cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

Biologics, such as brodalumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. Within this study we aim to investigate the predictive value of early serum trough levels of brodalumab and determine the therapeutic window of brodalumab in psoriasis patients.

Patients will be included after siging informed consent. After inclusion, patients will continue on standard dosing schedule of brodalumab (i.e. one loading dose first (210mg), once a week for 2 weeks (210mg), then a regular dose regimen (210mg) every 2 weeks). During each study visit, blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards brodalumab. In addition, the Psoriasis Severity and Area Index (PASI) and the Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
2. Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

1. Participants who have currently a predominant nonplaque form of psoriasis
2. Participants who are pregnant, nursing or planning a pregnancy
3. Participants who are unable or unwilling to undergo multiple venapunctures
4. Participants who are treated according to a different dosing schedule than standard dosing of brodalumab
PROficiency Based StePwise Endovascular Curricular Training: Multicentric Registry

The goal of this multicentric registry is to gather data from trainees completing PROSPECT: a PROficiency Based StePwise Endovascular Curricular Training to obtain basic cognitive and technical skills. The main goals are to identify if:

* Results from a previous randomised controlled trail can be reproduced in real life.
* Evaluate skills retention after program completion.
* Assess real life implementation of the training program.

A validated PROSPECT (PROficiency-based StePwise Endovascular Curricular Training) training has been integrated into the training of surgical residents to teach basic cognitive, technical and non-technical endovascular skills. The program uses virtual reality simulation and E-learning. During the four modules of the program, formative feedback is given after each training session. Only after achieving a predetermined benchmark score, trainees can progress to the next module.

Surgical trainees completing PROSPECT showed superior real live endovascular performance compared to the traditionally trained in a single centre randomised controlled trial (RCT). The curriculum was integrated locally, but also introduced in other centers: national and international. Local tutors teach the curriculum to trainees after standardized training on the modalities of PROSPECT by the researchers of the Ghent.

A registry is maintained and coordinated by the Ghent research group in which all educational data regarding this training is collected and processed anonymously.

Eligibility Criteria:
Inclusion Criteria:

* Surgical trainee
* Knowledge and technical skill level evaluated
* Demographics questionnaire and general MCQ test completed
* Endovascular simulated exercise completed after familiarization with the simulator

Exclusion Criteria:

* N/A
The Resilience Challenge: Fostering Emotional Resilience During a Time of National Stress

The goal of this clinical trial is to examine the effects of an online positive psychological intervention on positive emotion, anxiety, depression, feelings of social isolation, sleep disturbance and a sense of meaning and purpose in the general public. The main question it aims to answer is:

Will the practice of positive emotion skills via a self-guided online platform reduce feelings of anxiety, depression, social isolation, and sleep disturbance, as well as increase well-being, positive emotion, a sense of meaning and purpose, life satisfaction, and general self-efficacy?

Participants will take part in an online positive psychological skill learning intervention for 6-8 weeks. Prior to beginning, immediately after, and 4 weeks after, participants will fill out measures of their wellbeing.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old, Access to device connected to the internet

Exclusion Criteria:

* Under 18 years old
Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis

Systemic sclerosis (SSc) is a systemic autoimmune disease in which inflammation and fibrosis play a crucial role and lead to severe damage and failure of multiple organs such as the skin, joints, tendons, gastrointestinal tract, lungs, heart, blood vessels, and kidneys. It primarily affects women but disease is often more severe in males.

Systemic sclerosis (SSc) is a systemic autoimmune disease in which inflammation and fibrosis play a crucial role and lead to severe damage and failure of multiple organs such as the skin, joints, tendons, gastrointestinal tract, lungs, heart, blood vessels, and kidneys. It primarily affects women but disease is often more severe in males.

Sirtuins are a class of nicotinamide adenine dinucleotide-consuming enzymes that are implicated in numerous biological pathways .

Sirtuins are considered among the most promising targets for modulating aging-associated cellular and molecular processes and disease pathologies , The majority of studies have shown decreased SIRT expression in tissues and fibroblasts from patients with SSc compared to controls and in experimental fibrosis in mice .

Decreased SIRT3 levels and activity were observed in fibrotic areas of SSc and IPF lung tissues and SSc skin biopsies and explanted fibroblasts compared to controls , Wyman et al investigated the expression of all seven mammalian SIRTs in lung tissues and fibroblasts from patients with SSc and IPF and found a tendency for SIRTs to be decreased in patients with fibrosis compared to controls , with a particularly notable decline in SIRT7 .

