cyrilzakka/clinical-trials huggingface dataset:
A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

The purpose of the study is to assess the efficacy on joint damage and safety in RA patients treated with DMARDs in a double blind, placebo controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed as rheumatoid arthritis by the revised ACR criteria
* Those who have been treated with an adequate stable dose of either methotrexate, salazosulfapyridine or bucillamine
* Those who have at least one erosion on X-ray of hands, wrists or feet

Exclusion Criteria:

* Those who have been treated with any biologic drugs or leflunomide
* Those who meet Class 4 with the Steinbrocker functional classification
BEB Conditioning Regimen for Autologous Stem-cell Transplantation(ASCT) in Non-Hodgkin's Lymphoma

Phase II study for safety and efficacy of BEB (Bendamustine, Etoposide, Busulfan) conditioning regimen for ASCT in non-Hodgkin's lymphoma


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically diagnosed non-Hodgkin's lymphoma
2. 16 ≤ Age ≤ 65 years
3. Adequate cardiac function with cardiac ejection fraction greater than 50% by echocardiogram or multiple gated acquisition scan(MUGA)
4. Adequate kidney function with serum creatinine\< 2.0 mg/dL
5. Adequate liver function with /serum bilirubin lower than 2 times the normal upper limit, Aspartate aminotransferase(AST)/ Alanine aminotransaminase(ALT) lower than 3 times the normal upper limit. In case of DLBCL liver invasion; serum bilirubin lower than 5 times the normal upper limit, AST/ALT lower than 5 times the normal upper limit.
6. Adequate bone marrow function with absolute neutrophil count ≥ 1,500/µL; platelets ≥ 75,000/µL; hemoglobin ≥ 9.0 g/dL
7. Patients who voluntarily gave informed consent before performing any test that is not part of routine care of patients
8. Candidate for ASCT

Exclusion Criteria:

1. Positive serology for HIV, hepatitis C virus(HCV) If the hepatitis B virus(HBV) patient was administrated prophylactic antiviral agents. It would be eligible following the judgment of the investigator
2. Pregnant or breast-feeding. Females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial.
3. Patients with serious or uncontrolled medical condition; 1) Abnormalities in cardiac function or clinically significant heart disease such as congestive heart failure, arrhythmia, unstable angina with treatment within 6 months or acute myocardial infarction; 2) Previous history of serious neurological or psychiatric disease; 3) Acute, severe active infection requiring immediate treatment(Virus, Bacteria, Fungal infection); 4) chronic obstructive pulmonary disease requiring oral steroid therapy or Forced expiratory volume 1 sec(FEV1)\<0.8 L less than the test of pulmonary function at rest; 5) If there are other diseases that are deemed inappropriate as a target of the present clinical trial following the Investigator's judgment; 6) Congenital or acquired bleeding disorders
4. Patients receiving any other investigational systemic therapy (Hormone, Immune, chemotherapy)
5. Allergic to the investigational drug
6. Patients who have difficulty understanding the informed consent form or patients who did not give consent
7. Serum bilirubin upper than 2 times the normal upper limit
8. Major surgery procedure within 30 days prior to start of investigational treatment
9. Patients vaccinated against yellow fever
Intervention for Fatigue in HCT Recipients

The purpose of this study is to assess whether a cognitive-behavioral therapy (CBT) for fatigue intervention is acceptable, feasible, and effective at managing fatigue and improving quality of life for patients following hematopoietic stem cell transplant (HCT).

This research is being done to determine whether a cognitive-behavioral therapy (CBT) for fatigue intervention is feasible and effective at managing fatigue and improving quality of life in patients following hematopoietic stem cell transplant.

An open pilot of 6 participants will precede the randomized controlled trial. Study procedures for the open pilot include screening for eligibility, intervention Zoom sessions, questionnaires, and exit interviews with study staff.

Patients participating in the subsequent randomized controlled trial will be randomized into one of two study groups: CBT for fatigue intervention versus usual care.Study procedures include screening for eligibility, intervention Zoom sessions (intervention arm) or receipt of informational materials about fatigue (usual care arm), and completion of study questionnaires (after consent but before randomization and at approximately 3 and 5 months post-randomization).

