cyrilzakka/clinical-trials huggingface dataset:
A New Strategy for Preoperative Drainage of Resectable Pancreatic Head Cancer Combined Severe Obstructive Jaundice

Severe obstructive jaundice caused by pancreatic head cancer usually requires preoperative biliary drainage, but its necessity and effectiveness are controversial, and specific strategies lack clear standards. This study proposed a new strategy for preoperative biliary drainage using serum prealbumin as the main evaluation index, and compared it with the traditional strategy using serum total bilirubin as the main evaluation index. Through a randomized, controlled, multicenter prospective study, we explored the effects of different drainage strategies on the incidence of in-hospital complications and long-term prognosis of patients with resectable pancreatic head cancer, guided clinical decisions on preoperative drainage time and surgical timing, and provided high-quality evidence-based medicine for preoperative biliary drainage of pancreatic head cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Pathological diagnosis of pancreatic head cancer, or clinical diagnosis of pancreatic head cancer after multidisciplinary discussion, clear presence of obstructive jaundice caused by pancreatic head tumor, and planned to undergo radical pancreaticoduodenectomy
2. Preoperative imaging stage is resectable
3. Baseline serum total bilirubin ≥ 250μmol/L, and no history of preoperative biliary drainage
4. Age \>18 and ≤75 years old
5. ECOG(Eastern Cooperative Oncology Group) physical score ≤ 2
6. Signed informed consent, received preoperative endoscopic biliary drainage (ERCP) and radical surgery timing evaluation

Exclusion Criteria:

1. Combined with other malignant tumors
2. Combined with uncontrolled medical diseases or organ dysfunction and other absolute counterindications for surgery
3. Pregnant and lactating women
4. Patients who cannot tolerate preoperative biliary drainage or radical surgery
5. Other situations that are not suitable for inclusion in clinical trials
Phase I Dose Escalation of Stereotactic Radiosurgical Boost for Locally Advanced Esophageal Cancer

To study the safety and feasibility of stereotactic radiation dose escalation following neoadjuvant chemotherapy with concurrent conventionally fractionated radiation, by evaluating the acute and late toxicity of treatment.

This study will evaluate the safety and feasibility of delivering radiation dose escalation using hypofractionated radiosurgery in locally advanced esophageal cancer. The dose escalation will be delivered using an image-guided radiosurgical boost to the tumor volume, following a neoadjuvant regimen consisting of oxaliplatin, capecitabine, and conventionally fractionated radiotherapy. In addition, we will evaluate the utility of PET-FDG before and after neoadjuvant chemoradiation in predicting the pathologic response to pre-operative treatment. We will study the effect of this regimen on pathologic complete response rates and complete resection rates at surgery among patients with locally advanced esophageal cancer and determine patterns of failure and rates of progression-free survival. Finally, we plan to characterize in an exploratory manner the correlation between molecular markers and pathologic findings following pre-operative chemoradiation.

Eligibility Criteria:
Inclusion Criteria:- Confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus by pathologist.

* Endoscopic ultrasound or CT evidence of tumor penetration through the esophageal wall or involvement of regional lymph nodes, without evidence of distant metastasis
* No prior chest radiation therapy
* No prior chemotherapy for esophageal cancer
* Age greater than 18 years
* No infections requiring antibiotic treatment
* Able to care for self
* Patients must have acceptable liver, kidney and bone marrow function.
* The effects of the chemotherapy drugs on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use adequate contraception. Exclusion Criteria:- Patients receiving any other investigational agents
* Evidence of distant metastases
* Uncontrolled medical illness
* Any malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix.
* Pregnant and breastfeeding women are excluded.
* HIV-positive patients
Feasibility of Immunotherapy Administration to Patients With Bronchial Cancer in a Hospital-at- Home Setting (ImHADom)

This observational prospective monosite study aims to describe, for the first time, management in a hospital-at-home programme of patients treated by immunotherapy for bronchial cancer.

The feasibility in good conditions of this management, the patients' quality of life and their satisfaction will be evaluated.

Those last years, immunotherapy treatment for bronchial cancers allowed considerable progress in terms of tumoral answer, survival without progression and global survival. Usually administered in the day hospitalization department, its preparation and administration to the patient are compatible with hospital-at-home management. Currently, this offer of care is rarely proposed, and only in particular situations. At the Hospital of Pau, it was introduced recently. It is proposed to patients who have been receiving immunotherapy for at least 4 months. At the moment, there is no study stating the feasibility of home hospitalization for patients treated by immunotherapy. Given that there is neither regulatory obstacle nor any contraindication to care in home hospitalization, the choice of a descriptive study stands out.

