cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (NCT02719171)

This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability of risankizumab in participants with psoriatic arthritis (PsA).

Participants who had completed all doses of study drug and the Week 24 visit of M16-002 (NCT02719171; the lead-in study) were eligible to enroll in M16-244 (this study). Participants were allowed to either finish the Week 24 visit of the lead-in study and take the first dose of study drug for this study on the same day, or delay the start of this study up to 8 weeks if needed.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have completed all doses of study drug and Week 24 visit of the lead-in study.
* Women of childbearing potential who are sexually active, must agree to use at least one accepted method of contraception throughout the study, including 20 weeks after last dose of study drug is given.
* Women of childbearing potential must have a negative urine pregnancy test at Baseline (Week 0/V1).
* Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any study specific procedures.
* Participant is judged to be in good health as determined by the Investigator.

Exclusion Criteria:

* Female participant who is pregnant, breastfeeding or is considering becoming pregnant during study participation, including 20 weeks after the last dose of study drug is given.
* Premature discontinuation of the study drug in the lead-in study for any reason.
* Use of a biologic treatment other than risankizumab since first dose of study drug in the lead-in study.
* Time elapsed is \> 8 weeks since the Week 24 visit in the lead-in study.
* Active systemic infections during the last 2 weeks (exception: common cold) prior to the first dose, as assessed by the investigator.
Concurrent Subcutaneous Basal Insulin and Intravenous Insulin Pump in Hyperglycemic Crisis Patients Under Critical Care

The safety and efficacy of basal insulin during intravenous insulin infusion for hyperglycemic crisis patients under critical care is still unknown.

We assumed that concurrent basal insulin subcutaneous injection and intravenous insulin infusion for critically ill DKA and HHS patients would shorten the time of hyperglycemic crisis correction and achieved better glycemic control(decrease hypoglycemia and rebound hyperglycemia).

Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) are hyperglycemic crises sharing similar clinical features including hyperglycemia, dehydration and electrolytes abnormalities. Hyperglycemia results from relative deficient circulating insulin and oversecretion of glucagon, catecholamines, cortisol, and growth hormone. Glycosuria induced osmotic diuresis leads to dehydration and electrolyte abnormalities. Diabetic ketoacidosis is also characterized by increased gluconeogenesis, lipolysis, ketogenesis, and decreased glycolysis.\[1\] In critically ill and mentally obtunded patients with DKA or hyperosmolar hyperglycemia, continuous intravenous insulin is the standard of care.\[2\] Administration of subcutaneous insulin glargine during intravenous insulin infusion shortened the time of DKA correction and significantly decreased hyperglycemia after discontinuation of the intravenous insulin. \[3, 4\]The differences in rebound hyperglycemia rates were highly significant for at least 12 hours after transition to subcutaneous insulin regimens in the DKA and non-DKA patients as well as in organ transplant patients receiving steroids. \[4\] However, the previous studies only enrolled small numbers of patients(without Asian population) and excluded newly diagnosed hyperglycemia or critical illness and pregnant women. The safety and efficacy of basal insulin during intravenous insulin infusion for hyperglycemic crisis patients under critical care is still unknown.

The investigators assumed that concurrent basal insulin subcutaneous injection and intravenous insulin infusion for critically ill DKA and HHS patients would shorten the time of hyperglycemic crisis correction and achieved better glycemic control(decrease hypoglycemia and rebound hyperglycemia).

Eligibility Criteria:
Inclusion Criteria:

* Patients with hyperglycemic crisis(DKA, HHS or mixing type) receiving iv insulin infusion
* Patients admitted to the Changhua Christian Hospital Medical Intensive Care Unit(MICU)

Exclusion Criteria:

* pregnancy
* age under 18 years old
Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage

Aim of study: this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage.

Material and methods: The study will consist of two groups, each group has 10 Patients. The patients will be selected from the outpatient clinic of the orthodontic department at Mansoura University.

Patients will be divided into 2 groups, group 1 will be treated by direct bone anchored pull distal slider, and group 2 by indirect bone anchored dual force distalizer.

Aim of study:

this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage.

Participant and eligibility criteria:

The study will consist of two groups, each group has 10 Patients. The patients will be selected from the outpatient clinic of the orthodontic department at Mansoura University. pretreatment records will be taken including: intraoral and extraoral photographs, study models, panoramic radiographs, and lateral cephalometric radiographs.

Intervention:

written and informed consents will be taken from the patients.

