cyrilzakka/clinical-trials huggingface dataset:
Valproate Response in Aggressive Autistic Adolescents

This study will examine the effect of valproate, a medication used to treat seizures and bipolar disorder, on aggressive behavior in children and adolescents with autism.

Autism is a complex biological disorder that generally lasts throughout a person's life. It starts before age three and causes delays or problems with many different ways in which a person develops or grows. Some people with autism become very aggressive and can hurt others or themselves. This study will test the hypothesis that aggressive autistic adolescents will show a significantly greater response to valproate maintained at blood levels of 75-100 mcg/ml than to placebo. The study will also assess the safety of valproate in autistic adolescents. This represents the first double-blind study of valproate in mentally retarded/developmentally delayed populations.

Participants in this study will undergo DSM-IV evaluation, the Autism Diagnostic Interview-Revised and Autism Diagnostic Observation Schedule, and baseline blood tests. After baseline screening, all participants will be given a placebo for 1 week. Participants will then be randomized to receive either valproate or placebo for 8 weeks. Dosage adjustment according to blood levels drawn at the end of weeks 2 and 4 will be arranged with parents by a child psychiatrist without breaking the blind. The Aberrant Behavior Check-list-Community (ABC-C) irritability subscale will be the primary measure; the Overt Aggression Scale (OAS), ABC-C hyperactivity subscale, Clinical Global Impressions (CGI) problem severity, Self-Injurious Behavior Questionnaire (SIB-Q), and a valproate side effects checklist will be secondary measures.

Eligibility Criteria:
Inclusion Criteria

* Autism
* Lives in the Kansas City area

Exclusion Criteria

* Psychoactive maintenance medication
* Degenerative central nervous system disorder
* Unstable medical illness
* Seizures in the 6 months prior to study entry
* History of valproate sensitivity or previous liver disease
* History of ovarian cysts
* Low platelet count or raised liver transaminases
Brain and Genetic Predictors of Individual Differences in Pain and Analgesia

The purpose of the study is to gain a better understanding of pain processing in the brain. Our understanding of how pain is processed in the brain is limited. We are testing for individual differences in pain perception and emotion.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be registered in the Colorado Community Twin Sample (CTS).

Exclusion Criteria:

* Not being registered in the Colorado Community Twin Sample (CTS).
* Any MRI contraindications.
Does the Pain Experienced During Orthodontic Treatment and Bracket Removal Depend on the Architecture of the Bracket?

The present research aimed to thoroughly investigate the impact of bracket architecture on pain perception during active treatment, debonding, and adhesive removal.

100 consecutive patients who completed treatment with one of two bracket systems (2-slot brackets with integral base or conventional twin brackets with foil mesh) were included in this prospective clinical trial. Prior to the removal of brackets, participants were asked to evaluate the level of pain encountered throughout their orthodontic treatment with the fixed appliances, utilizing a 0-10 numerical rating scale, and to indicate the main cause of pain. Subsequently, brackets on the right side of both dental arches were debonded using the lift-off debonding instrument (LODI), while on the left side, the bracket removal pliers (BRP). The residual adhesive was removed through two methods (manual in the upper arch and rotary in the lower). The same scale was employed to assess pain levels during brackets and adhesive removal.

Eligibility Criteria:
Inclusion Criteria:

* fixed appliance in both dental arches
* brackets bonded using the Transbond XT adhesive system (3M Unitek, St. Paul, USA) following the manufacturer's instructions

Exclusion Criteria:

* periodontal disease
* restorations or caries on buccal surfaces of the teeth,
* consumption of analgesics within eight hours preceding the debonding appointment
Technology Assisted Treatment for Trichotillomania

Trichotillomania is characterized by recurrent hair pulling resulting in hair loss causing significant distress and impairment which persists despite repeated attempts to stop. Behavioral based therapies focused on increasing awareness of hair pulling followed by the use of an incompatible behavior have proven effective. In an effort to enhance awareness, a wrist worn motion detection device and a companion mobile application was created. In this study, we will test the initial efficacy of the HabitAware device and accompanying app as a system for delivering self-administered habit reversal training (HRT).


Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate;
* Current diagnosis of TTM (as assessed via TDI);
* Regular access to a smartphone with GPS capabilities (i.e., available for completing assessment probes throughout the day);

Exclusion Criteria:

* Currently receiving psychotherapy
* Other psychiatric condition requiring more immediate care
* Have previously used any behavior awareness devices (e.g. Keen)
DELTA Multihole TT Study

A retrospective study evaluating clinical and radiographic early outcomes of total hip arthroplasty and revision hip arthroplasty with DELTA Multihole TT cup.


Eligibility Criteria:
IInclusion criteria as per DELTA Multihole TT indications for use:

Age ≥ 18 years

* Non-inflammatory degenerative joint disease such as osteoarthritis or avascular necrosis;
* Signed Informed consent
* Hip dislocation using protruded liners, spacers;
* Rheumatoid arthritis;
* Post-traumatic arthritis;
* Correction of functional deformity in case of acetabulum verticalization, anteversion, and retroversion;
* Fractures of femoral neck;

If used in combination with spacers and hemispheric modules, other indications are:

* Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure;
* Clinical management problem where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results;
* Where bone stock is of poor quality or is inadequate for other reconstruction techniques as indicated by deficiencies of the acetabulum.

Exclusion criteria as per DELTA Multihole TT contraindications for use:

* Local or systemic infections;
* Septicaemia;
* Persistent acute or chronic osteomyelitis;
* Confirmed nerve or muscle lesion compromising hip joint function;
* Vascular or nerve diseases affecting the concerned limb;
* Poor bone stock compromising the stability of the implant;
* Metabolic disorders which may impair fixation and stability of the implant;
* Any concomitant disease and dependence that might affect the implanted prosthesis;
* Metal hypersensitivity to implant materials.

Additional exclusion criteria:

• Female patients who are pregnant, nursing, or planning a pregnancy.
RCT Long COVID-19 Rehabilitation

The Coronavirus 2019 (COVID-19) pandemic has resulted in at least four million infections in Norway. The vast majority of cases are diagnosed and followed up in the community, but some with extensive symptoms and large degree of reduced function are referred to regional Covid-clinics. In total this patient group is placing an enormous burden on the already over stretched health care services. As the pandemic subsides the emerging threat of long-term disability from COVID remains to be quantified. Brain fog and cognitive symptoms are common in long COVID in 30% of mild infections resulting in sick leave and loss of daily function, with women overrepresented among long COVID sufferers. The true prevalence and underlying mechanisms of long COVID remains to be quantified. Although vaccination prevents severe infection and death, we have little knowledge on how best to rehabilitate those who suffers from long COVID.

Here we propose to develop knowledge on treatment interventions to counteract disability from long COVID and lessening the burden on health care services. We will conduct a study of where we compare a short group intervention with systematic personalised neurocognitive rehabilitation to document symptom alleviation. Our overarching goal is to develop effective programmes for this evolving disease to reduce the suffering for the patients, and thereby reducing costs for health services and society at large.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms attributable to long COVID according to WHO definition \[14\] that affect their daily activities
* Positive Covid test; a home-test, PCR test or serology.
* Neurocognitive symptoms
* Age between 18 and 65 years
* Participant is able and willing to provide informed consent

Exclusion Criteria:

* Patients that do not want to comply to planned physical study visits
* Patients who are unable to complete surveys in Norwegian
* Patients with known chronic neurocognitive disease before Covid-19 or other diseases that can explain current symptoms
Curative Proton Beam Therapy for Patients With Lung Metastasis of Colorectal Cancer

Proton alone therapy is performed

-\> 5 times a week, 7200 cGy / 15 fractions for 3 weeks total

This clinical trial is a prospective, single-organ, phase II clinical trial to evaluate the efficacy of curative proton therapy for pulmonary metastasis of colon cancer diagnosed histologically as adenocarcinoma.

