cyrilzakka/clinical-trials huggingface dataset:
Selinexor in Advanced Liposarcoma

This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 342 total patients will be randomized to study treatment (selinexor or placebo).

In the Phase 2 portion of the study, 57 patients were randomized to selinexor (60 mg) or placebo at a 1:1 allocation ratio.

In the Phase 3 portion of the study, approximately 285 patients will be randomized to selinexor (60 mg) or placebo with a 2:1 allocation ratio.

Patients who progress during the blinded portion of the study will be unblinded and if receiving:

* placebo, may cross over to open-label selinexor (60mg twice-weekly)
* selinexor, will be withdrawn from further treatment and followed for survival

Study treatment will be given twice-weekly on Day 1 and Day 3 during Weeks 1-6 of each six-week (42 day) cycle until disease progression or intolerability.

Treatment will continue until one or more of the following occurs:

* Disease progression, as defined by RECIST v1.1 Response Criteria
* Clinical progression, as determined by the treating physician
* Unacceptable adverse events (AEs) or failure to tolerate study treatment
* Patient withdrawal
* Patient discontinuation due to non-compliance

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥12 years of age
2. Body surface area (BSA) ≥ 1.2 m2
3. Histologic evidence of DDLS at any time prior to randomization AND current evidence of DDLS requiring treatment
4. Must have measurable disease per RECIST v1.1 Response Criteria
5. Radiologic evidence of disease progression within 6 months prior to randomization. If the patient received other intervening therapy after documented disease progression, further disease progression must be documented after the completion of the intervening therapy
6. Must have had at least 2 prior lines of systemic therapy for liposarcoma (not to exceed 5 prior lines)
7. If patient received any previous systemic therapy, the last dose must have been ≥ 21 days prior to randomization (or ≥ 5 half-lives of that drug, whichever is shorter) with all clinically significant therapy-related toxicities having resolved to ≤ Grade 1

Exclusion Criteria:

1. Patients with pure well-differentiated liposarcoma (WDLS), myxoid/round cell or pleomorphic tumor histologic subtypes
2. Known active hepatitis B (HepB), hepatitis C (HepC) or human immunodeficiency virus (HIV) infection
3. Known central nervous system metastases
Cryotherapy With or Without Short-term Adjuvant Androgen-Deprivation Therapy in Prostate Cancer

This is an open-label randomized clinical study comparing primary prostate cryoablation alone (No-ADT group) with cryoablation plus short-term adjuvant androgen-deprivation therapy (Adj-ADT group) in the treatment of patients with high-risk localized prostate cancer.

Subjects (N=182) who have high-risk prostate cancer and have undergone primary prostate cryotherapy will be screened and randomized in a 1:1 ratio to receive either adjuvant ADT (Adj-ADT) or No-ADT until disease progression. Screening and randomization will be done within four weeks after cryoablation. Only those who are assigned to Adj-ADT will receive ADT for a total of 12 months. PSA will be checked every 3 months in the first year after Cryo and every 6 months thereafter. Long-term follow-up parameters include serum PSA and protocol-mandated biopsies (at 36 months after Cryo, irrespective of PSA levels if recurrence has not been documented). For-cause biopsy will also be done if post-Cryo PSA elevation reaches the Phoenix criteria (Nadir + 2 ng/ml) or when the treating physician thinks it necessary to document tumor recurrence.

Eligibility Criteria:
Inclusion Criteria:

1. Age\>20 years
2. Histopathology proven prostate adenocarcinoma
3. Non-metastatic localized disease
4. Prostate cancer is deemed high-risk for recurrence(PSA\>20 ng/ml, Gleason score\>=8, or clinical staging\>=T2c)
5. Subjects have undergone prostate cryoablation as the definitive treatment prior to enrolling the study
6. Subjects who have not been treated with any definitive treatments for prostate cancer, including radical prostatectomy or definitive radiotherapy. However, those who have undergone focal prostate cryoablation and have cancer recurrence are still eligible.
7. Subjects may or may not have received neoadjuvant androgen-deprivation therapy (ADT) in the forms of either castration (medical) and/or antiandrogens. Surgical castration (orchiectomy) is not allowed.
8. Subjects are willing to sign the informed consent and agree to comply with the study procedures

