cyrilzakka/clinical-trials huggingface dataset:
Social Anxiety Disorder Study Of Paroxetine

This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD).


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder) according to DSM-IV-TR criteria.
* Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.
* Patients have a minimum score of 60 on the LSAS total score.

Exclusion criteria:

* Patients primarily diagnosed with a disorder that is categorized into Axis I excluding SAD by DSM-IV-TR (e.g. major depression, dysthymic disorder, specific phobia (simple phobia) , obsessive compulsive disorder, panic disorder) within 24weeks before week -2.
* Patients with a history or complication of schizophrenia and bipolar disorder
* Patients with a complication of body dysmorphic disorder.
* Patients with evidence of substance abuse (alcohol or drugs)
* substance dependence by DSM-IV-TR criteria within 24 weeks before week -2.
* Patients who started psychotherapy and cognitive-behavioural therapy within 24 weeks before week-2, except for supportive psychotherapy.
* Patients receiving electro-convulsive therapy (ECT) within 12 weeks before week -2.
* Patients being pregnant, lactating or are of childbearing potential and are likely to become pregnant.
* Patients with 3 or more points of HAM-D Item No. 3, or who are likely to attempt suicide.
* Patients with a history or complication of cancer or malignant tumor.
* Patients receiving MAO inhibitors (FP®) within 14 days before expected week 0 visit date.
Serum Immunoglobulin (G) as a Marker of Diabetic Nephropathy

Diabetes mellitus is a chronic disease that affects 366 million people worldwide ( 6.4 % of the adult population ) and is expected to rise to 522 million by 2030 . Diabetic nephropathy occurs in approximately one - third of all people with diabetes and is the leading cause of renal failure in developed and developing countries Diabetic nephropathy is a severe complication occurring in diabetic patients and it is associated with an increased risk of all- cause mortality , cardiovascular disease and progression to end stage renal disease , requiring costly renal replacement therapy in the form of dialysis or transplantation


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetic patients

Exclusion Criteria:

* patients with diabetes type 1 ,
* pregnant and lactating females ,
* patients with any congenital disease , Infection , Smokers , alcoholics , and drug abusers .
(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors

This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antineoplastic activity of avapritinib (formerly BLU-285), administered orally (PO), in adult patients with unresectable GIST or other relapsed or refractory solid tumors. The study consists of 2 parts, a dose-escalation part (Part 1) and an expansion part (Part 2).


Eligibility Criteria:
Inclusion Criteria:

* For Part 1: Histologically- or cytologically-confirmed diagnosis of unresectable GIST or another advanced solid tumor. Patients with unresectable GIST must have disease that has progressed following imatinib and at least 1 of the following: sunitinib, regorafenib, sorafenib, dasatinib, pazopanib or an experimental kinase-inhibitor agent, or disease with a D842 mutation in the PDGFRα gene. Patients with an advanced solid tumor other than GIST must have relapsed or refractory disease without an available effective therapy.

OR For Part 2:

* Group 1: Patients must have a confirmed diagnosis of unresectable GIST that has progressed following imatinib and at least 1 of the following: sunitinib, regorafenib, sorafenib, dasatinib, pazopanib, or an experimental kinase-inhibitor agent, and the patient does not have a D842V mutation in PDGFRα.
* Group 2: Patients must have a confirmed diagnosis of unresectable GIST with a D842V mutation in the PDGFRα gene. The PDGFRα mutation will be identified by local or central assessment, either in an archival tissue sample or a new tumor biopsy obtained prior to treatment with avapritinib.
* Group 3: Patients must have a confirmed diagnosis of unresectable GIST that has progressed and/or patients must have experienced intolerance to imatinib and not received additional kinase-inhibitor therapy. Patients must not have a known D842V mutation in PDGFRα.
* Groups 1, 2 and 3: At least 1 measurable lesion defined by mRECIST 1.1 for patients with GIST.
* Groups 1 and 2: A tumor sample (archival tissue or a new tumor biopsy) has been submitted for mutational testing.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

* QT interval corrected using Fridericia's formula (QTcF) \>450 milliseconds
* Platelet count \<90,000/mL
* Absolute neutrophil count \<1000/mL
* Hemoglobin \<9 g/dL
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 x the upper limit of normal (ULN) if no hepatic metastases are present; \>5 × ULN if hepatic metastases are present
* Total bilirubin \>1.5 × ULN; \>3 × ULN with direct bilirubin, \>1.5 × ULN in the presence of Gilbert's Disease
* Estimated (Cockroft-Gault formula) or measured creatinine clearance \<40 mL/min Brain malignancy or metastases to the brain
* History of a seizure disorder or requirement for anti-seizure medication
* Group 3: Patients known to be KIT wild type.
Patient Knowledge on Pain Management and Safe Opioid Use

The purpose of this study is to examine what patients currently know about opioids, including their role in pain management, side effects, risks of abuse, and proper storage and disposal. It is critical for patients to be properly informed about opioid usage in treating postoperative pain, but current gaps in patient knowledge are not well understood.

