cyrilzakka/clinical-trials huggingface dataset:
Comparison of Different Objective Nociceptive Measurement Methods During Surgery

Traditionally, hemodynamic response e.g. pulse and blood pressure are used to evaluate pain in humans who are anesthetized. These values, however, can be affected by factors other than pain response . In this observational study, different types of digital methods are used that can distinguish signs of pain. However, the study aim to collect data and correlate in between different methods to ensure its reliability.

In humans who undergoing anesthesia or only receiving sedation with the addition of painkillers medication under surgery. Nociceptive response usually treats on the basis of hemodynamic and/or respiratory changes. These are interpreted together with a number of other parameters. The anesthetist can't be totally sure if it is nociceptive response or to light anesthesia given. Today, there are new monitors included techniques for measuring pain (nociception), but these are not used routinely.

By put sensors (adhesive patches) on the skin and connect to these new devices perhaps the anesthetist can be more sure what stimuli patient are responding from, pain or light anesthesia.

These techniques measure muscle activity including sweat gland which have been shown in other research studies demonstrate a higher accuracy regarding the response to nociception. The parameters are presented on a monitor as a value, 0-10 or 0-100. This research study is an observational study and intends to observe values / figures that arise from two different types of commercial monitors and manufactures. After the anesthesia, these values will be compared and evaluated in resect as well to hemodynamic response and in between monitors. The two techniques have never before been studied simultaneously on the same human been (control).

Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 yrs old,
* Patients who will be anesthetized or sedated under intervention surgery or surgery

Exclusion Criteria:

* Not speaking Swedish
* Neuro cognitive diorders e.g. dementia or can't respond on information given.
* Chronic pain
* Acute brain trauma
* Pregnancy
Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome

This trial will provide long-term data on safety, satisfaction and maintenance on therapy of fesoterodine (SPM 907) in subjects with overactive bladder syndrome.

Subjects completing the 12 week treatment period of SP583 had the opportunity to participate if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which could be followed on an annual basis.

Two primary efficacy variables will be assessed, which are observation and assessment of adverse events and duration on therapy.

Secondary efficacy parameters included various parameters derived from micturition diaries and the evaluation of Quality of Life questionnaires (KHQ and ICIQ-SF).

The most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.


Eligibility Criteria:
Inclusion Criteria:

* Participated in SP583

Exclusion Criteria:

* Failure to complete 12 week treatment with SPM 907
ANRS12373 GUNDO SO - Evaluation of an Empowerment Program for WLHIV in Mali

The objective of this research is to measure the short- and mid-term effects of an empowerment program focused on serostatus disclosure management for women living with HIV (WLHIV) in Mali on the "burden of secrecy".

Serostatus disclosure is a critical issue for persons living with HIV (PLHIV). Studies identified numerous benefits associated with disclosure, but various negative consequences have also been documented. Gender inequality must be taken into account regarding the disclosure issue, in particular in Mali, where women are economically dependent and have a low decision-making power. Moreover, in Mali, since 2006, PLHIV have a legal obligation to disclose their serostatus to their spouse and sexual partner(s) " as soon as possible, or within 6 weeks " after the diagnosis. Although this law is not enforced, it highlights the sensitive nature of the serostatus disclosure issue and raise concerns among PLHIV and other stakeholders.

To support women living with HIV (WLHIV), an empowerment program (Gundo-So) was implemented by ARCAD-SIDA in Mali, in collaboration with several partners. This program aims to empower WLHIV, so that they can make informed decision about disclosing or keeping their serostatus secret in their various life contexts, and that they can identify strategies to disclose or to keep the secret, as well as to manage potential negative reactions. Gundo-So ("The room of confidences") was adapted from a program established in quebec and has been implemented in Mali.

The objective of this research is to measure the short- and mid-term effects of an empowerment program focused on serostatus disclosure management for women living with HIV (WLHIV) in Mali on the "burden of secrecy".

The evaluation of the effects of the Gundo-So program will be helpful to assess the relevance of a national or subregional extension of the program, or even an adaptation to other target populations (e.g. heterosexual men and men who have sex with men living with HIV).

Eligibility Criteria:
Inclusion Criteria:

* women living with HIV
* living in Bamako area (Mali)
* over 18 years old
* knowing their serological status for more than 6 months and less than 5 years
* being available to participate in the 9 weekly sessions lasting about 2 hours each.

