cyrilzakka/clinical-trials huggingface dataset:
Pemetrexed in Patients With Soft Tissue Sarcoma

The aims of this trial are to evaluate the efficacy and tolerability of pemetrexed in patients with metastatic soft tissue sarcoma who have progressed after or during an anthracycline-based chemotherapy and to assess the toxicity profile

One therapy cycle takes a total of 3 weeks. On day 1, Pemetrexed is intravenously administered. The dosage is 500 mg/m2 over a period of 10 minutes. A repetition of this procedure is performed on day 22

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastasized or locally inoperable soft tissue sarcoma
* Progression or relapse after previous cytostatic treatment with adriamycin and/or an ifosfamide containing chemotherapeutic substance
* Two-dimensionally measurable/evaluable tumor parameters (according to WHO-criteria)
* Previous radiotherapy is acceptable as long as the irradiated area does not include the only measurable lesion
* Patient compliance and geographic proximity, which ensure the possibility of adequate Follow-up
* Life expectancy of more than 3 months
* ECOG \<= 2
* Age at least 18 years
* Adequate bone marrow function at the initiation of therapy
* Adequate kidney function
* Patient consent
* Patient ability to consent

Exclusion Criteria:

* Previous or concurrent irradiation of the indicator lesion
* Other concomitant tumor therapy
* Severe impairment in hepatic function
* Active Infection
* Previous treatment with Pemetrexed
* Second tumor within the past 5 years (excepting basal cell carcinoma, adequately treated carcinoma in situ of the uterine cervix, of the bladder urothelium or colon polyps including pTis and pTin)
* Severely symptomatic cardiovascular and cerebrovascular disease
* HIV, active Hepatitis B or C
* Dementia, Cerebral stroke with cognitive deficits
* Kidney function \<= 79 ml/min (calculated according to MDRD): Inability to interrupt treatment with NSAIDs/ASS/Cox-2 Inhibitors 2 days prior to and following administration of Pemetrexed. If a patient is taking an NSAID or salicylate with a long half-life it should not be taken five days prior to, on the day of or two days after application of Pemetrexed. Low dose acetyl salicylic acid administration is permitted (e.g. 100 mg/die.) There are no restrictions with kidney function greater than 80 ml/min.
* Inability or unwillingness to take folic acid, vitamin B12 or dexamethasone
* Pleural or pericardial exudate, ascites without a drain (3rd Space)
* Time Interval from the last course of chemotherapy \< 4 weeks
* Symptomatic CNS-Metastases
* Gravidity or Lactation
* Women of reproductive age without reliable contraception if not the following applies: Must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after treatment
* Positive serum or urine pregnancy test
* Participation in another trial at the same time
Using ChatGPT As a Job Coach for Adults with Autism Spectrum Disorder

The goal of this clinical trial is to examine the effectiveness of the ChatGPT-based job coach in helping ASD individuals prepare for job application, job interview, and interpersonal skills in workplaces. The main questions aim to answer are:

How can we develop a ChatGPT-based job coach system to assist individuals with autism spectrum disorder (ASD) in job applications, job interviews, and interpersonal skills in workplaces?

How effective is the ChatGPT-based job coach in helping ASD individuals (n=30) prepare for job applications, job interviews, and interpersonal skills in workplaces? What clinical correlates are associated with better effectiveness, and what are the interaction patterns between ASD adults and the ChatGPT platform?

Participants will complete assessment questionnaires (evaluating autism traits and empathy, approximately 30 minutes) and a one-hour job interview practice. Please follow the recommendations to use ChatGPT for completing your job resume, job type discussions, job interview preparation and practice, explanation of Asperger's traits for the workplace, and workplace social discussions. After one week of practice, you will fill out the assessment questionnaires and complete the job interview practice again.


Eligibility Criteria:
Inclusion Criteria:

* Young adult aged between 18 and 45 years who had a diagnosis of ASD from a licensed mental health or medical professional based on DSM-5;
* is motivated to have a job
* is able to use the ChatGPT on the computer under instruction (e.g., typing questions) and is able to provide feedback to the research team
* has a full-scale IQ \> 70 on WAIS-IV
* scored ≧ 26 on the caregiver-reported Autism Spectrum Quotient (AQ), indicating clinical impairment associated with ASD
* agree to audio and video recording during the interview rehearsal.

Exclusion Criteria:

* A history of major psychiatric disorders (e.g., bipolar affective disorder, schizophrenia, or psychosis) or neurological diseases
* visual impairment and/or hearing impairment that would preclude participation in the study
* refuse audio and video recording during the interview rehearsal.
Nurtured Heart Parenting Intervention for Child Behavioural Problems

Behavioural problems are prevalent in children, yet the consequences can be significant for the child, family and wider society. Effective intervention is paramount in reducing the impact of childhood behavioural problems. The Nurtured Heart Approach (NHA; Glasser \& Easley, 2016) is an atheoretical parenting intervention which aims to reduce childhood behavioural problems. Although used in clinical practice, there is little empirical research on the effectiveness of the NHA. The aims of the study were to examine whether the NHA reduced parent-reported child behavioural problems, reduced negative parenting practices, and increased parental reflective functioning.

