cyrilzakka/clinical-trials huggingface dataset:
Effect of Oral Enteral Nutrition in Nasopharyngeal Carcinoma Survivors With Swallowing Disorders

This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oro-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared.

Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma continues to be a challenge. This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oro-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment as well as adverse events are compared.

Eligibility Criteria:
Inclusion Criteria:

* Age between 30 and 65 years.
* With the history of Nasopharyngeal Carcinoma and radiation therapy.
* With dysphagia occurred at least three years after radiotherapy (confirmed by videofluoroscopic swallowing study), in need of and feasible for enteral nutrition support.
* Conscious and with stable vital signs;
* Willing to participate and sign the written informed consent form either personally or by a family member.

Exclusion Criteria:

* Presence of other diseases that might cause dysphagia.
* With distant metastasis of tumors, or complicated with severe systemic disorders or malignancies.
* Concurrent participation in other treatments that could interfere with the trial.
* Inability to cooperate with treatment due to aphasia, mental health issues, etc.
* Received tube feeding for enteral nutrition support within the past three years.
Impact of the Eurékoi Serious Game on Family Caregivers of Patients With a Major Neurocognitive Disorder

This study aims to assess the effectiveness of serious EUREKOI gambling on the anxiety of family caregivers of patients with newly diagnosed Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Men or women over 18 years old;
* Primary caregiver of a patient with a mild-stage major neurocognitive disorder newly diagnosed according to the DSM 5 criteria;
* Signature of informed consent.

Exclusion Criteria:

* Subject not speaking French, not reading French
* Subject with visual impairment
* Subject under tutorship or curatorship.
A Randomized Trial of Low-Dose Bevacizumab vs Laser for Type 1 ROP

This randomized clinical trial will compare retinal outcomes with low-dose intravitreous bevacizumab (0.063 mg) versus laser photocoagulation as treatment for infants with type 1 retinopathy of prematurity (ROP).

The study also will assess neurodevelopment, refractive error, visual acuity, and peripheral visual fields.

Infants with type 1 ROP and no prior treatment for ROP will be randomly assigned (1:1) to treatment with either intravitreous bevacizumab 0.063 mg or peripheral retinal laser ablation. Study exams will be at weeks 1, 2, and 4 weeks, and at 2 and 4-months post-treatment (and re-treatment when indicated). Additional study exams will occur at adjusted age 6 months, 1 year, and then annually for 5 more years. Non-study examinations will be at clinician discretion and are likely to occur more often. The primary outcome will be treatment success, defined as no worsening of ROP 5-13 days after treatment (or re-treatment if indicated), no plus disease or severe neovascularization 2 weeks to 6 months after treatment (or re-treatment if indicated), and no unfavorable structural outcome (or prior scleral buckle or vitrectomy) at 6 months adjusted age. Important secondary outcomes include the number of re-treatments, extent of retinal vascularization, refractive error, neurodevelopment assessed by the Bayley-4 test, IQ and neuropsychiatric testing, visual acuity, visual fields, and systemic morbidities.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \< 1251 grams
* Newly diagnosed (within 2 days) type 1 ROP in one or both eyes; meeting the following criteria:

  * Zone I, any stage ROP with plus disease, with retinal vessels or ROP in Zone II in any quadrant, or
  * Zone I, stage 3 ROP without plus disease, with retinal vessels or ROP in zone II in any quadrant or
  * Zone II, stage 2 or 3 ROP with plus disease

Exclusion Criteria:

* Previous treatment for ROP
* Stage 4 or 5 ROP in either eye
* All ROP in zone I in either eye (no retinal vessels or ROP extend into zone II in any quadrant)
* Either treatment could not be done within 2 days of diagnosis of type 1 ROP
* Investigator unwilling to randomize or parent unwilling to accept random assignment to either treatment
* Transfer to another hospital not covered by study-certified examiners anticipated within the next 4 weeks
* Active ocular infection or purulent nasolacrimal duct obstruction in either eye

One eye will be excluded, and other eye may be eligible, if either of the following are present:

* Visually significant ocular anomaly (e.g., cataract, coloboma)
* Opacity that precludes an adequate view of the retina
Intraoperative Methadone for the Prevention of Postoperative Pain

The pain felt after orthopedic surgery in the absence of adequate locoregional anesthesia is often insufficiently controlled, especially during the first 24 hours postoperatively.

Methadone, due to its long half-life, may provide better pain control after orthopedic surgery when associated locoregional anesthesia cannot be performed.

It may be impossible to perform loco-regional anesthesia in various contexts: patient refusal, pre-existing neurological impairment, infection at the injection site, coagulopathies, inability to cooperate, total language barrier, allergy to anesthetics, unavailability of equipment (ultrasound, etc.) or equipped room, lack of experience of nursing staff in performing the block and in the postoperative management of the patient.