Exclusion Criteria:

* having already participated in Gundo-So
Randomized, Controlled, Open, Comparative Intervention Study for Obesity Prevention in Children

Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.Patients will be randomly allocated into one of two behavior intervention groups or control group in ratio of 1:1:1.The study will consist of two main periods: an intervention period of 3 months followed by 21 months of a follow up period. During the intervention period, participants (parents or both parents and children, depending on randomization) will attend a behavior intervention program once a week, each session will last one hour and would be guided by dietician and psychologist. Follow up visits will be performed at the clinic (for participants in al 3 groups) at months 0, 3, 12 and 24.

Randomized, controlled, open, comparative intervention study in 270 children at risk for obesity.

Objectives:

1. To develop an intervention program for obesity prevention in children aged 5-10 years old, who are at risk to develop obesity
2. To compare between the efficacy of two different intervention programs and a control group in preventing obesity in the short and the long term.
3. To evaluate the role and significance of including parents in an intervention program for obesity prevention.
4. To identify demographic parameters, lifestyle characteristic and biochemical markers that predict the risk of developing obesity and the response for treatment.

Randomization:

Patients will be randomly allocated into one of two intervention groups or control group in ratio of 1:1:1. Each group will contain 12-15 participants.

Intervention groups:

1. parent's group- only parents will take part at the intervention program.
2. Parents and children group- both children and parents will take part at the intervention program, in two separate sessions.

Methods:

1. The study will be consist of two main periods: an intervention period of 3 months followed by 21 months of a follow up period. During the intervention period, participants (parents or both parents and children, depending on randomization) will attend a behavior intervention program once a week, each session will last one hour and would be guided by dietician and psychologist. Follow up visits will be performed at the clinic (for participants in all 3 groups) at months 0, 3, 12 and 24.
2. Height, weight, fat mass and waist circumference will be measured at 0, 3, 12 and 24 month. Height and weight of parents will also be measured at these visits.
3. Physical examination will be performed at 0, 3, 12 and 24 month.
4. Psychological and nutritional questionnaire (depression, quality of life and self estimation) will be filled at 0, 3, 12 and 24 month.
5. Fasting blood tests for: chemistry, hematology, lipids, glucose, insulin, TSH, adiponectin, IL-6 and TNFα will be performed at 0, 3, 12 and 24 month.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5-10 years old
* BMI in 85-98 percentile
* Both parents signing informed consent form

Exclusion Criteria:

* Chronic disease or chronic use of medication
* Incapability to perform all study procedure
Whole Grains, Gastric Emptying and Glycemic Response

Whole grains have been associated with controlled glycemic response and increased satiety compared to refined grains. However, the properties of whole grains which are responsible for these purported improved health outcomes are still unclear. The current study investigated the extent of whole grains' low glycemic property when food properties are controlled, and how this relates to gastric emptying rate and glycemic response.

It is generally assumed that whole grain foods confer a health benefit in regards to moderated glycemia and increased satiety compared to foods made from refined grains. However, the extent of whole grains' low glycemic property may be limited by certain factors. For example, physical properties such as viscosity or particle size and differing starch digestion rates of whole grain foods may strongly influence glycemic response and gastric emptying rate. In this study, whole and refined grain wheat porridges were prepared from materials originating from the same milling source, with matched pairs for viscosity, starch and dietary fiber contents, and particle size. Subjects consumed wheat porridges containing 13C-labeled octanoic acid for assessment of gastric emptying rate, and they wore a continuous glucose monitor for measuring postprandial glucose levels. The purpose of this research was to test the hypothesis that the purported moderated glycemic response and slow gastric emptying rate are dependent on how these foods are processed. This work highlights the need to consider specific properties of whole grain foods for desired health outcomes in order to optimize the design of whole grain-based foods.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-50 years old
* Healthy, normal BMI (18.5 kg/m² \<BMI \< 25 kg/m²)
* Be free of any gastrointestinal diseases, diabetes, cardiovascular diseases
* Be free of any wheat allergies and gluten intolerances or sensitivities
* Not be pregnant or nursing

Exclusion Criteria:

* No medical problems
* No medication
* Pregnant or nursing
Efficacy of Canrenone as add-on Treatment in Moderate to Severe ARDS in COVID-19

The main aim of the study is to estimate the potential efficacy of i.v. canrenone as add-on therapy on maximal medical treatment versus maximal medical treatment alone in treating moderate-to-severe ARDS due to SARS-CoV-2.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 80 y.o. Since over eighties are very fragile patients, a lot of confounding unpredictable events may interfere with the trial analyses; thus, these patients will be excluded from this exploratory proof-of-concept trial;
* COVID-19 diagnosis through swab within 14 days from the beginning of symptoms
* Hospitalization for moderate to severe ARDS (as determined by PaO2/FiO2 ≤300 mmHg at admission)
* Serum concentration of potassium ≤4.5 mEq/L
* Consent to participate

Exclusion Criteria:

* Invasive mechanical ventilation
* I.v. hydratation with Darrow's solution or half-strength Darrow's solution underway
* Acute cardiovascular event (acute myocardial infarction, acute ischaemic stroke)
* Current malignant disease
* Creatinine \>1.8 mg/dL (for women) and \>2.0 mg/dL (for men) or glomerular filtration rate \<50 mL/mm
* Systolic blood pressure \<110 mmHg and/or diastolic blood pressure \<60 mmHg
* Known or suspected hypersensitivity to canrenone
* Hyponatremia
* Anuria
* Familial history of porphyria
* Pregnancy and breastfeeding
* known or suspected hypersensitivity to canrenone
* Inclusion in any other pharmacological clinical trials
Transcultural Mindfulness Assessment: A Mixed Methods Analysis

Preliminary evidence attests to the effectiveness of mindfulness-based interventions in reducing symptoms associated with a variety of medical and psychological conditions. However, research progress has been hampered by discrepancies in how mindfulness has been operationalized, assessed, and practiced. Existing contemporary assessments of mindfulness were developed exclusively by Western scientists and have exhibited questionable validity, particularly among diverse cultural groups. Operational definitions of mindfulness are essential for the development of valid measures, which in turn are necessary for investigating the mechanisms of change in mindfulness-based interventions. Therefore, the overall goal of this study is to create a mindfulness measure that is informed by the experience of mindfulness experts - Theravāda, Tibetan, and Zen Buddhist clergy and lay practitioners. To do so, this study will employ the preliminary phases of the sequential exploratory mixed methods for instrument design model. The first phase will involve conducting open-ended interviews with Theravāda, Tibetan, and Zen Buddhist clergy and lay practitioners to ascertain expert information on mindfulness and closely related Buddhist concepts. This qualitative process allows the experts to define the phenomena of interest (i.e., addresses issues of validity). In the second phase, the investigators will use the themes and specific phrases evoked during the qualitative interviews to develop items for a draft closed-ended self-report measure of mindfulness. Following completion of the research outlined in this proposal, the investigators will submit a subsequent proposal to thoroughly evaluate the psychometric properties of our draft mindfulness questionnaire in a variety of different cultures and contexts. This measure can be beneficial in clinical research by helping to elucidate the mechanisms of change in mindfulness-based psychotherapies in the United States and equally so in other cultures such as Thailand, where mindfulness and other Buddhist practices have already been integrated into mainstream mental health treatment. Therefore, our aim is to create a measure that can help improve the assessment and clinical use of mindfulness.


Eligibility Criteria:
Inclusion Criteria:

* Zen, Theravada, or Tibetan clergy
* Zen, Theravada, or Tibetan layperson with meditation experience

Exclusion Criteria:

* Under 18 years of age
Oral Administration of Four Lactobacillus Species Preparation to Improve the Quality of the Neovaginal Flora in Male to Female Transsexual Patients

The aim of this study is the improvement of the penile linked neovaginal flora in male-to-female transsexuals after application of oral probiotics.


Eligibility Criteria:
Inclusion Criteria:

Participants underwent the sex reassignment surgery (SRS) with the technique of the inverted penile skin flap longer than 1 year.

All transsexual women treated according to the Standards of Care of the World Professional Association of Transgender Health (WPATH).

Exclusion Criteria:

* clinical signs of vaginal or urinary tract infection,
* abnormal neovaginal discharge,
* neoplasia,
* bleeding,
* diarrhoea,
* constipation,
* rectal pathologies including hemorrhoids,
* antibiotic therapy in the previous 4 weeks
Evaluating a Digital Sexual Assertiveness Intervention for ASMM

The purpose of this study is to test the effectiveness, likability, and implementation potential of PACT, an adapted digital program to teach non-heterosexual adolescent boys about sexual consent and condom negotiation in a randomized controlled trial over 9 months.

Because the PACT (Promoting Affirmative Consent among Teens) digital health intervention showed evidence of effectiveness at improving sexual consent cognitions in its first trial, and was found generally likable among adolescents, the research team has adapted the program to serve as sexual assertiveness (consent and condom negotiation) training. This adapted version is tailored to the specific needs of adolescent sexual minority males (ASMM), a population that has been historically underserved by traditional sex education while also experiencing disproportionately high rates of both sexual violence victimization and condom non-use. The evaluation of the adapted PACT program (now titled Promoting Assertive Communication among Teens) will take place in an RCT with a Type 1 effectiveness-implementation hybrid design. Surveys will be administered at pre-intervention, post-intervention, 3-month follow-up, and 9-month follow-up. The investigators will assess acceptability, implementation factors, and main and secondary outcomes related to consent and condom negotiation/use.

