cyrilzakka/clinical-trials huggingface dataset:
Rare Benign Lesion of Peins

PEKMB was first named and described by Lortat-Jacob \& Civatte in 1961 and by Bart \& Kopf later. This rare condition is mostly reported in elderly males. The keratotic scales is usually micaceous and resembles psoriasis. Most patients are above 50 years of age and are circumcised later in life, but also reported in younger age group. This mica like scales contains keratin which gets dissolved in 10% potassium hydroxide solution. Disease progression may lead to phimosis. Differential diagnosis of this disease entity include moniliasis, wart, psoriasis ,penile horn, circinate balanitis, erythroplasia of Queyrat, squamous cell epithelioma and verrucous carcinoma. It is primarily a benign entity, it is capable of invasiveness. Bart and Kopf considered it to be in intermediate stage between benign hyperplasia and squamous cell carcinoma. However, the histological spectrum can range from hypertrophic-hyperplastic penile dystrophy to verrucous carcinoma. Fibro sarcoma has been reported developing in a same patient. Etiology is unclear. Despite search for a viral agent, Human Papilloma Virus (HPV) has not been demonstrated and its role in pathogenesis or its transformation to verrucous carcinoma has been proved. The treatment of PEKMB should be conservative when there is no histological evidence of malignancy. All such patients should be followed up. Treatment choices include potent topical steroids, topical 5% 5-flurouracil cream1, 2, cryotherapy, radiotherapy and shaving biopsy plus electro coagulation. When frank malignancy is observed, excision with wide margin is the rule.


Eligibility Criteria:
Inclusion Criteria:

* 40 years
* failed medical treatment

Exclusion Criteria:

* psoriasis
* allergy
* trauma
Phase 1/2a Trial of YH12852 in Healthy Subjects and Patients With Functional Constipation

A randomized, double-blind/open-label, placebo/active-controlled, single/multiple dose, parallel, phase 1/2a trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of YH12852 in healthy subjects and patients with functional constipation


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be willing and able to provide written informed consent.
2. BMI within the range 18 to 25 kg/m2.

Exclusion Criteria:

1. History of positive serologic evidence for infectious disease including HBsAg, anti-HCV, anti-HIV.
2. Clinically significant lab/ECG abnormalities in the opinion of the investigator.
3. WOCBP who are unwilling or unable to use an adequate contraceptive method to avoid pregnancy for the entire study. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, bilateral tubectomy, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as amenorrhea for ≥ 12 consecutive months without another cause.

   Clinically acceptable contraceptive methods for this study: intrauterine devices (e.g., loop), physical barrier method (e.g., diaphragm, uterine cap, condom) with chemical barrier method (e.g., spermicide), sterile partner, practicing abstinence.
4. WOCBP who are willing to use hormonal methods or hormone-releasing device(e.g., mirena, implanon) for the entire study.
5. WOCBP who are pregnant or breastfeeding.
6. WOCBP with a positive pregnancy test prior to randomization.
7. Males who have not received a vasectomy must agree to use contraceptive methods defined in (a) and refrain from donating sperm throughout the study.
8. Presence of uncontrolled or severe medical illness.
9. Presence of a disease that require surgery at any time during the study.
Xolair Interventional Study in ASD Patients With Comorbid Atopy

Following the publication of two case studies that reported behavioral benefit in ASD patients treated with omalizumab, the investigators will conduct a pilot trial to test the proof-of-concept efficacy of omalizumab in ASD patients with comorbid atopic disease. Investigators will evaluate behavioral improvement using three questionnaires. Investigators will also perform fMRI on all subjects and obtain serum samples for quantification of immunological biomarkers. If the trial is conclusive, the investigators will conduct a larger-scale, randomized-controlled trial to further understand the pathology of allergy in this subpopulation of ASD patients and the efficacy of this intervention.

This clinical trial is a Phase I, single-arm, open-label study. All 20 subjects will be given the same dosage of the study drug. Following baseline testing, subjects will undergo treatment during a 24 week treatment period and will receive six subcutaneous injections total, one injection every 4 weeks. A 24-week follow-up period after the treatment period will be concluded with patient interview. Behavioral questionnaires will be administered throughout the duration of the trial. fMRI will be conducted at baseline and at the conclusion of the treatment period. Blood will be drawn for serum testing at baseline, at Week 12 during the treatment period, and at the conclusion of the treatment period. Vitals and CGI will also be assessed throughout the trial.

