cyrilzakka/clinical-trials huggingface dataset:
Efficacy Study Between Two Different Dosages of an Antiparasitic in Patients With Crusted Scabies

Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment. Ivermectin is a recommended treatment in common forms of scabies and represents a promising treatment in crusted scabies in case reports. However, response to ivermectin remains variable among studies, and there is no consensus on the schemes to adopt (dosages and administrations). Ivermectin at 400 µg/kg has already been used, without showing toxicity (in head lice treatment in particular). Investigators propose to demonstrate that 400µg/kg ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of scabies (crusted and profuse).


Eligibility Criteria:
Inclusion Criteria:

Patients ≥ 18 years old, diagnosed with severe forms of scabies

1. clinical criteria : cutaneous lesions of scabies

   * crusted scabies: at least two sites of hyperkeratosis will define crusted scabies and/or
   * profuse scabies : spreading lesions with erythematous scaly eruption of the neck, face or trunk without hyperkeratosis
2. paraclinical criteria:

   * Positive parasitological test
   * and/or dermoscopic exam with signs of scabies

Effective contraception for women in age of pregnancy Written consent from patient or his/her legal representant, trustworthy person or family member Affiliated to a social security scheme

Exclusion Criteria:

* Pregnant and/or breastfeeding women
* Intolerance to ivermectin or topical treatment (permethrin 5% cream) or emollient cream
* Use of anti parasitic drug (ivermectin or albendazole) within the past 7 days
* Abnormal liver test results: ALT and/or AST \>3N within the past 7 days (within 6 months if no hepatic history)
* Participation in other biomedical drug research
* Patient deprived of freedom
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Evaluating the Efficacy of Culturally Adapted iCT-SAD

The study will adapt and implement a Pakistani version of Internet-delivered Cognitive Therapy for Social Anxiety Disorder (iCT-SAD), assessing its effectiveness in reducing social anxiety symptoms among Pakistani individuals.

The study will adapt and implement a Pakistani version of Internet-delivered Cognitive Therapy for Social Anxiety Disorder (iCT-SAD), assessing its effectiveness in reducing social anxiety symptoms among Pakistani individuals. This randomized controlled trial will involve culturally tailored online therapy modules, therapist support, and regular progress assessments. The goal is to evaluate the efficacy of iCT-SAD in a Pakistani context, comparing outcomes to a control group. The primary outcome measure is the self-report Liebowitz Social Anxiety Scale, and secondary outcomes include other measures of social anxiety symptoms and processes, general mood and functioning, and response to treatment

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of SAD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* Aged 18-75 years
* Regular, access to an appropriate internet device
* Resident of Pakistan and can write and speak Urdu
* Participants not currently undertaking other structured psychological therapy during the trial

Exclusion Criteria:

* Current psychosis, bipolar disorder, antisocial personality disorder, or alcohol/substance use disorder
* Active suicidal ideation with intent or plan
* Previously received CT or cognitive behavioral therapy for SAD
A Study of Prophylaxis for Migraine Patients With Topiramate in India

The purpose of this study is to evaluate the safety and effectiveness of topiramate in preventing migraine among Indian participants requiring prophylaxis (measure taken to maintain health and prevent the spread of disease).

This is an open-label (all people know the identity of the intervention), multi-center (study conducted at multiple sites) study. In this study approximately 209 participants will be observed. Participants receiving topiramate will be observed monthly for 3 months. Safety assessments will include evaluation of adverse events and body weight of the participants which will be monitored throughout the study. The total duration of this study will be approximately 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Participants who experiencing migraine three or more times per month and require prophylaxis medication
* Participants having at least 6 months of migraine history (diagnosed as per international headache society criteria with or without aura)
* Other indications for migraine prophylaxis are: the use of acute treatment medication too frequently (more than 2 treatment days per week); an increasing frequency of headaches that are non-responsive to acute therapy; requiring rescue therapy more than once a month
* Participants who are seen to benefit from topiramate based upon the physician's judgment

Exclusion Criteria:

* Headaches other than migraine or episodic tension or sinus headaches or having headaches exceeding 15 days per month
* Onset of migraine after age 50
* An exclusively migraine aura without headache or a painful condition other than migraine pain
* Having significant history of unstable medical disease
* At risk in terms of the contraindication in the product insert of topiramate
Parent-adolescent Communication: Validation of a German Language Scale and Its Longitudinal Association with Adolescent Mental Health

A German version of the Parent-Adolescent Communication Scale (PACS, Barnes \& Olson, 1982) will be validated in a large sample of children (10-18 years) and their parents. As a secondary objective, the association of communication quality, children's somatic symptoms and mental health will be explored. After two years, participants from the community sample will be contacted again to see whether baseline communication quality predicts adolescent mental health two years later.