This study will help identify knowledge deficiencies and guide future patient education. Additionally, this study will examine possible patient factors that may be associated with these gaps. Evaluation of patient knowledge will be assessed through interviews conducted before patients' day of surgery.

Opioids are frequently prescribed to treat pain after surgery, and while these medications may be effective analgesics they are also susceptible to misuse and addiction. There are growing concerns that prescription opioids contribute to the existing opioid supply and become potential sources for abuse1,2. In fact, opioids are often abused by those using medications not prescribed to them but obtained from friends or relatives3,4.

Many patients who undergo surgery are not given adequate information about opioids and strategies for postoperative pain management. Studies find that inadequate knowledge and inability to recall postoperative pain regimens result in poor compliance5. Many patients are also unaware of how to properly store and dispose of prescription opioids1,6 and this predisposes them to opioid misuse and improper saving and sharing of pills6.

Little is known, however, about the specific gaps in knowledge and what patient demographics may be associated with lack of understanding. As an initial step toward addressing these issues, this study seeks to identify deficiencies in patient understanding of opioids and pain management.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 18 and 80 years old
* Undergoing primary total hip replacement surgery
* English speaking

Exclusion Criteria:

* Medical background (profession that involves the prescribing, dispensing, handling, or administering of opioids)
* History of chronic opioid use (continuous opioid use for 3 or more months)
* Opioid use within the past 3 months
* Non-English speakers
Mechanisms of Refractory Hypertension (Reserpine)

The study is deigned to determine if refractory hypertension is attributable to heightened sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic agent, in patients failing other classes of antihypertensive agents.

Patients with refractory hypertension, defined as uncontrolled office blood pressure despite use of 5 or more antihypertensive agents, including a thiazide diuretic and spironolactone. After withdrawal from other centrally-acting agents if needed, enrolled patients will be randomized to open-label reserpine 0.1 mg daily for 4 weeks. Twenty-four hour ambulatory blood pressure monitoring will be done at baseline, after the initial 4-week treatment period. All other antihypertensive medications will remain unchanged during the 4-week treatment period. The primary endpoint will be change in 24-hr ambulatory systolic blood pressure.

Eligibility Criteria:
Inclusion Criteria:

- adult with refractory hypertension defined as uncontrolled office blood pressure with use of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone

Exclusion Criteria:

* congestive heart failure (EF 40%)
* chronic kidney disease (GFR \<40 ml/min/1.73 mm)
* stroke and/or myocardial infarction or acute CHF exacerbation within last 3 months
* ongoing depression
* active peptic ulcer disease
* bradycardia \<50 beats per minute
* 2nd or 3rd degree heart block
* known intolerance of reserpine
* use of digoxin or tricycle antidepressants
Stereotactic Body Radiation Therapy vs. Microwave Ablation for Colorectal Cancer Patients With Metastatic Disease in the Liver

This study is a randomized phase II trial between microwave ablation (MWA) and stereotactic body radiotherapy (SBRT) - two standard treatment modalities for colorectal patients with metastatic disease in the liver. Primary endpoint is freedom form local lesion progression.

Colorectal cancer patients with 1-3 liver metastases (diameter ≤4.0 cm) found unsuitable for resection are randomized 1:1 to either MWA or SBRT. Chemotherapy is allowed. Curative treatment of extrahepatic disease must be initiated in patients with lung metastases and/or primary tumors. Patients will be analyzed according to the intention-to-treat principle.

Eligibility Criteria:
Inclusion Criteria:

1. Colorectal cancer patients with oligo metastatic disease in the liver (1 to 3 tumors), and where metastases are found unsuitable for resection because of

   1. non-resectability
   2. small metastasis localized deep in the liver, where a parenchyma sparing intervention is preferred over an extensive resection
   3. previous extensive liver surgery
   4. comorbidity
2. The multidisciplinary team should all agree that both percutaneous or open surgical MW-ablation and SBRT are safe as first treatment choice for the individual patient.
3. Tumor sizes ≤4.0 cm
4. Age \> 18 years
5. Signed informed consent

Exclusion Criteria:

1. Previous radiotherapy to the liver
2. Liver volume \< 700 ml
3. Another active cancer disease within the past 36 months
4. Not able to understand written or oral protocol information
A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis

To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2).