The study used a multiple baseline single case design. Parents of children with behavioural problems were recruited from CAMHS waiting lists. The NHA was delivered in a guided self-help format, using the Transforming the Intense Child workbook (Glasser, 2016) and weekly phone calls. Data collection involved psychometric measures of parent-reported child behavioural problems, parenting practices and parental reflecting functioning. Measures were repeated throughout baseline and intervention phases. A follow-up four weeks after the intervention included final measure administration and a change interview. The data were graphed and visually analysed. Supplementary analysis included reliable and clinically significant change, Tau-U and percentage exceeding the median. Framework analysis was used to analyse the change interview.


Eligibility Criteria:
Inclusion Criteria:

Participants will be parents/carers of children who have been referred to National Health Service (NHS) children's services for behavioural problems. Participants will be recruited from waiting lists of NHS children's services at the two research sites in the East Midlands.

Inclusion criteria:

* The referred child is aged between three and eleven years old.
* The referred child is on a waiting list for an NHS children's service at the two research sites.
* The referred child's behavioural problems are one of the primary reasons for referral to the NHS service.
* The parent/carer identifies the referred child's behaviour as problematic.

Exclusion Criteria:

* The referred child has a diagnosis of developmental delay or learning disability.
* The family is current receiving active multi-agency involvement (e.g. social care, police or youth offending in addition to NHS services).
* The parent/carer is aged under 18.
* The parent/carer is unable to read or speak English fluently.
Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL)

The purpose of this study is to determine the safety and compliance of initial intravenous (IV) antibiotics followed by oral antibiotic therapy following uncomplicated IVDA endocarditis. Endocarditis has a high rate of sickness and death, involves a long hospitalization and a long-term use of IV antibiotics necessitating six (6) weeks of in-patient hospital stay, and comes with a high cost.


Eligibility Criteria:
Inclusion Criteria:

* The age of the patient is ≥ 18.
* The patient has undergone an urgent or emergent primary cardiac valvar operation as treatment for IVDA endocarditis, with blood cultures positive for Streptococcus, Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative Staphylococci
* The patient has received 2 weeks of postoperative inpatient IV antibiotic therapy with negative blood cultures and no residual active infection by imaging (i.e. computerized axial tomography, echocardiography)
* The patient has the capacity to participate in a compliance tracking tool for medication administration (e.g. a centrally managed core site mobile Medisafe compliance https://www.medisafe.com/) as confirmed by both a physician and a care management team member

Exclusion Criteria:

* Inability to give informed consent
* Residual infection requiring IV antibiotic therapy
* Any persistent secondary noncardiac infection (e.g. infections of solid organs or joints)
* Known poor compliance or deemed incapable to comply with the compliance tracking tool
* Reduced absorption or inability to receive oral treatment due to a gastrointestinal disorder
* Any infection involving a more virulent organisms, such as fungal infections or infections with Serratia or HACEK infections (Haemophilus, Aggregatibacter, Cardiobacterium, Eikenella, Kingella).
* Cancer not otherwise in remission or in need of current or future oncologic therapy
* Medically immunocompromised state
* Reoperative valvar operation for IVDA endocarditis
* History of habitual noncompliance
* Pregnancy
* Mental incapacity
* Unable to perform local or institutional medical and psychiatric follow up
* Unstable home environment
* Inadequate access to mobile cell service (geographic/rurality)
Effect of Enzyme Replacement Therapy on Cardiac Function in Children With Gaucher Disease Type 3

all cases confirmed diagnosis of Gaucher disease type 3 recieving enzyme replacement therapy at Assiut university hospital

evaluate cardiac involvement in a group of GD type 3 patients, evaluate pulmonary hypertension and valvular involvement, compare the findings of basic echo before the start of replacement therapy as well as with healthy controls, to assess the effects of enzyme replacement therpay on the cardiac function.

Eligibility Criteria:
Inclusion Criteria:

* Any sex
* No age limit
* Gaucher disease type 3
* Receiving enzyme replacement therapy

Exclusion Criteria:

* Age18 years old
* Cases of gaucher type 1 and 2
* Other lipid storage disease
Knowledge Attitudes Beliefs and Practices Relative to HIV Among Sex Workers in French Guiana

The aim was to determine the knowledge attitudes, beliefs, and practices regarding HIV in a population of sex workers in French Guiana and in the Brazilian border town of Oiapoque. A standardized questionnaire was administered face to face to sex workers. Analysis of the questionnaires led to descriptive statistics. Multiple logistic regression models were computed to determine the predictors of condom use.


