cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Low-Level Laser Therapy Efficacy in Pain Management of Grade 2 Oral Mucositis Induced by Radiotherapy or Chemoradiotherapy: a Study in Patients With Upper Aerodigestive Tract Cancer

Prospective, monocentric, randomized phase II study evaluating Low-Level Laser Therapy (LLLT) as a treatment for the pain due to grade 2 oral mucositis in patients with upper aero-digestive tract cancer treated by radiotherapy or chemoradiotherapy.

Patients with upper aero-digestive tract cancer receiving their first cervicofacial radiotherapy or chemoradiotherapy will be included in this study if they suffer from oral mucositis due to their treatment.

The study procedure will consist in 5 applications of the LLLT that will be performed at three days intervals for a maximum duration of 15 days.

Each patient will be followed until 3 days after the end of the study treatment, for a total duration of the study of 18 days.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patients with upper aero-digestive tract cancer receiving a first cervicofacial radiotherapy or chemoradiotherapy
3. Patients with a grade 2 mucositis (according to the NCI CTCAE version 5.0) appearing during treatment.
4. Patients available to perform the LLLT treatment: 5 visits at 3 days intervals
5. Patients must provide written informed consent prior to any study specific procedures.
6. Patients affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Patients who have already received a cervicofacial radiotherapy
2. Patients who have already received an induction chemotherapy for their upper aero-digestive tract cancer
3. Patients under targeted therapy for their upper aero-digestive tract cancer
4. Patients under systemic corticotherapy
5. Patients with a non-grade 2 mucositis (according to the NCI CTCAE version 5.0)
6. Patients with ulceration or any other oral mucosa pathology than mucositis
7. Pregnant or breastfeeding women
8. Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure
9. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Effect of Alveolar Ridge Preservation on Implant Esthetic Outcomes

The purpose of this study is to evaluate esthetic outcome of implant supported single crowns after alveolar ridge preservation with beta three calcium phosphate with collagen type I in aesthetic region in upper jaw.


Eligibility Criteria:
Inclusion Criteria:

* healthy patients according to Classification of American Society of Anesthesiologists (ASA I)
* presence of 4 socket walls
* non-smokers
* good oral hygiene
* good occlusion

Exclusion Criteria:

* patients with alveolar ridge height less than 12 mm
* presence of acute or chronic oro-facial pain
* acute periapical infection
* injured soft tissue
* patients who had dental interventions in last 7 days
* patients who had any medications within last 24 hours
* patients with bruxism and para-functions
* patients with allergies to any of applied materials
Study of the Specific Seroprevalence of SARS-CoV-2 in a Sample of Patients and Salaried Staff From a French Anti-cancer Center at the End of the Containment Period of the SARS-CoV-2 Pandemic

Since March 2020, France has been confronted with the SARS-COV-2 pandemic. Analysis of the data of its spread would indicate that close contact between individuals is necessary and containment would be the best way to contain this virus. France has therefore been contained since March 17, 2020 until 11 May 2020.

In order to assess the impact of the measures taken (containment) to protect patients and salaried staff of a french anti-cancer center on the spread of the virus, this observational study assesses the specific seroprevalence of SARS-COV-2 in all caregivers and non-carers of this hospital and in patients treated in consultation, day hospitalization, full hospitalization at the end of the containment period.

The objective for the staff cohort is to describe the seroprevalence and the link between the seroprevalence and sociological / demographic factors relating to the category of profession, to the contacts with the patients, to the presence in the hospital during the period of containment, to the conditions of home containment.

The objective for the patient cohort is to describe the seroprevalence and the link between the seroprevalence and factors relating to the type of cancer treated, the type of treatment and their possible modification during the period of containment, to the conditions of home containment.


Eligibility Criteria:
Inclusion Criteria:

* Patient group:

Patient over 18 years old. Patient who gave his non-opposition to carrying out the study. Patient affiliated to the social security scheme.

* Salaried staff group:

Salaried staff over 18 years old. Salaried staff not opposing the carrying out of the study. Salaried staff affiliated to the social security scheme.