Group 1:

* Two metal bands will be chosen and fitted on the maxillary first molars.
* Rubber base impression material will be taken with bands in place.
* Two metal bands will be placed in their relative positions in the impression and then poured up with stone.
* Send it to the LAB for appliance fabrication.
* At delivery day, the appliance will be cemented on the maxillary first molars by glass ionomer luting cement and two miniscrews will be placed in their positions.
* The appliance will be activated by closed coil spring, which apply 300g force. Patients will be monitored every 3 weeks.

Group 2:

* Four metal bands ( two for maxillary first premolars and two for maxillary first molars ) will be chosen and fitted on the teeth.
* Rubber base impression material will be taken with bands in place.
* Four metal bands will be placed in their relative positions in the impression and then poured up with stone.
* Send it to the LAB for appliance fabrication.
* At delivery day, the appliance will be cemented on the teeth by glass ionomer luting cement and two miniscrews will be placed in their positions, and activated by compressing the NiTi open coil spring, which apply 300g force. Patients will be monitored every 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Dental class II.
* No or mild to moderate maxillary teeth crowding.
* Erupted or partially erupted maxillary second molars.
* No previous orthodontic therapy.
* Absence or minimum crowding in the mandibular arch.
* Good oral hygiene.

Exclusion Criteria:

* Dental class I, III
* severe maxillary teeth crowding.
* Extracted or badly decayed maxillary first molars.
* Previous orthodontic therapy.
* Severe crowding in the mandibular arch.
* Bad oral hygiene.
Immediate Treatment vs Colposcopic Follow-up for Biopsy-Proven CIN 1

This study looks at immediate treatment of a cervix with CIN 1 versus regular six-month follow-up with colposcopy and treatment if CIN 1 progresses.

In women who present with biopsy-proven CIN 1, to compare the management approach of regular colposcopic follow-up and only treating progressive disease using the LEEP, with an approach of immediate treatment using LEEP. The primary outcome is progression to more advanced disease (i.e., CIN 2, CIN 3 or cancer).

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will:

  * have documented CIN 1 by histologic assessment as the highest grade lesion present,
  * have the lesion confined to the cervix and completely visualized,
  * be 16 years or older.

Exclusion Criteria:

* any one of the following will be an excluding characteristic:

  * index Pap smear showing CIN 2, CIN 3 or cancer;
  * index Pap smear shows atypical glandular cells of unknown significance, glandular dysplasia, or malignancy requiring immediate investigation;
  * patients with previously identified CIN 1 by biopsy who are already in a colposcopic surveillance program;
  * unsatisfactory colposcopic exam defined as inability to see the extent of the lesion in the endocervical canal or absence of a lesion on the ectocervix but endocervical curettage shows CIN 1;
  * pregnancy;
  * prior therapy for dysplasia including medical (5FU), surgical (Laser, LEEP) or cryotherapy;
  * prior gynecologic cancer;
  * prior pelvic radiation therapy;
  * inability to attend outpatient follow-up visits because of geographic inaccessibility;
  * other malignancies except non-melanoma skin cancer;
  * immunosuppression due to diseases such as AIDS, organ transplantation, or on immunosuppressive medications such as prednisone, imuran or chemotherapy for diseases like systemic lupus;
  * cognitively impaired or otherwise unable to obtain written informed consent;
  * extension of the CIN 1 lesion to vagina or a separate vaginal lesion showing dysplasia;
  * colposcopically visible condyloma outside of the transformation zone;
  * known allergy to local analgesics;
  * clinically evident vaginitis must be treated and resolved prior to entry on the trial;
  * inability to read and respond in English/French;
  * failure to provide informed consent.
Dilators for Dyspareunia Prevention

This is a randomized clinical trial comparing rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with traditional posterior repair. Our hypothesis is daily use of vaginal dilators from post-op week 4 through week 8 after posterior repair will reduce the rate of de novo dyspareunia.


Eligibility Criteria:
Inclusion Criteria:

* Women who undergo pelvic organ prolapse surgery with a posterior repair
* Age ≥18 years
* Sexually active with heterosexual vaginal intercourse
* English speaking
* Available for 6 month follow up
* Able to complete study questionnaires
* Able to use dilators

Exclusion Criteria:

* Significant baseline dyspareunia
* Pregnancy by self-report or positive pregnancy test
* Prior pelvic radiation therapy
* Active pelvic infection, herpes, candidiasis
Prognostic Significance of Bioscore in Nonmetastatic Breast Cancer

assess the validity of applying the bioscore system to predict the disease-free survival (The percentage of people in a study or treatment group who have not experienced disease relapse in a defined period of time.) in breast cancer patients presenting to our

Retrospective cohort analysis of breast cancer patient's records for patients treated with surgery as an initial intervention at our department from 2015 to 2018 will be identified. Multivariate analyses of factors, including pathological stage (PS), T stage (T), nodal stage (N), grade (G), estrogen receptor (ER) status (E) and human epidermal growth factor receptor (HER2) status will be recorded to identify associations with disease-free survival DFS. A score of 0-4 will be assigned for each factor by considering the hazard ratio magnitude.

