cyrilzakka/clinical-trials huggingface dataset:
Internet-delivered Psychotherapy for Depression

Project aim: To compare the effectiveness and acceptability of a conventional and a religious internet-supported cognitive behavior therapy (iCBT) for depression in Romania.

Previous studies suggest that incorporating religious beliefs into conventional CBT appears to be helpful for religious individuals. In order to have two active comparable interventions the investigators added to the conventional CBT a similar set of exercises devised from the positive psychology paradigm.

Eligibility Criteria:
Inclusion Criteria:

* be fluent in Romanian
* be over 18 years
* have a diagnosis of current major depression disorder
* have access to an Internet connected computer

Exclusion Criteria:

* suicidal ideation
* ongoing psychological treatment for depression
* other primary disorder that need treatment
* obstacle to participation (i.e., long travel plans)
* recent change in psychiatric medication (i.e., during the last 6 weeks)
Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans

Objective: To compare the effect of guided tissue regeneration (GTR) + concentrated growth factors (CGF) + bone graft and CGF + bone graft in the treat of II° furcations of human mandibular molars. Methods: At least thirty II°furcation involvements in mandibular molars will be included and randomly divided into two groups. The experimental group will accept GTR + CGF + bone graft therapy, and the control group will accept CGF + bone graft therapy. The clinical examination and cone beam computed tomography (CBCT) will be performed at baseline and 1 year post-surgery.


Eligibility Criteria:
Inclusion Criteria:

* II° furcation involvements in mandibular molars
* after periodontal therapy.

Exclusion Criteria:

* not healthy
Impact of Exposure to Television and Electronic Devices on Attention and Language in Children

The objective is to examine association between TV exposure ,mobile device use and other electronic devices on attention and language development in children.

During the last few years, the time spent in front of various screens including:TV Sets, vedio games, smart phones \&computers has dramatically increased Television remains the predominant type of screen based activity among children.

Some studies showed that this trend has astrong negative influence on language development of children.

On the other hand.,other studies showed that infant directed informal computer use can be beneficial for language development in children.

Some studies proved that language development and vocabulary growth in young children are directly related to the amount of time parents spend speaking to them \& also reported that on examining language perception learning \&language production learning human human interactions had a strong influence on child's language development.

In spite of that, some parents believe that media content is educative for their children as increase their knowledge, other parents admitted to limiting their children's screen time to avoid conflict \& social isolation or distract children as they encourage parent children education to reinforce their relationship with their children.

Other researches proved that young children who spend more time on touch screen devices were more likely to have emotional problems .

In this study the investigators will discuss the positive and negative effects of screen exposure on attention and langage development of children.

Eligibility Criteria:
Inclusion Criteria:

1. Children aged from 2-6 years collected from clinics of phoniatrics.
2. A questionnaire will be given to their mothers inquiring about

   1. the age of child at first exposure to TV or electronic devices .
   2. the time of exposure to TV or electronic devices /day
   3. duration of viewing TV or electronic devices from first exposure until participation of this study.

Exclusion Criteria:

1. IQ test less than 80 (any mental disabilities )
2. Hearing impairement .
3. physical or motor.
4. history of active language intervention before study.
Assessing the Prevalence of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Undiagnosed Young Adults:A Cross Sectional Study

To asses the prevalence of Attention deficit hyperactivity disrorder in undiagnosed young adults.

Finding the prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in undiagnosed young adults using the questionnaire provided by WHO ,

Eligibility Criteria:
Inclusion Criteria:

* undiagnosed

Exclusion Criteria:

* diagnosed with any mental disability
The Coagulation Cascade in Idiopathic Pulmonary Fibrosis

The pathogenesis of idiopathic pulmonary fibrosis (IPF) is incompletely understood but recurrent epithelial injury occurs which evokes the coagulation cascade. Thrombin is produced as a result and is over expressed in IPF patients, so may be important in propagating disease activity. We aim to recruit patients with IPF and then complete FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose) PET (positron emission tomography) scans pre and post manipulation of the coagulation cascade to assess the role of this biological pathway in disease activity. Previous studies from our institution have demonstrated increased FDG avidity in the lungs of patients with IPF (assessed using FDG PET scans) but to date the cells and pathways responsible for this signal have not been identified and thus need further exploration.

