its medical and social consequences, AD represents a dual challenge to public health and society. The elderly want to stay in their homes even when their lives are altered by a chronic progressive disease. Their caregivers claim in turn a support at home. But this desire is questioned because of the characteristics of the disease, e.g. the altered relational function by the cognitive impairment and the behavioural disorders associated.

Outpatients non-drug therapies represent a potential support that adapts to patient with an AD or mixed dementia, especially in their milder forms.

The aim of the study is to evaluate the feasibility of a weekly rehabilitation's intervention at home and its acceptability by both the patient and the caregiver.

The study of its efficiency in terms of autonomy will be the next step.

The protocol is based on weekly rehabilitation's intervention at home. All home visits and assessments of the patient and his caregiver will be made by the rehabilitation's therapist himself.

Twelve weekly interventions at home are planed. The first five are needed to define a realistic and achievable goal of treatment which is accepted by the dyad and the therapist. The following seven interventions will achieve this goal by rehabilitation's intervention (e.g. occupational therapy, psychomotor approach).

Four filmed sessions for dyad's assessment are planned (at inclusion, at weeks 5 and 12 after inclusion and 3 months after the last intervention).

Eligibility Criteria:
Patient's inclusion criteria:

* Aged 65 and over
* AD or mixed dementia (DSM IV TR criteria), documented by a neuropsychological assessment and a brain imaging
* Living at home
* Having a caregiver (more than 2 visits per week)
* Agreement for the study

Caregiver's inclusion criteria :

* More than 2 patient's visits per week
* Agreement for the study

Patient's exclusion criteria:

* Life expectancy less than 1 year
* Guardianship
* Already having a rehabilitation program's therapy
* Participation in a pharmacological study

Caregiver's exclusion criteria:

- Medical condition requiring regular care
Establishment of Virtual Reality System for Stroke Patients With Aphasia

Aphasia can significantly influence a person's social relationship and quality of life. To achieve positive language outcomes, an intensive and high-repetition speech therapy is essential. However, due to the limited number of speech therapists, the intensity and frequency of training are often insufficient. Therefore, it is critical to develop other rehabilitation approaches to enhance the benefits of aphasia intervention. Virtual reality (VR) is an immersive and interactive computer simulation technology that can promote the ecological validity of speech therapy. In this study, we develop an innovative VR software for speech training to explore the effects of VR on various aspects of language outcomes.

We randomly assigned study participants into 2 groups: the traditional speech therapy (ST) group and the traditional ST with additional VR training (ST+VR) group. In the ST group, each participant received 1-hour traditional ST for each session. In the ST+VR group, an additional 30-minute VR training was administered immediately after each session of traditional ST. All participants received 3 sessions of treatment every week for 3 weeks. For outcome measurement, we administered Concise Chinese Aphasia Test (CCAT) at 3 different time points: before treatment, 1 day and 3 months after the completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stroke with aphasia, including fluent and non-fluent types
* Age between 20\~80-year-old
* Able to understand virtual reality training
* Able to cooperate with instructions and follow the rules
* Able to use the virtual reality controller and device
* Able to sign the subject's informed consent

Exclusion Criteria:

* Diagnosis of brain pathology other than stoke, such as brain tumor, Parkinson's disease, dementia
* Unable to cooperate with the instructions
* Unable to learn how to use the virtual reality controller and device
* Any medical diseases or unstable vital signs that may cause safety concern
* Severe hearing or vision impairments
* Have ever received any form of speech therapy or virtual reality training
Optimizing the Ambiance During Mealtimes in Dutch Nursing Homes

Optimizing the social and physical ambiance during mealtimes in Dutch nursing homes: implementation and evaluation of the effect with respect to quality of life, nutritional status and physical performance.

Study design: During six months the intervention group had their meals in family style, and the control group received the usual tray services.

Hypothesis: We hypothesized that the intervention program had a positive effect on quality of life, food intake, body weight, physical performance, and biochemical data (hematocrit, hemoglobin, leucocytes, ferretin, albumin, homocysteine and folate) among the residents in the intervention group, while these outcome measures would regularly decline among the residents in the control group.

