cyrilzakka/clinical-trials huggingface dataset:
R Retreatment in 1st Relapsed DLBCL

It is a phase II , multicenter, open label clinical trial. Only the relapsed DLBCL patients after 1st line induction treatment of 6\~8 cycles of RCHOP-like chemo will be enrolled to receive 3 cycles of RICE as salvage therapy.

After treatment each patient should be followed up for 2 years.


Eligibility Criteria:
Inclusion Criteria:

1. Relapsed DLBCL patients having received 6 - 8 cycles of RCHOP-like chemotherapy as 1st line induction treatment.
2. Disease relapsed no earlier than 6 months after prior induction treatment.
3. Confirmed CD20 positivity of the lymphoma at time of diagnosis (prior to induction therapy)
4. ECOG performance status of 0, 1 or 2 at time of inclusion (see Appendix IV )
5. Known IPI at time of diagnosis (prior to induction therapy)
6. Age ≥18 years and \<65 y
7. Life expectancy of \> 3 months
8. Be willing and able to comply with the protocol for the duration of the study
9. Agree to use effective contraception for the entire treatment period and during the 12 months thereafter
10. Patient's written informed consent

Exclusion Criteria:

1. More than one prior chemoimmunotherapy regimen.
2. Histologies other than DLBCL according to the WHO/REAL classification
3. History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin, surgically treated malignant melanoma or carcinoma in situ of the cervix within the last 5 years.
4. Major surgery, other than diagnostic surgery, within the last 4 weeks.
5. Evidence of CNS involvement patients
6. Unacceptable hematologic status at baseline prior to study start below any of the values listed: WBC: \<3 x 109/L; absolute neutrophil count (segmented + bands) \<1.5 x 109/L; platelets: \<100 x109/L
7. Abnormal liver function tests prior to study start above any of the values listed: serum bilirubin \>2 mg/dL (30 mmol/L); ALAT or ASAT \>2.5 x upper limit of normal range; or Abnormal renal function (serum creatinine \> 150 μmol/L ).
8. HIV-positive patients.
9. Contraindication to the investigational medication
10. Active viral hepatitis, specifically HBV or HCV infection
11. Serious underlying medical conditions, (e.g. ongoing infection, uncontrolled diabetes mellitus, severe cardiac dysfunction or angina, gastric ulcers, active autoimmune disease)
12. Life expectancy \< 3 months
13. Treatment within a clinical trial within 30 days prior to trial entry
14. Women who are breast feeding, are not using effective contraception, are pregnant
15. Patients under tutelage
Polish Version Fatigue Severity Scale

Fatigue is one of main symptoms in multiple sclerosis, amyotrophic lateral sclerosis and other diseases with profound effect on quality of life and professional and social functioning. Not infrequent it is misdiagnosed as sleepiness or other symptom. Fatigue severity scale is a time efficient and easy to apply instrument to assess the impact of fatigue on patient's life. The aim of this study is to validate the Polish-language version of the Fatigue Severity Scale.

Fatigue is one of main symptoms in multiple sclerosis, amyotrophic lateral sclerosis, post-polio syndrome, stroke, parkinsonism as well as in the chronic fatigue syndrome. It has profound effect on quality of life and professional and social functioning and in multiple sclerosis it is described as the worst symptoms by the 50% of patients. It is defined as the difficulty in initiating and maintaining a sustained mental or physical activity. Not infrequent it is misdiagnosed as sleepiness or other symptom. Fatigue severity scale (FSS) is a time efficient and easy to apply instrument to assess the impact of fatigue on patient's life. It has been translated and validated in Turkish, Russian, Hindi, Portuguese, and many other languages. FSS is a short, nine-item self-report questionnaire. Each item is a Likert scale, scored from one to seven, where seven refers to the most severely expressed aspect of fatigue. The aim of this study is to validate the Polish-language version of the Fatigue Severity Scale (pFSS). This version has been created according to widely accepted, respective standards, including translation by two independent native Polish-language speakers with acquired knowledge of English and backward translation by two independent native English-language speakers with acquired knowledge of Polish as well as with the pretesting on ten patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of definite multiple sclerosis or definite, laboratory-supported multiple sclerosis, or definite amyotrophic lateral sclerosis, or probable amyotrophic lateral sclerosis or probable, laboratory supported amyotrophic lateral sclerosis or ischemic stroke or - for healthy controls - lack of diseases, pharmacotherapy or habits, which could induce abnormal tiredness

