cyrilzakka/clinical-trials huggingface dataset:
Maintenance Therapy Using Lenalidomide in Myeloma

Maintenance treatment of myeloma.


Eligibility Criteria:
Inclusion Criteria:

* No signs of progression after transplant
* Effective contraception if necessary (oral contraception for females and barrier methods of contraception for sexually active males)
* No active severe infection
* Satisfactory restoration of the haematological parameters defined by: PN \>1,000/mm3 and Platelets \> 75,000/mm3
* Bilirubin \< 35 umol/l and GOT/GPT/PAL\<3N
* Creatinine \< 160 umol/l.
Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome

Burning Mouth Syndrome (BMS) is characterized by a burning sensation on the tongue or other areas of the mouth, often bilateral but occasionally unilateral. It is more prevalent in postmenopausal women. No specific ethnic or socioeconomic predisposition has been identified. The etiology and pathophysiology of BMS remain unknown. Various treatment approaches have been proposed, yielding conflicting outcomes and underscoring the need for further investigation.

Patients with BMS appear to respond well to long-term therapy involving systemic antidepressants and anxiolytics. The most promising therapeutic effects have been observed with clonazepam, which leads to a significant reduction in pain when applied topically or systemically. Capsaicin, an herbal remedy, also presents as an alternative treatment option, showing positive results in alleviating BMS symptoms when compared to a placebo. Photobiomodulation represents another non-pharmacological treatment possibility. It's analgesic action is possibly attributed to the inhibition of pain mediators. Alpha-lipoic acid (ALA) is dietary supplement employed in BMS treatment. It serves as a potent antioxidant naturally produced within the body, contributing to the mitigation of skin aging and reinforcing the effects of other biological antioxidants. Based on these findings, attempts have been made to demonstrate ALA's effectiveness in BMS management, concluding that ALA may offer benefits in this context.

Therefore, the objective of this study is to investigate, in adults with BMS, the impact of different therapeutic approaches on frequency, intensity, and location of pain, as well as on on quality of life.


Eligibility Criteria:
Inclusion Criteria:

* burning mouth syndrome;
* oral pain that recurs daily for \> 2 hours per day for \> 3 months;
* pain with burning quality and felt superficially in the oral mucosa;
* oral mucosa appears normal
* oral clinical examination, including sensory tests, is normal;

Exclusion Criteria:

* pregnancy;
* oral mucosal lesions;
* systemic diseases such as diabetes, anemia, deficiency of vitamin B1, B2, B6, B12, Fe, Zinc, and folic acid;
* gastroesophageal reflux;
* previous head and neck radiotherapy;
* Sjogren's disease;
* allergies;
* candidiasis;
* unstimulated saliva flow \< 0.25 ml/min and stimulated flow \< 1.0 ml/min will be excluded;
Efficacy Study of Multiple Micro Nutrients Supplementation

This study is initiated to investigate the effect of multi micronutrient supplementation for 12 months on serum haemoglobin level in Indonesian young children.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy Indonesian infants
* Age 8-10 month at baseline visit
* Willing to take 2 sachets of study product per day
* Planning to reside in the study area during the next 14-16 months
* Written informed consent by parent(s) or legally acceptable representative (in ICF there is statement that both are agree that child participate in the study)

Exclusion Criteria:

* Haemoglobin \< 8 g/dL at screening visit\*.
* Significant congenital abnormality which according to investigator's clinical judgement will interfere the study conduct and assessment
* Any known conditions likely to affect nutrient absorption diagnosed by the child's physician
* Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps for which special formula is required).
* Any other current or previous illnesses/conditions or intervention which according to investigator's clinical judgement could interfere the study conduct and assessment (e.g. chronic illness or physical or mental handicaps)
* Regular use of MMN supplements syrup (every day in \> 1 week) within two weeks prior to entry into the study.
* Not intending to use micronutrient supplements during the study
* Participation in any other studies involving similar investigational or marketed products concomitantly or within two weeks prior to entry into the study.
* Premature birth (gestational age \<37 weeks)
* Low birth weight (\< 2500 g)
* Severely under nutrition indicated by any of the following criteria: severely stunted: HAZ \< -3 SD; severely underweight WAZ \<-3 SD; wasted: WHZ \<-2 SD