Site and participants: Nursing homes volunteered to participate in the study. In each nursing home there was a control and intervention ward. Only residents with a chronic somatic disorder were included. Residents were excluded when they were in a terminal phase of a disease, had total parenteral feeding or were not able to give informed consent due to their physical or mental condition. The ethical committee and the client board of the nursing homes and the medical ethical committee of Wageningen University approved the study protocol.

Intervention: The intervention program lasted for six months and was based on an inventory research of mealtime ambiance models in the Netherlands. The program consisted of five aspects: table dressing, food services, staff protocol, residents' protocol, and mealtime protocol. Before the start of the meal, tables were set with tablecloths, full cutlery and plates. The cooked meal was served in dishes and residents had the opportunity to choose between two kinds of vegetables, two kinds of meat and potatoes.

Eligibility Criteria:
Inclusion Criteria:

* Nursing home residents with a chronic somatic disease and long term care

Exclusion Criteria:

* Residents were excluded when they were in a terminal phase of a disease, had total parenteral feeding or were not able to give informed consent due to their physical or mental condition.
Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers

This study aimed to evaluate the pharmacokinetic characteristics and bioequivalence of two olaparib tablets in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Had BMI 18.0 kg/m\^2, and weight ≥ 50 kg for male, or ≥ 45 kg for female
* Patients who were on olaparib treatment, had epithelial ovarian, fallopian tube, or primary peritoneal cancer, or were eligible for olaparib treatment judged investigators
* Had ECOG performance status 0-1
* Had life expectancy \>12 weeks
* Had Adequate organ function or clinically irrelevant abnormal result
* Agreed to use adequate contraception from 14 days before treatment initiation to 6 months after last dose

Exclusion Criteria:

* Allergic to any component of study drugs
* Had central nervous system metastases (stable and asymptomatic metastases were acceptable)
* Had other malignancy within 5 years
* Had disease affecting swallow or absorption
* Received major surgery within 1 month before study drug administration
* Had major disease
* Had continuous grade 3-4 adverse event
* Had drug abuse
* Had (suspected) pneumonitis
* Participated in other clinical trial of drug or device within 1 month
* Lost or donated blood \> 200 mL or received blood transfusion within 1 month
* With average alcohol consumption \> 14 units/week or cigarette consumption \> 20/day within 1 month
* Positive for human immunodeficiency virus, hepatitis B, C, or syphilis test
* Received strong or moderate CYP3A inducer or inhibitor within 3 half-lives of the drug
* Consumed grape fruit juice, or other food or beverage containing caffeine or xanthine
* For female, pregnant or breastfeeding
Innovative Approach to Reduce Lung Cancer Stigma

This is a feasibility study examining the feasibility and acceptability of a novel psychotherapy intervention on lung cancer patients who are experiencing stigma.

Experiences of stigma (perception and internalization of negative appraisal and devaluation from others) are pervasive for lung cancer patients. Previous work has shown associations between lung cancer stigma and detriments in clinically relevant outcomes such as depression, lower quality of life, and reduced engagement in cancer care.

The investigators previously developed Acceptance and Commitment Therapy for Lung Cancer Stigma (ACT-LCS) as a patient-focused intervention to reduce the self-blame, guilt and inhibited disclosure associated with lung cancer stigma. ACT-LCS is based in Acceptance and Commitment Therapy (ACT), a cognitive-behavioral treatment that promotes psychological flexibility through acceptance and valued direction.

This is a feasibility study examining the feasibility and acceptability of ACT-LCS.

Eligibility Criteria:
Inclusion Criteria:

* Proficiency in English
* Diagnosed with or treated for Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) within the prior 12 months.
* Scores of 37.5 on the Lung Cancer Stigma Inventory (LCSI) screening measure

Exclusion Criteria:

* Not proficient in English
Instrument Precision Study for Validation of Philips Dx

The objective of this study is to evaluate precision of the Philips Dx system.