Exclusion Criteria:

1. Those who have been treated with \> 8 weeks (collectively if not continuously) of neoadjuvant ADT prior to screening.
2. Subjects who have other cancer that is deemed not cured or are known less than 5 years except for basal cell carcinoma of the skin
3. Other conditions the investigators think may affect subject compliance or safety
Reduction Efficacy of OLOMAX for Blood Pressure and Low-density Lipoprotein Cholesterol in Hypertensive Patients With Dyslipidemia

This study is a large-scale, prospective, multi-center, and non-interventional observation study to observe blood pressure and blood lipid changes and safety during administration of olomax tablets for 24 weeks in hypertensive patients with dyslipidemia.

In this study, investigator will evaluate subjects' clinical performance in actual care. Laboratory test results such as demographic information and medical treatment, blood pressure, blood lipid test, and liver function test conducted at the start date of Olomax tablet administration and subsequent 24 weeks (± 8 weeks) will be collected. In the case of safety-related information, such as abnormal cases, data shall be collected at any time during the 24-week follow-up period if there is a visit by the study subject according to daily treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Adult aged 19 or older at the time of the baseline visit.
2. A patient with hypertension and dyslipidemia who is scheduled to administer olomax tablet according to investigator's medical judgement.

   * Patients who were previously taking more than two tablets of a single drug, low-density lipoprotein-cholesterol (LDL-C)
   * Patients who were previously only taking blood pressure-lowering drugs and did not take LDL-C-lowering drugs, but who need to take additional LDL-C-lowering drugs at the discretion of the researcher
   * Patients who were previously taking LDL-C lowering agents and did not take blood pressure lowering agents, but who need to take additional blood pressure lowering agents according to the researcher's judgment
   * Patients who have not previously taken both a blood pressure drop and an LDL-C drop but need additional simultaneous use at the discretion of the researcher
3. A person who can understand the information provided to him/her and may voluntarily sign a written consent form

Exclusion Criteria:

1. A person who falls under the prohibition of administration according to the permission for olomax tablet
2. A person who has a history of administering olomax tablets before participating in this study
3. In addition to the above, a person that the investigator thinks he/she is not suitable for participating in this observation study;
Parenteral Nutrition for Patients Treated for Locally Advanced Inoperable Tumors of the Head and Neck

Prevention of critical weight loss. In patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) weight loss is a relevant clinical problem during radiotherapy and might result in higher treatment related toxicity and discontinuation of a potential curative treatment. Thus the investigators want to evaluate the efficacy of overnight parenteral nutritional (PN) support in patients with SCCHN treated with curative radiotherapy (RTX) in combination with Cetuximab (E) or Cisplatin (P).

The investigators hypothesize that about 60% of patients receiving RTX without supplemental PN will suffer from critical weight loss of more than 5% during treatment - supplemental overnight PN might result in significant improvement of the nutritional status .

Eligibility Criteria:
Inclusion Criteria:

* Any patient who is eligible for definitive curative radio-chemotherapy with Cisplatin or radio-immunotherapy with Cetuximab.
* Written informed consent obtained prior to any study specific screening activities and patients have to be able to comply with this protocol.
* Histologically confirmed local advanced squamous cell carcinoma of the Larynx, Hypopharynx, Oropharynx or Cavum oris treated with definitive radiotherapy in combination with Cisplatin or Cetuximab.
* p16 status available
* Age ≥ 18
* Women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception.