This study will be proposed to all the patients for whom home hospitalization has been decided and scheduled by the healthcare team in a medical staff meeting.

The patients included in the study will be followed according to the common practice: a consultation every 3 months during 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over.
* with bronchial cancer treated with immunotherapy,
* having two assessments of the response to immunotherapy received in day hospitalization with efficiency (stability or partial response)
* without any graded higher than 1 adverse effects, or uncontrolled grade 1 adverse effects related to immunotherapy
* eligible for a home-based hospitalization

Exclusion Criteria:

* Patient receiving immunotherapy via temporary authorization for use,
* Frail patients requiring a frequent medical assessment thus day hospitalization cares
The Psychometric Properties of the Italian Version of the Reintegration to Normal Living Index in Complex Patients

Since the post-acute phase, patients have occupational needs related to social reintegration, that improve the autonomy, social roles in family, at work and in the community.

Unmet needs could lead to a lower level of social reintegration. Healthcare professionals should be able to recognize the level of social reintegration of complex patients discharged from the Physical Medicine Rehabilitation (PRM) unit with the aim to identify those who need intervention aimed at improving social reintegration.

The preliminary Italian version of the RNL index (RNLI) will describe the social reintegration level of the target population, once its psychometric properties will be tested.

The investigators will recruit three groups of participants to test the psychometric properties of the Italian version of the RNLI: complex patients, caregivers and stakeholders.

Phase_1: to test the Content validity. The content validity will be tested on 10 complex patients and 10 stakeholders, who will assess the clarity and relevance of the RNLI items, respectively. In this phase, complex patients are hospitalized in the PMR unit.

From this first phase, the investigators will obtain the preliminary Italian version of the RNLI to test its psychometric properties.

Phase_2: to test the Reliability, Construct validity and Responsiveness. During the hospitalization in the PMR unit, 138 patients and their caregivers will be recruited. During this phase, the investigators will detect the important occupational activities of complex patients enrolled through a semi-structured interview conducted in person.

After discharge, the investigators will contact the patients and their caregivers by telephone at different times (T0, T1 and T2) to test the following psychometric properties through the administration of the Italian version of the RNLI and the Canadian Occupational Performance Measure (COPM). Caregiver will have to answer to the RNLI as a proxy for the patient.

The contact times and the psychometric properties that will be tested are:

T0_ 2 weeks after discharge

* internal consistency
* inter-observer reliability
* convergent construct validity

T1_ 10-14 days after T0

- test-retest reliability

T2_ 6-8 weeks after T0

* discriminant construct validity
* responsiveness

Eligibility Criteria:
For patient:

Inclusion Criteria:

* hospitalized in the PMR unit of AUSL-IRCCS of Reggio Emilia
* Rehabilitation Complexity Scale Extended ≥ 9
* Discharge at home

Exclusion Criteria:

* language barrier
* comorbidities that limit communication and/or collaboration (eg aphasia, dementia, cognitive deficits, severe anxious-depressive syndromes pre-existent to hospitalization, etc.)
* discharge in residential structures, retirement homes or long-term care or transferred to acute wards for complications.

For caregiver:

main caregivers of the patients enrolled

For stakeholders:

a rehabilitation healthcare professional with at least 3 years of clinical experience in rehabilitation and reintegration into the living environment of highly complex patients
Observing Physiological Changes in Patients With Long-term Oxygen Therapy

In this project, the investigators aim to assess changes of physiological parameters obtained non-invasively through PPG and accelerometry signals between before and during LTOT (long-term oxygen therapy) and investigate if those changes are different in patients with worsening frailty and/or improving quality of life.

For this, they will record optical (PPG) and accelerometry data via a datalogger on 40 patients undergoing LTOT and assess the PPG-derived physiological signals.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18-year-old, and
* Chronic respiratory disease including a) chronic obstructive pulmonary disease, b) interstitial lung disease, c) pulmonary hypertension, d) bronchiectasis, and
* Prescribed new LTOT due to a chronic respiratory disease with resting and/or exertional hypoxemia, and
* Able to speak/read/understand German or French, and
* Willing and able to understand and provide signed informed consent

Exclusion Criteria:

* Pregnant or lactating women, or
* Inability to follow the procedures/instructions of the study (e.g. due to language, psychological disorders, dementia, etc.), or
* Patients having a subordination link to the investigators, or
* Patients with isolated nocturnal oxygen therapy or LTOT prescription for a heart disease, sleep associated breathing disorder, neuromuscular disease or lung cancer, or
* Known participation in another human research project (ClinO/HRO) that may affect the objectives of this study.
Efficacy of Nitrous Oxide in OCD: Pilot Study

This study investigates whether the commonly used and well-tolerated inhaled anesthetic nitrous oxide can rapidly improve symptoms of OCD.

