cyrilzakka/clinical-trials huggingface dataset:
Scaling Mental Healthcare in COVID-19 With Voice Biomarkers

This study aims to advance research on group sessions for mental health. The first-of-its-kind study measuring various features in a group setting, combining rich metadata in creating state-of-the-art machine learning models, and developing workflows for mental health that are both scalable and personalized.

The anticipated impact of this study is defining voice biomarker features and reward functions for a deep reinforcement learning based system from group interactions that improve depression and anxiety outcomes. The investigators' ability to quantify the real-time impact of human-intervention in scaled group video sessions can be very meaningful for creating best practices in the area where measurement is infrequent.

The investigators' priority is to scale the optimal mix of individuals for group therapy sessions based on reward functions that maximize improvements in depression and anxiety scores. Current group therapy appointments may track little save few who use various group feedback questionnaires (e.g. OQ, GCQ, or GQ). Voice biomarkers can play a key role in the real-time measurement of mental health.

The proposed work is to conduct a feasibility study on creating reward functions that most effectively enable engagement for group sessions as measured by voice biomarkers before, during, and after group video meetings.

Eligibility Criteria:
Inclusion Criteria:

* Ownership of a personal iPhone (version iOS 12.0 or later) and willingness to install and maintain the Kintsugi app for remote participation throughout the study duration
* Able to understand and comply with instructions in English

Exclusion Criteria:

* Has any other clinically significant medical condition or circumstance that, in the opinion of the Investigator, could affect patient safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study
* Has a visual or physical motor impairment that could interfere with study tasks
* Is site personnel directly affiliated with this study
Lifestyle Modification to Improve Diet in Women With GDM

The study aims to adapt a lifestyle modification program to engage GDM women early in the postnatal period to evaluate its effectiveness in reducing adiposity and metabolic parameters in the mother. Women will be randomized to receive a structured intervention or standard care.

A complex intervention based on a proven lifestyle modification program (LMP) will be delivered to participants randomized to the intervention arm, starting in the early postnatal period. The intervention will consist of individualized face-to-face counseling on diet and weight management, meeting with exercise instructor, followed by telephone contact.

Control will receive standard postnatal education materials and usual care provided by government health service.

Eligibility Criteria:
Inclusion Criteria:

1. Women who developed gestational diabetes in their most recent pregnancy
2. GDM is diagnosed according to the WHO 2013 criteria of FBG ≥ 5.1mmol/l, or 1 hour glucose ≥10.0mmol/l, or 2 hour glucose ≥ 8.5mmol/l during 75g OGTT performed at 24-28 weeks of pregnancy
3. Singleton pregnancy
4. Reside normally in Hong Kong
5. Able to communicate in Chinese
6. Willing to give consent and follow study procedures

Exclusion Criteria:

1. Subjects with pre-existing diabetes (T1D or T2D)
2. Subjects with life-threatening conditions including malignancy that is not in remission
3. Subjects with known psychiatric conditions including depression
4. Substance abuse or use of illicit substances
5. Subjects with significant renal impairment (eGFR\<60ml/min at baseline) or non-diabetic renal disease (e.g. biopsy-proven glomerulonephritis or obstructive uropathy)
6. Subjects on chronic corticosteroids treatment
7. Subjects with known myocardial infarction within the preceding 3 months
8. Major physical disability
9. Participation in other intervention trials
10. Surgical or medical interventions to treat obesity
11. Pregnancy at any point during the intervention period
Epidemiology and Pathophysiology of Parkinsonism in the Caribbeans

The primary aim of this study is to estimate the frequency and to characterize clinically atypical parkinsonism in the French West Indies and Guyana.

An atypical akineto-rigid parkinsonian syndrome, unresponsive to L-dopa has been evidenced in Guadeloupe. Abnormally frequent, this progressive supranuclear palsy (PSP)-like syndrome represents a new clinical entity. Unlike in classical PSP 70% of patients have myoclonus, 59% hallucinations, 78% REM sleep behavior disorders. Oculomotor pattern differs from classical PSP suggesting that cortical dysfunction predominates over brainstem impairments. Neuropathological examination in four patients has shown a widespread accumulation of the tau protein in the basal ganglia, the midbrain and cortical areas.

This syndrome has been associated to the regular consumption of food products derived from plants of the Annonaceae family, more specifically Annona Muricata (soursop), suggesting a toxic origin. We have already confirmed the neurotoxic potential of the lipophilic mitochondrial complex I inhibitor annonacin, the major acetogenin in Annona muricata. This class of compounds is specific to Annonaceae. Nanomolar concentrations of annonacin induce the death of dopaminergic neurons in culture, by impairment of energy production. Chronic systemic intoxication of rats with annonacin causes neuronal damage in the same brain regions that are damaged in patients with atypical parkinsonism. These results greatly suggest that the consumption of annonacea might contribute to the pathogenesis of the disease. The H1 subhaplotype in tau gene associated with PSP in Caucasians did not confer risk for PSP-like atypical parkinsonism in Guadeloupe.