Eligibility Criteria:
Inclusion Criteria:

* sex worker

Exclusion Criteria:

* not wishing to participate
A Study of Taurine in Patients With First-episode Psychosis Receiving Antipsychotic Treatment

The purpose of this study is to determine whether Taurine 4g is effective with antipsychotic medication in the treatment of First Episode Psychosis.Taurine may have an effect on cognition and symptoms. We are examining changes in symptoms and cognition over a 3 month period.

The core rationale of this study will be to prospectively investigate whether Taurine will improve and /or protect cognitive functioning and improve symptomatology in a cohort of 128 first episode psychosis patients.This is a randomized, double blind placebo controlled add on standard therapy trial of Taurine 4g , in young patients between 18-25 presenting to ORYGEN Youth Health a sub program of Melbourne Health and RAPPS, a subprogram of Southern Health with a first psychotic episode . Taurine will be compared with placebo added to standard treatment for a period of 12 weeks in a double blind fashion.Primary outcome measures will be psychopathology and cognition (MATRICS.

Secondary outcome measures will be tolerability and safety measures (drop-out rates, general side effect scale (UKU).

Patients who give informed consent will be randomised to receive treatment with Taurine 4g daily or placebo for 12 weeks.

Patients will be randomised by a dynamic randomisation method called minimization which allocates patients to treatment group by checking the allocation of similar patients already randomised, and allocating the next treatment group "live" to best balance the treatment groups across all stratification variables. The minimization will be carried out by the NHMRC clinical trials centre in Sydney , and the patient will be randomized to either placebo or vitamin.

Each patient will collect their tablets from the clinical trials pharmacy. The Clinical Trials Pharmacy will dispense either vitamin or placebo. All study personnel and participants will be blinded to treatment assignment for the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Male and females
* Between 18 and 25 years of age
* First Episode Psychosis
* Attending ORYGEN Youth Health, a geographical based catchment area service for young people aged between 15 and 25.

Exclusion Criteria:

* Organic disorders presenting with a psychotic syndrome (e.g. brain tumour, temporal lobe epilepsy, HIV encephalopathy)
* Mental retardation (unable and/or unlikely to give appropriate information of symptomatology or side-effects (IQ approximately lower than 80)
* History of clinically significant physical illness (e.g. terminal cancer, renal dialysis)
* History of brain surgery
* History of brain infarction
* Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception.
Evaluation of Weight Bearing After Total Hip and Knee Replacement

The regime in the aftercare after total hip and knee arthroplasty(THA/TKA) differs a lot between orthopedic surgeons concerning weight bearing. The type of implant and the way of implants' anchoring are considered.

In the literature there is no data so far about the way patient take care of the recommended weight bearing during the first 6 weeks after THA and TKA.

Over a one year period starting August 2010 all patients undergoing TKA or THA at the investigators institution will have a technical device in their shoes (sole) to measure the load in each step they do in these shoes during the first 6 weeks. Patients are asked to fill out a standardised pain protocol every day (VAS) and document need of pain medication. The investigators recommend 20kg of weight on the operated leg for 6 weeks and full weight bearing at the end of week six.

The investigators believe that patients will adjust weight bearing to their level of pain and not to their surgeons recommendations.


Eligibility Criteria:
Inclusion Criteria:

* received a THA or TKA in the mentioned period of time
* is able to walk on crutches
* is able to understand our recommendations
* signed informed consent

Exclusion Criteria:

* not able to walk on crutches
* not able to understand our recommendations
* other deformities of lower limbs
Quantitative Endoscopy of H&N

The last decade has seen progressive advances in RT delivery, such as intensity modulated radiation therapy (IMRT)and image-guided radiation therapy (IGRT), which now allow highly precise radiation dose delivery. Together, IMRT and IGRT offer the potential of more selective treatment of the primary tumour and surrounding neck nodes by reducing the dose inflicted on critical organs at risk without compromising tumour dose and. IMRT has been shown to significantly decrease radiation-induced toxicity, and is now considered standard treatment for H\&N tumors. With these advances in delivery technology, the accurate definition of the target is emerging as the weakest link in the radiotherapeutic treatment chain. Accurate target definition is the primary link on which all subsequent treatment planning and delivery depend and is therefore critical for successful RT. Incorrect target definition can result in poorer outcomes through either less tumour control, more normal tissue toxicity, or both. Computed x-ray tomography (CT) is the standard volumetric imaging modality for RT because of its high resolution, accurate definition of anatomy and its intrinsic measure of electron density necessary for accurate dose calculation. However, its ability to distinguish between tumour and normal tissue is limited due to a lack of contrast for structures of similar electron density and image artifacts for objects of high density. This additional noise can result in large inter-observation variability. Disease visible on endoscopy can be contoured and registered to the planning CT, allowing inclusion of superficial disease invisible on the volumetric CT image dataset into the treatment plan.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Histologic diagnosis of squamous cell carcinoma
* Primary cancer of the H\&N
* Intention to treat using external beam radiation therapy as part of standard radiotherapy.
* Ability to provide written informed consent to participate in the study