Exclusion Criteria:

* Presence of cognitive deficits or behavioral disorder, which could disturb participation in the study.
Low-Flow vs. High-Flow Nasal Cannula for Hypoxemic Immunocompromised Patients During Diagnostic Bronchoscopy

Pneumonia is a lung infection. Fiberoptic bronchoscopy is a test to diagnose the type of lung infection. While this procedure is being performed, a small amount of oxygen is delivered into the nose (low flow nasal cannula). Occasionally during this procedure, the blood oxygen of the patient may drop and an intervention such as increasing the oxygen flow, or placing the patient on a breathing machine is required. An alternative device called 'Optiflow' can provide high flow oxygen through nasal cannula, and is comfortable for patients. If Optiflow is used during bronchoscopy, it may prevent the blood oxygen from dropping.

Pneumonia is a lung infection that is a common complication in people with cancer, because of a weak immune system. Fiberoptic bronchoscopy is a test that is commonly used to help doctors diagnose the type of lung infection and treat it appropriately. It involves passing a thin tube with a camera at the end inside the lungs, and taking some fluid samples which are sent for analysis. While this procedure is being performed, a small amount of oxygen is delivered into the nose (low flow nasal cannula). Occasionally during this procedure, the blood oxygen of the patient may drop (even if the patient is receiving oxygen, and especially if the patient has severe pneumonia), and the procedure may have to be interrupted or prematurely stopped. If the oxygen level drops significantly, an intervention such as increasing the oxygen flow, or in the worst-case scenario temporarily placing the patient on a breathing machine is required. An alternative device called 'Optiflow' can provide high flow oxygen through nasal cannula, and is comfortable for patients. Optiflow was approved by Health Canada in 2006, and is commonly used in hospitals in Ontario and around the world to support patients whose blood oxygen is low. If Optiflow is used during bronchoscopy, it may prevent the blood oxygen from dropping.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥18 years scheduled to undergo FOB (as determined by their medical care team) who are immunocompromised (active hematologic malignancy or post hematopoietic stem cell transplant), and are hypoxic with pulmonary infiltrates. Hypoxia will be defined as requiring supplemental low flow oxygen ≥ 2L/min by nasal cannula to maintain SpO2 \>90%.

Exclusion Criteria:

1. requiring supplemental oxygen \> 8L/min by nasal cannula;
2. receiving HFNC before randomization;
3. nasal deformity or packing precluding HFNC use;
4. hypercapnia (PaCO2 \> 60) or respiratory acidosis (pH \<7.25);
5. requiring NIV for over 1 hour or intubated.
The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy

The purpose of this trial is to investigate the effect of gabapentin on thoracic epidural analgesia following thoracotomy, including assessment of both analgesia, pain intensity, pain quality and whether or not gabapentin prevents the development of chronic pain conditions following thoracotomy.

The main hypothesis is that gabapentin reduces the proportion of patients who develop a persistent pain condition following thoracotomy from 50% to 20%.

Furthermore gabapentin is expected to reduce both pain intensity measured on a 11-point numerical rating scale, usage of epidural infusions of local and/or opioid analgesics, morbidity, hospital length of stay, consumption of opioid analgesics and analgesia-related side-effects.

