cyrilzakka/clinical-trials huggingface dataset:
Validation of the TMD Pain Screener in a Specialized Headache Center

The purpose of the study is to investigate whether a questionnaire can be used to detect whether patients referred to the Danish Headache Center have a painful temporomandibular disorder (TMD).

TMD is a major public health problem that affects up to 15% of the adult population and can cause headaches that can be immediately difficult to differentiate from other headache types such as tension headaches and migraines. By applying the so-called diagnostic criteria for TMD through a standardized study program, TMD diseases such as myalgia of the jaw muscles, arthralgia and discus displacements of the jaw joints and jaw arthritis can be diagnosed. However, this requires dental expertise and is time consuming. At the Danish Headache Center, the current screening question is used for TMD in order to identify who could benefit from further investigation in dentistry. But it is still unknown how accurate these questions are in selecting those patients who have TMD diseases in a patient group with a headache. The investigators would like to investigate this in order to improve the referral procedure of headache patients for relevant dental treatment or physiotherapy. This is believed to be of importance both in a specialized unit such as the Danish Headache Center and in neurological medical practice.

Patients will be recruited who are referred to the Danish Headache Center, who have been given TMD screening questions and who have indicated in writing that they wish to be contacted for research projects.

In the study, 25 subjects with TMD screening question score of ≥ 3 points will be included, which will be gender and age matched with 25 subjects who have TMD screening question score of \<3 points. The patients will be interviewed to classify the patients headache 15 min and then have a jaw examination done and then the DC / TMD examination will be done and lasts approx. 30 min. The examination is performed by a skilled physiotherapist and it does not involve any side effects or risks.


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the ages of 18 and 75 who are referred to the Danish Headache Center

Exclusion Criteria:

* No known pre-existing significant TMD or dental disease that can cause headaches
* Anamnestic or clinical signs of a condition of any kind that is considered relevant by the investigating physician for participation in the study.
* Patients who do not wish to be informed of the findings of presence of TMD
Efficacy of Ivermectin in Outpatients With Non-severe COVID-19

This is a randomized controlled trial to evaluate the efficacy of ivermectin in reducing the risk of progression to severe disease and hospitalizations in COVID-19 patients.

This is a randomized controlled trial to evaluate the efficacy of ivermectin in COVID-19 outpatients reducing the risk of progression to severe disease.

Patients with COVID-19 infection are randomized to receive a single dose of 200mcg/kg of ivermectin or a placebo.

The randomization code is generated by the trial statistician. The allocation is made after fulfilment of both inclusion and exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Positive diagnostic RT-qPCR or antigen test for SARS-CoV-2
* Symptomatic patients with up to 8 days from the onset of symptoms, and asymptomatic cases with up to 5 days of positive test for SARS-CoV-2.
* Patients who agree to participate in the study by signing the informed consent.

Exclusion Criteria:

* Patients with severity criteria defined in the Coronavirus Disease Epidemiological and Laboratory Surveillance Guide (Version 3/11/2020)
* Pregnant or breastfeeding women
* Women of childbearing age and without commitment to use contraceptive methods during the study time.
* Inability to complete the study
* Current treatment with drugs known to interact with ivermectin
* Known intolerance to ivermectin, its derivate or any of its excipients.
* Patients with known Child-Pugh C liver disease
* Patients with prior ivermectin consumption in the 10 days prior to study entry.
Drug-Drug Interaction Study in Health Adult Volunteers

The purpose of this study is to assess the effects of K-877 on the pharmacokinetics of digoxin in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
* Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
* Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.
Improving Muscle Function in Nutritionally at Risk, Elderly Patients

The investigators propose to conduct a randomized, control trial of β-hydroxy-β-methylbutyrate (HMB) supplementation in elderly patients (≥65 years of age) with acute respiratory failure, who are identified at high risk for malnutrition by ICU-specific nutritional risk scores. Patients will receive either 3g of HMB daily, or control, daily until day 28 following randomization (even if discharged).The investigators will measure functional outcomes using standard, validated measures prior and after discharge.

The investigators propose to conduct a randomized, control trial of HMB supplementation in elderly patients (≥65 years of age) with acute respiratory failure, who are identified at high risk for malnutrition by ICU-specific nutritional risk scores. Patients will receive either 3g of HMB daily, or control, daily until day 28 following randomization (even if discharged).the investigators will measure functional outcomes using standard, validated measures prior and after discharge.