To assess the pharmacokinetic (PK) properties of total BAY1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with psoriasis (Part 2).


Eligibility Criteria:
Inclusion Criteria:

Part 1 (healthy male subjects)

* Healthy male subjects, 18 to 50 years of age (inclusive), and in good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening
* Body mass index (BMI) above or equal to 18.5 and lower or equal to 30 kg/m2 (BMI = body weight (kg) / \[height (m)\]2 and a body weight above or equal 50 kg Part 2 (patients with psoriasis)
* Male patients, 18 to 70 years of age (inclusive) or female patients of non-child bearing potential, 30 to 70 years of age (inclusive)
* Body mass index above or equal to 18.5 and lower or equal to 35 kg/m\*2 and a body weight above 50 kg
* A documented diagnosis of psoriasis, with a history of at least 6 months prior to study drug administration. Moderate to severe plaque psoriasis at screening, defined by: a) an involved body surface area (BSA) above or equal to 10% of BSA, b) a Psoriasis Area and Severity Index (PASI) score of above or equal, 12 c) a Physician's Global Assessment (PGA) score of above or equal 2.

Exclusion Criteria:

* History of hypersensitivity to any of the components of the study drug
* Any clinically relevant abnormal findings in safety laboratory parameters and ECG
* History of tuberculosis (TB) or active or latent tuberculosis
* Receipt of live or attenuated vaccine 90 days prior to the first dosing
Fall Risk Prediction and Reduction in Community Ambulators 65 Years of Age or Older

The purpose of this study is to assess the diagnostic efficacy of the Tinetti Assessment, Timed up and Go test (TUG) and Gait Speed on predicting fall risk in adults 65 years of age or greater who are community ambulators.


Eligibility Criteria:
Inclusion Criteria:

* adults 65 years or older who are community ambulators.

Exclusion Criteria:

* known neurological disorder;limitation secondary to recent orthopedic condition; currently resides at skilled nursing facility
Safety and Efficacy Study of BMS-908662 Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer

The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when administered alone or in combination with cetuximab

Phase 1: Single Arm Study

Phase 2: Randomized Controlled, Parallel

Eligibility Criteria:
Inclusion Criteria:

* Subjects with K-RAS (codon 12 or 13) or B -RAF (V600E) mutation positive advanced or metastatic colorectal cancer who have relapsed or are refractory to 2 or more standard systemic anticancer regimes for metastatic disease, or are intolerant to existing therapies.
* Histologic or cytologic confirmation of the diagnosis.
* Eastern Cooperative Oncology Group (ECOG) ≤ 1
* Adequate organ \& marrow function.

Exclusion Criteria:

* Uncontrolled or significant cardiovascular disease.
* Phase 2: Prior therapy with a RAF inhibitor.
iQuit Mindfully: Text Messaging for Smoking Cessation

The purpose of this study is to investigate text messaging as a way to enhance mindfulness-based treatment for smoking cessation.

This study is a pilot investigation of mindfulness-based smoking cessation treatment incorporating between-session text messaging ("iQuit Mindfully"). Participants will be randomly assigned to one of two groups: Mindfulness-based Addiction Treatment (MBAT) or iQuit Mindfully (MBAT with the addition of between-session text messages).

All participants will receive in-person group treatment based on the 8-week MBAT protocol in addition to nicotine patch therapy and self-help materials. Participants assigned to iQuit Mindfully will receive additional support via text messaging. Assessments will occur at baseline, at each of the weekly in-person visits, at end of treatment, and at 1-month follow-up. Feasibility, smoking abstinence, mindfulness practice, and indicators of tobacco dependence and psychological well-being will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65 years
* current smoker with history of \>5 cigarettes/day for past year (and expired carbon monoxide \>6 parts per million \[ppm\])
* motivated to quit within next 30 days
* valid home address in the greater Atlanta, Georgia area
* functioning telephone number
* own a mobile phone with text messaging capacity
* can speak, read, and write in English
* at least a sixth-grade level of health literacy

Exclusion Criteria:

* contraindication for nicotine patch
* active substance abuse/dependence
* regular use of tobacco products other than cigarettes
* current use of tobacco cessation medications
* pregnancy or lactation
* household member enrolled in the study
* current diagnosis of schizophrenia or bipolar disorder, or use of antipsychotic medications
* clinically significant depressive symptoms
Quadratus Lumborum Block in Pediatric Patients

Quadratus lumborum block (QLB) is a newly-defined trunk block performed with local anesthetic injection by imaging the abdominal muscles with ultrasonography (US) guidance; thus, analgesia is expected to be ensured from the T7-L1 dermatomal segment level.