Analysis of the correlation between pathological stage, T stage (T), nodal stage (N), grade (G), estrogen receptor (ER) status (E) and human epidermal growth factor receptor (HER2) status combined score and the disease free survival (DFS ).

Eligibility Criteria:
Inclusion Criteria:

- Female patients Newly diagnosed breast cancer patients presented to clinical oncology department, Assiut University in the period between (2015_2018).

Histologically confirmed invasive breast carcinoma (IBC) Age: ≥18 and older Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Complete medical records and follow up

Exclusion Criteria:

* Male patients No definitive surgery Incomplete medical records or follow-up status Unavailability of hormonal receptor status Carcinoma in situ or other rare tumors of the breast as phylloides tumors, pregnancy and lactation
A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
2. Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC
3. At least one measurable/evaluable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization

Key Exclusion Criteria:

1. Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC
2. History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization
3. Tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator
4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
5. Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
6. Prior malignancy active within the previous 2 years (exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast)
7. Active brain or leptomeningeal metastasis.
8. Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
9. Known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases, etc
10. Known history of Human Immunodeficiency Virus (HIV)
11. Has cardiovascular risk factors
12. Pregnant or breastfeeding woman.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Medical and Medico-economic Evaluation Comparing the Follow-up of Patients Undergoing Bariatric Surgery

Study design :

Prospective, longitudinal, observational (non-interventional), multicenter, comparative medico-economic study - RIPH2, with direct matching to SNDS data (National Health Data System)

Main objective :

To evaluate the effectiveness of a multidisciplinary, pre- and post-operative, care course for patients undergoing bariatric surgery


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for the Integrated group (SPOC)

  * Patient, male or female, at least 18 years old;
  * Patient undergoing bariatric surgery after the implementation of the integrated pathway (date depending on the deployment of the integrated pathway);
  * Patient informed and not objecting to this research;
  * Subject affiliated to or benefiting from a social security program.
* Inclusion criteria for the control group

  * Patient, male or female, at least 18 years old;
  * Patient undergoing bariatric surgery before the implementation of the integrated pathway (date depending on the deployment of the integrated pathway);
  * Patient informed and not objecting to this research;
  * Subject affiliated to or benefiting from a social security program.

Exclusion Criteria:

* • Protected patient : adult under tutorship, curatorship or other legal protection, deprived of his freedom by judiciary or administrative decision;

  * Patient hospitalised without consent
Emotion Processing Among Patients With ALS

The goal of this observational study is to learn about the emotional perception in people with ALS disease compared to people with other neuromuscular disease and healthy controls. The main questions it aims to answer are:

* How people with ALS judge happy and angry faces and what their "insight" into these judgements are like
* How their autonomic responses differ from the other two test group Participants will asked to judge if a face presents a happy emotion or angry emotion.

Researchers will compare the ALS group responses with neuromuscular diseases group and healthy control group responses to see if the ALS group judge more happy faces than angry.

Mild cognitive and behavioral changes occur in 35% of ALS patients and 10-15% of patients meet the criteria for FTD1-4. Recent research suggests changes in emotional perception and social cognition are a part of the neuropsychological changes in ALS, possibly associated with cognitive and behavioral symptoms seen in ALS-FTD5-9.

The aim of this project is to investigate emotional perception in ALS patients compared to healthy controls and patients with other neuromuscular diseases that do not affect the central nervous system. We use a simple emotion discrimination task to evaluate emotional bias and metacognition of emotion discrimination. Moreover, this project aims to explore the correlation between emotion perception and autonomic reactivity in ALS patients by recording heart rate frequency and respiration frequency during the EDT.

The project will contribute with deeper insights to the neuropsychological changes in ALS patients and the opportunity to quantify these changes. Thereby, the project will add new perspectives to the discussion of how we evaluate socio-emotional aspects of ALS in both clinical decision-making, guidance of relatives and future research.

