cyrilzakka/clinical-trials huggingface dataset:
Psychoeducation of Adult Siblings of ASD People (Autism Spectrum Disorder).

The aim of this study is to apply a psychoeducational program in adult siblings of people with ASD as a means to provide knowledge related to the disorder and improving their quality of life.

The psycho-educational program will be implemented in adult siblings of people with ASD and its effectiveness will be assessed.

Participation in this program is expected to contribute in the improvement of the quality of life of the participants, their siblings with ASD and those related to them. No risk is identified.

Autism Spectrum Disorder (ASD) is a neurodevelopmental lifelong disorder of which prevalence has been significantly increased through the decades. Notwithstanding the abundant research finding on the ASD people and their parents regarding their mental health, quality of life etc., limited evidence exists regarding the siblings of people with ASD. The aim of this study is to apply a psychoeducational program for ASD in adult siblings of people with ASD as a means of providing disorder - related knowledge and improving their quality of life. The psychoeducational program will provide basic knowledge about ASD, training on behavioral management, acceptance and ongoing support to serve the needs of people with ASD and their caregivers.

This study will be a randomized controlled trial (RCT) with voluntary participation. The psycho-educational program will be implemented in adult siblings of people with ASD, free of charge, it will be conducted online by certified trainers, due to the coronavirus pandemic and its effectiveness will be assessed. The sample will be recruited from the general population of Greece. Four groups, each divided into experimental groups and control groups, will be randomized.

To evaluate the effectiveness of the program, participants will be asked to complete the online questionnaires three times (before the psychoeducation, after completion and three months later).

Participation in this program is expected to contribute in the improvement of the quality of life of the participants, their siblings with ASD and those related to them. No risk is identified.

This study is part of a doctoral thesis in progress at the Hellenic Mediterranean University (HELMEPA), Department of Social Work.

The study is expected to start in April 2024 and to be completed about six months later.

Eligibility Criteria:
Inclusion Criteria:

* Adults
* Have a brother or a sister diagnosed with ASD

Exclusion Criteria:

* Underage
* No sibling with ASD
* Have two or more siblings with ASD
* Have already been trained to "Cygnet" psychoeducational program.
Open-Label Extension and Safety Study of Talazoparib

This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Female patients of childbearing potential must have a negative pregnancy test before the first dose of talazoparib and must agree to use a highly effective birth control method from the time of the first dose of talazoparib through 45 days after the last dose.
* Male patients must use a condom when having sex with a pregnant woman or with a woman of childbearing potential from the time of the first dose of talazoparib through 105 days after the last dose. Contraception should be considered for a nonpregnant female partner of childbearing potential.
* Female patients may not be breastfeeding at the first dose of talazoparib and must not breastfeed during study participation through 45 days after the last dose of talazoparib.

Exclusion Criteria:

* Permanently discontinued from any Medivation sponsored study with talazoparib alone or in combination with another agent.
* Received an antineoplastic therapy or investigational agent after treatment with talazoparib in the originating protocol.
* Has a clinically significant cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, infectious, metabolic, neurologic, psychologic, or pulmonary disorder or any other condition, including excessive alcohol or drug abuse, or secondary malignancy, that may interfere with study participation in the opinion of the investigator.
* Diagnosis of myelodysplastic syndrome (MDS).
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469

The objective of the single rising dose part (SRD) is to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male subjects. The objective of the food effect part (FE) is to investigate the relative bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.


Eligibility Criteria:
Inclusion criteria:

1. Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
2. Age within the range of 18 to 50 years
3. Body mass index within the range of 18.5 and 29.9 kg/m2
4. Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation.

Exclusion criteria:

1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement.
2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
3. In the SRD: serum creatinine laboratory value outside the normal range
4. Glomerular filtration rate (GFR) according to CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration)-Formula \< 60 ml/ min
5. Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
6. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
7. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug
Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth

Background: Dental caries is considered an oral health problem worldwide. In Chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy, keeps the vitality of the tooth using some inductive materials mineralized tissue formation.

Objective: The main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars.