Eligibility Criteria:
Inclusion criteria:

* Age between 18-30 years old.
* Clinical diagnosis of ASD during childhood that is still active.
* History of atopic diseases, including asthma, atopic dermatitis, and allergic rhinitis.
* Total serum IgE level ≥ 30 IU/ml and ≤ 400 IU/ml

Exclusion criteria:

* History of omalizumab use.
* Subjects who have used oral or systemic steroid burst within 6 weeks of study enrollment. Subjects who are receiving a maintenance dose of Prednisone of 5 mg/day or less will be allowed provided the dose of Prednisone is not changed during the study.
* Subjects actively taking the antipsychotic medication, Loxapine.
* History of cancer or pre-cancer.
* Subjects with active or unstable seizure disorder.
* History or active signs of psychosis.
* Body weight \> 90kg
* For subjects who meet allergic rhinitis inclusion criteria, RCAT \>20
* IQ \< 70
* Adaptive Behavior Composite score \< 90, based on the Vineland 3rd Edition
* Lactating or pregnant females. Xolair has not been sufficiently tested for safe use in pregnant females.
* Subjects who are deemed by the study staff to be unable to cooperate with or understand the instructions that will be given during the study.
* Subjects with severe medical condition(s) that in the view of a Physician Investigator prohibits participation in the study.
Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong

A randomized controlled trial to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong.

This is a single blinded randomized controlled trial aiming to evaluate the effectiveness of smoking reduction interventions for smoking parents in paediatric hospital setting in Hong Kong. This trial consists of a 24-week intervention period. Eligible families will be randomly assigned to either intervention group or control group. Smoking parent(s) in intervention group will be given face-to-face counselling on smoking reduction and adherence to nicotine replacement therapy (NRT) with motivational interviews, provision of NRT and monthly phone follow-up for counselling and support. Smoking parent(s) in control group will be given standard advice and information on smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

* Ethnic Chinese family with children aged younger than 18 years of age.
* Children who are admitted to the paediatric inpatient units or attend the paediatric specialist clinic at the Prince of Wales Hospital.
* Children with at least one custodial smoking parent who is living with them.
* Written informed consent obtained from parents.

Exclusion Criteria:

* Families not residing in Hong Kong.
* Children in foster care.
* Children with unclear custody.
* Smoking paediatric patients.
* Presence of smoking household members apart from the parents.
* Smoking parent who is contraindicated to use nicotine replacement therapy.
Smart Phone Application in the Secondary Clinical Prevention Management for Chinese Patients

The purpose of the study is to investigate the effects of smart phone app on the secondary prevention for patients with coronary heart disease post percutaneous coronary intervention.

The secondary prevention for patients with coronary heart disease post percutaneous coronary intervention (PCI) proved associated with a significant reduction in mortality rates and improvement in quality of life. For the limitation of socio-economic conditions, not all patients post PCI are in a position to receive continuous standardized secondary prevention management. Therefore a smart phone app for secondary prevention management post PCI will be installed on patients' smart phones in order to investigate its effects on risk factors control, medication compliance, as well as quality of life and adverse cardiac events in the next six months post discharge. Participants allocated to the control group will receive a booklet with general advice on secondary prevention of coronary heart disease. Patients in app group and control group will be interviewed by telephone at the 2nd week and the 3rd month, and at the 1st month and 6th month they will return our hospital for face to face follow-up and to compliance and medication adjustment, assessment of life quality, risk factors control and medication adherence.

Eligibility Criteria:
Inclusion Criteria:

* First diagnosis of coronary heart disease and received a PCI treatment.
* Age 18-65 years.
* Able and willing to provide written informed consent.

Exclusion Criteria:

* Speech communication barriers.
* Patients with a clear history of allergies to anti-platelet drugs.
* Patients with a clear history of allergies to anti-platelet ᵦ-blockers.
* Patients with a clear history of allergies to statin drugs.
* Patients with a clear history of allergies to antihypertensive drugs.
* Patients with a clear history of allergies to antidiabetic drugs.
* Patients with serious heart failure(better than NYHA class II).
* Patients with cerebral infarction or cerebral hemorrhage.
* Patients with liver dysfunction (AST and ALT\> 2 times that of the reference value).
* Patients with kidney dysfunction (creatinine clearance rate\< 60ml/min).
Different Localization Techniques for Non-palpable Breast Lesions Comparison: a Retrospective and Multicentric Clinical Study

Breast conservative surgery (BCS) is nowadays the standard of care for patients affected by early breast lesions. Screening programmes led to an increase of non-palpable breast lesion detection rates. These patients are often eligible for BCS and an accurate preoperative localization technique for the detection of the lesion is required to guarantee a safe surgical excision. The primary goal of BCS is to obtain a complete resection of the tumor with disease-free surgical margins. The presence of tumor on surgical margins on postoperative histological examination of the specimen increases the risk of local recurrence and it requires a surgical re-excision. For all these reasons different techniques for localization of non-palpable breast lesions have been developed over time. Since '70s the wire guided localization (WGL) technique has represented the gold standard; however it has several limitations such as wire migration or fracture and patient referred discomfort related to wire placement. Over time, other techniques have been proposed, such as the radioguided occult lesion localization (ROLL), radioactive and magnetic seeds, carbon dye and ultrasound-guided preoperative localization.