Eligibility Criteria:
Inclusion Criteria:

* Patients with systemic sclerosis diagnosed by 2013 ACR\\EULAR classification criteria of systemic sclerosis
* Patients' age \>18
* 25 rheumatoid arthritis patients as a control .

Exclusion Criteria:

-Overlap or mixed connective tissue diseases.
Chinese American Cancer Survivors Writing Study

The Chinese American Cancer Survivors Writing Study is a Randomized Controlled Trial (RCT) testing the feasibility and efficacy of the Expressive Helping (EH) intervention among Chinese American cancer survivors.

Chinese Americans are one of the fastest growing immigrant groups in the United States, but there is still a lack of culturally-sensitive and linguistically-appropriate resources and interventions for this group. To address this gap, the investigators will examine the efficacy and feasibility of Expressive Helping, a writing intervention designed to lead participants to write about their cancer experiences. Participants will be adult cancer survivors of Chinese descent. After screening and consent, eligible participants will be enrolled in a 1:1:1 randomized controlled trial. Assessments of psychological symptoms will occur at baseline (prior to randomization), 1-month post-intervention, 3-months post-intervention, and 6-months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old.
* Prefer speaking in Mandarin Chinese or Cantonese, and able to read and write Simplified or Traditional Chinese.
* Within 5 years after completing primary treatment or have completed primary treatment but still on medication for managing cancer-related symptoms.

Exclusion Criteria:

* Difficulties with writing
* Current active participation in support groups (i.e., attending more than once per week)
Study to Assess Impact of Dietary Supplement on Sleep Health

Sleep is essential for health and wellness. Sleep disruption can occur due to emotional stress, advancing age, hormonal imbalance, medications, and many other causes, some of which are presently unknown. Most pharmaceutical sleep products artificially induce sedation without providing quality sleep. Thus, a need exists for safe dietary supplement to promote and support healthy sleep that will encourage restful sleep. This study will examine the efficacy, tolerance, and safety of sleep supplement as compared to a placebo.


Eligibility Criteria:
Inclusion Criteria:

* The subject is male or female 20-60 years of age at the time of informed consent.
* Recorded baseline BMI is ≥18.5 and ≤29.9 kg/m2.
* A score of 5 or higher on the Pittsburgh Sleep Quality Index.
* Willing and able to give informed consent
* Willing to maintain consistent diet and physical activity through the study period.
* Willing to limit alcohol consumption to ≤14 drinks per week, no more than 4 drinks at a time, and no more than 1 drink within 4h of bedtime.
* Willing to limit caffeine consumption to no more than 4 servings per day and no caffeine within 6h of bedtime.

Exclusion Criteria:

* Could not or did not want to participate in clinical study.
* Taken nutritional supplements for sleep or stress in the previous 6 months.
* Have received non-pharmacological treatment for sleep disorders (eg. Cognitive behavioral therapy, relation therapy) in previous 6 months
* Any known allergy or intolerance to any of the ingredients contained in supplement.
* Planned surgical procedure during the course of the study.
* Used nicotine in the past 6 months.
* Have a major psychiatric disorder as determined by the Mini International Neuropsychiatric Inventory
* A history of unconventional sleep pattern, a diagnosed sleep disorder, or chronic medical condition that could affect energy/fatigue levels.
* Consume more than 400mg of caffeine per day in the past 2 weeks.
* Used any psychotropic medications, stimulants, cannabis, non-registered drug products, or illicit substances in the past 4 weeks.
* At risk of drug or alcohol abuse
* Used any sleep aids in the past 2 weeks.
* Employed in night shift work or rotational shift work
* Currently pregnant, nursing, planning to become pregnant, or unwilling to use a medically approved form of contraception will be excluded.
* Individuals who sleep more than 10 hours.
* Typically take a nap during the day.
* Those planning travel or vacation during the study period.
Internet-based Cognitive Behavioral Therapy (CBT) for Adolescents With Anxiety Disorders

Cognitive behavioral therapy (CBT) is a well-documented and effective method for the treatment of children and adolescents with anxiety disorders. Lately there has been an increase in the development and use of internet-based CBT programs (ICBT), as a means to reduce costs and enhance accessibility of psychological interventions. ICBT has proven efficacious towards adults with anxiety disorders. Research in the field of ICBT with children and adolescents is still in its infancy though and to date, no program targeting anxiety disorders has been developed nor evaluated in Denmark. The primary objective of this study is to investigate the efficacy of a newly developed internet-based treatment program for adolescents with anxiety disorders. The effect will be examined in a randomized controlled trial comparing ICBT to a wait-list control condition.