Eligibility Criteria:
Inclusion Criteria:

* Pour les patients :

  1. Patient ou tiers responsable ayant reçu une information sur l'étude et ayant signé le consentement éclairé
  2. Patient âgé de plus de 18 ans
  3. Patient consultant en neurologie ou en gériatrie pour symptomatologie parkinsonienne ou pour troubles cognitifs évocateurs d'une démence à corps de Lewy
  4. Patient domicilié aux Antilles-Guyane

     Pour les témoins :
  5. Conjoint ou accompagnant ayant reçu une information sur l'étude et ayant signé le consentement éclairé
  6. Personne âgée de plus de 18 ans
  7. Personne ne présentant pas de pathologie d'allure neurodégénérative (Parkinson, démence notamment)
  8. Personne domiciliée aux Antilles-Guyane

Exclusion Criteria:

Pour les patients :

1. Syndrome parkinsonien secondaire (post-traumatique, vasculaire, iatrogène, post encéphalitique)
2. Patient non affilié au régime de sécurité sociale
3. En cas de difficulté de suivi le patient sera exclu de l'étude longitudinale

Pour les témoins :

1. Personnes présentant des troubles cognitifs ou un syndrome parkinsonien diagnostiqué.
2. Patient non affilié au régime de sécurité sociale -
Effect of the Benson Relaxation Technique on Clinical Outcomes of Oncology Patients Admitted to Intensive Care Units

The benson Relaxation Technique (BRT), developed by Dr. Herbert Benson, is a method aimed at reducing stress and anxiety through a series of simple steps designed to elicit the "Relaxation Response." This response is a physiological state that counteracts the harmful effects of stress, characterized by decreased heart rate, lower metabolism, and reduced breathing rate

The benson relaxation consisted of the following steps: (1) Sitting or lying down quietly in a comfortable position; (2) Closing eyes; (3) Deeply relaxing all muscles, beginning at the feet and progressing up to the face. Keeping them relaxed; (4) Breathing through the nose. Becoming aware of breathing. Focus on a word, phrase, a short prayer, or only breathing. (6) Continuing for 15 minutes. When finished, sit quietly for several minutes, at first with eyes closed and later with eyes opened. Do not stand up for a few minutes.

According to the agreement, the patients in both groups were required to perform the Benson relaxation technique regularly twice daily (morning and evening) for three days in a row. Each session lasted 15 minutes

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18-60 years
* diagnosed with cancer
* alert and able to communicate.

Exclusion Criteria:

* Patients who refused to participate in the study
* Patients with cognitive impairment
* Patient who unable to communicate
Erythropoietin Therapy for Children With Cerebral Palsy

This randomized placebo-controlled trial aims to investigate the efficacy and safety of erythropoetin for children with cerebral palsy.

Cerebral palsy is a disorder of movement and posture resulted from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.

Many experimental animal studies have revealed that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed as follows;

1. Neuroprotection effect
2. Angiogenesis
3. Anti-inflammation.

On the basis of many experimental studies, erythropoietin is suggested as a therapeutic method for cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral Palsy
* Abnormal Muscle Tone
* Abnormal Brain MRI
* Willing to Comply with All Study Procedure

Exclusion Criteria:

* Known Genetic Disorder
* Other Etiologies Contributing Developmental Delay
* Coagulopathy
* Initial high Erythropoietin level in Serum
* Previous Erythropoietin Treatment before 3 months
* Presence of Drug Hypersensitivity Related to the Study Remedy
* Intractable Seizure Disorder
* Poor Cooperation of Guardian including Inactive Attitude for Rehabilitation
Does Adding Posterior Block to SFIB Increase the Quality of Analgesia in Hip Fractures?

The researchers aimed to compare the effects of adding a Deep Posterior Gluteal Compartment Block to a Suprainguinal Fascia Iliaca Compartment Block (SFICB) versus SFICB alone on pain, analgesic consumption, and positioning pain for neuraxial anesthesia.