Methodology: It is a randomized controlled study. groups signed the informed consent for clinical trial patients, a clinical evaluation of 90 permanent molars teeth through endodontic diagnostic tests and radiograph. will be conducted to determine diagnosis. Will be assigned randomly to the type of material to use and direct pulp teeth affected by caries coating is carried out; Patients will not have knowledge of the material to be used in the coating. The patient will be clinically evaluated at 1 week, 3 months and 8 months, and radiographically; at the beginning and end of the study. In each clinical control endodontic diagnostic tests of heat, cold, electric and percussion will be performed. In radiographic controls take a radiograph control with positioner or surveyor at baseline and 8 months, to evaluate the periapical status. Clinical success will consider that tooth in continuous controls and after 8 months presented vitality and radiographic signs of apical image without injury. Failure unresponsive to consider whether susceptibility testing of cold and electricity in more than one control and presents radiographic image with apical lesion.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients
* Patients with at least one full or partial tooth root development
* Clinical examination of the tooth must be selected diagnostic tests that are consistent with reversible pulpitis
* Radiographic examination should show images of normal tissues without signs of internal resorption, the remaining healthy coronary should be sufficient for an indication of direct restoration
* Teeth that have pulp exposure not exceeding 1 mm in size.

Exclusion Criteria:

* Every child with systemic and / or neurological conditions that make it impossible to focus on conventional dental clinic
* Teeth uncontrolled excessive bleeding during communication pulp those aiming or have plans to move during that time period of 8 months .
The Effect of Instrument Assisted Soft Tissue Mobilization in Female Patients With Myofascial Pain Syndrome

The primer aim of this study is to demonstrate the effecti of instrument assisted soft tissue mobilization on pain, functionality, quality of life and depression in the treatment of female patients with myofascial pain syndrome due to active trigger points in the upper trapezius muscles

Myofascial Pain Syndrome (MAS); It is a non-articular, non-inflammatory regional musculoskeletal pain syndrome characterized by myofascial trigger points located at muscle, fascia or tendon insertion sites and the spread of pain to reference areas by palpation of these points.

h The effectiveness of massage therapy in MAS is known. In this study, investigators will apply instrument assisted deep tissue mobilization (graston massage). Instrument-assisted soft tissue mobilization massage, which is a type of massage, will be applied by a physiotherapist who has a certificate on this subject and takes part as an assistant researcher in our study.

Soft tissue mobilization is a unique soft tissue mobilization combined with active mobility and stretching exercises already prescribed for patients with musculoskeletal injuries.

The various sizes and beveled edges of the stainless steel instruments allow physiotherapists to tailor treatment to different muscle structures facing myofascial constraints.

Localized increases in blood flow and soft tissue realignment lead to muscle function, increased normal joint motion, and decreased pain.

It has been investigated in the literature for many different diseases (trigger finger, nonspecific low back pain, myofascial pain syndrome) and found to be effective.CF

Eligibility Criteria:
Inclusion Criteria:

1. Being woman and between the ages of 18-45
2. Not to be in menopause
3. Pain in the upper trapezius area
4. Detection of a taut band in the upper trapezius region on examination
5. At least one active trigger point in the tension band in the upper trapezius region on examination
6. The pain caused by the compression of the trigger point is the pain that the patient complains about
7. Painful restriction of cervical lateral flexion motion during stretching
8. Pain 4 or more according to NRS

Exclusion Criteria:

1. major surgery or trauma to the musculoskeletal system, especially the spine and upper extremities 2.History of any operation related to the head and neck region 3. Neuromuscular disease 4. History of rheumatic disease, malgnite in the active period 4. Cervical discopathy, cervical spondylosis, pathologies related to the shoulder joint and surrounding soft tissues, scoliosis, kyphosis, leg length difference, polio sequelae, developmental hip dysplasia 5. Psychiatric disease (Beck Depression Inventory score of 30 and above) 6.Obese (BMI≥30 kg/m2)

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Rezum for 30-80ml Patients With Moderate-severe LUTS to Study Surgical Principles for Median Lobe Enlargement