The quality of parent-child communication (pcc) is likely to be of importance for child mental health, especially during adolescence. Therefore, pcc is relevant in etiologic research, diagnostics, and as a possible target for intervention in at-risk and clinical populations.

Up to now, there is no validated questionnaire in German language to assess pcc as parent and child self-report. A German translation of the widely used Parent-Adolescent Communication Scale (PACS, Barnes \& Olson, 1982) will be validated in this study. This questionnaire comprises 20 items that are identical in parent and child versions apart from the referent (my mother/my father/my daughter/my son). In the original scale, two subscales were found via factor analysis: Open communication and problems in communication (ten items each). Internal consistency was adequate in most studies. Several studies have shown associations between pcc and child mental health.

In the current study, the primary aim is to validate the questionnaire in a community, an at-risk, and a clinical sample, with the at-risk sample comprising parent-child dyads with parents seeking parenting advice. The clinical sample will be recruited among in- and outpatients at the Clinic for Child and Adolescent Psychiatry of the University Medical Center Hamburg-Eppendorf. Discriminative validity will be assessed in terms of group differences, construct validity in terms of correlations with different subscales on the parent-child relationship. With regard to the factorial structure, an exploratory factor analysis will be performed. As a secondary aim, the association between somatic symptoms, mental health, and pcc will be studied.

In the longitudinal part of the study, parent-child communication quality will be analysed as a predictor of mental health, especially depressive symptoms and somatic symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Consent to participate
* Child age: 10-18 years.

Exclusion Criteria:

- None.
Coping Skills Training (CST) for Children With Chronic Health Conditions

Purpose of the study The purpose of this study is to pilot an adapted Coping Skills Training (CST) intervention for feasibility and preliminary efficacy with a sample of children 8 to 12 years of age and their parents. The participants in this study at Children's Hospital of Wisconsin are dealing with one of three chronic health conditions (Rheumatologic Conditions, Epilepsy,Spina Bifida, and Asthma).

Research Questions/Study Aims

The research questions addressed in the full study are:

1. What is the impact of CST on child depression, QOL, health motivation, attitude toward illness, and self-management efficacy?
2. What is the impact of CST on parent depression, perception of child's quality of life, perception of impact of CHC on family, and family conflict?

Many children with chronic health conditions (CHC) are at increased risk for poor adaptation such as psychosocial problems, behavioral disturbances, and decreased quality of life (QOL). Their parents face economic, social and emotional challenges. In addition, management of the CHC and the involvement of the child in that management can severely challenge both child and parent. Effective coping has been shown to moderate the negative impact of CHC. This study is a pilot study to evaluate the feasibility and preliminary efficacy of adapting a Coping Skills Training (CST) intervention developed for children with diabetes. The CST intervention will be adapted for an integrated sample of school-aged children 8 to 12 years of age with four health conditions (Rheumatologic Conditions, Epilepsy,Spina Bifida, and Asthma). The study will be a randomized clinical trial with a wait-list control group. Each arm will consist of 25 families. CST is a 6-session group intervention based on cognitive behavioral and learning theory. The impact of CST on both outcomes (child: depression, QOL; parent: depression, Child QOL, CHC impact on family) and protective factors (child: health motivation, attitude, self-management efficacy; parent: family conflict) will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Male and female children ages 8 to 12 with no known severe cognitive delays,
* Who are English speaking,
* With one of the three target conditions; and
* Have at least one parent willing to participate.

Exclusion Criteria:

* Children with cognitive delay
Herbal Pralines - Oral Health

This randomized, double-blinded, placebo-controlled two-arm, parallel group clinical trial is designed to evaluate the impact of the consumption of two herbal pralines containing 200 mg nitrate on clinical signs of gingival inflammation (Bleeding on probing) without an accompanied professional mechanical plaque removal.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65 years,
* minimum of 20 % of the measure points showing a manifest bleeding after probing,
* no periodontal maintenance therapy within the past 4 months,
* a minimum of 10 remaining natural teeth

Exclusion Criteria:

* history of drug / alcohol abuse,
* systemic intake of antibiotics \< 6 months prior to the study period,
* regular use of anti-inflammatory drugs,
* regular use of antibacterial mouthwashes,
* known allergic reactions to any ingredient in the experimental pralines
* mean arterial blood pressure MAD \<80mmHg
* known allergies and intolerances to any of the ingredients of the experimental pralines
Ph 1 ADI-PEG 20 Plus Doxorubicin; Patients With HER2 Negative Metastatic Breast Cancer

