cyrilzakka/clinical-trials huggingface dataset:
A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer

The purpose of this study is to find out whether combining a shorter than standard course of ADT with standard prostate brachytherapy and hypofractionated external beam radiation therapy is a safe and effective way to prevent high-risk prostate cancer from coming back and/or spreading to other parts of the body.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically-proven diagnosis of prostate adenocarcinoma
* Clinical stage T3-4 or Gleason score 8-10 or PSA \>20 ng/ml

  °If radiographic T3-T4 is the only high-risk factor, it must be "consistent with" or \>90% probability of having T3-T4 disease determined by the reading radiologist.
* Decipher genomic score ≤0.6
* Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)
* Age ≥18
* KPS ≥70 or ECOG 0-2
* Estimated life expectancy \>5 years
* Baseline prostate volume ≤90 cc
* Baseline IPSS ≤20
* No contraindications to ADT, brachytherapy, or pelvic external beam radiation therapy as determined by the treating radiation oncologist per standard practice
* Patients who have already started ADT consisting of bicalutamide 50 mg PO daily with leuprolide or an equivalent GnRH analogue are eligible if given for ≤ 60 days prior to registration

Exclusion Criteria:

* Regional lymph node or metastatic disease
* Prior pelvic radiation
* Prior prostate surgery (including TURP or cryosurgery)
* Prior history of inflammatory bowel disease
* Unable to undergo anesthesia or brachytherapy
* Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer
A Phase II Trial of Induction Chemotherapy With ND-420, Cisplatin and Fluorouracil Followed by Surgery in the Treatment of Patients With Localized Squamous Cell Carcinoma of the Esophagus

Investigator will assign 53 patients who had been histologically proven localized squamous cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg/m2 on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every 3 weeks for 2 cycles and then followed by surgical resection. The successful rate of complete treatment per protocol and complete resection will be the primary variant to evaluate in our study.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have been histologically proven esophageal carcinoma (squamous cell carcinoma).
* The tumor had to be locally advanced (stage T2-3/N0, T1-3/N+, if technically resectable with curative intent).
* Patients must be 20 years of age.
* Patients must have an ECOG performance status score 2.
* Patients must have a life expectancy of at least 12 weeks.
* Patients must be accessible for treatment and follow-up at least for one year.
* Patients must sign the informed consent form.
* Patient must have:Hemoglobin level 9 g/dl; Neutrophil count 1,500/mm3; Platelets count 100,000/mm3; Serum bilirubin level 1.0 ULN; Serum transaminase (GOT, GPT) levels 2.0 ULN; Serum Alkaline phosphatase levels 2.0 ULN; Serum creatinine level 1.5 mg/dl or Creatinine clearance rate(CrCl)60 ml/min for the institution (calculated by the Cockcroft- Gault equation).

Exclusion Criteria:

* Patient who are receiving or had received concurrent radiotherapy, chemotherapy or other anticancer treatment for esophageal carcinoma.
* Patients with known history of severe hypersensitivity reactions to any medicine or to drugs formulated with polysorbate 80.
* Major surgery within two weeks prior to entering the study, excluding port-A insertion or feeding jejunostomy surgery.
* Patients with CNS metastasis, including clinical suspicion.
* Patients with clinically detectable peripheral neuropathy 2 on the CTC criteria.
* Mental statuses of patients are not fit for clinical trial.
* Fertile men and women unless using a reliable and appropriate contraceptive method.
* Patients with pregnancy or lactating, women considering pregnancy, possible pregnancy that without using effective contraception.
* Patients who have serious concomitant illness that might be aggravated by chemotherapy, as below included:Active cardiac disease (e.g. congestive heart failure, angina, arrhythmia, acute myocardial disease or other types of heart disease requiring treatment) within 6 months period preceding entry into the study; Uncontrolled infection (e.g. active infection that uncontrolled for 2 weeks under antibiotic therapy); Retention of body fluid (e.g. pleural effusion, ascites, pericardial effusion, and edema needing treatment); History of other than esophageal cancer, except curatively treated non-melanoma skin cancer or in situ carcinoma of the esophagus; and other conditions which will be judged by physician's discretion.
A Study to Evaluate the Efficacy and Safety of AD-208

The purpose of this study is to evaluate the efficacy and safety of AD-208.

The purpose of this study is to evaluate the efficacy and safety of AD-208 in male patients with androgenetic alopecia.

Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 18-50 years, inclusive
* Patients who meet the appropriate criteria according to the classification of hair loss
* Signed informed consent

Exclusion Criteria:

* Patients with hair loss disorders other than androgenetic alopecia
* Other exclusions applied
Clinical Effort Against Smoke Exposure in Cystic Fibrosis

The study will test the feasibility, acceptability, and preliminary efficacy of a multi-component smoking cessation intervention tailored to the needs of caregivers of children with CF and delivered in clinical settings as part of routine CF care. The ultimate goal of this effort is to reduce the exposure of children and adolescents with CF to tobacco smoke.

This is a single-center, randomized, open-label study to test the feasibility and acceptability (primary outcomes) and preliminary efficacy (secondary outcome) of a multi-component smoking-cessation intervention delivered by a tobacco treatment specialist (TTS) integrated in the multidisciplinary CF care team.

The intervention will be tested in a two-group design with a 2:1 allocation. Participants (dyads of caregiver/CF child) will be randomized to either intervention or control group. The intervention group (N=24) will receive the multi-component intervention (intake assessment, follow-up, help with obtaining nicotine replacement therapy, and CF-specific smoke exposure education). The control group (N=12) will receive usual care plus CF-specific smoke exposure education.

Eligibility Criteria:
Inclusion Criteria:

* Adult familial caregiver of a child with CF aged \<18 years
* Speak English
* Report smoking at least 1 cigarette in the previous week
* Not enrolled in a smoking cessation program

Exclusion Criteria:

* Do not report smoking at least 1 cigarette in the previous week
* Currently enrolled in a smoking cessation program.
Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis

The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

This will be a Phase 3, randomized, double-masked, parallel arm, positive-controlled non-inferiority study, in which up to 250 subjects (approximately 125 subjects per treatment arm) will be enrolled at up to 60 clinical sites. Patients with non-infectious anterior segment uveitis who are interested in participating in the study will be provided an informed consent form prior to screening. Screening/Baseline procedures which include BCVA, slit lamp examination, fundus exam, IOP by tonometry will be used to determine eligibility.

Eligibility Criteria:
Inclusion Criteria:

1. Age 12 to 85 years with a diagnosis of non-infectious anterior segment uveitis defined as an AC cell count of ≥ 11 cells
2. Receive, understand, and sign a copy of the written informed consent form
3. Be able to return for all study visits and willing to comply with all study-related instructions

Exclusion Criteria:
BIOLUX P-III SPAIN All-Comers Registry

The purpose of the BIOLUX P-III Spain registry is to further investigate the safety and clinical performance of the Passeo-18 Lux Drug Coated Balloon in the treatment of long atherosclerotic femoropoliteal artery lesions in daily clinical practice


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years or minimum age as required by local regulations
* Subject must be willing to sign a Patient Data Release Form (PDRF) or Patient Informed Consent (PIC) where applicable
* Subject classified as Rutherford class 4, 5 or 6
* TASC C or D lesion(s) in the femoropopliteal artery
* Lesion length \> 15 cm suitable for endovascular treatment treated with or scheduled to be treated with the Passeo-18 Lux drug releasing balloon

Exclusion Criteria:

* Life expectancy ≤ 1 year
* Subject is currently participating in another investigational drug or device study that has not reached its primary endpoint yet.
* Subject is pregnant or planning to become pregnant during the course of the study.
* Rutherford class \<4
* Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations).
* Intraprocedural decision not to proceed with the Passeo18 Lux DCB for any reason not related to the device (for instance blood flow limiting dissection after predilatation).
5 Years Quality of Life and Early Mobilization in ICU

In a study published in 2018 the research team had collected the Medical Research Council score (MRCs) at Intensive Care Unit (ICU) discharge.

The investigators would like to be able to examine, if the preliminary results obtained by in 2020 by Van Aerde's team are confirmed in their cohort.

The investigators hypothesize that patients with an MRCs less than or equal to 55 at discharge from the ICU, have a higher mortality rate than those with a score greater than 55.

The investigators would also like to examine whether or not an MRCs score ≤ 55 is associated with a difference in quality of life and autonomy, after 5 and more years post ICU.

Study design Prospective, observational study.

1. Research of vital status
2. Completion of two questionnaires (Short Form-36 and Katz Index of Independence in Activities of Daily Living), to assess quality of life and level of autonomy in activities of daily living, either by telephone or completed directly by hand by the patient from his place of residence.

Eligibility Criteria:
Inclusion Criteria:

* Have participated in the Promorea1 study
* Alive at the time the questionnaires were sent

Exclusion Criteria:

* Opposition to the use of vital status data
* Extra-national patient not on the national registry
Long Acting Paliperidone in Dually Diagnosed People With Schizophrenia: An Open-label Pilot Study

Comorbid substance abuse leads to many deleterious effects such as medical comorbidities and nonadherence, which is one of the most problematic issues. People with schizophrenia and substance use disorders (SUDs) are at an increased risk nonadherence compared to those who do not use alcohol and illicit drugs. The investigators propose that this new marketed injectable antipsychotic with many benefits over other available long acting injectable agents would be beneficial in the dually diagnosed population and may represent a specific schizophrenia subpopulation where long acting agents may be considered an important therapeutic option.