Exclusion Criteria:

* Distant metastases
* Prior radiation (Head and neck area)
* Pregnant or lactating women
* History of other malignancy; yet patients who have been disease-free for 5 years or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
* Concurrent other cancer therapy (chemotherapy, immunotherapy, antihormonal or biologic therapy) or concurrent treatment with an investigational drug.
* Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent.
* Participation in another interventional clinical study at time of study inclusion (except follow-up period without treatment for more than 30 days) or denial of the simultaneous participation in a non-interventional study by the PI of the study center.
Predicting Metastatic Oral Squamous Cell Carcinomas With Molecular Biomarkers Using Machine Learning

Application Management Team:

PI - Siu Wai Choi; email - htswchoi@hku.hk Delegates - Chui Shan Chu; email: sunshine.c@connect.hku.hk FollowUpUsers - Chui Shan Chu; email:sunshine.c@connect.hku.hk

Eligibility Criteria:

- patients were diagnosed with a baseline disease of oral squamous carcinoma.

Exclusion Criteria:

- N/A

Sample size:

- \~500 subjects

Source of Data:

- The data, such as age and medical records, would be obtained from Hospital Authority Clinical Management System (HACMS)

Statistical analysis:

- machine learning will be applied into analysis plan

Eligibility Criteria:
Inclusion Criteria:

* patients with oral squamous carcinoma
* received surgery from 1st October 2000 to 1st October 2019

Exclusion Criteria:

N/A
Multicenter Assessment of a Bedside-testing System (Nephrocheck™) for Acute Kidney Injury After Thoracoabdominal Aortic Surgery

Assessment of postoperative acute kidney insufficiency according to the KDIGO classification using the Nephrocheck system.

Multicentric, prospective study Open TAAA Repair in 3-4 centers in Germany and Europe


Eligibility Criteria:
Inclusion Criteria:

elective open TAAA repai

18-80 years

no pregnancy

Exclusion Criteria:

emergency treatment participation in another Trial renal replacement therapy
Algorithm Guided Treatment Strategies for Major Depressive Disorder

The purpose of this study is to compare treatment outcomes between measurement based Algorithm Guided Treatment and Treatment As Usual strategies in a Chinese population with major depressive disorder.

The AGT arm includes a 2-step medication monotherapy and a combination treatment algorithm. The first step (level 1) includes two medication monotherapy options: escitalopram and mirtazapine. For those participants who don't remit with the initial intervention after up to 6 to 12-week treatment, the second step (level 2) with a variety of treatment options will be provided. In level 2 intervention, a switch strategy for those who don't remit with escitalopram will be switched to mirtazapine, or for those who don't remit with mirtazapine will be switched to escitalopram, combination strategy (i.e. escitalopram plus mirtazapine) and augmentation strategy (i.e. escitalopram or mirtazapine plus either rTMS or mECT). Participants who don't get remission in level 1 intervention will be encouraged to enter level 2 interventions based on intend-to-treatment principle. The TAU arm as control intervention is performed using the psychiatrist's individual discretion based on his/her expertise and knowledge.

Participants will be recruited consecutively in 8 psychiatric settings across China and randomized into any of the two initial interventions of AGT or TAU arm. Follow-up interviews will be performed monthly for all participants who finish any acute treatment of AGT or TAU. The follow-up period will last up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for single or recurrent nonpsychotic major depressive disorder
* Age 18-75
* Written informed consent completed
* Scores 14 or higher on the 17-item Hamilton Depression Rating Scale
* Initial treatment with escitalopram or mirtazapine or other antidepressants is clinically appropriate

Exclusion Criteria:

* History of bipolar disorder
* Concurring psychotic disorders
* Scores 3 or higher on item 3 (suicidal) of HRSD-17
* History of nonresponse to an adequate trial of escitalopram and/or mirtazapine
* Has general medical condition, which contraindicates any leve 1 or 2 treatment option
* Is on concomitant medication, which contraindicates any leve 1 or 2 treatment option
* Any contraindication for mECT or rTMS
* Is pregnant or breast feeding or is planning to get pregnant
Efficacy and Safety of Systemic Treatments of Bone Metastases From Kidney Cancer in Patients Treated With Targeted Therapies

