cyrilzakka/clinical-trials huggingface dataset:
Registry Study for Pregnant Women With Iodine Overload

Pre-gestational performance of hysterosalpingography (HSG) using an oil-soluble iodinated contrast medium has been demonstrated to be the main cause of excessive iodine exposure for pregnant women. However, its long-term health effects on the mothers and offsprings have not been adequately elucidated. A case registry study is designed to follow up all the pregnant women with pre-gestational history of ethiodized-oil HSG examination and try to keep track of maternal and fetal outcomes.


Eligibility Criteria:
Inclusion Criteria:

Must be pregnant when enrolled in this study. Must have undergone examination of ethiodized-oil HSG before this pregnancy. Clinical diagnosis of iodine excess (with the mean urine iodine concentration ≥250μg/L and the serum iodine concentration \>92μg/L).

Exclusion Criteria:

Having past history of partial or total resection of thyroid glands. Having medical history of thyroid dysfunction before ethiodized-oil HSG examination.
Tipranavir Dose-response Study Using a Prototype Self-emulsifying Drug Delivery System (SEDDS) Formulation in Treatment-naive HIV-1 Infected Patients Report on the Post-study Option, a Treatment of Triple Therapy With Delavirdine, ZDV and 3TC Without Tipranavir

To investigate the safety of a standard triple therapy regimen of delavirdine (DLV), zidovudine (ZDV), and lamivudine (3TC) following 14 days of experimental treatment with regimens of tipranavir (TPV) with and without ritonavir (RTV)


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 RNA ≥ 5,000 copies/mL by Roche Amplicor assay
* CD4 cell count ≥ 50 cells/mm3
* Karnofsky performance status ≥ 80
* Age ≥ 13 years
* Screening laboratory values indicative of adequate baseline organ function, Grade 0 or 1 for laboratory values based on the ACTG toxicity scale grade. Selected stable \[2 months or longer\] Grade 2 laboratory abnormalities were subject to sponsor's approval
* Acceptable medical history and physical examination
* Agreement to use a barrier contraceptive method for at least 1 month prior to the administration of the study medication, during the study, and for 30 days after the end of the study
* Signed informed consent
* To enter the post-study option, patients have to have completed the 14-day tipranavir phase of the trial

Exclusion Criteria:

* Previous treatment with any antiretroviral drugs for more than 2 weeks
* Clinically significant, active and/or acute (onset within the prior month) medical problems including opportunistic infections, such as active cryptococcosis, Pneumocystis carinii pneumonia (PCP), herpes zoster, histoplasmosis or cytomegalovirus (CMV) , or non-opportunistic diseases including, but not limited to, progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy
* History of clinically significant nervous system or muscle diseases, seizure disorder, or psychiatric disorder that might impair compliance with the study
* Receipt of any known enzyme-inducing drugs including rifabutin, rifampin, carbamazepine, dexamethasone, phenobarbital, phenytoin, sulfamidine, sulfinpyrazone, or troleandomycin within 30 days prior to participation in the study
* Receipt of any investigational medication within 30 days prior to participation in the study
* Receipt of oral contraceptives within 30 days prior to participation in the study
* Pregnancy or lactation (serum ß-human chorionic gonadotropin (ß-HCG) test negative at second screen visit of the tipranavir phase of trial)
* Evidence of active substance abuse that, in the investigator's opinion, could affect study adherence
* In the investigator's judgment, inability to comply with the protocol requirements for reasons other than those specified above
Combined Conventional Speech Therapy and Functional Electrical Stimulation in Dysphagia Following Stroke

This study will evaluate the effectiveness of conventional speech therapy associated with functional electrical stimulation in patients with dysphagia after ischemic stroke. Included patients will be divided into two groups, where in the intervention group the speech therapy is associated to functional electrical stimulation, and in the control group, the patients will receive the conventional speech therapy with electrical stimulation Placebo with intensity 0hz.

Since the 1980's, electrical stimulation has been used for therapeutic purposes in Brazil, and, since 1990's, it has been used as a relevant therapeutic tool in the cases of oropharyngeal dysphagia in addition to speech therapy. Positive results have been observed in the treatment of swallowing disorders, including in patients that carry neurological diseases. However, there is no substantial evidences for this interventions.