This study was created to determine the safety and efficacy of treating prostatic hyperplasia with or without prominent median lobe enlargement with the REZUM technique. The systematic implementation of decisions for the location, vapor time, and the number of injections contributes to the Rezum procedure configuration for the median lobe treatment being safer and standardizer.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50 to 85 years who have been diagnosed with benign prostatic hyperplasia at Seoul National University Hospital and are scheduled to undergo endoscopic surgery.
* benign prostatic hyperplasia ≥ 30 and \< 80 ml
* Patients who have given written informed consent to participate in the study according to their age
* A urinary symptom score (International ProstateSymptom Score \[IPSS\] moderated (8-19 points) to severe (20-35 points)
* Measured Postvoiding Residual (PVR) \<250 mL

Exclusion Criteria:

* History of prostate or bladder cancer, neurogenic bladder, bladder calculus, or clinically significant bladder diverticulum
* Active infection, treatment for chronic prostatitis
* Diagnosis of urethral stricture, meatal stenosis or bladder neck contracture, damaged external urinary sphincter, stress urinary incontinence, post-void residual \>300 mL or urinary retention, or prior prostate surgery
* Men taking anticoagulants or on bladder anticholinergics or with severe cardiovascular disease
* PSA greater than 4.0 ng/ml (unless prostate cancer was ruled out by biopsy)
* Allergy to device materials, immune suppressants or corticosteroids use, and serious medical or mental illness.
Molecular Assessment and Profiling of Liver Transplant Recipients

The objective of this protocol is to conduct longitudinal and prospective studies of liver transplant recipients, using a multimodality approach, akin to that used in kidney transplantation. The primary aim will compare the clinical outcomes of LiverCare post-transplant surveillance in liver transplant with standard of care consisting of liver function tests, DSA measurements, drug level monitoring, and 'for cause' biopsy. The protocol will assess the correlation between clinical events (e.g. rejection, recurrent disease, biliary obstruction), dd-cfDNA levels, gene expression profiling, ability to assess microchimerism, develop predictive analytics, infectious disease diagnoses and finally examine graft histology.


Eligibility Criteria:
Inclusion Criteria:

* Liver transplant recipients \<60 days post-transplant (de-novo or re-transplant).
* Participant is willing and able to give informed consent for participation in the trial.
* Male or Female, aged 12 years or above (Gillick Competent).
* In the Investigator's opinion, is able and willing to comply with all trial requirements.

Exclusion Criteria:

* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
* Has evidence of significant post-transplant impairment of hepatic function which is unlikely to improve (determined by the PI).
* Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
* Participant with life expectancy of less than 6 months or is inappropriate for diagnostic monitoring through regular blood sampling.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Participants who have participated in another research trial involving an investigational product in the past 12 weeks\*.
* Multi-organ transplant recipients or dual organ transplant recipients.
* Patients with significant needle phobia.
A Comparison of Esmolol and Remifentanil to Reduce Blood Loss

In this prospective randomized study we aimed to compare the effects of esmolol and remifentanil on intraoperative bleeding surgical field conditions in nasal surgery

60 patients with ASA I-IIphysical status assigned for septoplasty will be enrolled in this prospective randomized trial. A standardized anesthesia induction and intubation with propofol and rocuronium will be used. Patients will be randomized in two groups. Group Esmolol (Group E n=30) will receive esmolol 500 mic kg-1 loading dose and a 50-500 mic kg-1 min-1 infusion and Group Remifentanil (Group R n=30) will receive remifentanil 0.1-0.3 mic kg-1 min-1 infusion to induce controlled hypotension. A 50-60 mmHg mean arterial pressure and a minimum 50 beat min-1 heart rate is targeted. Heart rate, blood pressures, peripheral oxygen saturation and bispectral index spectrum (BIS) will be recorded. Anesthesia maintenance will be provided with O2/N2O and desflurane-propofol balanced anesthesia and a BIS value 40-60 is targeted. The quality of the surgical field will be assessed by the surgeon by using a 10 point visual analog scale (B1) and a 6 point scale (B2) during surgery with 5 minute intervals. The amount of bleeding will be calculated at the end of surgery from the amount of blood and irrigation fluid collected in the suction tube. All complications and side effects will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II,
* between age 20-60

Exclusion Criteria:

* patients having bleeding disorders,
* arrhythmia,
* hypertension,
* endocrine, liver or kidney disease and
* those who are on antihypertensive,
* anticoagulant drugs
Brain Injury Inpatient Educational Intervention for Families and Caregivers

The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS) is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute, inpatient brain injury rehabilitation.