  \*Subject with haemoglobin level (finger prick blood sample) at screening visit between 8-10 g/dL will be given iron syrup supplementation for 1 month. Thereafter, haemoglobin level (whole blood sample) will be checked at baseline visit:
* If Hb \> 10 g/dL, subject is eligible for randomisation
* If Hb \< 10 g/dL, subject is not eligible for randomisation and will be given iron syrup supplementation for 2 months
Impact of Airways Function After HFNC Evaluated by IOS

In addition to pharmacological treatment, nonpharmacological treatment with high-flow nasal cannula (HFNC) may play a vital role in the treatment of patients with chronic obstructive pulmonary disease (COPD). The impulse oscillation system (IOS) is new noninvasive technique to measure the impedance of different portions of the airway with higher sensitivity than that of the conventional pulmonary function test (PFT). However, whether IOS is an appropriate technique to evaluate the efficacy of HFNC in improving the impedance of peripheral small airways in patients with COPD is unclear.

Participants with stable COPD from the chest medicine outpatient department will be randomized into two groups receiving HFNC or nasal cannula (NC) for 10 min followed by a 4-week washout period and crossover alternatively. We used a novel analytical measurement technique, IOS, to detect the difference in airway impedance in the participants after the HFNC or NC interventions. All data, namely IOS parameters, transcutaneous partial pressure of carbon dioxide, peripheral oxygen saturation, body temperature, respiratory rate, pulse rate, blood pressure, and PFT results at the time of pre-HFNC, post-HFNC, pre-NC, and post-NC, were analysed using SPSS (version 25.0, IBM, Armonk, NY, USA).

Eligibility Criteria:
Inclusion Criteria:

* age of 20 to 75 years old
* diagnosis of COPD made by pulmonologist (Kuo YL) if the patient had a long-term smoking or noxious gas exposure history, typical clinical manifestations, and airflow limitation with a postbronchodilator FEV1/FVC ratio of \< 0.7 in spirometry,4 and
* provision of written informed consent.

Exclusion Criteria:

* severe and unstable comorbidities or active malignancy
* history of obstructive sleep apnoea syndrome
* COPD exacerbation within the 4 weeks prior
* current use of long-term oxygen therapy or noninvasive ventilation or use within the 6 weeks prior
* cognitive impairment or a psychiatric disorder
* pregnancy
IMPlementation of Evidence Based Facility and Community Interventions to Reduce the Treatment Gap for DepRESSion

The goal of this Hybrid Type 2 Implementation-Effectiveness Cluster Randomised Controlled Trial is to reduce the treatment gap for depression through the integrated implementation of interventions in facility and community platforms, in Goa, India. The primary question is to examine whether a community intervention ("Community Model") enhances the demand for, and improves the outcomes of, an evidence-based, brief psychological treatment for depression delivered by non-specialist health workers in primary health care facilities ("Facility Model"). Participants in the Facility Model arm will receive only a psychosocial intervention for depression (the Healthy Activity Program - HAP) while participants in the Community Model will receive both the HAP and the community intervention. We will compare the Facility Model and the Community Model to assess if the latter is superior in increasing the demand for depression treatment in primary care, increasing uptake of treatment by people with depression, increasing treatment completion rates, and reducing the severity of depression.