Adding Deep Posterior Gluteal Compartment Block to Suprainguinal Fascia Iliaca Block applied before neuraxial anesthesia in hip fracture surgeries can reduce the pain sensation originating from the posterior region of the hip joint. Thus, participants can experience less pain in the perioperative period, consume less analgesics and reduce complications related to these in the postoperative period. In addition, possible complications can be prevented with early mobilization of the participants. It was aimed to compare the effects of adding Deep Posterior Gluteal Compartment Block to Suprainguinal Fascia Iliaca Block with only Suprainguinal Fascia Iliaca Block on these results.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Patients between the ages of 18-90
* ASA I, II, III
* Patients whose surgery duration does not exceed 2 hours
* Patients who will undergo surgery under spinal anesthesia

Exclusion Criteria:

* Patients who do not want to participate in the study/do not give consent
* Patients with a condition that prevents regional anesthesia
* Patients with cognitive dysfunction who are unable to evaluate the NRS score and who cannot use PCA (Patient Controlled Analgesia Device)
* History of hypersensitivity or allergy to local anesthetics
* Patients with psychiatric disorders and those using psychiatric medications
* Presence of hematological disease
* Presence of oncological disease
* Patients with serious major organ failure
* Presence of multiple fractures
* Patients with alcohol or drug addiction
* Patients who have used analgesic drugs up to 12 hours before surgery
* ASA IV-V patients
* Morbidly obese patients
Phase III Study of TAS-118 Plus Oxaliplatin Versus S-1 Plus Cisplatin in Patients With Advanced Gastric Cancer

The purpose of this trial is to evaluate the efficacy of TAS-118 plus Oxaliplatin compared with S-1 plus Cisplatin in overall survival in patients with advanced gastric cancer.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients who are diagnosed as gastric cancer.
* No prior treatment for gastric cancer.
* Negative or unknown for HER2 testing.
* ECOG performance status of 0 or 1.

Key Exclusion Criteria:

* Unmanageable diarrhea.
* Current peripheral sensory neuropathy or paresthesia.
* Pregnant or lactating female.
Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma

Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell Lung Carcinoma (NSCLC) treatment. To date, no powerful predictive biomarker of response has been found.

The investigators hypothesize that metabolomics profile could represent a potent biomarker of response to ICI

Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell Lung Carcinoma (NSCLC) treatment, both as first and second line of treatment. To date, no powerful predictive biomarker of response has been found. It has been recently shown that microbiota composition could dictate the ability of patients to respond to ICI. Since, the microbiota produces circulating metabolites that will subsequently act on immune system, the investigators hypothesized that metabolic signature, reflecting microbiota function, could represent a predictive biomarker of response to ICI.

Primary objective is to identify baseline metabolic signature (metabolomics analysis by Mass spectrometry) associated to ICI response. Secondary objectives are to link metabolic signature with microbiota composition (metagenomics analysis RNA 16S) and immune profile, and altogether with clinic response to ICI. Profile evolution (metabolic, metagenomics and immune) will be also analyzed at 2-month post ICI initiation and at tumor progression, if any.

In order to do so, the investigators thus plan to enroll 60 NSCLC patients treated by ICI as 1st, 2nd or 3rd line of treatment in CHUGA in 18 months. Blood as well feces will be collected prior to, and at 2 month following ICI treatment initiation as well as at progression. Will be excluded from this study, patients that have received antibiotic or corticotherapy 2 or 4 weeks before ICI initiation, respectively.

Eligibility Criteria:
Inclusion Criteria:

* NSCLC diagnosis
* Patient treated by a ICI in first, second or third line of treatment, or by the combination of chemotherapy and IPCI in first line of treatment
* Patient with at least one measurable lesion as defined by RECIST

Exclusion Criteria:

* Patient treated with antibiotic treatment within 2 weeks before the start of ICI or corticosteroids (\>20 mg per day) within 4 weeks before the start of ICI
Follow-up of the Patients Included in the EXESAS Study

Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It does multiply tenfold the occurrence of vascular events, particularly stroke. While Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term adherence to CPAP is a significant problem and search for alternative treatment is essential.

In the previous EXESAS study (NCT02463890) the investigators compare evolution of Apnea Hypopnea Index (AHI) in an exercise trained group performed through in a national based non-profit organization (Fédération Française d'éducation Physique et de Gymnastique Volontaire (FFEPGV)) using a medical established program (NeuroGyV) during nine months against a control group receiving only standard dietetic and physical activity counseling.

The first partial observations of the study EXESAS seem encouraging in the term of 3 months of training. However, in the longer term, there is not a coverage in the treatment of the moderate Sleep Apnea: Obstructive Syndrome (SAOS). Thus they can logically expect that the possible therapeutic effect of the exercise is not maintained in the long term after the stop of the training.