Slides were selected that contained clinically relevant histopathologic "features" that are generally encountered on surgical pathology slides. Twenty-one features, each selected from three different organs, were to be included to ensure that multiple tissue types were investigated. The study feature(s) as selected on each slide was defined as the "selected feature". In total 420 selected features were acquired and the slides holding these features composed the "slide set". The slideset consisted of 399 slides from 399 different participants.

1. Intra-system study. The full slide set was then divided over three subsets. Each subset was then scanned three times on one systems, with each subset being scanned on a different scanner. This means that each feature was scanned three times. Each of three pathologists read all three scans of the entire slide set. Intra-system precision was thereby determined.
2. Inter-system study. The full slide set was then scanned three times, each time on a different system, meaning that each feature was scanned three times. Each of three pathologists (different pathologists the ones used in the intra-system study) read all three scans of the entire slide set. Inter-system precision was thereby determined.

Eligibility Criteria:
Inclusion Criteria:

* Left-over specimens from subjects who already received their diagnosis and have received their treatment in accordance with the standard of care
* H\&E glass coverslipped slides with human tissue obtained via surgical pathology
* Selected slides fulfill the quality checks according to the Instructions for Use (lfU)
* Selected slides must be between 1-5 years since accessioning
* Selected slides and FOVs must contain a study feature that is: In it's natural environment (on slide and FOV); Readily observable (on slide and FOV); Not equivocal (on slide and FOV).

Exclusion Criteria:

* Selected slides contain indelible markings
* Selected slides contain damaged tissue
* More than one slide was selected for a patient (only one slide may be enrolled per patient).
Effect of Biliopancreatic Diversion on Glucose Homeostasis

Biliopancreatic diversion (BPD) surgery results in greater resolution of type 2 diabetes than all other bariatric surgical procedures, and it is hypothesized that this procedure has specific beneficial effects on glucose homeostasis beyond weight loss alone. The BPD procedure is performed in more than 150 patients/year by surgeons at the Division of Obesity and Metabolic Disorders, Catholic University of the Sacred Heart, School of Medicine, in Rome, Italy. The purpose of this study is to provide a better understanding of the effect of the BPD bariatric surgical procedure on insulin action and pancreatic beta cell function. It is hypothesized that weight loss achieved with BPD surgery will have greater effects on insulin sensitivity and beta cell function than weight loss induced by Roux-en-Y gastric bypass (RYGB).


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≥ 35 kg/m²
* Undergoing either the RYGB or the BPD procedure.
* Able to provide informed consent to participate in the research study

Exclusion Criteria:

* Weight \> 450 pounds
* Smoke \> 7 cigarettes per day
* Previous malabsorptive or restrictive intestinal surgery
* Pregnant or breastfeeding
* Inflammatory intestinal disease
* Diabetes
* Unstable dose of medications in the last 4 weeks before the pre-surgery metabolic studies
* Severe organ dysfunction
Multi-Media E-Book for Second-Trimester Termination Due to Fetal Anomaly

The subjects of this study are married couples who received termination of pregnancy, the main purpose is to explore the effectiveness of the e-book education model. Outcome indicators include anxiety, depression, and grief, as well as the satisfaction of the education.