Obsessive-compulsive disorder (OCD) is a chronic and disabling disorder characterized by recurrent intrusive thoughts and associated compulsive behaviors that is estimated to affect more than 3 million individuals in the US each year.

This study seeks to explore whether a single inhalation of nitrous oxide gas may bring about rapid symptom relief in OCD.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Primary diagnosis of OCD
* Sufficient severity of OCD symptoms
* Ability to tolerate a treatment-free period
* Capacity to provide informed consent

Exclusion Criteria:

* Psychiatric or medical conditions that make participation unsafe
* Pregnant or nursing females
* Concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)
Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma

To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma.

To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years.
* Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.
* ECOG 0-3
* Histology reviewed by reference pathologist
* Lesion can be assessed
* Can tolerate radiotherapy and Fluzoparib (Fluzoparib group)
* Agree contraception.
* Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed

Exclusion Criteria:

* No gross tumor post-resection in other center.
* Contraindications to Fluzoparib, including allergic to Fluzoparib, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.
* Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.
* Benign histology
* Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)
* STS can be cured by extensive operation alone.
* Previous irradiation to the same area
* radiological evidence of distant metastases
* Other contraindications, can't tolerate operation or other treatment needed in this study.
Open Label Safety And Efficacy Study Of Pregabalin In Subjects With Nerve Pain Asociated With Human Immunodeficiency Virus (HIV) Neuropathy

To evaluate the safety and efficacy of pregabalin in reducing neuropathic pain associated with HIV neuropathy


Eligibility Criteria:
Inclusion Criteria:

* Participation in the preceding A0081066 double-blind trial met the entry criteria for that trial and completed A0081066 study through visit 7

Exclusion Criteria:

* Experienced serious adverse event during the A0081066 trial that was considered related or possibly related to study medication by the investigator or sponsor
* non-compliant during A0081066 trial
* clinically significant or unstable medical condition both HIV-related and non-HIV related including but not limited to, cardiac, pulmonary or hepatorenal disease that, in the opinion of the investigator, would compromise participation in the study
STN-Stimulation Versus Best Medical Treatment in Advanced PD

Assessment of the therapeutic effect of deep brain stimulation of the subthalamic nucleus compared with drug treatment alone in patients with advanced Parkinson's disease.

Patients are randomized either to medical treatment or subthalamic stimulation. The observation period was 6 months. The primary outcome criterium: PDQ-39 and UPDRS III.

Eligibility Criteria:
Inclusion Criteria:

advanced Parkinson's disease with UPDRS III score \>29/104 or Dyskinesia score \> 2 or tremor \>2

Exclusion Criteria:

age\>75 years depression psychosis surgical contraindications
Dose-ranging Study of Nemolizumab in Atopic Dermatitis

Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.

The aim of the study is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving topical corticosteroids, who were not adequately controlled with topical treatments.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥ 18 years (or legal age when higher)
* Chronic AD, that has been present for at least 2 years before the visit
* Eczema Area and Severity Index (EASI) score ≥12
* Investigator Global Assessment (IGA) score ≥ 3
* AD involvement ≥ 10% of Body Surface Area (BSA)
* Severe pruritus on at least 3 of the last 7 days before the visit
* Documented recent history (within 6 months before the visit) of inadequate response to topical medications
* Female subjects must fulfill one of the criteria below:

  * Female subjects of non-childbearing potential
  * Female subjects of childbearing potential who agree to a true abstinence or to use an effective or highly effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration

Exclusion Criteria:

* Body weight \< 45 kg
* subjects with a medical history of asthma requiring hospitalization in the last 12 months before screening visit and/or whose asthma has not been well-controlled during the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) \<80% of the predicted value
* Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period
* Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit or during the run-in period
* History of intolerance to low or mid potency TCS or for whom TCS is not advisable
Genetics of Central Nervous System Arteriovenous Malformations (GENE-MAV)

Cerebral and medullary arteriovenous malformations (AVMs) lead to arterial and venous networks to communicate pathologically, creating an arteriovenous shunt. The occurrence of intracranial haemorrhage is the most important prognostic factor of AVMs because it is associated with a significant morbidity and mortality. The genetic, molecular and cellular mechanisms that cause vascular malformations of the central nervous system are partially known and the influence of genetic damage on the prognosis of AVMs is poorly known.