Exclusion Criteria:

* Patient group:

Minor patient, under legal protection or subject to a legal protection measure Patient deprived of liberty or under guardianship Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons Patient refusal to participate Pregnant or nursing mothers

* Salaried staff group:

Underage salaried staff or under legal protection Salaried staff deprived of liberty or under guardianship Inability of the salaried staff to submit to the monitoring of the test: filling out the questionnaire and taking a blood sample Salaried staff refusal to participate in the study
Protocol for a Multicentre Survey of Patients With Treatment Resistant Hypertension

Project aims to determine the number of individuals with treatment resistant hypertension and to define the characteristics of these patients and estimate disease frequency. The study will be a retrospective review of medical record data based upon de-identified information and will require no patient contact.


Eligibility Criteria:
Inclusion Criteria:

* \> = 18 years of age
* No known secondary cause of hypertension
* History of uncontrolled hypertension while using 3 or more anti-hypertensive agents
* Controlled blood pressure using 4 or more different anti-hypertensive agents

Exclusion Criteria:

N/A
A New Non-invasive Marker to Detect Silent Hypoxia in Patients Undergoing Cardiac Surgery

In patients undergoing cardiac surgery under cardiopulmonary bypass, some organs like brain and heart are preserved while others (skin, gut and skeletal muscle) are being underperfused. This phenomenon is related to silent peripheral vasoconstriction that is not clinically available but threatens end-organ perfusion and carries the risk of multi-organ failure. By measuring non-invasively the somatic-to-cerebral oxygen saturation gradient, the present study aims at detecting silent peroperative hypoperfusion episodes. The investigators hypothesize that gradient, measured during the surgical procedure, will predict the occurrence of anaerobic metabolism, ascertained by an elevation of blood lactate concentration, measured in intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yo
* Cardiac surgical procedure under cardiopulmonary bypass
* High-risk surgical patient fulfilling one of the following items:

  * Euroscore \>= 6
  * Ejection fraction \< 40%
  * Creatinine clearance \< 40mL/min
  * Pulmonary arterial pressure \> 45mmHg
* Signed informed consent
* Social security affiliation

Exclusion Criteria:

* Emergency situation
* Patient on ECMO
* Pregnancy or lactation
Weight Management in Overweight Endometrial Cancer Patients Undergoing Fertility-sparing Treatment

In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into two groups. The test group was given weight management, while the control group was given routine care. Relevant information such as body morphology and composition, glycolipid metabolism, molecular typing and tumor outcomes of the subjects were collected. By evaluating the tumor outcome and changes in glycolipid metabolism indicators, to confirm the effectiveness and safety of weight management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.

Obesity is recognized as a major risk factor for the development of endometrial cancer. Notably, several retrospective studies have shown that obesity reduces complete remission and pregnancy rates and increases recurrence rates in patients with endometrial cancer and atypical hyperplasia who undergo fertility-sparing treatment. Guidelines or consensus statements for fertility-sparing treatment in endometrial cancer recommend weight management. However, prospective intervention studies on the effectiveness of systematic weight management models in patients receiving reproductive function-preserving treatment for endometrial cancer and atypical hyperplasia are lacking. This study therefore aimed to investigate the impact of the weight management on body morphology and composition, glycolipid metabolism, and tumor outcomes in overweight and obese patients with endometrial cancer and atypical hyperplasia who underwent reproductive function-preserving treatments.In this study, overweight and obese patients with endometrial cancer treated with fertility- sparing therapy were randomly divided into two groups. The test group was given weight management, while the control group was given routine care. Relevant information such as body morphology and composition, glycolipid metabolism, molecular typing and tumor outcomes of the subjects were collected. By evaluating the tumor outcome and changes in glycolipid metabolism indicators, to confirm the effectiveness and safety of weight management for overweight and obese patients with endometrial cancer and treatd with fertility preservation.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years old
* diagnosed as endometrial cancer or atypical hyperplasia
* immunohistochemical staining and sequencing of pathological tissue
* fertility-preserving therapy
* BMI≥25 kg/m2
* informed consent.

Exclusion Criteria:

* those with communication barriers
* pregnant women
* medical and surgical serious complications: urinary calculi, history of renal failure or severe renal insufficiency, familial dyslipidemia, severe liver disease, chronic metabolic acidosis, history of pancreatitis, severe diabetes mellitus, active gallbladder disease, fat dyspepsia, severe cardiovascular and cerebrovascular diseases.
Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly

To examine the safety and immunogenicity of two formulation of liposomal adjuvant / delivery system (VaxiSomeTM=CCS-Cholesterol \[CCS/C\]), combined with commercial influenza vaccine in an elderly healthy population when given once intramuscularly (IM).


Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry, male or female;
* able to comply with all the study requirements;
* in stable good health as determined by medical history; physical examination; clinical judgment of the investigator.
* Have adequate renal function (renal clearance of at \> 30ml/min)
* Have normal liver function (hepatic transaminases \[ALT and AST\] \< 43 U/L)
* Have hemoglobin \> 11.5 g/L

Exclusion Criteria:

* Any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: cancer, except for localized skin cancer;
* Advanced congestive heart failure; Acute exacerbation of Chronic obstructive pulmonary disease (COPD); Autoimmune disease, Acute or progressive hepatic disease; Acute or progressive renal disease with a renal clearance of at \< 30ml/min ; Severe neurological or psychiatric disorder; History of Guillain Barré syndrome; Severe asthma.
* Clinically significant symptoms of neurological disease; untreated hypertension; increased liver enzymes.
* History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
A Study of ADH300004 in Surgically Resected Primary or Metastatic Colorectal Cancer and Liver Biopsy, or Planned Hepatic Resection

5 fluorouracil (5 FU), one of the most actively investigated anti-cancer drugs, is rapidly inactivated by the enzyme dihydropyrimidine dehydrogenase (DPD). ADH300004 blocks DPD. This study will examine the kinetics of inhibition and recovery of the metabolic pathways for fluoropyrimidines in subjects who receive a single oral dose of ADH300004, and may allow optimization of oral 5 FU dosing to subjects in future studies.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* \> or = 19 years of age
* Patients with histologically confirmed:

  * primary or metastatic (known or suspected) colorectal carcinoma requiring planned surgical resection with hepatic biopsy and systemic chemotherapy , or
  * primary or metastatic neoplastic disease within the liver from any origin requiring planned surgical resection and systemic chemotherapy
* Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing

Exclusion Criteria:

* Lack of known or suspected metastatic disease in the liver
* Known DPD deficiency
* Severe infection
* Inability to take oral medication
* The need for treatment with any fluoropyrimidine within 8 weeks of any ADH300004 dose
* Stroke, major surgery, or other major tissue injury within 30 days before study entry
The Effects of Frailty on Opioid Consumption

The FRAIL scale will be applied to patients at the preoperative visit. According to the FRAIL Scale, patients will be divided into 3 groups as Non-frail (Group I), pre-frail (Group II) and frail (Group III). After routine preoperative preparation and monitoring, patients will be given spinal anesthesia. Demographic data and intraoperative data of the patients will be recorded. Patients will be transferred to the post-operational post-operative care unit (PACU) and patient-controlled analgesia (PCA) will be applied to each patient with a standard protocol. In the postoperative period, the need for analgesics will be recorded for 24 hours, and if additional analgesics are needed, they will be recorded. Pain scores of the patients will be evaluated for 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* patients who will undergo unilateral, primary total knee arthroplasty
* Patients who will be operated with spinal anesthesia

Exclusion Criteria:

* Patients with ASA IV and above physical status
* Uncooperative patients
* Patients who do not speak Turkish
* Patients on routine opioid use
Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator

The TRIUMPH study is a post-market, international, multicenter, interventional, prospective, single-arm study intended to evaluate the sustainability of pain control and psychosocial and functional responses utilizing a multiple-waveform enabled neurostimulator in subjects with chronic, intractable pain of the trunk and/or limbs.

TRIUMPH study will utilize the multiprogram trial stimulator or invisible trial system with BurstDR for the trial evaluation period and the Prodigy or Proclaim Elite family of neurostimulators with tonic or BurstDR waveform at permanent implant and follow-up for pain control and improvement of psychosocial function. The follow-up visits will be scheduled at 3, 6, 12, 18, and 24 months post permanent implant

Eligibility Criteria:
Inclusion Criteria:

1. Subject has chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.
2. Subject has a score of 6 or higher on the numeric rating scale (NRS) for average pain specific to the area(s) of chronic pain being treated over the past 24 hours at the baseline visit.
3. Subject is considered by the Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions For Use.
4. Subject is 18 years of age or older at the time of enrollment.
5. Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits.
6. Subject has signed and received a copy of the Ethics Committee/Institutional Review Board (EC/IRB) approved informed consent.