Patients who meet the selection criteria should be selected, signed for consent, and treated 5 times a week for 7200 cGy / 15 fractions alone for 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically diagnosed colon adenocarcinoma in primary or metastatic lesions..
2. If there is no other remote metastasis other than lung, or if there is, control is possible
3. If there are less than 2 lung metastatic lesions
4. If they refuse lung surgery or surgery is inappropriate (medically unsuitable for surgery due to surgery refusal, diabetes mellitus, high blood pressure, pulmonary disease, heart disease, etc., repeated surgery, poor systematic function, short disease-free period, etc.)

Exclusion Criteria:

1. Other histologic cancer other than adenocarcinoma of the colorectal
2. Colorectal cancer without primary lesion resection
3. If there is another remote metastasis and is not completely resected or regulated
4. If the patient has experience of other invasive cancer diagnosis within 5 years of colorectal cancer diagnosis
5. Pregnancy and women under lactation
Cavity Evaluation Before Intracytoplasmic Sperm Injection

Uterine cavity evaluation is an integral part of assessment Of women for ICSI

Transvaginal us is the main role in this aspect

Eligibility Criteria:
Inclusion Criteria:

* women with infertility more than one year

Exclusion Criteria:

* 2omen with medical disorders
Increased Proportion of Lower Energy Density Items vs. Nutritional Labelling at an Online Supermarket

This study will be a 2x2 randomised controlled trial with information-based intervention (no labelling / labelling) and structural intervention (default proportion / increased proportion of lower energy density food items) as between-subject factors and energy density (kcal/g) of food purchases during an online supermarket-shopping task as dependent variable. This study will use an online supermarket platform developed to mimic an online supermarket website and participants will be asked to complete a shopping task using a pre-determined shopping list of 10 items.

See attached protocol documents.

Eligibility Criteria:
Inclusion Criteria:

* United Kingdom residents
* Aged ≥ 18 years
* Fluent in English
* Have access to a computer and Internet
* Responsible for a substantial proportion of household grocery shopping

Exclusion Criteria:

* Unable to provide informed consent and to comply with the study requirements
* Any dietary restriction (vegetarian, vegan, gluten-free, sugar-free, dairy or lactose free, food allergy, other)
Electrochemotherapy of Gynecological Cancers

To determine the effectiveness, feasibility and safety of electrochemotherapy in treatment of local and/or regional recurrences of gynecological cancers with electrochemotherapy in which standard treatment options have been exhausted.


Eligibility Criteria:
Inclusion Criteria:

1. Local or regional relapse of gynecological tumors in which standard treatment options have been exhausted.
2. Age more than 18.
3. Life expectancy more than 3 month.
4. Performance status Karnofsky ≥ 70 or WHO \< or 2.
5. Treatment free interval minimum 2 weeks.
6. Patient must be mentally capable of understanding the given information and regarding treatment and any adverse reactions that may occur during treatment.
7. Patient must give informed consent.
8. Patient must be discussed at the multidisciplinary team before entering the trial.
9. Patient should be suitable for anesthesia.

Exclusion Criteria:

1. Visceral, bone or diffuse metastases.
2. Life-threatening infection and/or heart failure and/or liver failure and/or other severe systemic pathologies.
3. Significant reduction in respiratory function.
4. Age less than 18 years.
5. Coagulation disturbances (those who do not respond on standard treatment with vitamin-K or fresh frozen plasma).
6. Cumulative dose of ≥ 400 mg/m2 bleomycin received.
7. Impaired kidney function (creatinin \> 150 µmol/l).
8. Patients with epilepsy.
9. Pregnancy.
10. Patient incapable of understanding the aim of the study or disagree with the entering into the clinical study.
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral HMS5552 in Healthy Volunteers

The objectives of this study is to determine the safety profiles, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following single ascending doses in healthy adult subjects.