Multicenter, randomized, open-label, 2-arm, parallel-group, phase III study whose goal is to assess the efficacy and safety profile of bone-targeted treatments (Arm A: denosumab or zoledronic acid) versus the control arm (Arm B: no specific treatment) in patients with bone metastases under targeted therapy for Metastatic Renal Cell Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Histologically proven mRCC.
* Administration of one of the systemic agents in use for the treatment of mRCC (no more than three prior systemic therapy regimens). Patients with at least 6 months of 1st line treatment and a bone event may be included.
* More than 1 bone metastasis.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
* Adequate renal function (serum creatinine ≤ 200 mmol/L or creatinine clearance ≥ 30 mL/min according to Cockroft formula or MDRD formula for patients older than 65 years).
* Covered by a medical insurance.
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
* Signed informed consent.
* Accepting to use effective contraception during study treatment and within 5 months after final dose of study therapy.

Exclusion Criteria:

* Prior bisphosphonate or denosumab treatment in the year before inclusion.
* Imminent or ongoing nerve or spinal compression as per the investigator's judgement.
* Ongoing first-line therapy, started for less than 6 months (patients with BM at time of metastases diagnosis will initially benefit from the angiogenesis targeted agents used and are not at higher risk).
* Anticancer treatment under investigation.
* Paraneoplastic hypercalcemia (corrected total calcium \> 2.7 mmol/L).
* Grade 4 toxicity under previous targeted agents.
* Liver failure (AST and/or ALT ≥ 5.0 x upper limit of normal (ULN) or total bilirubin beyond normal limits).
* Severe hypocalcaemia \> 2.8 mmol/l.
* Fructose intolerance.
* Invasive dental procedure (i.e. tooth extraction, dental implants, oral surgery) within the 10 days prior to randomization or required dental procedures at the pre-inclusion dental examination.
* Psychological, familial, sociological, geographical conditions that would limit compliance with study protocol requirements.
* Pregnant or breastfeeding woman. Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior inclusion.
* Life expectancy ≤ 3 months.
* Participation to another clinical trial that might interfere with the evaluation of the main criterion.
* Known hypersensitivity to the active substance or to any of the excipients of bisphosphonate or denosumab.
Study to Evaluate Estradiol Vaginal Tablets vs Promestriene Vaginal Cream

This is a study to evaluate the acceptability, efficacy and preferences of 10 of estradiol vaginal tablets vs promestriene vaginal cream

This is an observational, prospective, open-label, parallel-group study to evaluate the acceptability, efficacy, and preferences of postmenopausal women older than 45 between 10 micrograms of estradiol vaginal tablets vs promestriene vaginal cream

Eligibility Criteria:
Inclusion Criteria:

Postmenopausal women aged 45 years or older. Women will be considered postmenopausal with more than 12 months since last menstrual period

* Women who have been prescribed vaginal estradiol tablets or vaginal promestriene cream· Women who have read and signed the Informed Consent Form
* Women with an intact uterus
* One or more vaginal symptoms (dryness, soreness, irritation, dyspareunia) rated as moderate to severe. Symptoms are moderate if the patient needs a treatment and feels discomfort. Symptoms are severe if the patient needs a treatment, and feels such a degree of discomfort that this could severely impact the subject's daily activities
* In case of doubt, blood estradiol concentration will be determined, and the subject will only be enrolled if the levels are equal to 30pg./ml. or less.

Exclusion Criteria:

* Women who had a known or suspected history of breast carcinoma

  * Estrogen dependent neoplasia. Women with a known, past or suscpected Estrogen-dependent malignant tumours such as endormetrial or ovarian cancer
  * Positive or suspicious mammogram results
  * Any systemic malignant disease
  * Hormone therapy treatment (sex hormones or vaginal treatments or steroids) in the last three months Women who had abnormal vaginal bleeding or uterine bleeding of unknown cause
  * Vaginal infection requiring treatment
  * Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) Untreated endometrial hyperplasia Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency) Active or previous arterial thromboembolic disease (e.g. angina, myocardial infarction) Acute liver disease, or history of liver disease as long as liver function tests have failed to return to normal Known Hypersensitivity to the active substances or to any of the excipients Porphyria
  * Any serious disease or chronic condition that could interfere with study compliance
  * History of thrombolytic disorders
  * Use of vaginal contraceptives (DIU, vaginal ring...)
  * Participation in another clinical trial in the last three months.
GlucoVIP - Diabetes Treatment by Glucobay® With a Special Therapeutic View to Chosen Patient Groups