Exclusion Criteria:

1. Subject currently has a spinal cord stimulation system implanted.
2. Subject has previously failed spinal cord stimulation (SCS) therapy (either trial system evaluation or permanent implant).
3. Subject has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine.
4. Subject has or plans to have a Peripheral Nerve Stimulation system (PNS), Peripheral Nerve field Stimulation system (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump.
5. Subject is currently participating in another clinical investigation with an active treatment arm.
6. Subject unable to read and/or write.
Efficacy of New Ergonomic Device in Non-Specific Neck Pain.

The goal of this clinical trial is to learn if smartphone holder works to treat neck pain in adults. It will also learn about the usability of smartphone holders. The main questions it aims to answer are:

* Does the smartphone holder decrease pain level and improve function in case of neck pain?
* How likely will the participants recommend the holder for their friends?

Researchers will compare adding the holder to the commonly used exercises for neck pain to a group which will receive the common exercise only. To see if the holder can modify neck pain.

Participants will:

* Do the exercise with or without using the holder
* Visit the clinic 3 times per week for a month for receiving exercise
* Keep a diary of their usage for the holder


Eligibility Criteria:
Inclusion Criteria:

* • Subject's age ranges from 18-45

  * Having neck discomfort symptoms that were triggered by certain neck positions and by palpating the cervical musculature for at least three months
  * Smartphones addiction \>6hours per day

Exclusion Criteria:

* • Pregnancy.

  * Neck pain associated with whiplash injuries or trauma
  * medical red flag history (such as tumour, fracture, metabolic diseases, rheumatoid arthritis and osteoporosis)
  * Neck pain with cervical radiculopathy or neck pain associated with externalized cervical disc herniation.
  * If the patient had previous surgery in the neck area (irrespective of the reason for the operation)
Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue

To collect and preserve glioblastoma tissue during standard of care tumor resection surgery and blood for future molecular and genetic testing. Tissue for research will be collected from three different regions within the same tumor to study how these regions differ in their structure, DNA, and RNA and also to compare the data obtained from this testing to imaging data found in the medical record. The goal of this study is to help us better understand what the glioblastoma tumor tissue looks like and how it functions. This understanding can lead to new therapies for the treatment of glioblastoma in the future.


Eligibility Criteria:
Inclusion Criteria:

1. Have the appearance of high-grade glioma on magnetic resonance (MR) imaging if allowed to consent and will undergo the procedure if the frozen is consistent with glioblastoma or gliosarcoma OR Patients with a history of histologically confirmed diagnosis of World Health Organization Grade glioblastoma or gliosarcoma that are undergoing repeat resection of a recurrent tumor as identified on preoperative MR imaging
2. Aged ≥ 18 years old
3. Contrast-enhancing tumor volume of at least 10 cc on the preoperative, volumetric MRI within 1 month prior to surgery
4. Provision of signed and dated informed consent form by participant or legally authorized representative (LAR), if applicable

Exclusion Criteria:

1. Has a history or current evidence of any medical condition, therapy, or laboratory abnormality that might confound the results of the study or is not in the best interest of the participant, in the opinion of the treating investigator.
A Trial to Evaluate Para-aortic Lymphadenectomy for Gastric Cancer

To evaluate the survival benefit of para-aortic lymphadenectomy in potentially curative gastrectomy

Radical gastrectomy with regional lymphadenectomy is the only curative treatment option for gastric cancer. The extent of lymphadenectomy, however, is controversial. The two European randomized trials only reported an increase in operative morbidity and mortality, but failed to show survival benefit, in the D2 lymphadenectomy group. We conducted a randomized controlled trial to compare the Japanese standard D2 and D2 + para-aortic nodal dissection.

Eligibility Criteria:
Inclusion Criteria:

- Preoperatively,

1. histologically proven adenocarcinoma
2. 75 years old or younger
3. forced expiratory volume in one second ≥ 50 %
4. arterial oxygen pressure in room air ≥ 70 mmHg
5. creatinine clearance ≥ 50 ml/min
6. written consent. Intraoperatively
7. Macroscopic T staging is T2-subserosa, T3, or T4
8. potentially curative operation is possible
9. no gross metastasis in para-aortic nodes (frozen section diagnosis not allowed)
10. peritoneal lavage cytology is negative for cancer cells

Exclusion Criteria:

1. Carcinoma in the remnant stomach
2. Borrmann type 4 (linitis plastica)
3. synchronous or metachronous malignancy in other organs except for cervical carcinoma in situ and colorectal focal cancer in adenoma
4. past history of myocardial infarction or positive results of exercise ECG
5. liver cirrhosis, or chronic liver disease with indocyanine green test ≥10%