This will be a randomized, double-blind and placebo-controlled safety study with single oral doses of HMS5552 given to healthy volunteers.

The primary objective is to characterize the safety profiles of HMS5552 following single ascending doses (SAD) in healthy adult subjects.

The secondary objectives include:

1. To assess the pharmacokinetic profiles of HMS5552 after single dosing
2. To assess the preliminary pharmacodynamic profiles of HMS5552

Each study subject will receive a single oral dose of HMS5552. During each dosing, eight subjects will be allocated to receive HMS5552 and two subjects will be allocated to receive placebo treatment.

Several doses of HMS5552 will be tested. Dose titration or reduction is determined for each cohort based on the safety and pharmacokinetic data obtained from the lower dose cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Female and male volunteers, 18 to 45 years of age
* BMI: 18 to 24 kg/m2
* Fasting plasma glucose: 3.9 to 6.1 mmol/L
* Glucose level at 2 hours following oral glucose tolerance test \<7.8 mmol/L
* HbA1c: 4 to 6.5%
* Normal supine blood pressure and normal ECG recordings

Exclusion Criteria:

* Female with child-bearing potential
* Evidence of clinically-significant renal, cardiac, bronchopulmonary, vascular, gastrointestinal, allergic, neurologic, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, cancer, hepatitis or cirrhosis.
* Intake of grapefruit or anything that may affect liver enzyme function within 1 month prior to the dosing day
* Clinically-relevant deviation from normal in the physical examination
* Subjects with a medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator
Long-term Study of KAD-1229 in Type 2 Diabetes Patients

The purpose of this study is to evaluate the long-term safety and efficacy of KAD-1229 as combination therapy with biguanide or DPP-4 inhibitor in type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patients who show inadequate glycemic control with diet, and biguanide or DPP-4 inhibitor monotherapy
* Age in the 20 years or over inclusive
* HbA1c in the range of ≥ 6.5 to \< 9%

Exclusion Criteria:

* Type 1 diabetes mellitus
* Patients with serious diabetic complications and other serious complications
Comparative Evaluation of the Performance of Different Thromboplastin Reagents on Prothrombin Time and Factorial Assays in Situations of Isolated Extrinsic Pathway Factor Deficiency or Liver Damage.

Primary purpose :

Compare the sensitivity of several thromboplastin reagents of various origins to prothrombin time and factor II, V, VII and X assays in two different populations of patients :

* Patients with an isolated extrinsic pathway deficiency (acquired or congenital) of factor II or V or VII or X.
* Patients with an hepatocellular insufficiency generally associated with coagulopathy (with an intensity proportional to the degree of hepatic impairment).

Results of this work should improve knowledge of sensitivity of the screening test represented by the prothrombin time, depending on the origin of thromboplastin reagent used, in relation with coagulopathies mentioned above, as well as the performance of factors II, V, VII, X assays. This work would help to choice of the most suitable reagent for the needs of each hemostasis laboratory/center.


Eligibility Criteria:
Inclusion criteria :

* Plasma samples from patients addressed to the laboratory of the Strasbourg University Hospital (Strasbourg France) collected and anonymized after completion of the routine testing.
* Patient with an isolated or combined extrinsic pathway factor deficiency (factor II, V, VII, X).

Exclusion criteria :

* Patient treated with an oral anticoagulant treatment.
* Patient treated with a parenteral anticoagulant treatment (apart from therapeutic dosages of unfractionated heparin and low molecular weight heparin).
Investigation of Knowledge and Practices Regarding Pediatric Osteoporosis in Türkiye

The goal of this observational- cross sectional study is to investigate the knowledge and practices of physicians in Physical Medicine and Rehabilitation (PM\&R), Pediatrics, and Orthopedics regarding pediatric osteoporosis. The main question it aims to answer is:

What are the levels of knowledge and approaches of physicians in PM\&R, Pediatrics, and Orthopedics regarding pediatric osteoporosis, and how can a psychometrically valid and reliable data collection tool be developed to measure these?