Patients with IPF who meet all the inclusion criteria (and none of the exclusion criteria) will be assessed and invite to participate.

They will undergo baseline assessment with lung function, 6 minute walk test and health quality assessments.

Blood tests will assess the pro-coagulant state of these individuals. They will undergo a baseline FDG PET scan followed by manipulation of the coagulation cascade with 24 days (+/- 3 days) dabigatran. They will then complete a second FDG PET, health quality assessments and blood tests to demonstrate target engagement.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of IPF based on multi disciplinary meeting discussion following review of the clinical history, characteristic features on HRCT (high resolution CT scan) and/or usual interstitial pneumonia (UIP) histology.
* Written informed consent obtained from subject.

Exclusion Criteria:

* Age \<40 or \>80 years
* Renal impairment as defined by a creatinine clearance of \<30 millilitres/min
* Significant liver impairment with evidence of synthetic dysfunction
* Any contraindication to anti-coagulation including previous life threatening or serious bleed or bleeding tendency.
* Co-administration of any concomitant medications prohibited in full protocol. N-acetyl cysteine, prednisolone up to 10mg daily and pirfenidone are permitted.
* Pregnant, breast feeding or unwilling to practice birth control during participation in the study (females of child bearing age).
* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient of the quality of the data.
Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence

This is a prospective, single arm study, consisting of 20 women with abdominal surgical wound dehiscence that requires secondary closure. The participants will receive a weekly application of ActiGraft for 4 weeks, or until complete healing of the wound (the earlier of the two).

An historic matched-control group of 20 patients will be compared retrospectively


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Women that had a laparotomy no more than 3 weeks before accrual.
* Surgical wound dehiscence that requires a secondary closure.
* Time from wound dehiscence \>24 hours and \<6 days.
* The open wound includes epidermis, dermis and sub cutaneous fat.
* The patient can sign an informed consent form.

Exclusion Criteria:

* Patients with necrotizing fasciitis
* Patients with fascial dehiscence
* Cannot withdraw blood in the required amount (up to 18 mL per week).
* Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Subjects who are taking oral anti-coagulants or anti-agreganrts will not be excluded.
* Pregnancy
* Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive systemic steroids (Prednisone- more than 10mg/d or equivalent).
Clinical Investigation of the Multi4 System

A Clinical Investigation to Confirm Performance and Safety of the Multi4 System in Patients with Suspected Recurrent Bladder Cancer Lesions

The overall purpose of this study is to confirm performance and safety of Multi4 Medical Device System when used as intended: to cauterize, remove, and automatically collect multiple tissue samples through the working channel of an endoscope.

The safety profile will be documented by collecting data on frequency and severity of complications, AEs such as bleeding and perforations.

Eligibility Criteria:
Inclusion Criteria:

* Previous bladder cancer Ta/T1 G1-3
* Recurrence of urinary superficial/ non-muscle-invasive bladder cancer visible at cystoscopy, estimated size \< 10 mm
* Willingness and ability to provide informed consent
* Age ≥18 years

Exclusion Criteria:

* Implantable Cardioverter Defibrillator (ICD) that cannot be inactivated
* Current/ongoing untreated urinary tract infection
* Pregnancy or breastfeeding
* Be identified by the Investigator as inappropriate from a medical or compliance perspective to participate in this investigation
A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment

The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.


Eligibility Criteria:
Inclusion Criteria

* Participants must have a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 40.0 kg/m2 inclusive at screening.
* Participants must have a body weight ≥ 50 kg at screening.
* Participants must be afebrile (febrile is defined as ≥ 38°C or 100.4°F) at screening, check in, and predose.