This research study is expected to last about 3 years. It is expected about 66 people will take part in this research study.

The National Heart, Lung, and Blood Institute of the National Institute of Health is providing funding for this project.

Eligibility Criteria:
Inclusion Criteria

* adult patients (≥ 18 years)
* have the ability to speak and read English
* have undergone autologous or allogeneic transplant \> 6 months prior to enrollment
* no evidence of disease relapse requiring therapy
* no new other malignancy requiring therapy after transplant
* report moderate to severe fatigue in the past week (FSI average severity item rating ≥ 4 of 0-10)
* are currently receiving their care at the MGH Blood and Marrow Transplant Clinic

Exclusion Criteria

* Patients with active cognitive impairment or uncontrolled psychiatric illness such as schizophrenia that the treating clinician believes prohibits informed consent or participation in the intervention
* Patients already receiving CBT care
* Patients living with untreated sleep apnea
* Patients with hypoxemia requiring oxygen supplementation
Low Dose Lignocaine Injections as a Treatment Option for Acute Lumbosacral Radiculopathy

Low back pain is one of the most common ailments that plagues patients, with nearly 80% of the population developing some form of back pain in their lifetime. Up regulated sodium channels in the nerve root or dorsal root ganglion are the basic cause for the mechano-sensitization and injecting the drug in the peripheral end of the nerve will block these sodium channels, since functionally both ends of the pseudo unipolar neuron are the same.

Low back pain is one of the most common ailments that plague patients, with nearly 80% of the population developing some form of back pain in their lifetime. Of all the causes of low back pain, the most common is lumbar radicular pain which may result from irritation of the nerve fibers or dorsal root ganglia due to intervertebral disc prolapse, degenerative spondylolisthesis or spinal canal stenosis. \[1\] Up regulated sodium channels in the nerve root or dorsal root ganglion are the basic cause for the mechano-sensitization and injecting the drug in the peripheral end of the nerve will block these sodium channels, since functionally both ends of the pseudo unipolar neuron are the same. \[2\]There have yet been no studies done to prove the efficacy of peripheral nerve block as an alternative to lumbar epidurals. We would like to share our experience of peripheral nerve blocks with low dose local Anaesthetics as the treatment of acute lumbosacral radiculopathy.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 years to 60 years
* Pain involving up to two segmental levels (L4, L5 and S1).
* Average pain score of ≥5 on an 11-point NRS.
* Tenderness over the concordant peripheral nerves (Gore sign +)
* Computed tomography/Magnetic resonance imaging evidence of nerve root pain concordant with the side and level of clinical features.

Exclusion Criteria:

* Coagulopathy and/or patients on anticoagulants.
* Infection at the site of injection.
* Hypersensitivity to a local anaesthetic agent.
* Evidence of significant sensory or progressive motor deficit.
* Presence of cancer as a cause of back pain.
* History of previous backs surgery/epidural steroid injection.
Melatonin Gel As an Adjuvant in the Surgical Management of Intrabony Defects

Surgical periodontal therapy is a commonly employed treatment approach aimed at arresting disease progression and promoting tissue regeneration. Despite advancements in surgical techniques, adjunctive therapies are being explored to enhance the outcomes of periodontal surgical debridement. Melatonin, a hormone primarily known for its role in regulating the sleep-wake cycle, has emerged as a promising candidate for periodontal therapy. It possesses potent antioxidant, anti-inflammatory, and immunomodulatory properties, which make it an attractive therapeutic agent for treating periodontitis. Additionally, melatonin has been linked to bone metabolism, with evidence suggesting its involvement in bone formation and remodeling processes. Bone regeneration is a vital aspect of periodontal therapy, as the restoration of lost osseous structures is crucial for long-term stability of affected teeth. Previous studies have suggested that melatonin may exert positive effects on bone formation by promoting osteoblast differentiation, stimulating matrix synthesis, and inhibiting osteoclast activity. However, limited research has been conducted to specifically evaluate its influence on bone regeneration in the context of surgical periodontal flap therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Both genders within age range of 35-55 years.
2. Patients diagnosed with periodontitis Stage III (Caton et al., 2018; Papapanou et al., 2018).