Within the context of a research and teaching clinic at the Department of Psychology and Behavioral Sciences, Aarhus University, Denmark, 70 adolescents aged 13-17 with a primary anxiety disorder as assessed by the ADIS C/P will be randomly allocated to either a 3 month wait-list control condition or a treatment condition.

The treatment consists of an internet-based self-help program for adolescents with anxiety disorders called 'Chilled Out', based on material from the well-established manualised group-treatment Cool Kids Program: Adolescent version. It consists of 8 CBT-inspired modules of approximately 30 minutes each distributed over a 14-week period. The program is interactive using a combination of different media (text, audio, illustrations, cartoons, and videos) to deliver psychoeducation and CBT-inspired techniques, activities and exercises for adolescents to manage their anxiety. In addition, the adolescent will receive a limited amount of therapist support calls.

Participants (youth and parents) are assessed with semi-structured diagnostic interviews and self-report measures before treatment, after 14 weeks (post treatment) and 3 months after treatment (follow-up).

Participants are assessed at pre, post and 3-month follow up.

Eligibility Criteria:
Inclusion Criteria:

* a primary diagnosis of separation anxiety disorder, generalized anxiety disorder, social phobia, specific phobia, obsessive compulsive disorder or panic disorder
* age between 13 and 17 years
* ability to read and write in Danish
* direct access to a home computer and internet

Exclusion Criteria:

* high degree of comorbid depression (CSR above 5 as measured with ADIS-IV)
* substance abuse
* current self-harm or suicidal ideation
* pervasive developmental disorder
* learning disorder
* intellectual disability
* psychotic symptoms

All participants are asked not to make changes to their medication status during the course of the trial
Effect of Resistant Starch (Type-4) on Metabolic Syndrome

Metabolic syndrome is a condition characterized by excess body weight, large waist circumference, high cholesterol and glucose in the blood, and hypertension. People with metabolic syndrome are at increased risk for heart diseases. Research shows benefits of regular fiber intake in metabolic syndrome. However, due to altered taste and texture of the high fiber foods, long term intake of fiber is a challenge for metabolic syndrome patients. This study is designed to find if blinded-substitution of regular wheat flour in domestic kitchen with wheat flour enriched by an adaptable type of fiber (resistant starch-4), minimizes metabolic syndrome symptoms. this special type of fiber is also obtained from wheat.


Eligibility Criteria:
Inclusion Criteria:

- Any individual aged 18-80 years

Exclusion Criteria:

* Pregnant
* Lactating
* Requires special diets or dietary regimens
* On long term antibiotic therapy
* Diagnosed with gastrointestinal diseases (Irritable Bowel syndrome, Crohn's disease or Colitis)
* Immune compromised
* Have cancer
Effect of Clitoris Location on Orgasm

Topography and location of clitoris and its parts may affect the orgasm

Orgasm measurement via Orgasm domain of Female Sexual Function Index, clitoris volume, suprapubic angle, urethra-levator gap, suburethral triangle area measurement could made using 4 D transperineal ultrasonography. Clitoris fourchette distance, clitoris perineal body distance, clitoris urethra distance could made with special compasses.

Eligibility Criteria:
Inclusion Criteria:

* Sexually active women between 18 and 50 years old
* BMI below 40 kg/m2

Exclusion Criteria:

* BMI over 40 mhg/m2,
* Women younger than 18 years old
* Virgins
* No active sexual intercourse, women with
* Handicapped to get lithotomy position
* Active vulvar and vaginal infection
* Psychiatric diseases
* Drug usage that may cause sexual dysfunction, menopause.
Ultrasound Features of Trigger Finger

Our aim in this study; to compare the ultrasound findings seen in trigger finger patients with healthy volunteers. Thus, ultrasound findings associated with trigger finger development will be documented

A1 pulley thickness, flexor tendon thickness, and presence of nodules at the MCP joint level of the trigger finger patients will be recorded. The same measurements will be made in age- and sex-matched healthy volunteers, followed by comparison and analysis.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years
* To have trigger finger (for patient group)
* Not to have trigger finger (for healthy group)

Exclusion Criteria:

* Aged under 18
* Wound or infection in the imaging area
Quality of Life Before and After Radiotherapy in Patients With Head and Neck Cancer

Worldwide, head and neck cancers (HNCs) are widespread (650,000 cases per year) and cause more than 330,000 deaths per year. Almost all cases, about 90%, are cancers of the oral cavity, oropharynx, and larynx.