In addition gabapentin is expected to improve postoperative recovery by means of postoperative lung function, walking ability, health related quality of life and patient satisfaction


Eligibility Criteria:
Inclusion Criteria:

* Elective lung resection via thoracotomy
* Age \> 18 and \< 80 years

Exclusion Criteria:

* Inability to answer the detailed questionnaires on pain and quality of life
* Psychiatric disease (ICD-10)
* Severe renal impairment (se-creatinin \> 110 mmol/l)
* Known allergy to gabapentin, morphine, bupivacaine and / or ibuprofen
* Standard use of opioid analgesics
* Treatment with anticonvulsants or tricyclic antidepressants
* Use of antacids 24 hours before the intake of study medication
* Contraindicated placement of a thoracic epidural catheter
* Previous ipsilateral thoracotomy
* Presence of a chronic pain syndrome
* Acute pancreatitis
* A history of past or current alcohol and / or illegal substance abuse.
* A history of gastric or duodenal ulcer
* Gastrointestinal obstruction
* Pregnancy
* Participation in another intervention study
The Effects of Remimazolam on the Incidence of Severe Hypoxia During Sedated Hysteroscopy for Assisted Reproduction in Overweight or Obese Patients

Hypoxia is a common adverse event during sedated hysteroscopy for assisted reproduction, and it is more likely to occur in overweight or obese patients. In sedated gastroscopy, the incidence of hypoxia with remimazolam is lower than that with propofol. The present study is a single-center, randomized, single-blind, controlled clinical trial. Overweight or obese patients undergoing sedated hysteroscopy for diagnosis and treatment, with ASA grade I or II, were selected as subjects and randomly divided into an experimental group and a control group, with 300 subjects in each group. Sedation induction and maintenance are performed using remimazolam or propofol combined with remifentanil, respectively, to compare the incidence of severe hypoxia during surgery between the two groups of patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 20 and 50 years.
2. Patients undergoing sedated hysteroscopy for assisted reproduction.
3. ASA classification I-II.
4. BMI ≥ 23 kg/㎡.
5. Patients who have signed an informed consent form.

Exclusion Criteria:

1. SpO2 \< 95% in patients inhaling air upon entering the room.
2. Diagnosed with chronic obstructive pulmonary disease (COPD) or currently suffering from other acute and chronic lung diseases requiring long-term or intermittent oxygen therapy.
3. Patients with a history of mental and neurological disorders: such as depression, severe central nervous system depression, Parkinson's disease, basal ganglia disease, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis, etc.
4. Patients with severe liver dysfunction.
5. Patients with severe renal insufficiency (requiring dialysis before surgery).
6. Severe heart failure (METS \< 4).
7. History of drug abuse and/or alcohol abuse within the 2 years preceding the screening period (consuming more than three times the standard alcoholic beverages daily, approximately 10g of alcohol, or equivalent to 50g of Chinese alcohol).
8. Allergies or contraindications to benzodiazepines, flumazenil, opiates and their rescue medications, propofol, eggs, or soy products.
9. Breastfeeding women.
10. Patients whom investigator believe are unsuitable for participating in this trial.
Dolutegravir + Rilpivirine Switch Study (DORISS)

The primary objective of the study is to evaluate the capacity of Dolutegravir + Rilpivirine vs. continued triple combination HAART to maintain plasma HIV RNA ≤ 50 copies/ml throughout 24 weeks in patients with plasma HIV RNA ≤ 50 copies/mL for at least 2 years under conventional HAART (2 NNRTI + 3rd agent).

The main secondary objectives are the following:

* % of virologic success (plasma viral load ≤ 50 copies/mL) at W24 and W48
* % of patients who maintain a plasma viral load ≤ 50 copies / ml from D0 to W48
* % of virological failure defined by two consecutive plasma viral load \> 50 copies/mL
* Profile of genotypic resistance in case of virological failure.