Eligibility Criteria:
(A) Contact Coverage Outcome

Inclusion Criteria

* Adults (\>18 years)
* Residing in the clusters included in the trial
* Speak English or one of the local languages (Konkani, Marathi, Hindi)

Exclusion Criteria

* Patients with significant speech, hearing, or language impairment that interferes with completion of the screening and/or receipt of psychosocial intervention
* Patients who present to the health centre for emergency medical attention
* Patients with active psychotic symptoms

(B) Effectiveness Coverage Outcome

Inclusion Criteria

* Adults (\>18 years);
* Residing in the clusters included in the trial
* Speak English or one of the local languages (Konkani, Marathi, Hindi).
* Screen positive for moderately severe or severe depression (total score \>14) on the Patient Health Questionnaire-9 items (PHQ-9)

Exclusion Criteria

* Patients with significant speech, hearing, or language impairment that interferes with completion of the screening and/or receipt of psychosocial intervention
* Patients who present to the health centre for emergency medical attention
* Patients with active psychotic symptoms
Lumbar Puncture Video Study

The purpose of this study is to improve the lumbar puncture (LP) consent process for pediatric patients. Though a commonly performed and safe procedure, LP can be anxiety-provoking for parents. By using an educational video on a handheld device at the time of consent, we hope to improve parent understanding and comfort with the procedure.

Introduction: Lumbar puncture is a safe procedure commonly performed on pediatric patients for a variety of indications. Parents are informed of and consented to this procedure, but are often left with concerns and doubts. There are no published studies of the nature of the concerns of parents in North America, and no studies examining a process to improve pediatric lumbar puncture consent. Here the investigators conduct a randomized control study of a short educational video on a handheld device as an adjunct to the formal consent process.

Methods: 72 patients were enrolled, evenly divided between the control arm and video arm of the study. A survey was provided examining four key indices: parent self-rated understanding of the procedure, their perception of its safety, their perception of the painfulness and their overall comfort with their child undergoing LP. In addition, demographic characteristics such as prior experience with LP or epidural, language spoken at home, age of the child and indication for lumbar puncture, as well as qualitative information about parent concerns were collected.

Eligibility Criteria:
Inclusion Criteria:

* parent of a patient less than 17 years of age
* parent present for consent
* patient under the care of the neurology team (directly or consulting)
* consenting physician able to communicate with parent directly or through a translator

Exclusion Criteria:

* patients with emergent indications for lumbar puncture, such as bacterial meningitis
* parent's unable to communicate in English and no translator was available
* consent not performed in person (over the phone)
A Trial to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial-Onset Seizures

The purpose of this study is to evaluate the efficacy and safety of 200 and 400 mg/day of orally administered Lacosamide as adjunctive therapy compared with placebo in Japanese and Chinese adults with uncontrolled Partial-Onset Seizures with or without secondary generalization.


Eligibility Criteria:
Inclusion Criteria:

* Subject has had an Electroencephalogram (EEG) and a brain Computerized Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam consistent with a Diagnosis of Epilepsy with Partial-Onset Seizures according to the International Classification of Epileptic Seizures (1981)
* Subject must have been observed to have Partial-Onset Seizures for at least the previous 2 years despite prior therapy with at least 2 Anti-Epileptic Drugs (AEDs)(concurrently or sequentially) and must have been observed to have on average at least 4 Partial-Onset Seizures per 28 days with a seizure-free phase no longer than 21 days in the 8-Week Period prior to entry into the Baseline Period. In the case of Simple Partial Seizures, only those with motor signs will be counted towards meeting the inclusion criterion
* Subjects must be on a stable dose regimen of at least 1, but no more than 3 AEDs (concurrent stable Vagus Nerve Stimulation (VNS) is not counted as an AED). The VNS must have been in place for at least 6 months prior to study entry. The dosage of concomitant AED therapy and the settings of the VNS must be kept constant for a period of at least 4 weeks prior to entry into the Baseline Period
* Minimum Body Weight of 40 kg

Exclusion Criteria:

* Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt) or has a suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening
* Subject has a current or previous diagnosis of Pseudo-Seizures, Conversion Disorders, or other non-epileptical events that could be confused with Seizures
* Subject has Seizures that are uncountable due to Clustering (ie, an episode lasting less than 30 minutes in which several Seizures occur with such frequency that the initiation and completion of each individual Seizure cannot be distinguished) during the 8-Week Period prior to Visit 1
* Subject has a history of Primary Generalized Seizures
* Subject with a history of Status Epilepticus within the 12-Months Period prior to Visit 1
* Subject who underwent surgery for Epilepsy within the 2 Years Period prior to Visit 1
* Subjects with cardiac, renal, hepatic, endocrinological dysfunction or psychiatric illness that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
Postoperative Surgical Site Infection afterENT Bone Flap Surgery

In 2017, the French Society in anesthesia and reanimation published new recommendations on intraoperative antibiotic prophylaxis. Now, no more than 48 hours of antibiotic prophylaxis applies to any otolaryngology surgery, regardless of patient's medical history or type of flap used to rebuild. This has resulted in an alignment of our local protocol in Croix-Rousse hospital.

However, after few years, our local impressions are that bone flap surgeries are very likely to provide surgical site infections (osteo-articular or non-osteo-articular infections).

The prejudice of these postoperative site infections is significant, with serious consequences,. of both functional and aesthetic sides.

We wanted to objectify this impression by retrospectively analyzing the data relating to patients operated on for bone flapsurgeries.

Knowing the operation site infection rate after surgery for otolaryngology bone flap surgery will allow us to objectively understand the infectious risk of these surgeries, in particular the risk of osteoarticular infection. Identifying operation site infection factors will allow us to better target and prevent them.

The goal is to find out if the antibiotic prophylaxis currently recommended is sufficient and effective for this type of surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient operated for bone flap in Croix-Rousse hospital, in otorhinolaryngology department, since september 2012 and until January 2019

Exclusion Criteria:

* patient's opposition to participate in the study
The Influence of Oral Probiotics on the Microbiome and Lipidome

The purpose of this study is to measure oil production of the face, facial properties, and gut bacteria in people being given oral probiotics. Probiotic supplements contain active cultures of bacteria that are thought to be beneficial to human health.The investigators want to find out if probiotics taken by mouth alter the bacteria in subject's gut and subject's skin oil production compared to a placebo. This is a single blind study and subject may receive a probiotic or a placebo for the first half of the study and a placebo or a probiotic for the second half of the study. Subject will not know what was given to participants.

Antibiotics are widely used within dermatology for the treatment of chronic skin conditions such as acne, rosacea, and atopic dermatitis. Previous studies have shown that oral probiotics may be beneficial for skin disesaes such as atopic dermatitis and acne, but a mechanism for how the gut communicates to the skin remains elusive.

The balance between short chain fatty acids and long chain fatty acids has been proposed as one factor in how bacteria in the gut are able to communicate with the rest of the body. Studies in Dr. Sivamani's lab have shown that subjects with acne have a reduced level of short chain fatty acids in their blood when compared to age-matched control (unpublished).

The aim of this study is to understand how oral probiotics may alter the gut microbiome and if they can augment the short chain fatty acids in the blood lipidome. Ultimately, the investigator's goal is to find suitable alternatives for the use of antibiotics in the treatment of chronic skin conditions so that the amount of antibiotics that are in use can be reduced.

Eligibility Criteria:
Inclusion Criteria

• 18 years of age or older

Exclusion criteria

* Those on oral antibiotics within a month of initiating the study.
* Subjects must have no history of diabetes, known cardiovascular disease, known immunocompromised condition, malignancy, kidney disease, or chronic steroid use.
* Subjects must have no history or diagnosis of gastrointestinal inflammatory diseases.
* Those with BMI higher than 30 kg/m²
* Those on topical medications to the face such as retinoids or antibiotics who are not willing or medical unable (in the judgement of the investigator) to discontinue use for two weeks prior to the study and for the duration of study participation.
* Those that have undergone a change in hormonally based therapies, such as but not limited to oral contraceptive pills or progesterone based pills within the last two months. Progesterone releasing IUDs are considered hormone releasing therapy.
* Use of medications that alter blood lipids, such as statins and anti-hyperlipidemic medications
* Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
* Pregnant women
* Prisoners
* Adults unable to consent
Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors

The study aims to assess the effect of smart watches and continuous glucose measuring devices on cardiovascular risk factors.