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol, and has been used to treat patients that have cancers that require arginine. In this study, ADI will be combined with the well known chemotherapy Doxorubicin and the safety and potential efficacy of this combination will be explored in patients with HER2 Negative Metastatic Breast Cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Biopsy proven HER2 negative metastatic breast cancer (dose escalation portion and MTD expansion portion) or advanced solid tumor (dose escalation portion).
2. ASS deficiency (defined as \<50% ASS expression) demonstrated on tissue specimen by Immunohistochemistry (IHC). Cytology and fine need aspirate specimens are not acceptable for ASS testing.
3. Unresectable disease or subject refused surgery.
4. Measurable disease as assessed by RECIST 1.1 criteria (Appendix A).
5. Failed available therapy known to confer clinical benefit but no more than 4 prior lines of chemotherapy for metastatic disease.
6. Time to treatment failure from doxorubicin containing regimen ≥ 12 months if previously treated with doxorubicin.
7. Age ≥ 18 years.
8. ECOG performance status of 0 - 2. -

Exclusion Criteria:

1. Serious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.
2. Prior epirubicin exposure of \> 600 mg/m2.
3. Pregnancy or lactation.
4. Expected non-compliance.
5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.
6. Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or ≤ Grade 1 AEs, or deemed irreversible from the effects of prior cancer therapy. AEs \> Grade 1 that are not considered a safety risk by the Sponsor and Investigator may be allowed upon agreement with both.
7. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the Investigator will not affect subject outcome in the setting of breast cancer diagnosis.
8. Subjects who had been treated with ADI-PEG 20 previously.
Osteochondritis Dissecans of the Knee

Osteochondritis dissecans is a relatively common...


Eligibility Criteria:
Inclusion Criteria:

* Osteochondritis dissecans diagnosis code (ICD-8 to -10) in the medical records of KUH
* Knee OCD verified from the medical records

Exclusion Criteria:

-Any other medical condition
Local Cecal Cancer - Optimization of Surgical Treatment

The purpose of this study is to determine the clinical efficacy, safety, and oncologic outcomes of ileocecal resection (ICR) with D3 lymphadenectomy compared to standard right hemicolectomy(RHC) for cecal cancer.

The design involves random allocation of eligible patients to ICR or RHC group in 1:1 ratio.

Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience.

Regular quality control includes the requirement to photograph the surgical specimen with a mark to determine the extent of lymphadenectomy performed and the number of the lymph node group.

After surgery patients are treated according to local standards, regardless of whether ICR or RHC was performed. Short-term and long-term outcomes are recorded according to the protocol.

Intervention. In all cases the tumor is localized in the area of the cecum; the border of the transition to the ascending colon is the upper lip of the ileocecal valve. The patient is not included in the study if the preoperative stage of examination reveals: synchronous cancer, distant metastasis (M1), locally advanced nature of the primary tumor (cT \> 3).

All patients will be randomly divided into two groups in a 1:1 ratio.

1. Research group (ICR) - Laparoscopy ileocecal resection with extended D3 lymphadenectomy (including 201, 202, 203 and 213 groups of lymph nodes). The minimum distance from the tumor is 10 cm, along the line of adequate blood supply. Next step - formation of a manual double-row ileo-ascendo-anastomosis.
2. Control group (RHC) - Laparoscopy right hemicolectomy with D3 lymphadenectomy (including 211, 212, 221, 222-rt groups of lymph nodes). Next step - formation of a manual double-row ileo-transverse-anastomosis.

Expected Results. The ICR will improve the short-term results of treatment of patients with cecal cancer compared with the standard RHC technique without affecting long-term results.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* ECOG status 0-2.
* Histologically confirmed adenocarcinoma of the colon.
* Clinical stage T1-3; N+; M0.
* The physical status from ASA classification I, II, III or IV.
* Written informed consent.

Exclusion Criteria:

* Synchronous or metachronous malignancy.
* Locally-advanced tumor (T\>3).
* Presence of distant metastases (M1).
* Complicated tumor: obstruction, perforation.
* Neoadjuvant chemotherapy.
* Medical contraindications for surgical treatment.
* Pregnancy or breast feeding.
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol.
Studies of Application of Combined General Anesthesia and Bilateral TPVB in OPCABG

This study intends to compare the combination of general anesthesia (GA) and single-shot bilateral thoracic paravertebral block (TPVB) by ropivacaine in the patients undergoing off-pump coronary artery bypass surgery ( OPCAB) with traditional general anesthesia (GA) perioperative management of patients, committed to reducing patient's physical and psychological stress by surgical trauma, achieve the purpose of fast recovery, in order to establish an more effective perioperative management during off-pump coronary artery bypass surgery, improve patients' satisfaction and to accelerate postoperative rehabilitation safely.