   Test site criteria: (probing pocket depth ≥6mm and CAL ≥5mm and 3-wall intrabondy defect). All these criteria will be determined after phase I conventional periodontal therapy.
3. Patients with three-wall intrabony defects.
4. Systemically free patients as evidenced by Burket's oral health history questionnaire (Glick et al., 2008)
5. Ability to attend the treatment sessions and comply with the procedures, recall visits and oral hygiene measures.

Exclusion Criteria:

1. Smokers. (Reynolds et al., 2015)
2. Drug abusers.
3. Pregnant or lactating females.
4. Patients under any medication that affect periodontal healing.
5. Vulnerable individuals.
Verification of Endotracheal Tube Placement by Ultrasound in the Obese Patient

The purpose of this study is to determine whether verification of correct tube placement after endotracheal intubation in the obese patient can be conducted as fast with ultrasound as with the conventional method of combined auscultation and capnography.

The investigators hypothesize that ultrasound is a faster method for verifying correct endotracheal tube placement in the obese patient than combined auscultation and capnography.

Both verification methods are conducted in all patients and patients act as their own control

Eligibility Criteria:
Inclusion Criteria:

* Planned for bariatric surgery in general anaesthesia
* Planned for endotracheal intubation
* BMI above 30

Exclusion Criteria:

* Predicted difficult airway in the pre-anaesthesia airway evaluation.
* Unpredicted difficult airway during induction of anaesthesia where assistance is needed by the investigators.
Intervening Factors in Tooth Color Assessment

The aim of this study is to evaluate the influence of several factors (light, extrinsic stain removal and operator's experience) in tooth color assessment. Tooth color will be assessed by two different operators with visual shade guides under standardized light conditions and using a light correcting device (Smile Lite) or with a dental spectrophotometer in human subjects. Color measurement will be made before and 1 week after dental prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Capability to sign the informed consent
* Presence of upper teeth canines and central incisors, free of tooth decay, dental fillings, endodontic treatment or fixed rehabilitation
* Tooth color at least A3 in one of the included teeth
* Teeth should be possible to be subject to tooth color assessment with the predefined methods (color within the visual shade guides range)
* Absence of fixed orthodontic appliances or severe tooth structure anomalies

Exclusion Criteria:

* Pregnant patients
* Patients subjected to professional dental prophylaxis in less than 4 months
Simulation in Physical Therapy Students

This randomized trial included physiotherapy students, randomized in two groups, experimental one included simulation for developed competencies related to clinical reasoning in physiotherapy interventions for people with low back pain. The second group developed role-playing. this protocol allows us to compare two strategies with simulation for to promote clinical decisions in physiotherapy practice.

Low back pain (LBP) is symptomatology with a high global prevalence; health professionals, including physiotherapists, must have the skills to create professional interaction plans that permit a better quality of life for consultants. Clinical simulation can be a pedagogic setting that facilitates students with adequate training to acquire skills that improve professional reasoning in this clinical situation. The objective of this study was to compare the effects of clinical simulation with a simulated patient (SP) versus simulation with role-playing (RP) in physiotherapy students for decision-making in clinical skills while caring for a person with LBP. Methods. An experimental study, with 42 participants from two Colombian universities, randomized into two groups (SP n = 21, RP n = 21). The clinical skill was evaluated during the interaction with a person with LBP for which the Objective Structured Clinical Examination (OSCE-ML) was validated for individuals with low back pain; thereafter, a pedagogical method was conducted that included clinical simulation and, finally, the OSCE-ML was applied again to compare both groups.