This nex study suggests studying the profit of the exercise on sleep apneas for the patients who were initially in the control group in the EXESAS study and to observe if the preservation of a regular physical activity for the group which was trained in EXESAS study is associated with a preservation of the AHI after the additional year of follow-up without additional intervention

Eligibility Criteria:
Inclusion Criteria:

* Included in the previous EXESAS study
* Signature of consent

Exclusion Criteria:

* Patients being already treated for sleep apnea or clinical status (cardiovascular comorbidities) justifying an immediate initiation of CPAP
* Daytime sleepiness (ESS score \> 10)
* Known respiratory or heart disease (or discovering during stress test) contraindicated exercise training
* Patients with Parkinson's disease
* AHI \> 30
Montelukast in Bronchiolitis Obliterans Syndrome

Chronic rejection (or Bronchiolitis Obliterans syndrome-BOS) is a major cause of mortality and morbidity after lung transplantation. Because montelukast has been shown to be of some efficacy in a similar disease (Obliterative Bronchiolitis after bone marrow transplantation), the investigators would like to test if montelukast can indeed slow down the progression of chronic rejection after lung transplantation.

* Prospective, interventional, randomized, double-blind, placebo-controlled trial.
* Clinical setting (tertiary University Hospital).
* Investigator-driven, no pharmaceutical sponsor.
* Lung transplant recipients.
* Add-on of study-drug (placebo or montelukast) to 'standard of care'
* 1:1 inclusion ratio (placebo:montelukast).
* Randomisation at diagnosis of chronic rejection after informed consent.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fBOS
* Signed informed consent
* Age at least 18 years old at moment of transplantation
* Able to take oral medication

Exclusion Criteria:

* Retransplantation
* Previous organ transplantation
* Multi organ transplantation
poSt Covid-19 Infection centraL sENsitisaTion

The aim of this study is to evaluate whether there are indicators of central sensitisation in patients post covid-19 infection.

The COVID-19 pandemic is currently a serious global public health concern. This disease is caused by a novel coronavirus which was first discovered in Wuhan, China in 2019 and later spread rapidly throughout the world. Symptoms of the disease can manifest as fever, cough, encephalitis, myalgia, fatigue, muscle weakness, arthralgia, anosmia, and impairment in other bodily functions in the acute phase. In 17% to 67% of cases, COVID-19 patients will develop acute respiratory distress syndrome (ARDS) and critical illness. Besides the impact on the respiratory system, coronaviruses have an effect on other systems including the central nervous system, cardiovascular system, musculoskeletal system, and gastrointestinal system.

The term central sensitivity syndrome (CSS) describes a group of medically nonspecific disorders, such as fibromyalgia, chronic fatigue syndrome, and irritable bowel syndrome, for which central sensitivity might be a common etiology. Despite the lack of a solid outcome measurement, the Central Sensitization Inventory (CSI) was previously introduced as a screening instrument for clinicians to help identify patients with a CSS. Furthermore, quantitative sensory testing can be used to identify and quantify sensory disfunctions by evaluating a variety of parameters including pain thresholds, temporal summation, and conditioned pain modulation (CPM). Previous research in patients with chronic pain resulted in less efficacious CPM, increased nociceptive facilitation and decreased pain thresholds.

In post covid-19 patients, potential long-term secondary effects on the musculoskeletal system such as muscle weakness, decreased muscle mass, and myopathies have been brought under attention. Persisting symptoms are a frequently reported complaint in patients recovered from COVID-19 infection with at least 1 symptom, particularly fatigue and dyspnea. Fatigue is also one of the core symptoms in central sensitisation disorders, leading to the hypothesis that central sensitisation might be the underlying common etiology in chronic pain patients and patients post COVID-19 infection. Therefore, the aim of this study is to evaluate whether there are indicators of central sensitisation in patients post covid-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosed covid-19 infection that took place at least 6 months before study inclusion.
* Cognitive and language functioning enabling coherent communication between the researcher and the participant.
* French-or Dutch speaking persons.

Exclusion Criteria:

* Covid-19 infection \< 6 months ago.
Quality of Life After Breast Cancer Surgery

The goal of this observational study is to prospectively collect data on quality of life after oncoplastic breast surgery.

Participants will be followed-up and answer quality of life questionnaire for a duration of 5 years after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over
* Patient with breast cancer of any stage (including in situ) or healthy individual at high personal risk.
* Patient requiring breast surgery under general anesthesia, whether for therapeutic or prophylactic purposes.
* Patient capable, in the opinion of the investigator, of complying with the requirements and restrictions of the study.
* Patient followed in the center on a regular basis according to standard recommendations.

Exclusion Criteria:

* Patient requiring surgical intervention under local anesthesia only.
* Patient requiring surgery for the installation or removal of an chemotherapy implantable port only.
* Patients with a history of cancer other than breast cancer. Patients with a history of cancer more than three years old are eligible if they are treated and considered cured. Patients with a history of cervical carcinoma in situ or non-melanoma skin carcinoma are eligible.
* Impossibility of being subject to regular monitoring for geographical, social or psychological reasons.
* Patient under protective measure