Exclusion Criteria

* Participants must not have any history of chronic pruritus or dermatologic syndromes that may be confounded with reactions to mezigdomide.
* Participants must not have any history of malignancy of any type other than in situ cervical cancer or surgically excised non-melanomatous skin cancers.
* Participants with an inability to tolerate oral medication.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Medical Marijuana and Its Effects on Motor Function in People With Multiple Sclerosis

Medical marijuana is commonly prescribed people with Multiple Sclerosis (MS) for symptom, e.g. spasticity and pain, management. Unfortunately not much is known about its effects outside the treatment for these 2 symptoms. Several previous studies have suggested people with MS using medical marijuana have lower levels of physical disability and improved walking abilities. A major limitation of these previous studies is that the investigators used subjective measures of motor function. In this proposed observational case-control study the investigators plan to objectively measure multiple domains of motor function, such as: fatigue, strength, and walking ability. No marijuana will be brought on to campus or given to participants.

To investigate the effects of medical marijuana usage on physical function the investigators will employ an observational case-control design. Cases (MS medical marijuana users) will be compared to age, sex, and disease duration matched controls (MS non-cannabis users).

Eligibility Criteria:
Inclusion Criteria:

* Medically diagnosed with MS,
* 30-60 years of age,
* Moderate disability (Patient Determined Disease Steps score 2-6).

Exclusion Criteria:

* Relapse with the last 60 days,
* High risk for cardiovascular disease (American College of Sports Medicine risk classification),
* Changes in disease modifying medications within the last 45 days,
* Concurrent neurological/neuromuscular disease,
* Hospitalization within the last 90 days,
* Inability to understand/sign informed consent.
The Impact of a Web-based Patient Decision Aid for Women Considering Breast Reconstruction

This study evaluates the impact of an online patient decision aid on the process of decision making regarding breast reconstruction and the decision quality in women with breast cancer undergoing mastectomy and considering immediate breast reconstruction. Half of participants will receive care as usual and access to the online decision aid, while the other half will receive care as usual including a standard information leaflet.

Rationale: In the Netherlands, of the approximately 15,000 women who are diagnosed with breast cancer each year, about 40% undergo mastectomy. A wide variety of breast reconstructive methods are offered to these women. In most cases, there is no clear medical recommendation on which procedure is the best. Decisions for breast surgery and reconstruction are frequently made during an emotionally burdensome and restricted timeframe. Women may find it hard to make a decision for the type of surgery and reconstruction, some feel that the decision is hurried and uninformed, and many have some degree of regret about their decision at a later date. To support women in making a well-informed decision about breast reconstruction, an online patient decision aid (pDA) has been developed.

Objective: The primary objective of the study is to evaluate the impact of the use of the online pDA on the process of decision making regarding breast reconstruction and the decision quality. The secondary objective of the study is to evaluate the impact of the use of the online pDA on patient reported health outcomes, to identify possible moderators of the effect, and to investigate the cost-effectiveness.

Hypotheses: It is hypothesized that the online pDA, as compared to usual care, will improve the decision making process about breast reconstruction (i.e. leads to less decisional conflict, higher satisfaction with information, higher levels of preparedness for decision making and higher perceived levels of shared decision making) and that it will improve the decision quality (i.e. leads to higher levels of knowledge about breast reconstruction and lower levels of regret).

Study design: A multicenter randomized controlled trial (RCT) will be performed in eight hospitals. All consenting participants will be randomized into one of the two study arms (intervention group or control group). Women in both groups will be invited to complete questionnaires at baseline (i.e. before randomization), 1 week after consultation with a plastic surgeon and 3 and 12 months after breast surgery.

Study population: 250 women will participate.

Eligibility Criteria:
Inclusion Criteria:

* female (≥18 years);
* diagnosed with breast cancer or carcinoma in situ;
* will be treated with mastectomy and is eligible for immediate breast reconstruction;
* is referred to a plastic surgeon (consultation takes place ≥3 working days after study invitation);
* has internet access and sufficient computer skills;
* is able to read and speak the Dutch language.