The investigators hypothesize that this inexpensive nutrient, HMB, along with our supportive measures, reduces muscle loss, improves physical muscle function, and improves quality of life in the longer term following critical illness.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age ≥65 years.
2. Acute respiratory failure (ARF, defined by expected mechanical ventilation for \> 72 hours from the point of screening)
3. Elevated nutritional risk (NUTRIC score\>5 - see below).

Exclusion Criteria:

1. Over 72 hours from ICU admission.
2. Not expected to survive another 48 hours
3. Lack of commitment to full, aggressive care
4. Patients who have an absolute contraindication to EN (obstruction, perforation, high output fistula),
5. Pregnant women
6. Prisoners
7. Known allergy to study nutrients
8. Unable to walk prior to current illness.
Use of Clarithromycin in Mustard-Induced Bronchiolitis

We looked for the effectiveness of low-dose long-term prescription of clarithromycin in mustard-induced chronic pulmonary lesions, especially bronchiolitis obliterans


Eligibility Criteria:
Inclusion Criteria:

* His/her own will to participate
* Documented chemical exposure
* Clinical, spirometric and radiological findings were compatible with BO on High Resolution Computed Tomography (HRCT)

Exclusion Criteria:

* any drug reactions during the trial
* history of sensitivity to macrolides
* diarrhea, gray stool, jaundice, eosinophilia, acute cholestatic hepatitis, pruritis, dark urine, abdominal pain, osteomatosis, depression, taste change, behavioural changes, early fatigue, odynophagia, glossitis , dizziness
* co-adminstration of: terfenadine, theophylline, carbamazepine, ergotamine, dihydroergotamine, warfarin, cisapride, digoxin, triazolam, phenytoin, steroids, any immunosuppressive, any systemic antibiotics
* using drugs that he/she cannot discontinue
* using drugs with potential interaction
* subject will to exit from the trial
* history of lobe resection of lung
* history of exacerbation in the last month prior to the beginning of trial
* continuous need to oxygen
* use of corticosteroids in last week prior to the trial beginning
* Radiographic evidence of pneumonia, active tuberculosis, lung carcinoma, or an infection that necessitated the use of an antibiotic
* exacerbating of subjects
* creatinine srum level more than normal
* increasing ALT, AST levels
* total bilirubin more twice than normal
* subjects who did not use their drugs properly
This Prospective Study Has 2 Objectives: First, to Assess the Post-obturation Pain Utilizing Bioceramic Sealer and One Cone Technique. Second, to Compare the Intensity of Post-obturation Pain Following Unintentional Sealer Extrusion

Root canal treatment is essential step to eliminate pain and preserve tooth structures. However, errors could happen unintentionally such as ledge, perforation and sealer extrusion.

Pain through an endodontic treatment is one of the elements that most of the patients seek treatment to be relived.

One the current systemic review analyzed the pain after root canal treatment could be up to half the patients.

The purpose of this study is to evaluate and record the postoperative pain among patients who are undergoing root canal treatment.


Eligibility Criteria:
"Inclusion Criteria":

* Primary root canal
* Asymptomatic tooth with or without apical radiolucency
* Patient older than 18 and younger than 70
* American Society of Anesthesiology (ASA) Class I or II

"Exclusion Criteria":

* Patient with preoperative pain
* Periodontal probing more than 5mm
* When patency could not be achieved
* pregnant patient.,
* patients who could not properly follow the instructions for filling the visual analog card (VAS) were excluded.
* Previously treated or initiated
Pilot Study Immunomonitoring Natural Killers Cells in Patients With Myeloid Malignancies Treated With Lenalidomide

This project is a framework for developing new therapeutic strategies for acute myeloid leukemia(AML)based immunotherapy.

the role of NK cells was demonstrated in AML and especially GVL effect (graft versus leukemia) during allogeneic transplantation in these patients. However, it has been shown that the phenotype of NK cells and their cytotoxic functions were altered during this malignancy. In addition, in these patients, impaired NK function is associated with relapse.

lenalidomide it would have a beneficial effect on NK cells of AML patients? Does it have a role in leukemic cells in this malignancy? what is its effect on the production of pro-inflammatory cytokines? In vitro data show an effect of lenalidomide on the phenotype of NK cells from healthy donors and patients with LAM, and despite these phenotypic changes, the cytotoxic capacity of NK is not altered.Lenalidomide also induces a significant increase in the production of TNF-alpha (tumor necrosis factor) by NK.

