cyrilzakka/clinical-trials huggingface dataset:
Fruquintinib in the Cross-line Treatment of Refractory mCRC

This is a real-world study. Patients with metastatic colorectal cancer who have progressed (PD) after third-line treatment with fruquintinib combined with PD-1 inhibitors will receive fruquintinib combined with TAS-102 as fourth-line therapy. The objective of this study was to observe the efficacy and safety of cross-line（from third to fourth line）treatment with fruquinitinib.

This is a real-world study. Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received. The primary endpoint was observation the overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102. The study objective is to explore the possibility of cross-line rechallenge of fruquinitinib.

Eligibility Criteria:
Inclusion Criteria:

-

To be enrolled in this study, patients must meet all of the following criteria:

1. Age ≥18 years, ≤75 years;
2. No gender limitation;
3. Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received.
4. Expected survival ≥12 weeks
5. Must have at least one measurable lesion (RECIST1.1).
6. Full organ and bone marrow function.

Exclusion Criteria:

-

Patients will not be admitted to the study if they meet any of the following criteria:

1. Patients with contraindications to study drugs (fruquinitinib, PD-1 inhibitor, TAS-102);
2. allergic to the investigational drug or any of its adjuncts;
3. There are other non-investigational drugs during third-line and fourth-line treatment;
4. Pregnant or lactating female subjects;
5. Patients with a large number of pleural effusion or ascites requiring drainage;
6. Patients considered unsuitable for inclusion in this study by the investigators.
Amnion Membrane Versus DFGG Using the Tunneling Technique in Management of Gingival Recession Defects.

Treatment of gingival recession is indicated mainly for esthetic reasons and keratinized tissue augmentation (Zucchelli and Mounssif, 2015). An array of surgical techniques has been proposed by the literature to cover gingival recession defects with well-documented successful outcomes. The selection of one technique over the other depends on many factors. Some of these factors are related to the gingival recession defect itself, others are related to the anatomy of the palatal fibromucosa, or related to the patient variabilities (Zucchelli and De Sanctis, 2000).

Controversy exists in the literature regarding the patient morbidity after connective tissue graft harvesting. Inconclusive postulations have been made about the post-operative patient morbidity outcomes and root coverage outcomes when comparing connective tissue graft harvesting in comparison to allograft membranes used for root coverage.

The use of connective tissue graft in combination with root coverage techniques remain the gold standard for root coverage procedures. The problem with the connective tissue graft is that harvesting a graft from the palate increases morbidity, needs an extra surgical site which is more traumatic for the patient, depends on the donor tissue which could be limited, increases surgical chair-time and needs increased surgical skills (Cortellini \& Pini Prato 2012).

The rationale behind the use of amnion membrane is to avoid the morbidity inherent with connective tissue graft harvesting.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years.
* Periodontally and systemically healthy.
* Presence of RT1 or RT2 buccal gingival recession defects ≥2 mm in depth.
* Full-mouth plaque and bleeding score of \<15% and no probing depths \>3 mm.
* Absence of non-carious cervical lesions (NCCLs) and non-detectable cemento-enamel junction (CEJ) at the defect sites.

Exclusion Criteria:

* RT3 recession defects.
* Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
* Presence of caries lesions or restorations in the cervical area.
* Intake of medications which impede periodontal tissue health and healing.
* Medical contraindications for periodontal surgical procedures.
* Uncooperative patients not willing to complete the follow up period.
* Pregnancy and lactation.
Upper Extremity Rehabilitation Using SMART Glove System With Transcranial Direct Current Stimulation

The aim of this study to investigate the effect of combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke. We hypothesized that experimental group (VR-based training with dual-tDCS) would improve distal upper extremity function rather than control group (VR-based training with dual sham tDCS).

This is a double-blind, randomized controlled study. Patients were randomly assigned to 1 : 1 ratio to experimental group (VR-based training with dual-tDCS; VR-Dual) or the control group (VR-based training with dual sham tDCS; VR-Sham) . For both conditions, VR-Dual and VR-Sham group commenced at the same time (20 minutes). The therapist and patients were blinded as to whether the patients received real or sham tDCS. The study was approved by the Ethics Committee of the National Rehabilitation Center, Korea, and all participants provided written informed consent before enrollment.