The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS), developed by J. Niemeier and J. Kreutzer, is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute brain injury rehabilitation. Program development was guided by considerable clinical experience, research review, and solicited consumer feedback.

The intervention has been manualized to facilitate efficient and effective administration. Now, a rigorous investigation involving randomized assignment to treatment and control groups is needed to empirically examine outcomes. Helping family members to cope more effectively has the potential to improve outcomes for persons with ABI. Strengthening families can enable persons with ABI to live more independently, achieve greater community integration, and live healthier lives. The investigation serves as a logical next step forward in advancing our understanding of standardized interventions designed to serve the family unit.

Eligibility Criteria:
Inclusion Criteria:

* Family members/caregiver friends of patients with ABI will be eligible to participate in the present investigation. ABI is defined as damage to brain tissue caused by stroke, aneurysm, anoxia, non-progressive brain tumor, infection, or an external mechanical force as evidenced by: loss of consciousness, post traumatic amnesia (PTA), objective neurological findings, or skull fracture.
* Lacerations and/or bruises of the scalp or forehead without other criteria listed above will be excluded.
* All family member participants and patients must be at least 18 years of age or older and able to understand and provide consent (or assent in the case of the patients).

Exclusion Criteria:

* Family members at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators, will be excluded from the study.
How Microbes and Metabolism May Predict Skin Cancer Immunotherapy Outcomes

The purpose of this research study is to examine the relationship between the microbiota (microscopic organisms) in the gut and the activity of the immune system during skin cancer immunotherapy.

Details will be available upon publication.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age.
* Diagnosis of skin cancer.
* Planning to initiate or already on ANY type of immunotherapy.
* Able to provide urine and stool specimens.

Exclusion Criteria:

* Bowel resection.
* Major GI surgery in the past 5 years other than cholecystectomy and appendectomy.
A Study of Zidovudine (AZT) Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients With Little or No Previous Treatment

To compare, in zidovudine (AZT)-naive patients, the safety, tolerance, and efficacy of saquinavir mesylate (Ro 31-8959) alone versus AZT alone versus AZT in combination with Ro 31-8959, zalcitabine (ddC), or both. To compare various disease markers among the different regimens.

Patients are randomized to receive a minimum of 80 weeks of AZT alone, AZT plus ddC, AZT plus Ro 31-8959, or all three drugs.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Erythropoietin and G-CSF.

Concurrent Treatment:

Allowed:

* Local skin radiotherapy.

Patients must have:

* HIV infection.
* CD4 count 50 - 350 cells/mm3.
* No prior antiretroviral therapy OR less than 16 weeks of prior AZT.
* No acute serious opportunistic infections requiring immediate treatment.
* No unexplained fever persisting for 14 days within 90 days prior to study entry.
* No significant unexplained diarrhea persisting for 14 days within 30 days prior to study entry.
* No visceral Kaposi's sarcoma or lymphoma currently requiring chemotherapy and/or radiotherapy.
* Life expectancy of at least 80 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Malabsorption.
* Severe chronic diarrhea.
* Inadequate oral intake (unable to eat one or more meals daily because of chronic nausea, emesis, or abdominal/oral-esophageal discomfort).
* Any grade 3 or worse toxicity.
* Inability to comply with study requirements.

Concurrent Medication:

Excluded:

* Other investigational agents.
* Antineoplastic agents.
* Biologic response modifiers (including interferons).
* Foscarnet.
* Anti-HIV drugs other than the study drugs.

Concurrent Treatment:

Excluded:

* Radiotherapy (other than local skin radiotherapy).

Patients with the following prior condition are excluded:

History of non-Hodgkin's lymphoma.

Prior Medication:

Excluded:

* Acute therapy for opportunistic infection within 14 days prior to study entry.
* Prior HIV proteinase inhibitor.