Eligibility Criteria:
Inclusion Criteria:

* 14-17 years old
* lives in the U.S.
* identifies as a queer teen guy or sexual minority male

Exclusion Criteria:

* younger than 14
* older than 17
* does not live in U.S.
* does not identify as a queer teen guy or sexual minority male
Caudal Block Versus Local Wound Infiltration for Inguinal Procedures

Single-centre observational study to analyse whether there is a difference in post-operative pain scores and set up time when comparing caudal block with local wound infiltration

Inguinal procedures in children are surgical frequently performed in an outpatient setting. This study analyzed regional analgesia for inguinal procedures in toddlers comparing caudal block with local wound infiltration and assessed post-operative pain scores as well as process times.A number of documents were compiled to inform and record data: a standard anaesthesia protocol, a documentation sheet for intraoperative recording, an information leaflet for the parents and a documentation sheet for the post-operative course of 24 hours .

Caudal anaesthesia was performed after induction of anaesthesia. In patients getting wound infiltration ropivacaine 0.375% 0.5 ml kg-1 was injected subcutaneously after closing of the fascia transversalis.

Parents were informed about the study and invited to participate upon arriving on the outpatient ward if the patient fulfilled the following inclusion criteria: scheduled for elective inguinal procedure, age three to 72 months, no contraindication for either local or caudal analgesia, no comorbidities. If parents agreed to participate, written informed consent was obtained. Pain score and administration of analgesics, vomiting, interval until micturition and interval until mobilization as well as sleep quality during the first post-operative night were documented by the parents in the provided booklet.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* no return of questionnaire
* parents do not understand language
Gastric Banding After Failed Gastric Bypass

The safety and efficacy of the Adhesix Bioring adjustable gastric band will be assessed in patients after failed RYGB.


Eligibility Criteria:
Inclusion Criteria:

* Patient must sign the informed consent form prior to the index-procedure.
* Patient with failed RYGB defined as patients with EWL \<50%.

Exclusion Criteria:

* Patient has a life expectancy of less than 2 year.
* Patient who is most likely expected not to be compliant with the proposed follow-up visits.
Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children

Poor control of chemotherapy-induced nausea and vomiting has a major clinical and psychological impact in patients treated with chemotherapy. Metabolic, nutritional and mechanical complications, as well as psychological repercussions, complicate the therapeutic management of the patient and can lead to poor compliance, a deterioration in the general condition or even prolongation of hospitalizations and a delay in the implementation of chemotherapy cures. The control of induced chemo- and radio-induced nausea and vomiting rests above all on their prevention. At present and in most centers, the prevention of nausea and vomiting in the pediatric onco-hematology department of the CHU de Nice is based exclusively on drug treatments, according to a protocol established according to the emetogenic risk of the chemotherapy received.

We propose a study evaluating the effectiveness of the stimulation of acupuncture points by low frequency laser therapy associated with antiemetics in the management of chemotherapy induced nausea and vomiting in patients of 2 to 20 years followed in the service of analgesics. pediatric onco-hematology.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of malignant pathology with indication of chemotherapy with moderate to severe emetogenic potential
* Indication of at least three identical chemotherapy cures
* Age between 2 and 20 years
* Prescription of an anti emetic protocol
* Karnosky / Lansky Index\> 60%

Exclusion Criteria:

* Proven laser contraindication
* Vomiting in the 24 hours before starting treatment
* Presenting a brain lesion responsible for nausea and vomiting
* Pelvic abdominal irradiation the week before the start of treatment
* Treatment with benzodiazepines or opioids the week before treatment
* Pregnant women
Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma

This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15


Eligibility Criteria:
Inclusion Criteria

* Patients must be 18 years of age or older at the time of enrollment.
* Patients must be diagnosed with active and measurable relapsed/refractory multiple myeloma.
* Patients must have failed at least 3 prior lines of therapy which must have included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug or biologic. Failure of treatment and measurable myeloma disease are defined as per 2016 IMWG criteria.
* Patients must have clinical performance status of ECOG 0-2.
* Patients must have adequate vital organ function as defined by:
* Hemoglobin ≥8 g/dL
* Absolute neutrophil count \> 1000/ mm3
* Platelets \> 50,000/mm3
* ALT/AST levels lower than 3-fold of normal
* Creatinine clearance ≥45 mL/min/1.73 m2
* Normal cardiac and pulmonary function
* No thromboembolic events in the past 3 months
* No heparin allergy or active infection

Exclusion Criteria

* Patients who have any active and uncontrolled infection.
* Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above 40 mg/day prednisone equivalent).
* Patients who have active central nervous system disease.