Eligibility Criteria:
Inclusion Criteria:

* first-time ischemic or hemorrhagic stroke
* unilateral upper extremity functional deficits after stroke
* presence of a score of at least 3 points on the Medical Research Council (MRC)
* a score ≥ 4 on the Brunnstrom stage
* a score ≥ 25 on the Korean version of the Mini-Mental Status Exam (K-MMSE)

Exclusion Criteria:

* age \< 20 years
* wrist and finger spasticity with the Modified Ashworth Scale (MAS) score ≥ 2
* uncontrolled hypertension, heart problems, infection, or any history of seizure or epilepsy
* neurological disorders that cause motor deficits
* being unable to perform the task or to understand instructions
* presence of pacemaker, pregnancy, cognitive impairment, or psychiatric disorders
Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T

The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).

Subjects will receive sipuleucel-T, and potentially other medications, as part of the clinical trial in which they are concurrently enrolled. For this study, cellular and humoral immune responses will be assessed. No additional study treatments will be conducted beyond what is required for the subject's concurrent clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 18 years of age
* Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT)
* Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
* Subjects must understand and sign an informed consent form prior to their first leukapheresis

Exclusion Criteria:

•None
Nutrition Education to Promote Calcium Intake Among 30-65 Year-old Women in Vietnam

Osteoporosis is an important public health problem in Vietnam, with one in ten Vietnamese women suffering from it. There is enough evidence demonstrating that low calcium intake is one of the risk factors for osteoporosis among Asian women in general and Vietnamese women in specific. It is reported that the intake of calcium among Vietnamese women is under 400 mg/day, which is less than the daily recommendation of 1,000 mg/day by the Vietnam National Institute of Nutrition, even though calcium-rich foods are largely available in Vietnam. Therefore, the purpose of this study is to promote dietary calcium intake among Vietnamese women aged 30-65 years through implementing a nutrition education intervention.

Vietnamese women aged 30-65 years without medical problems that could interfere with the calcium consumption, such as kidney stone, kidney and liver diseases. The women will be excluded if they are blinded, deaf, or have general learning disability.

Outcomes of the study are dietary calcium intake, calcium knowledge, and osteoporosis health belief. A quantitative questionnaire is being used to collect these data.

Eligibility Criteria:
Inclusion Criteria:

* women aged 30 to 65 years

Exclusion Criteria:

* have medical conditions that can interfere with calcium intake, such as physician-diagnosed kidney stone, kidney and liver diseases, etc.
* blind, deaf, and have general learning disability
Observational Study in the Management of Ulcerative Colitis With Oral 5-ASA

The objectives of this study are to investigate how oral 5-ASA drugs have been used in the condition without symptoms such as abdominal pain or diarrhea/bloody stool (remission stage), or in the transition from the condition with symptoms such as abdominal pain or diarrhea/bloody stool (active stage) to the remission stage in ulcerative colitis and to study how many patients will be able to maintain the remission stage during the observation period and how many times the patients will experience the active stage (relapse), as well as how symptoms will change during the observation period to discover better treatment plans.

Period: 2012-2014 Observation Time: 0, 26week, 52week

Matters investigated:

1. pUCDAI scores(Stool frequency, Bloody stool, Physician's global assessment)
2. Medication adherence (VAS scale)
3. Remission, Relapse
4. Age, gender, body height, body weight, date of diagnosis, extension of inflammation, classification by clinical course, smoking, alcohol, work, disease complication, duration of remission maintained to enrollment(remission patient)

Eligibility Criteria:
Inclusion Criteria:

1. Outpatients
2. Adult patients who have been diagnosed with mild to moderate active ulcerative colitis or ulcerative colitis in the remission stage according to the diagnostic criteria for ulcerative colitis (draft revised on February 13, 2010)
3. Patients who have been treated with remission induction therapy or remission maintenance therapy with oral 5-ASA drugs (Pentasa® tablets 250 mg, Pentasa® tablets 500 mg, Asacol® tablets 400 mg and Salazopyrin® tablets 500 mg as well as drugs that have been proved equivalent to these drugs)
4. Patients who have received adequate information regarding this study and understood thoroughly, and then voluntarily submitted written consent forms upon participation in this study

Exclusion Criteria:

1. Patients with severe active ulcerative / fulminant ulcerative colitis according to the diagnostic criteria for ulcerative colitis (draft revised on February 13, 2012)
2. Patients who have received total / subtotal colectomy
3. Patients who have been complicated with malignant tumor
4. Patients who are pregnant or possibly pregnant
5. Other patients whom investigators and subinvestigators considered inappropriate to participate in this study
A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

The purpose of the study is to research how much ixekizumab enters the bloodstream and how long the body takes to get rid of the drug and the safety of ixekizumab and any side effects that might be associated with it. The study has two parts: A single-dose part and multiple-dose part. The single dose part of this study will last up to 24 weeks, including the screening period. The multiple dose part of this study will last up to 32 weeks including the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged ≥18 years.
* Diagnosis of chronic plaque psoriasis for ≥6 months before baseline.
* Candidates for phototherapy and/or systemic therapy.
* ≥10% body surface area (BSA) involvement at screening and baseline.
* static Physician's Global Assessment (sPGA) score ≥3, and Psoriasis Area and Severity Index (PASI) score ≥12 at screening and baseline.

Exclusion Criteria:

* Clinically significant flare of psoriasis during the 12 weeks before baseline.
* Systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks. prior to baseline or topical psoriasis treatment or medicated shampoo within 2 weeks prior to baseline .
* Current or recent use of any biologic agent within the required washout periods.
* Clinical evidence or suspicion of active tuberculosis or previously had evidence of active tuberculosis and did not receive appropriate and documented treatment.
Use of Vibration to Improve Visual/Spatial Neglect in Patients Affected by Stroke

This study will measure if five minutes of vibration to the upper back neck muscles, prior to standard of care treatment, will improve symptoms of spatial neglect and/or activities of daily living function for patients who have had a stroke.

Spatial neglect is a common syndrome following stroke, most frequently of the right side of the brain. Such patients fail to be aware of objects or people to their left. This study is being done to learn if vibration treatment can improve visual/spatial neglect and activities of daily living in stroke patients better than current standard intervention.This treatment will be performed by occupational therapist practitioners prior to regular occupational therapy session using a vibration tool.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* demonstrated visual/spatial neglect, as demonstrated by NIH Stroke Scale (NIHSS) and deficits in assessing tactile extinction and visuospatial neglect done on admission.

Exclusion Criteria:

* severe pain or skin disease at the posterior neck
* severe atherosclerosis of carotid arteries by an ultrasonic evaluation
The Effects of High-Intensity Functional Training in Tactical Populations

The purpose of this study is to investigate the effects of high-intensity functional training (HIFT) as compared to traditional resistance training (RT) and concurrent training consisting of RT and high-intensity interval training (HIIT) on physical performance metrics, body composition, and mental and physical readiness of tactical personnel.

This study assesses the impact of 8-weeks of high-intensity functional training (HIFT) as compared to traditional resistance training (RT) and concurrent training consisting of RT and high-intensity interval training (HIIT) on various performance outcomes. The main questions the study aims to answer are:

* Evaluate the distinct effects of HIFT, RT, and RT plus HIIT over eight weeks on physical performance and body composition measures in tactical men and women.
* Determine the distress, training load, and physical readiness associated with each of the three distinct training interventions over eight weeks.

Participants will:

* Take part in 10-weeks total of study-related activity.
* Complete four total sessions of pre and post-testing sessions, which include body composition, maximal oxygen uptake testing (VO2max), upper and lower body maximal strength, and lower body power.
* Be randomly assigned to an exercise training intervention.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between the ages of 18 and 35 (inclusive) and enrolled in a reserve officer training corps program.
* Subject has provided written and dated informed consent to participate in the study.
* Subject is in good health as determined by medical history and is cleared for exercise.
* BMI between 17.0 and 29.9 kg/m2.
* "Good" category or greater for their aerobic capacity according to the American College of Sports Medicine (ACSM) normative data for their age and sex as measured at their baseline visit.