Evaluation of safety and effectiveness of Glucobay® under daily-life treatment conditions in a large sample of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with untreated or pretreated diabetes mellitus or patients for which acarbose is indicated and without acarbose treatment within the last three months before study inclusion. The decision for treatment type and duration is taken by the investigator and is made before inclusion into the study.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.
Seizure Prophylaxis in Aneurysm Repair

After a thorough review of the existing literature as well as a review of our own practice, the investigators have concluded that the decision to treat patients undergoing aneurysm repair with levetiracetam has reached true clinical equipoise. In other words, the investigators cannot favor a decision to either administer or not administer this drug in these patients based on the existing information. The utility of anti-epileptic prophlaxis in the perioperative period for patients undergoing intracranial aneurysm repair remains a common practice that is not supported by the current literature that includes retrospective analyses as well as prospective trials for similar but not identical types of patients. The investigators propose to settle this dilemma by performing a prospective randomized trial in patients undergoing aneurysm repair in order to definitively determine if the common practice of perioperative antiepileptic drug administration has any utility. The study will be extended to June 2024 to allow for a 5 year follow up of the last enrolled patient in June, 2019.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years)
* Presence of intracranial aneurysm (with or without rupture)
* Treating surgeon has recommended surgical repair of the aneurysm

Exclusion Criteria:

* History of seizures within last 10 years
* History of epilepsy
* History of prior stroke
* Currently prescribed medication with anti-epileptic activity (keppra, dilantin, tegretol, lamictal, topamax, etc.)
* Brain tumor
* Pregnant or nursing woman
* Known levetiracetam allergy
Evaluation of Daily Disposable Lenses With Multi-Purpose Solution (MPS)

The purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027.

Corneal staining and subjective responses for ocular redness and comfort will be compared.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
* Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History of hypersensitivity to any components of the multi-purpose solution.
* Evidence or history of ocular conditions as prescribed in protocol.
* One functional eye or a monofit lens
* Any slit-lamp finding score equal to 1 at Visit 1 of each study period.
* Significant corneal staining at visit 1 of each study period as prescribed in protocol.
* Other protocol-defined exclusion criteria may apply.
Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches

This study aims to examine the long-term effect of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, on chronic headaches following mild traumatic brain injury (mTBI). rTMS has been shown to be effective in reducing chronic headaches without side effects commonly seen in medications, such as sleepiness and addiction. This study uses rTMS to manage chronic headaches to improve post-concussion symptoms and reduce the economic burden due to delayed recovery. This project aims to better identify biomarkers for diagnosis and prognosis and maximize recovery from mTBI.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 55 years old who were actively working prior to mTBI
* mTBI with loss of consciousness for less than 30 min, initial Glasgow Coma Scale between 13 and 15, or post-traumatic amnesia for ≤ 24 hours
* diagnosis of persistent post-traumatic headache according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria
* headache develops within 7 days after head trauma
* headache persists for \>=3 months after head trauma despite receiving standard care
* average persistent headache intensity is \>= 3/10 of the numerical rating scale (NRS) on \>=3days/week
* no evidence of radiculopathy or peripheral neuropathy on electromyography or clinical evaluation
* no evidence of other possible causes of headaches

Exclusion Criteria:

* history of chronic headache diagnoses such as migraine, tension, or cluster headaches prior to the incidence of mTBI
* history of other neurologic conditions with medications affecting the central nervous system
* contraindications of receiving TMS (e.g., a history of epileptic seizure and having implants like a cardiac pacemaker or intracerebral vascular clip