Intraoperative administration of methadone in these settings may be superior to sufentanil for pain control during the 24 hours post orthopedic surgery, and the pain control provided by methadone does not appear to imply a higher likelihood of adverse events related to opioids.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years old
* ASA 1-3 status
* Elective partial or total hip and knee arthroplasty

Exclusion Criteria:

* Patient refusal
* Preoperative renal failure (serum creatinine \> 2 mg/dL or 1.5-fold
* Increase in basal plasma creatinine or GFR \< 90 ml/min/1.73m2)
* Significant hepatic dysfunction (PT \<50% or increase in 3 times basal transaminases)
* Known heart failure
* Preoperative hemodynamic instability (preoperative use of inotropes or vasopressors)
* Known methadone or sufentanil allergy
* Preoperative opioid use or history of opioid abuse
* Pregnancy and breastfeeding.
A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers

This study will explore the drug behavior and safety following a single dose of three different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in an immediate-release formulation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and/or healthy females subjects who are of non-childbearing potential.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
* Clinically significant infections within the past 3 months
Faslodex Registry: Fulvestrant in Current Clinical Practice

The sequential administration of endocrine therapies to patients with advanced breast cancer requires the availability of therapies with different modes of actions, so that tumours developing resistance to one agent are not cross resistant to another. Because of its mechanism of action, fulvestrant is distinct from other hormonal therapies, which therefore limits the possibility of cross-resistance with other therapies such as tamoxifen and the aromatase inhibitors (AIs)

* In this way, patients may benefit from an extended period of endocrine treatment, which has considerable tolerability and quality-of-life advantages over cytotoxic chemotherapy.
* In Belgium, fulvestrant is indicated for treating postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen treatment. However, little information is currently available on how fulvestrant is actually being used by physicians in Belgium. The optimum sequence of endocrine treatment for advanced breast cancer has yet to be defined and may depend on certain patient or disease characteristics.

Fulvestrant has been granted reimbursement by the Belgian Health authorities (RIZIV/INAMI) with the recommendation to collect the real life data necessary to assess the patients' breast cancer treatment history that may influence the actual endocrine treatment sequence according to physicians current clinical practice..


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer

Exclusion Criteria:
Physical Activity Intervention in Preschool Children

In this research project, the investigators addressed if incorporating physical movements with preschoolers will help increase their ability to retain concepts learned in preschool such as letter, sound and number recognition. Movement plays an important role in the brain. Exercise shows many benefits for the brain to help maintain clearer thought, improve memory, and increase activity in the brain, especially the areas involved in memory, attention, and language. The following research includes an eight week study of the implementation of movement breaks with one preschool class, while using another class as a control group. During the two weeks of baseline data, data was collected from every student in both groups on their letter recognition with both upper and lower case, letter sound identification, and number recognition for numbers 0-10. The group that implemented movement breaks had three-five minute scheduled times to stop for movement. Data was collected and compared between the two groups to find differences in their academic performance.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled preschool student

Exclusion Criteria:

* Enrolled in multiple preschool classes
Hereditary Angioedema Kininogen Assay

A multicenter epidemiological observational study aiming to explore the cleaved high-molecular weight kininogen (cHMWK) including identification and characterization of other metabolite/biomarkers in HAE type 1/2 patients

Hereditary angioedema (HAE) is a rare autosomal dominant genetic disorder characterized by recurrent tissue angioedema episodes, mainly caused by mutations in the SERPING1 gene that encodes C1 inhibitor (C1-INH), a protease involved in limiting bradykinin production. Low levels of C1-INH (HAE type 1) or dysfunctional C1-INH (HAE type 2) lead to bradykinin accumulation, resulting in capillary leakage and tissue swelling.

High Molecular Weight Kininogen (HMWK) proteolysis, by active plasma kallikrein, results in bradykinin and cHMWK generation.

The goal of this study is to explore the cHMWK concentrations in HAE type 1/2 patients, as a biomarker for this disease.

The HAEKA study is performed in collaboration with Shire. Shire is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent is obtained from the participant
* The patient with diagnosis of Hereditary Angioedema (HAE) type 1/2 based on international guidelines
* The patient experienced ≥4 HAE attacks within last 12 month before enrolment in the study
* The participant is older than 18 years old

Exclusion Criteria:

* Inability to provide informed consent
* The patient is not diagnosed with Hereditary Angioedema (HAE) type 1/2
* The patient experienced ˂ 4 HAE attacks within last 12 month before enrolment in the study
* The participant is younger than 18 years old
Perfusion Index (PI) and Pleth Variability Index (PVI) in Patients With Interscalene Blocks in Orthopedic Surgery

The purpose of this study is to:

1. To describe effects of interscalene nerve blocks on perfusion index (PI) and pleth variability index (PVI) (Radical 7, Masimo Cooperation, Irvine, CA) before and after induction of general anesthesia.
2. To compare effects of fluid-bolusing on PI and PVI of the anesthetized and non-anesthetized limb.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for shoulder or upper arm surgery
* ASA 1-3
* written informed consent
* approval from the local ethics committee

Exclusion Criteria:

* arrhythmia
* patients suffering from severe vascular disease, coronary artery (CCS IV) disease
* anaemia (haemoglobin \< 7mg/dl)
* patients in whom a tidal volume of 8ml/kg cannot be delivered safely
Prospective Study for Neuromelanin Image Analysis

In order to develop an image analysis system that automatically detects and quantifies neuromelanin, this study aims to construct a database of a wide sample by collecting brain MRI neuromelanin images prospectively.


Eligibility Criteria:
Parkinsin group

Inclusion Criteria:

* Adults over 19 years old
* Those who have clinically shown Parkinson's symptoms such as tremor, Rigidity, Bradykinesa and gait disturbance and are scheduled to take MRI scans
* Dopamine transporter imaging shows a significant decrease in visual dopamine intake
* A person who can read and understand the description and informed consent form
* Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions

Exclusion Criteria:

* Patient with a history of claustrophobia and mental illness;
* Patient with metallic substances in the body
* Any female subject who is likely to be pregnant who does not agree to contraception in a medically permitted manner during this clinical trial period
* Pregnant or lactating women
* Other cases where the investigator judged that it is difficult to participate in the study;

Healthy volunteer group

Inclusion Criteria:

* Adults over 19 years old
* A person who has no family history or diagnostic history of movement disorders;
* A person with a score of 8 or higher on the CCSIT(cross cultural smell identification test)
* A person with a score of 27 or higher on the MMSE Test
* No Parkinson's symptoms on a neurological examination
* Upon hearing and fully understanding the detailed explanation of this clinical trial, a person who has voluntarily decided to participate and agreed in writing to comply with the precautions

Exclusion Criteria:

* Patient with a history of central nervous system disease or cognitive disorder
* Patient with a history of claustrophobia and mental illness;
* Patient with metallic substances in the body
* Any female subject who is likely to be pregnant who does not agree to contraception in a medically permitted manner during this clinical trial period
* Pregnant or lactating women
* Other cases where the investigator judged that it is difficult to participate in the study;
Treatment of Cutaneous Leishmaniasis With Liposomal Amphotericin B in the Elderly

A randomized controlled pilot trial with the aim of identifying the dose of liposomal amphotericin B associated with the highest cure rate in Cutaneous Leishmaniasis (CL). We selected 28 patients of both sexes, aged 60 years or older, diagnosed with CL and confirmed by detection of L. braziliensis DNA. The groups were treated with different total doses of medication: G1: 12 mg/kg; G2: 18mg/kg; G3: 24 mg/kg. Clinical and laboratory evaluations were carried out during the period of 180 days (D0, D15, D30, D60, D120, D150 and D180).

The study was carried out through a randomized and double-blind pilot clinical trial, with the inclusion of patients treated at the Corte de Pedra Health Center, endemic region for Cutaneous Leishmaniasis. Twenty-eight patients participated in the study, after accepting and signing the Free and Informed Consent Form they were randomized through the list generated electronically by the website www.randomization.com and allocated into three groups.

The groups were treated with liposomal amphotericin B (AmBisome®) with three different total doses: Group 1 (G1) total dose of 12 mg/kg (10 patients). Group 2 (G2): 18 mg/kg (9 patients). Group 3 (G3): 24 mg/kg (9 patients). The drug was used twice a week in a hospital outpatient setting. Clinical evaluations were performed before starting therapy (D0), and at D15, D30, D60, D120 and D180. Laboratory evaluations (hemogram, BUN, Creatinine, K, ALT, AST) were determined on D0, D15 and D30 or D60.

Eligibility Criteria:
Inclusion Criteria:

* CL clinical diagnosis (presence of an ulcer)
* CL confirmed by detection of amastigotes in pathology and/or positive PCR for L. braziliensis in tissue obtained from the ulcer border
* Presence of one to a maximum of three ulcers
* Ulcer size between 1 and 5 mm
* Ulcer evolution of 1 to 6 months

Exclusion Criteria:

* Previous CL treatment
* Renal or hepatic disease
* HIV co-infection.
Hypofractionated Radiosurgery for Localised Prostate Cancer

Hypofractionated radiosurgery has been investigated in a few trials and appears to be safe and feasible.

Investigators initiated this multicenter phase II prospective trial to analyse feasibility (toxicity) of hypofractionated radiosurgery with 5 fractions in patients with localised prostate cancer, who are ineligible for the "PREFERE trial" under the hypothesis that the ratio of patients with late toxicity ≥ grade 2 after 1 year amounts 2,8% and is significant lower than 17.5%.