Eligibility Criteria:
Inclusion Criteria:

* Physiotherapy students in five-semester from Universidad de La Sabana and Universidad de Boyacá

Exclusion Criteria:

* under-age subjects
* those who had been internally or externally transferred from another academic program in health,
* exchange students
* those repeating
* with prior experiences in simulated practice in other assignments
DetectAB - Detecting Antibiotics

The secretion of different kinds of antibiotic drugs in sweat is investigated. The concentration and pharmacodynamics of antibiotic drugs in sweat and blood will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Ability to understand the purpose of the study, provide signed and dated informed consent and qualify for therapeutic drug monitoring
* In-patients receiving intravenous therapy with last resort antibiotics Cefepim, Floxapen, Imipenem or Vancomycin for at least 24 hours
* Glomerular Filtration Rate \>/= 50 ml/Min

Exclusion Criteria:

* Glomerular Filtration Rate \< 50 ml/Min
Effects of Snack Types on Acute Glucose and Insulin Response

The purpose of the present study was to determine the effects of different type of snack consumption on postprandial satiety, glucose, insulin, antioxidant capacity and anxiety in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* 18-55 years old

Exclusion Criteria:

* Smoker
* Pregnant woman
* Required dietary supplement use
* Required medication of metabolic disorders
* Allergy to nuts or gluten (wheat)
A Study of Endobiliary Radiofrequency Ablation in Malignant Biliary Obstructions

The purpose of this study is to assess the impact of temperature-sensitive radiofrequency ablation (RFA) immediately before biliary stent placement on duration of biliary stent patency and re-intervention free survival. This is a research study meant to collect information to help other patients with malignant biliary strictures in the future.


Eligibility Criteria:
Inclusion Criteria:

* Malignant biliary stricture
* participants have or will have a biopsy-confirmed pancreaticobiliary or ampullary malignancy that have agreed to undergo radiofrequency ablation (RFA) with placement of biliary stents
* Patients with life expectancy greater than 3 months
* Able to provide consent

Exclusion Criteria:

* Patients who are pregnant
* Patients with cirrhosis
* Patients with significant liver metastasis \&gt;30% on radiologic imaging suggestive of poor liver function that will not improve despite endoscopic drainage.
* Patients who have undergone prior biliary decompression stents or percutaneous drainage that cannot be removed at time of ERCP and thus preclude effective RFA
* Patients with altered anatomy unable to undergo conventional ERCP (i.e., history of Roux-en-Y gastric bypass)
Chest Physiotherapy and Aerobic Training in Children Post Abdominal Surgery

This study will underscore the clinical importance of integrating chest physiotherapy and aerobic exercise training into the post-abdominal surgery care regimen for young children.By improving physical fitness levels, these interventions contribute significantly to the overall recovery process and enhance the well-being of pediatric patients. Implementing such strategies can optimize functional outcomes, reduce complications, and promote a faster return to normal activities, thereby improving the quality of life for young patients undergoing abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age from 5 Years to 15 Years, Gender: Both, Details: Children who underwent abdominal surgery, having stable vitals, admitted in PICU and pediatric wards

Exclusion Criteria:

* Patients with severe neurological illness, uncooperative patients, comatose patients, patients who are unwilling to enroll in study
Time - Related Cuff Pressure and Volume of the Laryngeal Tube With the Use of Nitrous Oxide

The purpose of this study is to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.

Background : The laryngeal tube airway (LT) is an extraglottic airway device with a proximal and distal conical cuff designed to secure a patient's airway during either spontaneous breathing or controlled ventilation. Application of this device with the use of N2O may be related to the ischemic change of the oropharyngeal mucosa. The objective of this study was to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.

Methods : Seventy-five patients were studied with the use of LT size 4. N2O (66%) and isoflurane were used to maintain anesthesia. Initial intracuff pressure and volume were recorded for airway sealing during ventilation. Time-course changes of the intracuff pressure followed by recording every 10 min. If the intracuff pressure reached 100 cmH2O, the cuff was deflated to the initial intracuff pressure and the volume of deflated air and postoperative airway complications were recorded.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist physical status I or II
* Undergoing elective orthopedic surgery and surgery of breast under general anesthesia with an expected duration of 60 min or more

Exclusion Criteria:

* Height was \< 155 or \>180 cm (for the use of laryngeal tube size 4)
* Body mass index ≥35 kg/m2
* Preexisting laryngotracheal disease
* Risk of pulmonary aspiration of gastric contents.
Evaluation of the Efficiency of Autologous Adipocytes Graft in Endoscopic Treatment in Vesico-Renal Reflux in Children

Urinary tract infection (UTI) is a common problem in childhood associated with vesico-renal reflux (VRR) in 25-40% of children. A persistent VRR and repeated pyelonephritis may predispose to renal scarring and chronic renal failure with an end-stage renal failure in up to 3% of children.Defining a standard behaviour facing VRR in children is not easy because of the lack of reliable evidence. Numbers of studies compare prospectively or retrospectively, medical, endoscopical and surgical treatment.Surgical techniques are effective but invasive and not free of complication. Medical treatment is submissive to a good observance. The introduction of endoscopic techniques permits to prevent UTI and new renal failure by VRR elimination. Since the beginning of the endoscopic treatment, several bulking agents have been proposed. The ideal agent should be easy to inject, stable in time and should be safe. Of course it should be at least as efficient as actual bulking agent. The use of Teflon was the first wave of success of endoscopic treatment. But sudden passion of Teflon has been darkened by the notion of migration. Since, others substances have been proposed, autologous or exogenous, resorbable or not. But none was ideal and no solutions were found facing problem of biocompatibility or long-term stability.Using adipose tissue as a bulking agent is ancient in plastic surgery and indications had known a leap forward in the last century with Coleman who introduced a new technique called "lipostructure". This technique has known a growing interest in the restoration of all volume defects in plastic surgery because of the stability of the graft. We propose to apply this technique to VRR management in children in order to combine innocuousness and efficiency.


Eligibility Criteria:
Inclusion criteria :

* sexe : male and female
* age : 3 to 15 years
* written consent
* Vesico-renal reflux staged I to III revealed by a pyelonephritis ; after failure of medical treatment or parent refusal of medical treatment or initial renal failure.

Exclusion criteria :

* Before 3 years or older than 15 years
* insulino-dépendant diabet
* neurologic bladder
* abnormalities of the urinary tract
* kidney transplantation
* past history of bladder surgery
* anorexia (BMI \<12)
* Vesico-renal reflux staged IV or V
* Active urinary tract infection
A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers

Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours in preventing the appearance of classical lesions following prodromal symptoms (tingling or burning sensation) based on thermographic assessment among recurrent cold sore sufferers.


Eligibility Criteria:
Inclusion Criteria:

* Be known to be a cold sore sufferer and presenting a prodromal stage with pain
* Sign the written informed consent form prior to enrolment in the trial;
* Be aged 18 to 75 years;

Exclusion Criteria:

* If female, are pregnant, planning pregnancy or lactating;
* Have a known hypersensitivity to penciclovir or any ingredients of the vehicle;
* Have already ongoing classical cold sore lesions at the baseline visit;
* Have taken any cold sore product, analgesic or NSAID in the 24 hours before the baseline visit;
* Have applied a cosmetic lip balm on their lips in the 12 hours before the baseline thermographic assessment;
* Are known to be immunosuppressed (acquired, congenital or therapeutic);
* Have been involved in any investigational protocol within the 30 days prior to the trial;
* Have evidence or history of drug or alcohol abuse;
Effect of Local Infiltration Anesthesia With Ropivacaine on Pain After Primary Total Hip Arthroplasty

Background: The Local infiltration analgesic (LIA) technique has been widely used to reduce opioid requirements and improve the patient's mobilization after total hip arthroplasty (THA). However, the evidence for LIA in THA remains to be clarified.

Purpose: To evaluate whether a single shot LIA in addition to a multimodal analgesic regimen reduces acute postoperative pain and opioid requirements after THA.


Eligibility Criteria:
Inclusion Criteria:

* all patients receiving total hip arthroplasty in the study period

Exclusion Criteria:

* contraindications to receive spinal anesthetic, Dexamethasone or Acetaminophen.
* Patients who received general anaesthetic
* patients who will get a different operation than standard direct lateral surgery
* Patients with osteosynthesis to be removed in the same operation