1. Study design: The study subjects were couples of obstetric inpatients who would receive termination of pregnancy. Both groups were assessed by the obstetrician in the outpatient clinic who must be admitted to the hospital to terminate the pregnancy. After receiving consent, a pre-test is performed in the clinic. The pre-test included questionnaires (basic attribute, State-Trait Anxiety Inventory (STAI) - the State Anxiety Scale (S-Anxiety), Perinatal Grief Scale (PGS), Beck Depression Inventory). After complete pre-teat, study nurse will provide the experimental group a QR Code to enter the cloud system (Hama Star e-book network platform), enable the couples to read the content at home; the control group receives traditional oral instructions. When the experimental group entered the delivery room, the researcher used the Hama Star e-book network platform to play the content of the termination of pregnancy e-book education model, and discussed the content with them; the control group receives regular traditional education model, with booklet and oral instructions, the intervention is about 20-25 minutes. The experimental group is able to use e-books as needed during induction, hospitalization, and after discharge. Two post-tests are conducted for follow-up. Both groups write the first post-test questionnaire (State-Trait Anxiety Inventory (STAI) - the State Anxiety Scale (S-Anxiety), Perinatal Grief Scale (PGS), Beck Depression Inventory) 60 minutes after education. Then, complete the second post-test questionnaire at the next appointment a month after.
2. Randomization Process: This study used a two-group pre- and post-test mode in experimental design, and random allocation to assign subjects into experimental and control groups. Participants were randomly allocated to the experimental or control group in a 1:1 ratio using the network randomization tool (www.randomizer.org/).
3. Sample size calculation:G-power version 3.1 was used to calculate the required sample size for the study. Set power 0.8, α = 0.05, based on the effectiveness (effect 0.30), the number of samples required for each group in this study is 32, because the tracking period is up to half a year, with a loss rate 50%, the two groups need a total of 96 participants.

Eligibility Criteria:
Inclusion Criteria:

1. At least 20 years old
2. Consciousness clear and capable of complete the questionnaires
3. Able to communicate in Mandarin or Taiwanese
4. Agree to participate in the study and sign the consent

Exclusion Criteria:

1. Emergency admissions for induction.
2. Non-medical reasons and pay own expenses to terminate the pregnancy
3. Have psychiatric illness history or other disorders that affect cognitive function
Role of the Gut Sweet Taste Receptor in the Secretion of Satiation Peptides

The purpose of this study is to determine the functional significance of sweet taste receptors in the secretion of gastrointestinal (GI) satiation peptides by using a specific sweet taste receptor antagonist to block sweet taste perception in the gastrointestinal tract.

There is strong evidence that taste signaling mechanisms identified in the oral epithelium also operate in the gut. It is suggested that open-type enteroendocrine cells directly sense nutrient via alpha-gustducin coupled taste receptors to modulate the secretion of glucagon like peptide-1 (GLP-1) and peptide YY (PYY). Several nutrient responsive G-protein coupled receptors have been identified in the human gut, including the sweet taste responsive T1R2/T1R3 heterodimer, the amino acid/umami responsive T1R1/T1R3 as well as GPR120 for unsaturated long-chain free fatty acids. The functional significance of sweet taste receptors in mixed liquid meal-stimulated secretion of GLP-1 and PYY will be determined by intragastric infusion of a 500 mL mixed liquid meal with or without lactisole (450 ppm)in a double blind, 2-way crossover trial including 16 healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* BMI of 19.0-24.5
* age 18-40 years old
* stable body weight for at least 3 month

Exclusion Criteria:

* smoking
* substance abuse
* regular intake of medication
* medical or psychiatric illness
* gastrointestinal disorders or food allergies
Study Evaluating Single Doses of BLI-489 in Healthy Subjects

The purpose of this study is to evaluate the safety, and tolerability of single doses of BLI-489 administered intravenously in healthy subjects, and also how the drug is absorbed and eliminated.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women of nonchildbearing potential, 18 to 50 years of age inclusive at screening.
2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg.
3. Healthy as determined by the investigator on the basis of the screening evaluations.
4. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion Criteria:

1. Presence of history of any disorder that may prevent the successful completion of the study.
2. History of drug abuse within 1 year.
Real-World Study (RWS) of Lanreotide Autogel (LAN) for the Treatment of Patients With Acromegaly in China

This study aims to assess the one-year effectiveness and safety of LAN among patients with acromegaly in China in routine clinical practice. In addition, the study is designed to understand the real-world treatment patterns and outcomes of LAN among Chinese patients with acromegaly.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are able to comply with the protocol
* Participants with serum IGF-1 level above the ULN for age and sex, and serum fasting GH level above 2.5 μg/L
* Participants with acromegaly who are naïve to LAN treatment and about to initiate LAN

Exclusion Criteria:

* Participants who are currently participating in any investigational study or clinical trial of acromegaly
* Pregnant participants
* Participants with hypersensitivity to somatostatin or related peptides or to any of the excipients