Eligibility Criteria:
Inclusion Criteria:

* Be between ages 18 and 64
* Either gender
* Any race
* Meet DSM-IV-TR criteria for Schizophrenia or Schizoaffective Disorder.
* Alcohol and/or cannabis use defined as a DSM-IV diagnosis abuse, dependence or regular use defined as 3 times per week during the past year
* Agree to take or use birth control during the study.

Exclusion Criteria:

* Previous lack of response or serious adverse event to risperidone or paliperidone.
* Currently on a long acting injectable antipsychotic.
* A score of less than 10 on the Evaluation to Sign Consent (ESC).
* Medical illnesses, which may compromise safe study participation.
* Pregnant and lactating females.
* QTc interval \> 450 milliseconds males or \> 470 milliseconds in females
* Currently on acamprosate, naltrexone and disulfiram.
Study on the Early Warning and Treatment of Cervical Spondylosis of Cervical Type on Young People Based on the " Move Generate Yang " Theory

The incidence of cervical spondylosis on young people is increasing every year. Suffering from this disease will affect the normal life and learning of young people. Episode younger and incidence higher of this disease could increase health care spending of the government in the economy. Cervical spondylosis of cervical type is the main type of cervical spondylosis of young people. Patients of cervical spondylosis of cervical type always manifest the head, neck and shoulder pain accompanied by corresponding pressure point, the X-ray display of Upper cervical curvature change and instability of intervertebral joint performance ,and the dynamic lateral X-ray shows vertebral instability or trapezoidal change. The conservative treatment is the primary and preferred treatment of the disease.

This study is designed as a random, control, single blind study. It will recruit 140 cases of cervical spondylosis of cervical type. Both the treatment group and the control group will be randomly assigned 70 cases. Patients in the treatment group will be treated by Massage of chiropractic and adjusting cervical curvature and practice Sishi Daoyin for 4 weeks，and the control group by conventional massage and cervical traction. The total study includes 2 views that are baseline and post-4week intervention. At all of the 2 views, all participants will be examined range of motion of cervical vertebra, cervical curvature, and Surface Electromyography of neck muscles, and will be estimated scores of The Neck Disability Index(NDI), the Northwick Park Neck Pain Questionnaire (NPQ),Short-form McGill Pain Questionnaire(SF-MPQ) and Evaluation of the therapeutic effect. This study aims to investigate the efficacy of Massage of chiropractic and adjusting cervical curvature and Sishi Daoyin practice, and discover the correlation between these scales and these objective indicators to discover the indicators of early warning signs of cervical spondylosis of cervical type of young people.

Quality control: The study site and all researchers must comply with the required qualifications. All researchers must be trained before the study. The study will take a number of measures to ensure the recruitment of the required sample size, and compliance of intervention providers and participants.

Eligibility Criteria:
Inclusion Criteria:

* meet the diagnostic criteria of cervical spondylosis of cervical type
* first invasion and not receive any treatment
* X-ray shows cervical curvature go straight
* volunteered to join the test, and sign " informed consent " persons

Exclusion Criteria:

* suspected or confirmed bone and joint and soft tissue tumors, and so on
* suffer from cardiovascular, lung, liver, kidney and hematopoietic system serious illness or impairment
* lesions of skin ( such as damage, burns, and so on ) where massage will be applied
* severe congenital malformation of cervical vertebra
* incapacitated or unable to independently read and write
* other conditions which researchers consider appropriate to participate in this study
Thrombocytopathy in Gaucher Disease Patients

In Gaucher disease type I bleeding is a common presenting symptom, that may manifest itself as frequent nose bleeds, easy bruising but can also cause substantial bleeding after surgical or dental procedures and may occur in association with pregnancy or delivery . The bleeding tendency is usually considered to be secondary to thrombocytopenia However 50,000 platelets are enough in healthy people to give a normal bleeding time but are associated with significant bleeding tendencies in Gaucher patients. Bleeding tendency might be attributed by genetic inherited or Gaucher related coagulation factors abnormalities which in some cases stabilize with ERT. However, In other cases the etiology is an abnormality of platelet function. This thrombocytopathy has not been delineated and apart from a few aggregation studies, no systematic analysis has been published that convincingly shows the cause of the disturbed function. While, experience shows that enzyme replacement (ERT, i.e: imiglucerase, Cerezyme®) reduces this bleeding tendency, in part due to the improvement in the thrombocyte count and elevation in coagulation factors, it is less clear what effect ERT has on the thrombocytopathy. This has clinical significance when patients need to be prepared for surgery or delivery or in the event of a major bleed. There is no consensus as to how patients should be prepared or treated. Different centres use different approaches. When the procedure is elective ERT is appropriate but in other situations DDAVP, fresh frozen plasma and platelet infusion are possible treatments. Even activated factor VII has been used when bleeding was not controlled. As in any other coagulation abnormality, treatment should be tailored to the specific cause of the bleeding diathesis. The aim of this study is to define the etiology of platelet dysfunction in Gaucher patients.