Exclusion Criteria:

* Participants with any musculoskeletal injuries that would prevent completion of these exercise programs.
* Participants with any metabolic disorder, including known electrolyte abnormalities, uncontrolled diabetes, uncontrolled thyroid disease, adrenal disease, or hypogonadism.
* Participants with a history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.
* Participants who have lost or gained greater than eight pounds within three months prior to study enrollment.
* Participants currently taking hyperlipidemic, hypoglycemic, anti-hypertensive, or anti-coagulant medications.
* Participants who are pregnant or lactating.
Health Consequences of Wintering in the French Southern and Antarctic Territories

Polar stays expose people to extreme climate, isolation and confinement. The combination of these factors induces psychological disorders, sleep disorders, immune and endocrine disturbances, and deficiencies. In the TAAF, (French Southern and Antarctic Lands) two types of population coexist: winter residents, exposed to these stressors over long periods, and country people, who benefit from milder conditions and only make short stays. In this context, the investigators have decided to set up this cohort study with the objective of comparing the state of health of the winterers of the TAAF from 2012 to 2017 with that of the country people of the same period, before their stay, during and the year following their return.

Participants will answer to a questionnaire. This questionnaire will determinate participants health about following areas : psychological disorders, sleep disorders, immune and endocrine disturbances, and any deficiencies.

Eligibility Criteria:
Inclusion Criteria:

for the exposed group are:

* To have carried out one or more wintering in one of the districts of the TAAF, that means a stay of at least six consecutive months including winter;
* Have started their first wintering between 01jan2012 and 31dec2017;
* Know how to read and write French.

for the non-exposed group are:

* To have taken part in one or more summer campaigns between 01jan2012 and 31dec2017;
* Never have overwintered;
* Not having been refused wintering for health reasons or following psychological tests;
* Knowing how to read and write French.

Exclusion Criteria:

* Persons under guardianship or guardianship, deceased persons, persons refusing to participate in the study
Ultrasound-Guided Oblique Short-Axis Adductor Canal Block.

The ideal pain management for knee surgery should provide excellent analgesia while minimizing opioid consumption and allowing early mobilization and rehabilitation.

The use of the continuous technique in ACB allows the delivery of a larger quantity of local anaesthetic into the adductor canal than in the single-shot technique.

The usual approach for ultrasound-guided ACB catheter insertion is through short-axis in-plane approach in which the ultrasound transducer is applied horizontally over the femoral artery and saphenous nerve. In this approach, the catheter is inserted through a 90-degree angulation with the nerve which might make the catheter insertion difficult.

In the new oblique position, the catheter will be inserted in a less than 90-degree angulation. This study speculates that decreasing the angle of catheter insertion will make catheter insertion easier and faster.


Eligibility Criteria:
Inclusion Criteria:

* adult patients more than 18 years
* ASA I-III
* scheduled for unilateral knee surgery under spinal anesthesia with an adductor canal perineural catheter planned for postoperative pain control

Exclusion Criteria:

* Patient who had an allergy to any drug used in the study
* Patients with neuropathy of any etiology in the affected extremity, hepatic or renal failure.
* pregnant females
* Patients who are unable to communicate with the investigators and hospital staff
Evaluation of the Efficacy of Transcranial Magnetic Stimulation on Resistant Auditory Hallucinations in Schizophrenia

This open naturalistic study aims to evaluate the efficacy of rTMS in routine practice on auditory resistant hallucinations (AHR) of patients with schizophrenia. To this end, two stimulation methods will be offered to patients: the rTMS stimulation method and the cTBS stimulation method.We principally use the AHRS scale to evaluate the effectiveness of rTMS on RAH in patients with schizophrenia. Our main hypothesis is that rTMS used under naturalistic conditions, in addition to antipsychotics, would allow a relative improvement of resistant auditory hallucinations assessed by the AHRS scale between baseline and end of treatment in patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient diagnosed with schizophrenia according to DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
* Presence of auditory hallucinations: Resistant auditory hallucinations: resistance to treatment with 2 different well-conducted antipsychotics.
* Patient agreeing to participate in the study and having signed an informed consent
* Patient with French language skills
* Affiliation to a social security system
* Women of childbearing age must be on contraception and have a negative pregnancy test (βHCG)

Exclusion Criteria:

* Have a contraindication to MST: intracranial foreign body, unstabilized epilepsy, cochlear implant
* Presence of an unstabilized medical condition
* Pregnant woman (Women of childbearing age without effective contraception)
* Current or less than one month old engagement in another research protocol
* A person who is subject to a safeguard of justice measure
* An adult under curatorship
* Minor patients with mental health problems
* Pregnant or breastfeeding women
* A person in a social fragility (Persons deprived of liberty by a judicial or administrative decision, hospitalized persons)
* Persons incapable or unable to give consent