Eligibility Criteria:
Inclusion Criteria:

* ALS patients, ambulant and hospitalized

  * Able to give informed consent
  * Diagnosed with ALS or probable ALS according to the existing revision of the El Escorial Criteria 21,22.
* Patients with a peripheral neuromuscular disease, ambulant and hospitalized

  * Able to give informed consent
  * Diagnosed with a peripheral neuromuscular disease, that does not affect CNS, including but not limited to Myasthenia Gravis and polyneuropathy
* Healthy controls

  * Able to give informed consent
  * Age and gender matched to ALS patients

Exclusion Criteria:

* All Participants

  * Other severe medical, neurological, or psychiatric disorders
  * Visual impairment to an extent that interferes with the ability to perform of the test
  * Severe motor or cognitive deficits, to the extent that the test-task cannot be performed
  * Alcohol or drug abuse to an extent the interferes with task performance
* Patients with a peripheral neuromuscular disease

  ● Familial predisposition to ALS
* Healthy controls

  * Familial predisposition to ALS (first degree relatives)
  * Medical treatment that affects the central nervous system (e.g., antidepressants)
The Effect of Doxycycline 100mg and Doxycycline 20mg in Treatment of Mild and Moderate Acne

The purpose of this study is to compare the safety and efficacy of twice daily subantimicrobial dose doxycycline 20mg with daily doxycycline 100mg in treatment of mild and moderate Acne.


Eligibility Criteria:
Inclusion Criteria:

* Acne

Exclusion Criteria:

* Pregnancy
Prospective Research in Memory Clinics (PRIME)

The purpose of the PRIME Study is to examine the current management and outcomes of patients with mild cognitive impairment or dementia. Approximately 4500 patients will be enrolled in this disease registry across 12 sites in Australia. Clinical, treatment, health status and economic data will be acquired over 3 years. The study will identify the relationships among demographic variables, prognostic features, geographic setting, treatment options and clinical, economic and health status (activities of daily living and caregiver impact) outcomes.

A complete record of patient care will be collected to provide detailed information on the management and outcome of mild cognitive impairment and dementia and the profile of patients at participating sites. The data will be used to build models looking at the effect of management of these conditions on principal clinical events, health status and economic outcomes. This will provide the foundation for subsequent objective and prospective evaluation of evidence-based strategies for the optimal treatment of mild cognitive impairment and dementia in Australia. This study is not prescriptive, but will instead examine the influence of a whole range of routinely used management strategies on clinical and economic outcomes among mild cognitive impaired and dementia patients in Australia. This 'practice based' approach is increasingly widely used and is a useful tool for elucidating the relative effectiveness of different management strategies and for exploring relationships between patient characteristics, treatment and outcomes. Observational study - no study drug administered.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dementia under the DSM-IV criteria, or of Mild Cognitive Impairment, using the Peterson Criteria
* Living in the community (home, apartment or collective housing with nursing care available for less than 40 hours per week)
* Patient able to provide written informed consent, or provision of written informed consent by a legal guardian/proxy
* Availability of a caregiver willing to provide consent for required components of the study
* Fluent in English
* May be participating in a Phase IV or other post-marketing follow up study of an approved product for treatment of dementia

Exclusion Criteria:

* No concomitant life-threatening illness (a condition which is likely to interfere with the patient's ability to complete the study)
* Not unwilling or unable to complete the study
* Not concurrently participating in a clinical trial of an investigational drug (phase I, II or III)
* Unwillingness of patient or legal guardian / proxy to provide written informed consent
* Unwillingness of caregiver to provide written informed consent
* For patients with diagnosis of mild cognitive impairment: current or previous treatment with any cholinesterase or memantine
Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)

Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED.

The study will consist of a 30 day screening/washout phase at the end of which qualified subjects will be assigned to alfuzosin 10 mg tablets once a day. Subjects will be treated for 90 days. The total duration of the study will be 120 days.

Eligibility Criteria:
Inclusion Criteria:

* Males 45-75 years of age
* Confirmed diagnosis of BPH/lower urinary tract symptoms (LUTS) and ED
* Men with steady partner and who agree to attempt sex once a week.

Exclusion Criteria:

* Prostate cancer
* Prostatitis
* Penile disease
* Cardiac co-morbidity
* Pre-existing co-morbid conditions
* History of sensitivity to the drug or similar drugs
* Enrollment in another clinical trial
* Impaired hepatic function
* Impaired renal function
* Mental conditions rendering subject unable to understand the study
* Subjects not likely to comply with protocol