In this study, the electrotherapy will be used as a complement to conventional speech therapy and performed the application of electrical stimulation protocol in dysphagia, through the apparatus Neurodyn Portable TENS/FES (transcutaneous electrical neurostimulation/ functional electrical stimulation), which is a transcutaneous neuromuscular stimulator flow TENS/FES from two channels with independent intensity adjustment. It is about a non-invasive technique with no systemic effect, causing no dependence or undesirable side effects, and consists by gentle application in electrical stimulation, through electrodes placed in body areas affected by pain or to activate skeletal muscles and produce movements. A channel of electrodes will be placed in the submental region and the other channel on the thyroid cartilage., in formation of a T. The explication of the procedure in the patient treatment, is describing the sensations that he should expect that happened during the stimulation. The intensity of necessary flow to apply in the treatment, will depend in the sensation of the patient, therefore, it is applicable until the tolerance level or desirable muscular contraction. Thus, the treatment should be initiated with minimal levels of intensity, by being carefully raised if appropriate effects are achieved on the procedure and according to the patient report.

Eligibility Criteria:
Inclusion Criteria:

* Stroke - ischemic type;
* Dysphagia following stroke;
* 40 to 70 years old;
* Exclusive enteral Feeding;
* Glasgow \> 11.

Exclusion Criteria:

* Pregnants;
* Febrile Condition;
* Neoplasia;
* Pacemaker;
* Cochlear Implant;
* Anxious Patient;
* Degenerative Neurological Diseases.
Differential Efficacy of Supportive and Interpretative Psychodynamic Techniques for Dependent and Self-critical Depressive Patients

Post-hoc analysis of psychotherapy outcome data suggest that psychodynamic techniques for Major Depressive Disorder are differentially efficacious dependent on personality traits of the patient. More specifically, supportive techniques are hypothesized to be more efficacious for dependent patients, interpretative techniques to be more efficacious for self-critical patients, and mixed supportive/interpretative techniques to be more efficacious for mixed dependent/self-critical patients. Moreover, supportive techniques are hypothesized to impact on depressive symptoms through increased relational capacities while interpretative techniques impact through increased self-understanding.

These hypotheses are tested in an experimental single case design with three dependent, three self-critical and three mixed dependent/self-critical depressive patients. These patients go through a time-limited (50 sessions) experimental treatment which exists of a sequence of four A phases (control conditions), one B phase (supportive techniques only), one C phase (interpretative techniques only), and one BC phase (mixed supportive/interpretative techniques).


Eligibility Criteria:
Inclusion Criteria:

* Patient meets criteria for Major Depressive Disorder (as assessed by SCID-I and DSM-IV-TR)
* Patient is prepared to give informed consent

Exclusion Criteria:

* Patient uses antidepressant medication during the treatment
* Patient scores 3 on the suicide item of the BDI-II
* Patient meets criteria for psychotic or personality disorder (as assessed by SCID-II)
A Study to Assess the Impact of Lebrikizumab on Health-Related Well-Being and Control of Skin Manifestations in Participants with Moderate-to-Severe Atopic Dermatitis

The main purpose of this study is to evaluate the impact of lebrikizumab treatment on the overall well-being of adult participants with moderate-to-severe AD in real-world clinical practice settings across Europe, as measured using validated 5-item World Health Organization Well-being Index (WHO-5) and to investigate effectiveness and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on participants in terms of disease symptomatology/control, fatigue, work impairment, patient's relationship with their skin, and overall QOL among adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Adult (greater than or equal to \[\>=\] 18 years) male or female participants with diagnosis of moderate-to-severe Atopic dermatitis.
* Adult participants prescribed lebrikizumab as part of routine/usual care to manage their moderate-to severe Atopic dermatitis.
* Willingness and ability to participate in the study; participants must give their written consent to participate.