Experimental radiosurgery of prostate with 5 fractions each with 7,00 Gy (total application rate of 35,00 Gy).

Planned visits are: Baseline, visits at every radiation day and four follow ups (4-6 weeks, 3 months, 6 months and one year after last day of radiation).

Eligibility Criteria:
Inclusion Criteria:

* Localised, histopathologically confirmed Prostate Cancer (cT1-3 N0 M0)
* Gleason-grade ≤7
* Guideline-based staging
* Age ≥ 60 years
* PSA \< 15 ng/ml
* Volume of the prostate \<80 cm³
* IPSS-Score ≤12
* Written informed consent

Exclusion Criteria:

* History of prior pelvic radiotherapy
* Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold),
* Immunosuppressive therapy
* Relevant comorbidity thought to adversely affect treatment compliance,
* Legal incapacity or lack of informed consent
Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT

The purpose of this study is to determine, whether there is clinical benefit of using fdg-PET/CT (F-18-fluorodeoxyglucose- positron emission tomography/computed tomography)compared to contrast-enhanced CT in primary treatment of advanced epithelial ovarian cancer (EOC)

* Objectives

  * the impact of preoperative PET/CT compared to CT on EOC stage definition
  * to compare the value of preoperative PET/CT, CT and laparoscopy in intra-abdominal tumour assessment. Laparotomy findings evaluated by surgeon and histopathologic results serve as the reference standard.
  * to compare serum markers HE4(human epididymis protein 4) and CA125 (cancer antigen 125) with FDG-PET/CT and CT in treatment response evaluation during neoadjuvant chemotherapy and primary treatment of EOC
  * to compare FDG PET/CT based treatment response evaluation with RECIST and GCIG criteria
* Methods

  * All the patients will undergo FDG-PET/CT prior surgery, after possible neoadjuvant chemotherapy (NACT) and 4 weeks after completion of primary platinum-based chemotherapy.
  * CA125 and HE4 levels are measured pre-operatively, with every chemotherapy cycle and regularly during follow-up until 1st disease relapse


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients with advanced epithelial ovarian, primary peritoneal cancer or fallopian tube cancer.
* age 18-79 years
* informed concent

Exclusion Criteria:

* diabetes (for PET/CT analyses)
* previous cancer
ACT With Feedback for Post Traumatic Stress Disorder (PTSD)

The purpose of this study is to explore the efficacy of Attention Control Training with the inclusion of feedback for Post Traumatic Stress Disorder (PTSD).

It seems that the most efficient ABMT method to balance attention bias variability (ABV) among individuals with PTSD is Attention Control Training (ACT). This type of training is designed to balance attention allocation towards threat-related and neutral stimuli. A few studies have further shown that this training type succeeds in balancing the aberrant fluctuations in attention bias observed in patients with PTSD, and that this leads to a reduction in PTSD symptoms (Badura-Brack et al., 2015).

The purpose of the current study is to examine the efficacy of ACT that also includes feedback. Specifically, we intend to test whether the inclusion of feedback on top of standard ACT may enhance training efficacy in reducing ABV and in reducing PTSD symptoms.

The aim of the current study is to explore the efficacy of Attention Control Training with the inclusion of feedback for Post Traumatic Stress Disorder (PTSD).

Individuals with PTSD exhibit increased threat-related attention bias variability (ABV; Lacoviello et al., 2014; Naim et al., 2015). Based on these findings, computerized training methods aimed to modify the attention bias were developed (Attention Bias Modification Training; ABMT).

It seems that the most efficient ABMT method to balance ABV among individuals with PTSD is Attention Control Training (ACT). This type of training is designed to balance attention allocation towards threat-related and neutral stimuli. A few studies have further shown that this training type succeeds in balancing the aberrant fluctuations in attention bias observed in PTSD, and that this leads to a reduction in PTSD symptoms (Badura-Brack et al., 2015).

The purpose of the current study is to examine the efficacy of ACT that also includes a feedback component. Specifically, we intend to test whether the inclusion of feedback on top of standard ACT may enhance training efficacy in reducing ABV and in reducing PTSD symptoms.

For this purpose, we will recruit 60 IDF veterans diagnosed with PTSD that will be randomly assigned to one of two conditions: ACT with feedback or ACT with yoked sham feedback.

We expect that ACT with feedback will produce greater reduction in PTSD symptoms and in ABV relative to ACT with yoked sham feedback.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PTSD according to the DSM-5 and related to military service, ages 18-65

Exclusion Criteria:

* Psychotic or Bipolar disorder, drug and alcohol abuse, other psychological treatment, vision problems that are not overcome with regular glasses, physical disability that prevents ability to operate computer.