Within a period of 4 months 100 patients will be recruited and randomised to the intervention or control arm (1:1) for a duration of 3 months. Randomisation will be stratified by age, sex, BMI, diabetes, blood pressure, and duration after finishing cardiac rehabilitation. Patients randomised to the intervention arm will be given a smart watch as well as a continuous blood glucose measurement device with detailed instructions. At baseline and at the end of the study questionnaires will be answered and anthropomorphic measurements attained. Blood samples will be drawn at baseline and after an intervention period of 3 months in all subjects. Additional data on sleep, temperature, heart rate (resting and exercise), breathing rate, activity and exercise, oxygen saturation and daily weight will be collected through the Fitbit web application programming interface (API).

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the subject
* Completed outpatient cardiac rehabilitation
* Diagnosis of coronary heart disease
* Access to a smartphone for the duration of the study
* 18 years or older on the date of consent

Exclusion Criteria:

* Diseases which limit physical activity including angina with incomplete revascularisation, arrhythmogenic cardiomyopathy, stroke with residual disease, and major orthopaedic disorders
* Known or suspected non-compliance
* Inability to follow the procedures of the investigation, e.g., due to language problems, psychological disorders, dementia, etc. of the subject
* Diabetic patients receiving insulin therapy
* Lack of proficiency with smart phone/watch
* Current participation in any other clinical trial, which may confound the results of this trial.
* NYHA (New York Heart Association) class III or IV congestive heart failure
* Pregnancy
Clinical Effectiveness of Exposure Based Cognitive Behavioral Group Therapy for IBS

The aim of the study is to evaluate the effects of a specific Cognitive Behavioral treatment protocol for patients with IBS used in routine care at a gastroenterology unit in Stockholm. The research question is whether the treatment has the same effects in routine care as it has had in efficacy studies.

The treatment is given by licenced psychologists (with CBT training) face-to-face in groups of 4-7 participants and lasts for ten sessions (ten weeks, normally).

IBS is a debilitating condition that affects approximately one out of eleven persons world wide. It is often called a functional disorder, a term used to characterize painful conditions, whose biological mechanisms are not fully understood.

Diagnosis is made based on symptoms and exclusion of other conditions rather than specific tests or biological markers.

Treatment usually starts with diet counselling and a change of eating habits. If symptoms persist, a physician can prescribe medication of different types. But for some patients neither change of diet, nor medication is sufficient. Some of these patients may benefit from psychological treatment. There are a few different psychological treatments that have been proven efficacious in clinical trials. Most researched is Cognitive Behavior Therapy (CBT).

Our study is a clinical effectiveness trial without a control group. The data comes from a gastroenterology clinic in Stockholm and is collected as part of the work with continous improvement at the clinic.

Patients with diagnosed IBS are offered group treatment with a specific CBT protocol developed by our research group at Karolinska Institutet. The treatment comprises 6 different modules and stretches over ten sessions. The modules are: 1. Information regarding the treatment, IBS and mindfulness. 2 Hypervigilance and anxiety. 3. Behaviors and thoughts. 4. Behavior change part one - toilet habits including exposure to feared situations. 5. Behavior change part two - exposure to symptoms and avoidance/control behaviors. 6. Summary and relapse prevention.

Group sizes range from 4-7 patients and the treatment is given by licenced psychologists who are employed at the clinic.

Eligibility Criteria:
Inclusion Criteria:

- Diagnosed with IBS

Exclusion Criteria:

* Severe psychiatric condition (for example severe depression, self injuring, psychosis, PTSD)
* Unable or unwilling to participate in group therapy
Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye

The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear


Eligibility Criteria:
Inclusion Criteria:

* Mild, moderate or Severe Symptoms of Dry Eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Use of systemic medications affecting dry eye
* Pregnancy or planning a pregnancy
* Contact lens wear