Exclusion Criteria:

* Hypersensitivity to the active substances or to any of the excipients of lebrikizumab (Ebglyss®).
* Participants with pre-existing helminth infections. These participants should be treated for helminth infection before starting lebrikizumab therapy.
* Concomitant use of live and live attenuated vaccines.
* Pregnant women, except when the potential benefit justifies the potential risk.
* Participants included in a clinical trial at baseline or at any time during the planned study period.
* Participants unable to comply with the requirements of the study or who, in the opinion of the study physician, should not participate in the study.
* Participants for whom medical chart is inaccessible to physicians to complete baseline data collection.
A Phase I Study to Assess PSMA+ and PSMA- Tumour Lesions

CB307 is a trispecific Humabody® targeting CD137; PSMA; and human serum albumin (HSA) undergoing Phase 1 assessment in patients with PSMA+ solid tumours. This sub study will assess the biodistribution of radiolabelled CB307 in patients with advanced and/or metastatic solid tumours that are PSMA+.

Phase 1, Open-label, single centre, non-randomised study during which, enrolled patients will undergo a number of PET scans following administration of 89Zr-CB307, in order to assess the uptake of the radiolabelled drug. A post-treatment tumour biopsy for the assessment of PSMA expression will also be taken, if medically feasible, after the last PET scan.

The sub-study consists of 2 parts: an Optimisation Phase (Part A) and an Expansion Phase (Part B).

In Part A, both 89Zr-CB307 and CB307 will be administered to patients. The timing of the scans, post-dose tumour biopsy and CB307 dose will be optimised as determined by the Optimisation Review Committee (ORC).

In Part B (Expansion Phase), 89Zr-CB307 PET scanning will be performed based on the optimal dosing and timing determined in Part A.

The sub-study will continue for 7 days after the tracer injection. Patients will then be enrolled into the main study and will receive Cycle 1 Day 1 (C1D1) CB307 treatment according to the main study protocol.

Eligibility Criteria:
Inclusion Criteria:

* Capable of understanding the written informed consent.
* Aged at least 18 years.
* Not amenable to standard of care.
* ECOG PS of 0 or 1.
* Documented histologically confirmed diagnosis of PSMA+ advanced or metastatic solid tumours.
* Has radiologically measurable disease per RECIST v1.1 or elevated serum PSA for castration resistant prostate cancer patients with only bone metastases.
* Adequate organ function.
* Willing to have a biopsy sample taken immediately after the last PET scan before initiation of the main study.

Exclusion Criteria:

* Subjects with autoimmune disease or regular immunosuppressants.
* Has discontinued from anti-CTLA 4, anti-PD1 or anti-PD-L1 antibody because of intolerable toxicity.
* Has brain metastasis including leptomeningeal metastasis or primary brain tumour.
* Has current or history of CNS disease.
* Has known active infection.
* Biopsy cannot be safely obtained after the last PET scan, and not provided their consent.
Auditory Verbal Hallucinations in Schizophrenia

Auditory verbal hallucinations (AVHs) are speech perceptions in the absence of a relevant external stimulation. Some accounts of AVHs claim that a deficit in inner speech monitoring would cause the verbal thoughts of the patient to be perceived as external voices resulting in AVHs.

In order to examine whether AVHs correspond to self-generated inner speech, the present study aims at collecting speech muscle activity during covert AVHs (without articulation), overt speech and rest. Surface electromyography (sEMG) is used on schizophrenia patients and control subjects to detect any speech muscle activity during AVH.


Eligibility Criteria:
Inclusion Criteria:

Healthy controls:

* must be more than 18 years and less than 60 years old
* pre-inclusion medical examination
* must have signed consent form
* must be able to read stimuli on a screen

Schizophrenia patients:

* must be more than 18 years and less than 60 years old
* pre-inclusion medical examination
* must have signed consent form
* must be able to read stimuli on a screen
* diagnosed with a schizophrenia disorder according to DSM-IV TR (diagnostic and statistical of mental disorders) (PANSS item P3 greater than 4)
* prior evaluation of the secondary effects of any medication via Barnes and AIMS scales
* affiliated with the French social security
* if under guardianship, must have additional consent form signed by guardian

Exclusion Criteria:

Healthy controls:

* if aged less than 18 years or more than 60 years
* diagnosed with any psychiatric disorder
* with any language disorder (aphasia, SLI, dysarthria, stuttering, etc.)
* with auditory impairment
* pregnant, parturient, breast-feeding

Schizophrenia patients:

* if aged less than 18 years or more than 60 years
* significant secondary effects of antipsychotic medication, measured with the Barnes and AIMS scales
* with a neurodegenerative disease
* with any language disorder (aphasia, SLI, dysarthria, stuttering, etc.)
* with auditory impairment
* pregnant, parturient, breast-feeding
Cognitive Interference Task on Alcohol Craving and Consumption

The purpose of this study is to test a brief task of playing the game Tetris to reduce alcohol cravings and alcohol use. Women who are seen at primary care and recruited through the community will be asked to rate alcohol craving and use for a 1-week baseline period. Then they will be randomly assigned to play the Tetris game on their phones daily or to a control condition for a 2-week period. Participants will also complete a cue-reactivity task, that involves viewing pictures of alcohol and rating cravings.


Eligibility Criteria:
Inclusion Criteria:

1. Female, any race or ethnicity, age 21 to 65 years old.
2. Able to comprehend English.
3. At least one heavy drinking per week (i.e., consuming at least four or more drinks in one day) for the last two weeks
4. Internet access and reliable electronic device

Exclusion Criteria:

1. More than four heavy drinking days per week.
2. Currently engaged in treatment for Alcohol Use Disorder (AUD).
3. Current clinically significant bipolar affective disorder, schizophrenia, or psychotic disorder.
4. Pregnant.
5. Imminently suicidal or homicidal.
6. Participants taking psychoactive medications that may affect alcohol craving or consumption.
7. A score of 10 or higher on the Clinical Institute of Alcohol Withdrawal Revised (CIWA-R).24
Clinical Profile and Outcome of Perforated PUD

Perforated peptic ulcer disease (PPUD) is series illness that need emergency intervention. Its overall clinical profile and treatment outcome was also not well studied in developing countries. Therefore the study was aimed to see the outcome of surgical intervention and associated factors.

The study was a retrospective observational study conducted using the medical records of patients operated on for perforated peptic ulcer disease at a multicenter, in eastern Ethiopia.

This study was designed to investigate the clinical characteristics and treatment outcomes among adult patients presented to the study areas. Three teaching Hospitals and one Regional Hospital were chosen and data collection was effected for two years. One hundred seventy patients participated in this observational study.

Eligibility Criteria:
Inclusion Criteria:

* All adults with a diagnosis of perforated PUD managed at HU until discharged

Exclusion Criteria:

* Patients who were referred to other institutions before official discharge, Incomplete Medical record
A Registry Study on Safety Surveillance of Dazhuhongjingtian (a Chinese Medicine Injection) Used in China

The purpose of this study is to make a cohort event monitoring to see whether and how Dazhuhongjingtian injection in hospital results in adverse events or adverse drug reactions

Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can few be found now.A registry study for Dazhuhongjingtian injection safety surveillance with 3000 patients will be conducted from June.2017 to Dec.2019.Eligibility criteria Patients who will use Dazhuhongjingtian injection in 4 selected hospitals from2017-2019.

Eligibility Criteria:
Inclusion Criteria:

- An anticipated sample size was caculated in this study, about 3000. Patients using Dazhuhongjingtian injection from 2017 to 2019 in 4 hospitals

Exclusion Criteria:

none
Internet-delivered Cognitive Behavioural Therapy for Persons With Spinal Cord Injury