It also seems to have an effect on leukemic blasts of AML. So, the investigators hope this study confirm these results in vivo in peripheral blood cells in patients treated with lenalidomide.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years and above,
* Patient with myeloid acute leukemia or with myelodysplasic syndrome, treated or should be treated with Revlimid,
* Signed consent to participate,
* Patient affiliated to a social security system or benefiting from such as a system.

Exclusion Criteria:

* Allogeneic patients beyond,
* Patient deprived of liberty or under supervision of a guardian,
* Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons.
Bariatric Surgery and Pharmacokinetics of Valsartan

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on valsartan are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Repeatability and Reproducibility of Cirrus HD-OCT Measurements of Illumination Areas Under the Retinal Pigment Epithelium

The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurement of illumination areas under the retinal pigment epithelium (RPE).

This is a prospective, single site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. The study will be divided into two phases. In Phase 1, the inter-device variability of Cirrus HD-OCT measurements of illumination areas under the RPE will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of illumination areas under the RPE will be determined. In each of these phases, the Macular Cube 200 x 200 scan and the Macular Cube 512 x 128 scan will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 50 years of age and older diagnosed to have advanced dry AMD with geographic atrophy.
* Geographic atrophy lesions should:

  * Not be greater than 5 mm at the widest diameter. The entire lesion(s) should fit into the 6x6 mm scan area of the Cirrus HD-OCT.
  * Not be smaller than 1.25 mm2.
  * Not be confluent with peri-papillary atrophy.
  * Not be combined with other lesions such as CNV.
* Able and willing to make the required study visits.
* Able and willing to give consent and follow study instructions.

Exclusion Criteria:

* History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye.
* Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction.
* Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
* Concomitant use of hydrochloroquine or chloroquine.
* Unable to make the required study visits.
* Unable to give consent or follow study instructions.
Hand10 Questionnaire in Individuals With Carpal Tunnel Syndrome

Hand10 questionnaire, Boston Carpal Tunnel Syndrome Questionnaire and Arm Shoulder Questionnaire for patients with carpal tunnel syndrome and Hand Deficiencies Questionnaire (DASH) will be applied one week apart to investigate the validity of the questionnaire.

Test-retest reliability and internal consistency will be determined using Intraclass Correlation Coefficient analysis and Cronbach alpha, respectively. The validity of Hand10 in individuals with CST will be determined using the Pearson Correlation Coefficient analysis, the Arm, Shoulder, and Hand Disability Questionnaire and the Boston Carpal Tunnel Syndrome Questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Patients who volunteer for treatment
* 18-70 years old patients
* With patients diagnosed with CTS

Exclusion Criteria:

-Patients who have had surgery on the wrist area
Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy

Gastroenteroscopy diagnosis and treatment drugs need to meet the needs of quick onset, quick recovery and less anesthesia complications. Remimazolam is an anesthetic sedative independently developed by China. It is a new short-acting GABA(A) receptor agonist. Remimazolam has the advantages of rapid onset, rapid recovery, antagonist, controllable degree of cardiovascular and respiratory depression, low incidence of hypotension and respiratory depression. However, elderly patients as important and special patients, there are still a lack of relevant studies and reports.

In order to verify the safety and effectiveness of remimazolam in the gastroenteroscopy treatment of elderly patients, it can reduce the incidence of intraoperative hypotension or respiratory depression rate, improve the quality of recovery of elderly patients.

Patients are fasted for at least 6 hours and water for at least 2 hours. After entering the gastroscopic room, patients took 0.1 g of dacronin hydrochloride glue in the throat for about 5 minutes, instructed the patient to be in the left recumbent position and nasal catheter oxygen (4 L / min), finger oxygen and blood pressure ; after static pushing sufentanil 0.08 μg/kg, respectively, give remimazolam or propofol for sedation; MOAA/S score ≤ 3 , start gastrointestinal endoscopy, maintain MOAA/S ≤ 4 during the operation. After the end of gastrointestinal treatment, the patient is moved to the recovery room for recovery. The evaluators also assessed the incidence of blood oxygen saturation \< 90%, the incidence of respiratory rate \< 8 times/min, the incidence of hypotension, the time of improved aldrete≥9, the time of discharge score ≥9 points, the postoperative cognitive function, amnesia, anxiety, dizziness, pain, nausea, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥60, no gender limitation;
* Patients receiving gastroscopy or gastrointestinal endoscope;
* ASA physical status score of I to III;
* 18 kg/m² \< BMI \< 30kg/m²;
* They clearly understand and voluntarily participate in the study and sign informed consent