The trial will be conducted according to the design below, in 3 steps:

* Step 1: enrollment of 80 patients (40 in each arm)
* Step 2: enrollment on hold until W16 data from the 40 patients enrolled in the intervention arm have been analyzed.
* Step 3: resumption and completion of enrollment if conditions for resuming enrollment at the end of step 2 are fulfilled, i.e. if the percentage of patients randomized to the intervention arm who have a plasma viral load ≤ 50 copies/mL from D0 to W16 is significantly \> 70%, which translates in a maximum of 6 virologic failures.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* HIV-1 infection
* Treatment with suppressive triple HAART (2 NRTI + either 1 PI/r, or 1 NNRTI, or INI), unchanged for \> 6 months, Intra-class substitution within past 6 months is not considered as a treatment change.
* Plasma HIV-RNA ≤ 50 copies/mL for \> 2 years
* CD4 cell count \> 350/mm3 for \> 6 months
* No prior virologic failure under an NNRTI-containing or an INSTI-containing ART regimen
* No NNRTI mutation on pre-ART genotype (if no pre-ART genotype available: no NNRTI mutation on DNA genotype at screening) among the following: K101E/P, E138A/G/K/Q/R/S, V179L, Y181C/I/V, Y188L, H221Y, M230I/L/V, L100I + K103N/S, L100I +K103R +V179D.
* No mutation (either on pre-ART genotype or on DNA genotype at screening) among the following: T66K, G118R, V151L, S153F/Y, R263K, T66K + L74M, E92Q + N155H, Q148R +N155H, Q148H/K/R with at least one mutation of L74I or E138A/K/T or G140A/C/S
* Negative HBs Ag
* Informed consent form signed by patient and investigator
* A specific consent for the pharmacokinetic substudy will be signed by the 10 patients of the pilot phase of the trial who will be randomized to the Dolutegravir + Rilpivirine arm and will volunteer for this PK study
* Patient covered with health insurance
* Effective contraception

Exclusion Criteria:

* HIV-2 infection
* Dialysis or severe renal failure (creatinine clearance \< 30 ml/min)
* History of decompensated liver disease
* History of HIV-associated neurocognitive disorders
* AST or ALT \> 5 x ULN
* Positive HBc Ac and negative HBs Ac
* Patient receiving a proton pump inhibitor that cannot be switched to another anti-secretory drug
* Current pregnancy or breastfeeding
* Patient involved in another research that precludes enrolment in another trial
* Patient under guardianship, or deprived of liberty by a court or administrative decision.
THE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS WITH OSTEOPOROSIS AND PERIODONTITIS

Inflammatory mediators in periodontitis may lead to elevated systemic cytokine levels, resulting in increased bone resorption including the jaws. Osteoporosis may have an influence on the periodontal condition of post-menopausal women and the risk for periodontal disease may increase due to osteoporosis. The hypothesis of the study was that non-surgical periodontal treatment and medical treatment of osteoporosis by bisphosphonates may improve the clinical outcomes and decrease salivary levels of IL-1β, IL-17, ALP and 8-OHdG. Therefore, the aim of this study was to evaluate the mechanism of bi-directional relationship between osteoporosis and periodontal diseases and to investigate the outcomes of non-surgical periodontal treatment with regard to salivary levels of IL-1β, IL-17, 8-OHdG and ALP in patients with periodontitis and osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* The participants were postmenopausal patients defined as absence of menstruation for at least 12 months.
* Patients with periodontitis;
* Patients who had no systemic diseases and were periodontally healthy (no attachment loss),
* Patients who were treated with oral bisphosphonate at least one year (70 mg tablet once weekly)

Exclusion Criteria:

* if they had received any periodontal treatment in the preceding three months,
* if they were pregnant or in the period of lactation,
* if they had systemic diseases that may interfere with normal healing mechanism,
* if they had taken antibiotics, anticonvulsants, immunosuppressants, calcium channel blockers in the preceding six months.
* Smokers
Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer

The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well tolerated in treating participants with measurable breast cancer gene (BRCA)1- or BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists.