In conventional clinical practice, HNCs are treated primarily with radiation therapy (RT), often used in combination with surgery and/or chemotherapy. Like most anti-neoplastic therapies, RT carries significant adverse effects both acute and chronic. Both types of adverse effects have a significant impact on quality of life (QoL).

The aim of the study is to examine the worsening of QoL in patients with HNC before and after cancer therapy and to assess the extent that each factor has in its worsening.


Eligibility Criteria:
Inclusion Criteria:

* patients between the ages of 18 and 75 years;
* patients who presented at their first dental visit with a diagnosis of HNC.

Exclusion Criteria:

* patients who had already undergone cancer therapies (excisional surgery or chemotherapy or radiation therapy) at the time of the first dental visit;
* patients with depression or social anxiety;
* patients with language difficulties.
Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

This study was a single-center, randomized, controlled prospective study. Those who had premature ovarian failure and who had fertility requirements were enrolled in the study. To determine the efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of patients with POI.

According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was hormone replacement combined with transplantation of umbilical cord mesenchymal stem cells (test group). Group B was the hormone replacement group (control group).

Eligibility Criteria:
Inclusion Criteria:

1. Those who meet the POF diagnostic criteria and have no spontaneous follicular activity;
2. Married, 20 years old ≤ age \< 40 years old;
3. The average diameter of each ovary is \> 10 mm;
4. Have agreed to sign the informed consent form.

Exclusion Criteria:

1. Female and/or male chromosomal abnormalities;
2. Endometriosis, adenomyosis;
3. Postoperative ovarian borderline or malignant tumor;
4. Uterine dysplasia;
5. Associated with female autoimmune disease or other serious internal surgical diseases;
6. hormone replacement contraindications;
7. In the past 1 year, had received an experimental study of premature ovarian failure in the external hospital;
8. Male azoospermia or severe oligozoospermia.
Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)

Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. Two fixed-dose regimes of RUTF will be tested against the current fixed-dose regimen of RUSF for children with MAM.


Eligibility Criteria:
Inclusion Criteria:

1. Age 6-59 months
2. Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year
3. Uncomplicated moderate acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility
4. Pass appetite test conducted at the time of enrollment
5. Consent for randomization into the study given by mother, father, and/or other primary caregiver
6. Mid-upper arm circumference of 115-124 mm without nutritional edema
7. Weight-for-height Z-score (WHZ) between -2 and -3

Exclusion Criteria:

1. Complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. This includes, but is not limited to: a. Hypothermia b. High fever c. Signs of hypoglycemia d. Lethargy or altered mental status e. Moderate to severe dehydration f. Shock g. Other medical complications requiring hospitalization or higher-level medical evaluation
2. Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months
3. Known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food
The Effect of Music Therapy on Upper Extremity Functions and Quality Of Life in Individuals With Cerebral Palsy

The main purpose of this study is to investigate the effect of music therapy on the upper extremity functions and quality of life of individuals with Cerebral Palsy (CP). The secondary aim is to investigate the effect of music therapy on the sensory functions of the upper extremity in individuals with CP. Adolescent individuals with hemiparetic CP will participate in this study, and the participants will experience music therapy, which is a scientific intervention approach. If music therapy has a positive effect on upper extremity functions, they will be more active in daily life and their quality of life will increase. In the light of these data to be presented, a contribution will be made to the evidence level of music therapy in the literature and to the content of SP upper extremity rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 6-21
* With upper extremity dysfunction
* MACS score between 2-4,
* According to MAS, spasticity severity ranges from (1+) to (3),
* Individuals diagnosed with hemiparetic Cerebral Palsy who are at a cognitive level that can follow simple instructions during applications and evaluations will be included.

Exclusion Criteria:

* Having another neurological disorder
* Having undergone upper extremity orthopedic surgery or Botulinum Toxin A (BTX-A) application in the last 6 months,
* Individuals currently receiving another rehabilitation program in addition to classical physiotherapy for upper extremity rehabilitation will be excluded from the study.
A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Chronic hepatitis C infection for at least 6 months duration
* Hepatitis C genotype 1a or 1b
* Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
* Patient showed a previous null response to therapy as defined by \< 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion Criteria:

* Hepatitis C infection with a genotype other than genotype 1a or 1b
* Body mass index \<18 or \>/=36
* Hepatitis A, hepatitis B, or HIV infection
* Herbal remedies \</=1 month prior to the first dose of study drug