Exclusion Criteria:

* Endoscopic diagnosis and treatment techniques with complex operation are required;
* Patients with respiratory management difficulties;
* Anemia or Thrombocytopenia;
* Have a history of drug abuse and/or alcohol abuse within 2 years prior to the beginning of the screening period;
* Patients with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive medication (sital systolic blood pressure ≥160 mmHg at screening stage, and/or diastolic blood pressure ≥100 mmHg at screening stage);
* Allergic or contraindicated to benzodiazepines, opioids, propofol, lidocaine and their components;
* Participated in clinical trials of other drugs as a subject within the last 3 months;
* The investigator considered the patients unfit to participate in the trial.
Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study

The purpose of this study is to see if the clinical outcome success rate of Total Ankle Arthroplasty is similar to that of Ankle Arthrodesis over a period of 10 years. This will include looking at whether Total ankle arthroplasty results in a lower rate of hindfoot arthrosis and arthritis after surgery compared to ankle joint arthrodesis and if the rate of complications and revision surgery is acceptable when compared to Ankle Arthrodesis over a period of 10 years.


Eligibility Criteria:
Inclusion Criteria:

* Eighteen (18) or older
* Known to have ankle arthritis for more than six (6) months
* Tried non operative treatment measures (eg. activity modification, physiotherapy, orthotics, bracing etc.) and have not improved
* Patient tests (questionnaires) show that ankle arthritis is severe
* Patient willing to take part in the study, including signing consent form after carefully reading it

Exclusion Criteria:

* Dead Bone in the Ankle
* Severe foot or Ankle Deformity
* Prior Ankle Fusion or Replacement
* Active or Prior Infection in the Ankle
* Obesity (greater than 250 lbs)
* Medical Conditions precluding safe surgery
* Nerve or Muscle disease
* Severe osteoporosis
GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer

To investigate the efficacy of GV1001 in sequential combination with gemcitabine in locally advanced and metastatic adenocarcinoma of the pancreas.

The trial is a Phase III, multinational, multicentre, controlled, randomised open-label trial. It will involve 520 advanced pancreatic cancer patients. Patients will be randomly assigned to receive Gemcitabine alone or GV1001 plus GM-CSF followed by addition of Gemcitabine at the time of 1st progression of disease. The experimental treatment is given prior to the current standard treatment in 50% of the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas.
2. Adequate hematological parameters:

   Hemoglobin \>/= 9.5 g/dL \[SI units, 5.9 mmol/L\] WBC \>/= 3000/mm3 \[SI units, \>/= 3 x 109/L\] Platelets \>/= 100,000/mm3 \[SI units, \>/= 100 x 109/L\]
3. Adequate baseline liver function:

   Total Bilirubin \< 3x ULN and

   Without liver metastases:

   AST (SGOT) \</= 2.5 x ULN ALT (SGPT) \</= 2.5 x ULN

   With liver metastases:

   AST (SGOT) \</= 5 x ULN ALT (SGPT) \</= 5 x ULN
4. Serum creatinine \</= 1.5 mg/dL \[SI units, 132 µmol/L\].
5. Performance status ECOG 0-1.
6. Male or female 18 - 75 years inclusive.
7. Minimum life expectancy of 3 months.
8. Written informed consent.

Exclusion Criteria:

1. Treatment with chemotherapy for pancreatic cancer.
2. Treatment with other investigational drugs within the last 4 weeks prior to inclusion
3. Immune-suppressive therapy \<4 weeks prior to inclusion
4. Chronic corticosteroid use except for asthma inhalers / topical use
5. Radiotherapy within 8 weeks of randomisation.
6. Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix.
7. Known diagnosis of HIV (AIDS), Hepatitis B, C.
8. Known history of or co-existing autoimmune disease.
9. Known CNS metastases.
10. Clinically significant serious disease or organ system disease not currently controlled on present therapy.
11. Pregnancy or lactation.
12. Women of childbearing potential not using reliable and adequate contraceptive methods\*
13. Known sensitivity to any components of vaccine, gemcitabine or GM-CSF.
14. Unable for any other reason to comply with the protocol (treatment or assessments).

    * Adequate contraceptive methods are defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.