In the study, the aim was to compare the postoperative analgesic effect of quadratus lumborum block in pediatric patients undergoing lower abdominal surgery

Patients included in the study were randomly divided into 2 groups. Cases were assessed as intravenous opioid with 1 mg/kg tramadol HCl (Group O, n=20) or ultrasonography-guided quadratus lumborum block (Group B, n=20).

Total analgesic amounts in 24 hours and first analgesic requirement times recorded.

Eligibility Criteria:
Inclusion Criteria:

* The study included 40 cases undergoing lower abdominal surgery aged from 3 to 16 years with ASA (American Society of Anesthesiologist) I-II level.

Exclusion Criteria:

* Cases with ASA III-IV health level and those with a history of allergy to local anesthetic medications were not included in the study.
A Study of Vismodegib (GDC-0449) in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

This is an open-label, non-comparative, multicenter, expanded access study of Vismodegib (GDC-0449) in patients with locally advanced basal cell carcinoma (BCC) or metastatic BCC (mBCC) who are otherwise without satisfactory treatment options.


Eligibility Criteria:
Inclusion Criteria:

* For patients with mBCC, histologic confirmation of distant BCC metastasis
* For patients with locally advanced BCC, at least one histologically confirmed lesion 10 mm or more in diameter and written confirmation from a surgical specialist that the tumor is considered inoperable or that surgery is contraindicated
* For patients with locally advanced BCC, radiotherapy must have been previously administered for locally advanced BCC, unless radiotherapy is contraindicated or inappropriate. For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.
* Patients with Gorlin syndrome may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above
* Patients with measurable and/or non-measurable disease (as defined by RECIST) are allowed
* Adequate organ function
* For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 12 months after discontinuation of Vismodegib (GDC-0449)
* For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 3 months after discontinuation of Vismodegib (GDC-0449)

Exclusion Criteria:

* Pregnancy or lactation
* Life expectancy \< 12 weeks
* Concurrent non-protocol-specified anti-tumor therapy
* Completion of most recent anti-tumor therapy at least 21 days prior to initiation of treatment
* Uncontrolled medical illnesses such as infection requiring treatment with intravenous antibiotics
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk from treatment complications
* Unwillingness to practice effective birth control
PREDICTive FactOR of Overall Survival Among Geriatric Assessment Tools and Disease Related Factors in Elderly Patients With High Risk Myelodysplastic Syndromes.

No prospective study was conducted in elderly patients with cancer to assess the relative value of disease-related and patient-related prognosis factors. Patient-related prognostic factors have been highlighted in elderly patients with cancer resulting in the necessity of a geriatric assessment. The impact on overall survival of all of these factors was recognized in elderly people with cancer but remains unknown in High Risk Myelodysplastic Syndromes (HR-MDS). Therefore this information could be crucial to better select geriatric assessment domains relevant for the prediction and to recommend simplified tool after stratification of geriatric assessment domains thanks to their predictive value.

The main hypothesis is that patient-related factors will have a better capacity to predict survival and treatment tolerance than disease-related factors in HR-MDS aged 75 and over and that the predictive value will be different among assessment tools which allows a selection of reduced number of tools for clinical use.

To best knowledge estimation of predictive value of geriatric assessment tools remains unknown and explains why no standardization of practice exists. In testing all tools at the same cohort of patients allows to compare different tools and to define minimal and optimal geriatric assessment for HR-MDS. To determine the best strategy of geriatric assessment will allow in a second time to measure the impact of the use of this geriatric standardized evaluation by comparing patients'care and prognosis according to the use or not by the doctors of the new scores.

Research outcomes are various medical, economic and ethic. Medical because decision-making will be improved with simplified geriatric assessment; economic because a better knowledge of geriatric assessment will improve treatment toxicity prevention and decrease treatment costs. Ethic will be associated with this project because a better knowledge of geriatric assessment tools to predict survival and tolerance treatment could improve the choice of best supportive care if prognosis markers are not favorable to active therapy. This project could induce important modification of practice in this area to an improved personalized treatment and simplification of geriatric assessment allowing a large diffusion in hospitals and clinics.


Eligibility Criteria:
inclusion criteria:

* Diagnosis of HR-MDS inferior to 6 weeks,
* No treatment received before inclusion,
* IPSS superior to 1 (intermediate 2 and high risk IPSS categories),
* Social system affiliation,
* Informed consent signed.

exclusion criteria:

* Patient eligibility to stem cell transplantation,
* IPSS inferior or egal 1 (low or intermediate 1 IPSS),
* Concomitant investigational trial participation, which could interfere,
* Patients under legal protection.