Exclusion Criteria: None
Study to Evaluate the Safety and Efficacy of ASC40 in Subjects With Moderate to Severe Acne Vulgaris

This is a phase2, randomized, double-blind, multi-center, multi-dose and placebo parallel controlled design. The subjects in the study group were given double-blind drugs, and they were taken (orally) after dinner every day according to the requirements of clinical trial scheme.


Eligibility Criteria:
Key Inclusion Criteria:

* 18-40 years old (including 18 and 40 years old);
* Investigator's Global Assessment of subject at baseline period was at 3-4.
* Facial skin lesions of subject need counting as follows: 30 \~ 75 inflammatory lesions (the total number of papules, pustules and nodules is 30 \~ 75, including no more than 2 nodules), 30 \~ 100 non-inflammatory lesions (the total number of open and closed comedones is 30 \~ 100);

Key Exclusion Criteria:

* Known to be allergic or hypersensitive to ASC40 tablets;
* Facial nodules of subject is more than 2 facial nodules
* The subject with cystic acne
* Subject with secondary acne such as occupational acne (e.g., chloroacne) and acne caused by corticosteroids (e.g., chloroacne or acne caused by drugs);
* Serum AST, ALT≥3ULN and Cr exceeded the upper limit of normal range
Age and Refraction in Predicting Myopia Progression in COVID-19

To determine the longitudinal changes of age and refraction in predicting myopia progression with risk under the coronavirus disease 2019 (COVID-19) pandemic in a 3-year follow-up of a Chinese cohort.

This was part of the large-scale Tianjin Eye Study, a population-based cohort study that longitudinally investigates the relationship between the age, refraction, and development of childhood RE in Tianjin, China.

Eligibility Criteria:
Inclusion Criteria:

* no concurrent eye disease;
* age 6-15 years.

Exclusion Criteria:

* significant systemic illnesses
* ocular conditions that could affect the corneal curvature, including congenital corneal diseases,
* pterygium, keratoconus, other corneal degeneration or dystrophy conditions,
* media opacity, uveitis, glaucoma
* a history of intraocular surgery, refractive surgery,
* neurologic or retinal diseases, current corneal refractive therapy (ortho-K),
* low-dose atropine therapy for myopia control
Transcutaneous Posterior Tibial Nerve Electrostimulation With Low Dose Trospium Chloride in OAB in Females

This study was done to verify whether the combination of transcutaneous posterior tibial nerve stimulation (TPTNS) with low dose trospium chloride in the treatment of females with overactive bladder (OAB) would be more effective than TPTNS alone after failure of behavioral therapy.

The investigators randomized 30 women with OAB, in two groups: G I (15 patients) received 30 minutes TPTNS, three times a week; GII (15 patients) received TPTNS plus Low dose trospium chloride (20 mg once daily); all for 8 weeks. Patients were evaluated using Overactive Bladder Symptom Score questionnaire (OABSS), Incontinence Impact Questionnaire-short form 7 (IIQ-7), 3 day voiding diary and urodynamics at weeks 0 and 8.

Eligibility Criteria:
Inclusion Criteria:

* Thirty adult female patients having OAB symptoms (wet type) and proved to have detrusor overactivity by urodynamics

Exclusion Criteria:

1. Patients having urinary tract infection or bladder outlet obstruction.
2. Patients having neurological diseases.
3. Patients having gynecological problems as genital infection, pelvic organ prolapse or genital tumors.
4. Patients with electronic implants such as heart pacemakers.
5. During pregnancy
6. Patients subject to seizures
Interest of Combining Speech Therapy With a Non-invasive Brain Stimulation (tDCS) for the Aphasic Patient