Currently there are several studies of comparison between the WGL and the more modern techniques. All of these data claim the effectiveness of the new "wire-free" methodics ensuring a safe surgical resection with tumor-free margins and, in some cases, a better aesthetic result.

Studies of comparison between the modern techniques are limited. There is no scientific evidence of the superiority of a technique over the other. A multicentric Italian survey demonstrated that the most used localization techniques nowadays are the WGL, ROLL, the magnetic seed and the carbon dye.

The aim of this retrospective study is to compare these techniques to assess their efficacy in the localization of non-palpable breast lesions.


Eligibility Criteria:
Inclusion Criteria:

* Female sex;
* Patients who underwent breast conservative surgery for non-palpable occult breast lesions;
* Intraoperative localization of breast lesion with WGL, ROLL, magnetic seed, carbon dye;
* Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5).

Exclusion Criteria:

* Diagnosis of benign breast lesion, both on preoperative needle breast biopsy (B2) or on fine needle breast aspiration (C2);
* Clinically palpable breast lesion;
* Localization of a non-palpable lesion through two or more different techniques;
* Breast tumor localization with clip in patients who underwent neoadjuvant chemotherapy.
The Effect of Reiki on the Anxiety Level of Mothers

The aim of this study is to determine the effect of Reiki applied to mothers whose children were treated in the hospital on the anxiety level.

Hypotheses 01; there was no difference between the anxiety score of the reiki group and the anxiety score of the control group.

The study will be carried out in three different groups. The practice will start with meeting the women whose children were treated in the hospital. After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Reiki Group The intervention will be applied to the reiki group to be applied in the hospital room. Reiki therapy will be applied by a practitioner with a Reiki application certificate in the application laboratory for 30 minutes while the participants lie down with their eyes closed. 4 sessions of reiki application will be applied to the intervention group for a week. Anxiety level after 4 sessions will be recorded.

Placebo Reiki will be applied to the participants in the group in the application hospital room. The practice will be carried out in the application laboratory for 30 minutes, with the participants sitting with their eyes closed. Reiki life energy will not be transferred to participants in the placebo reiki group. Since the participants' eyes are closed, they will not know that there is a transfer. Placebo Reiki application will be performed in the room 4 times during a week. Placebo application will start, and the first anxiety scores will be recorded. After 4 sessions, anxiety scores will be recorded.

control group; the first anxiety scores will be recorded. After a week later anxiety scores will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* At least the 3rd day of hospitalization

  * Their child has an acute or chronic disease
  * Able to speak and write Turkish and have no communication problems
  * No psychiatric history and not using medication
  * Not drinking alcohol in the last 24 hours
  * Those who have not received body-mind therapy (yoga, reiki, massage, meditation) in the last six months
  * Mothers who volunteer to participate in the research will be included.

Exclusion Criteria:

Reiki practitioner or who also has an instructor

* Having time and communication problems that cannot answer the questions asked
* Mothers who do not volunteer to participate in the study will not be included in the study.
Improving White Matter Integrity With Thyroid Hormone

Animal studies have shown that thyroid hormone can improve white matter integrity after damage to myelin, which insulates and protects nerves. It is currently unknown whether this type of repair can occur in humans. The purpose of the proposed study is to examine the impact of thyroid hormone on white matter integrity in humans using two complementary, state-of-the-art neuroimaging techniques: high angular diffusion imaging and multicomponent relaxometry.

The ability to promote and support remyelination has wide-ranging implications for a number of neuropsychiatric conditions from multiple sclerosis to major depression. Pre-clinical evidence has demonstrated that thyroid hormone treatment, in the form of triiodothyronine (T3) or tetraiodothyronine (T4), can promote and support remyelination by increasing myelin basic protein mRNA and protein, oligodendrocyte proliferation and maturation, and fractional anisotropy (a diffusion imaging measure of white matter integrity). Pilot data from the investigator's studies suggest that baseline thyroid status is correlated with the integrity of white matter tracts associated with major depression. To date, the impact of thyroid hormone administration on white matter tracts has not been studied in vivo in adult humans. The purpose of the proposed pilot study is to examine changes in white matter tract integrity using high angular diffusion imaging and multi-component relaxometry in a population of subjects clinically indicated to receive thyroid hormone for hypothyroidism. The investigators will scan patients with hypothyroidism at the initiation of treatment and at three and six months after starting thyroid hormone treatment. The investigators will also administer scales assessing mood and cognition which have been shown to correlate with white matter integrity. The investigators hypothesize that thyroid hormone treatment will be associated with an increase in fractional anisotropy, a decrease in radial diffusivity, and an increase in the myelin water fraction (markers of improved myelination) that will correlate with improvements in cognition and mood ratings. If successful, this will be the first demonstration of improved white matter integrity with thyroid hormone replacement and pave the way for therapies designed to restore structural brain connectivity.