Participants, including PM\&R, Pediatrics, and Orthopedics physicians, will complete an online questionnaire consisting of demographic and clinical practice questions, as well as items measuring their knowledge about pediatric osteoporosis. The study also includes a pilot test with a subset of participants to evaluate the clarity and reliability of the questionnaire.

The aim of this study was to investigate the knowledge and approaches of physicians in Physical Medicine and Rehabilitation (PM\&R), Pediatrics, and Orthopedics regarding pediatric osteoporosis. A secondary aim was to develop and evaluate the psychometric properties of a data collection tool designed to measure knowledge and practices related to pediatric osteoporosis.

The Pediatric Osteoporosis Knowledge and Practice Assessment Scale, used as the data collection tool, was developed based on evidence-based guidelines and the International Society for Clinical Densitometry Pediatric Position Statements. The scale consists of a preliminary section assessing demographic data and clinical practices, and a second section measuring knowledge levels. The questions were designed with "true" (1 point), "false," and "I don't know" (0 points) options, similar to the Osteoporosis Knowledge Questionnaire, which is intended for adults. The questions were categorized into general knowledge and diagnosis, risk factors, assessment, and treatment.

Content validity of the scale was ensured by a panel of experts in the field. The scale was distributed online via Google Forms and applied to 321 physicians. A pilot test was conducted with 10 PM\&R physicians to evaluate its clarity. To assess reliability, the scale was administered twice to 30 physicians with a one-week interval.

Eligibility Criteria:
Inclusion Criteria:

* Physicians specializing in Physical Medicine and Rehabilitation (PM\&R), Pediatrics, or Orthopedics
* Able to read and understand the language in which the questionnaire is provided,
* Internet access to complete the online survey distributed via Google Forms
* Willing to participate and provide informed consent
* Actively practicing in their respective specialty.
* Involved in the care of patients where knowledge about pediatric osteoporosis is relevant

Exclusion Criteria:

* Surveys with incomplete or inconsistent answers that do not meet the study's data quality standards
* Participants who have been involved in the development or validation of the Pediatric Osteoporosis Knowledge and Practice Assessment Scale
"Effects of Neuromuscular Blocking Agents on End Expiratory Lung Volume During Moderate-severe ARDS"

This is a monocentric, prospective, observational study that will be conducted in the general ICU of San Gerardo Hospital (Monza, Italy). Study protocol will be started when NMBAs infusion will be stopped for clinical reason until regain of spontaneous breathing activity.

Patients will be enrolled at the moment of NMBAs infusion interruption ("baseline" phase). Clinical data will be collected: hemodynamics, ventilation parameters and respiratory mechanics, arterial blood gas analysis, drugs used for sedation and their dosages. An EIT belt will be positioned around the patient's chest when clinical signs of spontaneous breathing activity will be detectable (unstable flow curve on the ventilator, deflection in airway pressure during an expiratory pause). In this phase ("NMBA interruption") same clinical data will be collected as at baseline. Patients will be ventilated in the same ventilation mode as before (Volume Controlled mechanical ventilation), but the inspiratory trigger on the ventilator will be turned on to reduce patient-ventilator asynchronies. When an EIT trace lasting at least 10 minutes will be recorded, an NMBA bolus (as prescribed by the treating physician) will be administered and a continuous infusion will be restarted. Clinical data will be collected again in this phase ("NMBA restart").


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate-severe ARDS (according to Berlin definition)
* Patients treated with NMBAs
* age\>18 years old

Exclusion Criteria:

* pregnancy,
* presence of air leaks (ex. presence of broncho-pleural fistula or pneumothorax)
* presence of contraindications to EIT belt positioning ( ex. presence of pace-makers, presence of unstable spinal fractures).