Cerebral and medullary arteriovenous malformations (AVMs) are morphologically abnormal vessels located on the surface or in the cerebral or medullary parenchyma. These vascular lesions cause the arterial and venous networks to communicate pathologically, creating an arteriovenous shunt.

The prevalence of cerebral Cerebral and medullary AVMs in general population is difficult to establish given the rarity of the condition. However, it is estimated at around 1 per 10,000 inhabitants (0.01%). About 15-20% of the cerebral vascular accidents are asymptomatic at the time of diagnosis. The occurrence of intracranial haemorrhage is the most important prognostic factor because it is associated with a significant morbidity and mortality. The management of an AVM is usually carried out in a multidisciplinary way, combining interventional neuroradiology, neurosurgery and vascular neurology.

The genetic, molecular and cellular mechanisms that cause vascular malformations of the central nervous system are partially known. Several recent research works highlight mutations in the RAS-MAPK or MAPK-ERK signalling pathway in AVMs. In cases of cerebral AVMs considered to be sporadic, a somatic KRAS/BRAF mutation has recently been demonstrated in tissue samples of operated AVMs.

Except in the case of Hereditary Haemorrhagic Telangiectasia (HHT or Rendu-Osler-Weber syndrome), the influence of genetic damage on the prognosis of AVM is poorly known. It is also interesting to note that genetic screening is not routinely performed in patients with cerebro-medullary AVMs and that therefore the prevalence of these clinical entities in patients with AVMs is not known.

Eligibility Criteria:
Inclusion Criteria:

* Patient with a vascular malformation of the cerebral or medullary identified on diagnostic imaging (angio-CT, angio-MRI or diagnostic angiography) for which clinical monitoring alone or intervention (endovascular treatment, surgery or radiosurgery) is planned in the centres participating in the research.

Exclusion Criteria:

* Pregnant, parturient or breastfeeding woman
Thermic & Lipemic Properties of Dietary Carbohydrates

The purpose of this study is to determine if consumption of meals containing carbohydrates with different glycemic index (a high glycemic index meal and a low glycemic index meal)have different effects on energy expenditure, type of metabolic fuels used for energy, blood lipids and lipoproteins, and sensations of hunger, fullness, and the hormones related to satiety.

Little is known about the metabolic effects of chronic dieting and weight cycling in humans, but limited evidence suggests that fatty acid oxidation may be depressed leading to periodic elevation of circulating lipids associated with meal ingestion and preferential storage of fat in adipose tissue. With the traditional approach of restrictive dieting failing to result in permanent weight loss and, possibly producing abnormalities in lipid metabolism, it is important to evaluate alternative approaches to achieve a healthy body weight through improved metabolism. In this study the investigators will test the postprandial metabolic effects of standard mixed meals containing carbohydrates with high glycemic index and compare these effects to responses obtained with standard mixed meals, matched for protein and fat content but containing carbohydrates with low glycemic index.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 25 and 30 kg/m2
* Having regular menses
* Willing to refrain from restrictive dieting during the course of the study

Exclusion Criteria:

* Pregnant or currently planning a pregnancy
* Cigarette smoking
* Taking medications to induce weight loss or change appetite
* History of cardiovascular disease
* History of metabolic disorders, including diabetes
A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)

This randomized parallel group study will assess the efficacy and safety of erlotinib \[Tarceva\], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally, days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* male patients, \>/=18 years of age
* former smoker (smoked \>/= 100 cigarettes in his lifetime and quit \>12 months before enrollment)
* locally advanced (stage IIIb), metastatic (stage IV) or recurrent squamous non-small cell lung cancer
* prior platinum-based therapy for advanced NSCLC
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* uncontrolled symptomatic central nervous system (CNS) metastases
* prior therapy against epidermal growth factor receptor (EGFR)
* \>1 prior chemotherapy for advanced/metastatic NSCLC
* radiotherapy \<28 days prior to enrollment
* history of melanoma at any time, or another malignancy in the last 5 years except for carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or surgically cured malignant neoplasias with a disease-free interval of \>5 years
* not fully treated eye inflammation or infection, or predisposing conditions