Eligibility Criteria:
Inclusion Criteria:

* Age: 21-60 years of age
* A diagnosis of primary hypothyroidism from autoimmune thyroiditis (Hashimoto)
* Able to give informed consent.

Exclusion Criteria:

* Major depressive disorder with or without active suicidal ideation
* Mild or major neurocognitive disorder;
* Presence of contraindications to magnetic resonance imaging (presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
* Inability to tolerate small, enclosed spaces without anxiety (e.g., claustrophobia)
* Unwilling/unable to sign informed consent document
* Positive urine drug screen results;
* Pregnancy (positive pregnancy test), trying to become pregnant, or lactation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients

Treatment and rehabilitation after transfemoral amputation represents a challenging medical field, involving intersectoral parties. Although treatment guidelines exists, their implementation is difficult. This study is conducted to evaluate the need to practice these guidelines in order to gain best benefits for the patients. Focus is set of early inpatient rehabilitation and the role of a microprocessor-controlled prothesis (Kenevo, Ottobock).

Right after major surgeries, e.g. amputations, inpatient rehabilitation follows in Germany. Costs are covered by different insurances, like public or private health care insurances or German pension insurance. Usually, inpatient rehabilitation lasts for 3 weeks. But after some surgeries, like amputation, patients need more time to recover and fitting of a prosthesis takes additional time. Therefore guidelines state, that rehabilitation should take up to 6-8 weeks after major amputation. To provide evidence to these guidelines, we conducted this study.

Patients' choice on rehabilitation clinic decides on their assignment to the study group or control group. Inpatient rehabilitation is monitored with outcomes measurements. 3 measurements are carried out in the study group within rehabilitational stay of around 6 weeks (admission - middle - discharge) and 2 measurements are carried out in the control group within rehabilitational stay of around 3 weeks (admission - discharge). After discharge from rehabilitation, assessment of patient reported outcome measurements is continued every 6 weeks for both groups. Follow-up phase ends with 24 weeks after admission to rehabilitation.

For subanalysis, different prosthetic devices (non-microprocessor-controlled vs. microprocessor-controlled prosthesis) are compared.

Eligibility Criteria:
Inclusion Criteria:

* inpatient rehabilitation stay after transfemoral amputation or knee disarticulation
* anticipated K-level 1 or 2
* body weight no more than 125kg (authorized body weight for prosthetic device)
* German speaking
* able to give informed consent

Exclusion Criteria:

* non-German speaking
* not able to give informed consent
* body weight over 125kg
Usefulness of Nasal Continuous Positive Airway Pressure (CPAP) Treatment in Patients With a First Ever Stroke and Sleep Apnea Syndrome

MAIN AIMS: to analyze the efficacy of nasal CPAP treatment in patients with ischemic first-ever stroke and Sleep Apnea Syndrome (SAS) in terms of: early neurological outcome, functional recovery, quality of life influence, stroke recurrence and survival.

SECONDARY AIMS: to evaluate the feasibility of the treatment in this type of patients at short and long time.

DESIGN: clinical randomized case-control study.

PATIENTS: younger than 75 years with a First-Ever stroke with at least one of the following criteria: snoring, observed apnea, Hypertension or Ischemic Cardiopathy.

MEASUREMENTS: protocol to define subtype stroke and parenchymatous and vascular location; sleep questionnaire (including Epworth Sleepiness Scale); Respiratory Polysomnography (RPSG). If RPSG shows an AHI \> 20, with predominant obstructive events, patients will be randomized in a CONTROL GROUP (conventional treatment) and a TREATMENT GROUP (with Nasal CPAP). Follow up for both groups at 1, 3, 12 and 24 months will include: early neurological outcome, body mass index (BMI), blood pressure (BP), functional recovery (Barthel Index/Canadian Scale), quality of life (SF36), recurrences, vital status. Nasal CPAP titration will be performed by means of an automatic system (Autoset Portable ST). Compliance will be recorded. If a negative RPSG is obtained (AHI \< 10) (NO SAS GROUP) or with AHI \< 20 (mild SAS) the usual treatment and the same follow up protocol will be established.

STATISTICS: the sample size is initially calculated in 10 patients for each group, considering this is part of a multicenter study including 8 centers. If no differences are found, depending on the statistical power the investigators will consider including more patients. The different groups will be compared for the analyzed variables with the corresponding tests.


Eligibility Criteria:
Inclusion Criteria:

* First ever stroke
* Any Sleep Apnea symptom
* Hypertension

Exclusion Criteria:

* Aphasia
* Cognitive impairment
* Hypersomnolence