Exclusion Criteria:

* Prior complete or partial radiation therapy to H\&N
* Prior complete or partial surgery of the tumour
* Contraindications to full dose radiation therapy including pregnancy, lactation, connective tissue disorders, serious co-morbid illness
* Concurrent illness or condition that precludes subject from undergoing endoscopy or CT scanning
* Psychiatric or addictive disorders that preclude informed consent or adherence to protocol
Treatment of Ilioinguinal Entrapment Syndrome - an Often Overlooked Cause of Chronic Pelvic Pain

Neuralgic pain caused by entrapment of peripheral nerves is an often overlooked cause of chronic pelvic pain. The objective of the present study was to assess pain and quality of life in women with pain caused by entrapment of the ilioinguinal nerve, iatrogenic after surgery but also found without previous surgery. In a controlled prospective cross-over study 19 women were randomized either to medical treatment or to resection of the nerve. Statistically significant improvements were found after surgical resection.


Eligibility Criteria:
Inclusion Criteria:

* Pelvic pain in which a careful investigation has shown signs of ilioinguinal nerve entrapment

Exclusion Criteria:

* Drug abuse
Myomectomies:Tumor Characteristics and Clinical Implications

This project focuses on myomectomy patients in reproductive age. The aim is to study both the molecular characteristics of uterine fibroids and to characterize the clinical effects of surgical treatment.

Patient series is mainly retrospective and consists of individuals who have undergone myomectomy at Helsinki University Central Hospital (HUCH) during 2009-2015. In addition, the investigators have started a prospective sample collection starting in October 2015, collecting samples from myomectomies.

Clinical data sources include medical records, specific questionnaires and a quality of life -questionnaire filled by patients.


Eligibility Criteria:
Inclusion Criteria:

* Uterine leiomyoma
* Seeking for surgery

Exclusion Criteria:

* Language proficiency in Finnish, Swedish or English
Pharmacokinetics and Pharmacodynamics of Two Prolonged-release Formulations of Vamifeport in Healthy Adults

This is a phase 1, single-center, randomized, open-label study to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of vamifeport after multiple oral administrations of one immediate-release (IR) formulation and after single and multiple oral administrations of two prolonged-release (PR) formulation in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 60 years when providing written informed consent.
* Healthy, as determined by the investigator based on review of defined assessments during Screening.
* Body weight between 50 and 100 kilograms (kg) (inclusive) and body mass index within the range 18.0 to 32.0 kg per meter squared (kg/m2) (inclusive) at Screening and Day -1.

Exclusion Criteria:

* Any clinically relevant abnormal 12-lead ECG finding at Screening or Day -1 (as deemed by the investigator).
* Serum ferritin of \< 30 nanograms per milliliter (ng/mL) or \> 300 ng/mL for assigned male at birth (AMAB) subjects or \<16 ng/mL or \> 300 ng/mL for assigned female at birth (AFAB) subjects at Screening or Day -1.
* Hemoglobin \< 13 grams per deciliter (g/dL) (8.1 millimoles per liter \[mmol/L\]) for AMAB subjects or 12 g/dL (7.5 mmol/L) for AFAB subjects at Screening or Day -1.
* Blood draw or donation of blood (\>= 450 mL) within 3 months before Screening, plasma from 2 weeks before Screening, or platelets from 6 weeks before Screening.
A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America

A Prospective, Multicenter, Non-Interventional Study of Primary Data Collection, Designed to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcomes in Patients with Breast Cancer in Latin America.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmed newly diagnosed stage I to IV (recurrent or de novo) breast cancer no more than 12 months prior to site activation, although they can have received anti-cancer treatment during that time

Exclusion Criteria:

* Patients not receiving treatment for breast cancer with national approved drugs according to standard of care and in line with the current summary of product characteristics (SPC) /local labeling
* Patients not receiving the Roche studied medicinal product, but a biosimilar
Alveolar Cleft Hard- and Soft Tissue Reconstruction With an Autogenous Tooth Derived Particulate Graft

The present study aims at clinical and radiographic evaluation of the safety and efficacy of Bonmaker ATB powder combined with a novel split thickness papilla curtain flap in the treatment of alveolar cleft defects.


Eligibility Criteria:
Inclusion Criteria:

* children with alveolar cleft
* patient presented at least three deciduous teeth scheduled for extraction.

Exclusion Criteria:

* major relevant clinical diseases,
* systemic use of steroids,
* current or previous intravenous bisphosphonate treatment,
* acute infection at the operation site.