Aphasia is a frequent symptom after a left hemisphere stroke. It has serious impacts on social, family and professional lives. Aphasic patients need to be rehabilitated. To date, no pharmacological treatment being available only speech and language therapy (SLT) can improve patients, but its efficiency is moderate. Several studies have investigated the link between the recovery of language and neural reorganization. tDCs, a noninvasive technology for modulating neural excitability, could potentiate the effects of the SLT. About 25 studies in literature have described beneficial effects of tDCs coupled with SLT on aphasic patients. However to the investigator knowledge the feasibility of tDCs and speech therapy in clinical pathways has never been investigated. That is why the investigator propose to study in real care conditions how SLT proves more efficient on the recovery of language in a discursive assessment when coupled with active stimulation than with placebo stimulation.

This is a multicenter, cross-over, randomized, controlled and double blind study. 24 patients will be included between November 2015 and November 2017.

During each session of speech and language treatment, aphasics will receive a weak 2 milli amperes (electric) current delivered by a tDCs device for 20 minutes. The stimulation will be either active or placebo. Each stage of the cross over will last three weeks. Patients will be administered the usual number of SLT sessions, no particular therapy being imposed. To evaluate the long-time effects of the therapy, three follow-up measures will be proposed.

Eligibility Criteria:
Inclusion Criteria:

* Patient more than 18 years
* Aphasic Following a brain injury identified by MRI.
* Present a aphasia severity score\> 1 on the Boston Diagnostic Aphasia Examination (BDAE) severity scale.
* No Post stroke delay is retained but the patient should be stable from a medical point of view.
* Master Of the French language in spoken and written
* Affiliated to a social security
* Patient Who signed the informed consent

Exclusion Criteria:

* Other previous neurological pathologies
* epileptic crisis during the previous 2 months
* Patient denies
* Presence of a cranial flap
* intracerebral metal hardware Presence
* Patient under guardianship
* Patient unable to understand the study
* Patient subject to an exclusion period for another search.
Coil Hysteroscopic Tubal Occlusion in the Treatment of Hydrosalpinx

this study is to investigate the success rate of proximal tubal occlusion with coil devices in women with hydrosalinx and to observe there pregnancy rate with IVF-ET.

In this study, investigators will recruit 80 females with unilateral or bilateral hydrosalpinx as confirmed by HSG. Tubal ligation may be a safe and effective method in the treatment of hydrosalpinx. But in this study, investigators will use fiber platinum coils to occlude the tubes. After the treatment, IVF-ET will be applied,and then the patients' pregnancy rate will be assessed in the following-up.

Eligibility Criteria:
Inclusion Criteria:

1. Have unilateral or bilateral hydrosalpinxs as evidenced by HSG.
2. laparoscopic surgery was considered to be contraindicated because of ex-tensive pelvic adhesions.
3. Are willing to undergo a hysterosalpingogram (HSG) 1 months after fiber platinum coil placement to confirm proximal tubal occlusion.
4. Are willing to participate in this clinical study .Are able to comprehend and give informed consent for participation in this study.
5. Have read, understood and signed an informed consent form .

Exclusion Criteria:

1. Active or recent upper or lower pelvic infection
2. Known hypersensitivity to nickel as confirmed by skin test
3. Known allergy to contrast media Pregnancy or suspected pregnancy
4. Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum
5. Poor general or gynecologic health
6. Inability or refusal to provide informed consent
Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Open Trial

The primary aim of the present study is leverage existing infrastructure to develop novel technological features for a novel personalized smartphone intervention system, called the Mobile Application to Prevent Suicide (MAPS), and to establish feasibility, acceptability, safety, and estimate key parameters for secondary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).


Eligibility Criteria:
Inclusion Criteria:

* Presence of suicidal ideation and/or suicidal behavior in the past month
* Between the ages of 18 and 70
* Able to read, write, and understand English well enough to complete study procedures
* Owns a smartphone

Exclusion Criteria:

* Current psychotic or manic symptoms severe enough to interfere with completion of study procedures