Hypothesis: The investigators expect to see a difference between platelets activation profile among imiglucerase treated and untreated patients with at least a partial restoration of platelets function due to treatment commencement.

Objectives:

Delineating the cause of the thrombocytopathy in Gaucher disease patients:

1. Identifying thrombocytopathy among a cohort of 70 Gaucher patients managed (treated and untreated) in our clinic using a panel of platelets function tests.
2. Understanding the etiology for platelets dysfunction in Gaucher disease.
3. Evaluating the impact of Imiglucerase treatment duration and Gaucher disease severity on platelet function

Eligibility Criteria:
Inclusion Criteria:

* Gaucher disease patients
* Patients who do not receive any medicine that affects platlats

Exclusion Criteria:

* Treatment with enzyme replacement therapy other than Imiglucerase
FuRST 2.0 Cognitive Pre-Testing

The FuRST 2.0 scale is being developed as a Patient Reported Outcome (PRO) with information coming directly from the Huntington's Disease Gene Expansion Carrier (HDGEC) and companion through self-report. The purpose of this study is to identify real or potential comprehension or usage problems with questionnaire items or response options. Through a process of structured cognitive de-briefing with HDGEC participants and companions, independently, followed by qualitative analysis, the final phrasing of the individual items and response options for the scale will be generated. Depending on the results of the first round of cognitive pre-testing, additional rounds of cognitive pre-testing may be required.


Eligibility Criteria:
Main criteria for inclusion:

1. HDGEC participant must be a participant in Enroll-HD (NCT No.: NCT01574053)
2. At least 18 years of age
3. Must be fluent in English and had his primary education in English
4. Must be willing and able to provide written informed consent

Pre-Manifest HDGECs

Criteria 1-4, and:

1. CAG length greater than or equal to 40
2. Disease Burden Score greater than or equal to 250 (calculated by the equation:

   \[CAGn-35.5\] X age)
3. UHDRS Diagnostic Confidence Level (DCL) \< 3
4. At least five Pre-Manifest HDGEC participants should have a companion who is willing to participate in this study and complete the scale independently.

Early-Manifest (Stage 1\&2) HDGECs

Criteria 1-4, and:

1. CAG length greater than or equal to 36
2. DCL=4
3. UHDRS Total Functional Capacity (TFC) ≥7
4. Participants whose companion is willing to participate in this study and complete the scale independently

Main criteria for exclusion:

1. Significant cognitive or any other impairment sufficient to interfere with study associated tasks as judged by the study Investigator or the Investigator's designee
2. Currently participating in a clinical trial involving an investigational medicinal product
Long-term 24-month Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 (Sodium Deoxycholate Injection)

The objective of this non-treatment, placebo-controlled, observational, 24-month follow-up study was to evaluate the long-term efficacy and safety of subcutaneous (SC) injections of deoxycholic acid (ATX-101) in the submental area. No treatment was administered in this study. Participants who previously received deoxycholic acid injections in studies ATX-101-10-16 \[NCT01305577\] or ATX-101-10-17 \[NCT01294644\] were enrolled in this non-treatment observational follow-up study to further evaluate safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent before any study-related activities are carried out
* Any participant who successfully completed the final visit (visit 7) of a phase 3 clinical trial, ATX-101-10-16 or ATX-101-10-17 for the reduction of submental fat, i.e. subjects must have at least one study treatment administered and have completed the predecessor study up to visit 7
* Willingness to comply with the schedule and procedures of the study

Exclusion Criteria:

* Participants who, since the completion of the prior phase 3 study ATX-101-10-16 or ATX-101-10-17, have had or who are undergoing treatment that may affect the evaluation of the submental area (e.g. - but not limited to - long-term treatment with systemic corticosteroids, liposuction, surgery or other lipolytic treatment in the submental area, treatment with radio frequency, laser procedures, chemical peels, dermal fillers in the neck or chin area or botulinum toxin injections in the neck or chin area)