This is a Phase II, open-label, non-comparative, international, multicenter study to assess the efficacy and safety of olaparib when given orally twice daily (bd) in participants with advanced BRCA1- or BRCA2- associated breast cancer. Two sequential participant cohorts will receive continuous oral olaparib in 28-day cycles. The first cohort will receive 400 mg bd and the second cohort will receive 100 mg bd.

Eligibility Criteria:
Inclusion Criteria:

* Advanced breast cancer with positive BRCA1 or BRCA2 status
* Failed at least one prior chemotherapy
* In investigators opinion, no curative standard therapy exists
* Measurable disease

Exclusion Criteria:

* Brain metastases
* Less than 28 days since last treatment used to treat the disease
* Considered a poor medical risk due to a serious uncontrolled disorder
Quadratus Lumborum vs Caudal Epidural Block for Perioperative Analgesia in Pediatric Patients for Upper Abdominal Surgeries

Compare between the analgesic effect of the Ultrasound-guided quadratus lumborum block and single Caudal epidural injection in pediatric patients undergoing surgeries with supraumbilical incisions.


Eligibility Criteria:
Inclusion Criteria:

* Any pediatric patient aged from 2 to 8 years undergoing abdominal Surgery with Supraumbilical umbilical incision

Exclusion Criteria:

* parents refusal to participate in the study,
* previous history of allergy to local anesthetics
* hemodynamic instability
* Coagulopathy,
Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma

The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.

For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and chemotherapy is controversial. Some studies demonstrated the advantage of upfront radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Age range 14-70 years old
* Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Without prior history of pancreatitis
* Adequate bone marrow and organ functions

Exclusion Criteria:

* Low risk population (Definition: stage I without local invasion, B symptoms and high LDH level)
* Pregnant or lactating women
* With contraindication of steroid including uncontrolled diabetes
* Serious uncontrolled diseases and intercurrent infection
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
HDUPE 2004: Gastro-Oesophageal Haemorrhage in Emergency : Gastric Préparation to Endoscopy

Gastric lavage is usually used for gastric preparation before endoscopy in patients with upper gastrointestinal bleeding. However, the benefit-risk balance of putting a nasogastric tube in these patients is not clearly defined. This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid to put a gastric tube for the management of upper gastrointestinal bleeding.

Acute upper gastrointestinal haemorrhage is one of the main digestive emergencies involving hospital admission. Endoscopic examination plays a key role to determine the cause of the bleeding and to carry out a therapeutic procedure. Endoscopic performance depends on the quality of the examination that may be hampered by residual blood in the gastric cavity. Gastric lavage is usually performed to clear the stomach. However, several teams consider that it is possible to avoid putting a nasogastric tube because it is ineffective in half of the patients, disagreeable in most of them, can induce side effects and need a long time work for nurses. It could be replaced by the use of Erythromycin. There are no official recommendations in that field. Recent studies have shown that Erythromycin, a macrolide antibiotic with gastro kinetic properties can accelerate gastric emptying by inducing gastric contraction. This motilin receptor agonist could improve the gastric cleaning and the quality of endoscopic examination and decrease its duration.

This randomized trial is aimed to determine if the use of erythromycin IV before endoscopy could avoid putting a gastric tube for the management of upper gastrointestinal bleeding. It is a prospective, controlled, randomized, multicentric study with a blind assessment of the main criteria. All patients aged more than 18 years with an acute upper gastrointestinal bleeding, defined by melena or hematemesis, managed by emergency department are enrolled. 270 patients are expected. Informed consent including for endoscopic examination and no contraindication for using Erythromycin (QT enlargement) is needed. Patients are randomized in three groups: Erythromycin alone, nasogastric tube with gastric lavage alone or both Erythromycin and nasogastric tube. Patients are followed-up until first month after bleeding. The main criteria are the visualization of the gastric tract and the other criteria are rebleeding until D 30, transfusion, gastric tube or erythromycin complications.

Eligibility Criteria:
Inclusion Criteria:

* Hematemesis or melaena
* No QT enlargement

Exclusion Criteria:

* Refusing endoscopy
* Glasgow \< 15