In Canada the prevalence of spinal cord injury (SCI) is approximately 85,556, with incidence rates of traumatic and non-traumatic SCI at 1,785 and 2,286 cases per year, respectively. Common secondary health conditions experienced by individuals with SCI include psychological distress and pain. Appropriate management of these secondary conditions, through a multidisciplinary approach, is imperative as they have been shown to contribute to slower recovery, increased negative outcomes, and greater rates of rehospitalizations and health care utilization. However, resource limitations can restrict the ability of service providers to deliver these integrative biopsychosocial approaches in the community. Guided internet delivered cognitive behavioural therapy (ICBT) program offers an alternative approach for psychosocial service delivery in the community. The program provides online structured self-help modules based on the principles of cognitive behavioural therapy (CBT) in combination with guidance from a coach through weekly emails and telephone calls. ICBT was shown to have similar effects to face-to-face CBT. Results from the investigator's pilot pre-post study (ClinicalTrials.gov: NCT03457714), found significant effects of guided ICBT on primary outcome of depression (d=1.20, p=.02) post-intervention and gains were maintained at 3-month follow-up among persons with SCI. Significant improvements in secondary outcomes including pain interference, resilience, positive affect, self-efficacy, ability to participate, and grief were also found.These studies demonstrate that guided ICBT is a safe and effective alternative to face-to-face interventions and it may be beneficial for underserviced populations.

In the proposed trial, the investigators will examine the efficacy of the Guided ICBT Chronic Conditions Course for persons with SCI versus an online SCI Rehabilitation Education program. All participants will complete questionnaires prior to the start of the program, before each lesson of the program, once they have completed the program, and 3 months after completing the program. The primary outcome measures include anxiety and depression. As part of the battery of questionnaires administered after the completion of the program, clients will be asked to rate the program content, the overall service, and their satisfaction with the program.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* residing in Canada
* endorsing symptoms of anxiety or depression
* diagnosed with a spinal cord injury
* condition does not impact ability to complete treatment (ex.cognitive impairment)
* able to access a computer and internet service
* willing to provide a physician as emergency contact

Exclusion Criteria:

* high suicide risk
* suicide attempt or hospitalization in the last year
* primary problems with psychosis, alcohol or drug problems, mania
* currently receiving active psychological treatment for anxiety or depression
* not present in country during treatment
* concerns about online therapy
Cellulitis Optimal Antibiotic Treatment

To determine whether a short course of oral flucloxacillin (5 days) is non-inferior to a standard course (7 days) in terms of pain over days 6-14 (indicative of persistence or recurrence associated with the symptoms of most importance to patients) in adults with cellulitis of the leg presenting in primary care.

Cellulitis is a deep infection of the skin and subcutaneous tissues and most often occurs in the legs. It is a painful condition that is associated with inflammation and swelling of the site, and often systemic symptoms such as fever, headache, muscle aches, malaise, and fatigue. Patients report feeling unwell and that it has a significant impact on their mobility and ability to carry out their usual activities. NICE guidelines recommend oral flucloxacillin 500-1000 mg four times daily for 5-7 days as first-line treatment for most patients with cellulitis in the community, but most prescriptions are dispensed for a 7-day course. We will be assessing the effectiveness and safety of a 5-day treatment vs. the standard 7-day treatment. We also aim to evaluate the cost-consequences of a shorter course from an NHS and personal perspective. Participants will be randomly allocated to one of two groups. In addition to usual care, participants will either be assigned to a 5-day oral flucloxacillin course or a standard 7-day flucloxacillin course. Participants will be prescribed a 5-day course of oral flucloxacillin, and two additional tablets will be posted to the participants which will either be the antibiotic or a placebo tablet. Participants will be asked to fill out daily questionnaires and express their experiences with the shortened course and taking part in the trial.

Eligibility Criteria:
Inclusion Criteria:

* Must be aged 18 years or older
* Currently showing symptoms of cellulitis (such as pain, tenderness, redness, other change in skin color, warmth to touch) in one leg for 10 days or less
* Pain rated as 3/10 or higher on a numerical rating scale (0-10) at baseline assessment
* Be willing to be randomized to either trial arm (5-day or 7-day treatment)
* Able to complete trial procedures in the English language.

Exclusion Criteria:

* Have penicillin allergy
* Have bilateral cellulitis
* Have had antibiotics for cellulitis within the past month
* Have post-operative cellulitis (within 30 days of operative procedures on the same leg)
* Have cellulitis resulting from human/animal bite injury
* Have Cellulitis associated with chronic (\>6 weeks) leg ulceration
* Require immediate hospital admission or out-patient intravenous antibiotic therapy