This study intends to compare the combination of general anesthesia (GA) and single-shot bilateral thoracic paravertebral block (TPVB) by ropivacaine in the patients undergoing off-pump coronary artery bypass surgery ( OPCAB) with traditional general anesthesia (GA) perioperative management of patients, committed to reducing patient's physical and psychological stress by surgical trauma, achieve the purpose of fast recovery, in order to establish an more effective perioperative management during off-pump coronary artery bypass surgery, improve patients' satisfaction and to accelerate postoperative rehabilitation safely. Patients included in the study (approximately 60 cases) will be randomly divided into PVB(T2/3+T5/6)+GA experimental group (A), PVB(T3/4)+GA experimental group (B)the conventional GA control group (C). All groups received the preoperative preparation, anesthesia and postoperative treatment according to the traditional manner, the group A of patients has been received bilateral thoracic paravertebral block (TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml\*4), group B will received bilateral thoracic paravertebral block (TPVB T3/4)by ropivacaine(0.3%,20ml\*2).,while the group C will received the conventional general anesthesia management without block.

Eligibility Criteria:
Inclusion Criteria:

* Heart function grade II - III (Using the cardiac function classification method formulated by American Heart Disease Institute)
* The in - hospital was treated with off pump coronary artery bypass grafting（CABG) operation and general anesthesia.
* Had a good cognition, and signed the informed consent.
* Aged between 35 and 80.
* The age, clinical examination and other generally situation of the two groups of patients had no statistical significance.

no merger of valvular disease left ventricular ejection fraction \> 40%, do not need intraaortic balloon counterpulsation support, without spinal deformity, no vertebral side clearance space-occupying lesions

Exclusion Criteria:

* Combined with other blood coagulation dysfunction, serious brain, liver and kidney dysfunction, endocrine system diseases and serious infectious disease.
* Patients with severe mental disorders cannot cooperate with the treatment.
* Emergency operation
* Have taboo of Echocardiography and pulmonary catheterization by echocardiography.
* Allergic to Local anesthetics drug.
* Suspected or had alcohol, drug abuse history.
* Spinal or paravertebral lesions.
Multidisciplinary Shared Decision Making of Fertility Preservation in Young Women With Breast Cancer

Multidisciplinary shared decision making of fertility preservation in Young womenwith Breast Cancer (MYBC): A Pragmatic stepped wedge cluster randomised trial


Eligibility Criteria:
Inclusion Criteria:

* Women aged 19 to 40 years old
* A person diagnosed with breast cancer by biopsy
* Those who don't have evidence of distant metastasis
* Eastern Cooperative Oncology Group(ECOG) performance status: 0-2 score
* Before registering for clinical trials, chemotherapy, radiation therapy, anti-hormone therapy, immunotherapy, and surgery are not performed
* A person who has fully understood and listened to the explanation of this clinical trial and then gave written consent

Exclusion Criteria:

* Histologically, a person diagnosed with follicular or sarcoma
* Those with a history of breast cancer (including recurrent breast cancer)
* A person diagnosed with another cancer before breast cancer
* A person diagnosed with metastatic breast cancer
* A person who has a mental illness and has a hard time understanding clinical trials
* Those who plan to conduct follow-up observation elsewhere(to change of hometowm)
* Menopausal factors without menstruation after more than a year from the last menstrual date
* A pregnant woman
* Inappropriate for participation in clinical trials
Validation of the SD-ICU. A Risk Assessment Tool of Unplanned ICU Readmission

In a recent study, which included 845 patients that at the time of ICU discharge had at least one risk factor for readmission, the investigators' group developed a new readmission risk score in the ICU, Safe Discharge from ICU (SD-ICU), using parameters easily and routinely measured in ICU: the Charlson comorbidity (ICC), the TISS-28 (Therapeutic Intervention Scoring System - 28), the length of stay in ICU and age. Through ROC curve analysis, the investigators found that patients with a score above 14.5 had a high probability of readmission.

The objective of this study is to validate the Safe Discharge from ICU (SD-ICU) score as a tool to predict unplanned readmissions to the intensive care unit.

All adult patients discharged from a 37 bed general ICU from April 2014 to March 2015 will be included in the study. The SD-ICU score is routinely calculated at the time of discharge from the ICU. Patients will be divided into two groups: those with SD-ICU score\> 14.5 (group 1) and those with a score equal to or less than 14.5 (group 2). The two groups will be compared with respect to the frequency of unplanned readmissions. Stepwise, multivariate logistic regression will be used to investigate the association between the risk factors for readmission used in SD-ICU score and ICU readmission as outcome.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients discharged from a general ICU

Exclusion Criteria:

* Patients under 18 years old
* Those that were not candidates for ICU readmission (interhospital and home care transfer)