cyrilzakka/clinical-trials huggingface dataset:
Study to Understand Pain Experiences in Relationships

Chronic pain is a highly prevalent and costly health care problem. Yet, little is known about the optimal ways for health care providers and family members to respond to the distress expressed by people with chronic pain. The aim of the current study is to compare two models of responsiveness to identify responses that result in better functioning and adjustment. An experimental design will be used to test the extent to which emotional validation (e.g., an empathic response to distress) increases or decreases pain behaviors during physical activity. Romantic partners of individuals with chronic pain will be randomly assigned to receive validation or control training. Following training, people with chronic pain and their partners will engage in a discussion about pain and complete household tasks to examine the effects of partner training on communication, pain intensity, and pain behavior. Additionally, each individual in the couple will complete self-report measures after the discussion, after the household tasks, and one-month following the laboratory visit.


Eligibility Criteria:
Inclusion Criteria:

* Romantic couples who are married or living with each other for 6 months or longer or have been in a romantic relationship 2+ years.
* One individual in the couple must have chronic muscoskeletal pain, lasting 3 months or longer. Participants may have multiple pain sites.
* The individual with chronic pain must report that their pain occurs nearly daily.
* The individual with chronic pain must have an average pain intensity of 3 or greater on an 11-point scale (from 0: no pain to 10: worst pain imaginable)
* The individual with chronic pain must have an average pain interference of 3 or greater on an 11-point scale (from 0: does not interfere to 10: completely interferes)

Exclusion Criteria:

* One or both individuals in the couple are unable to speak, read, or write in English.
* Both individuals in the couple have chronic pain. Couples may consist of one individual with chronic pain and one individual with "minimal pain", which we define as having some aspects of chronic pain but not all (e.g., has had nearly daily pain for 4 months but rates their pain below 3 in regards to interference and intensity)
* One or both individuals in the couple have widespread pain (e.g., fibromyalgia)
A Trial of One-week on/One-week Off Temozolomide Versus Continuous Dose-Intense Temozolomide in Patients With Glioblastoma Multiforme at First Relapse

The purpose of this study is to evaluate the clinical benefit and safety of two different Dose-Intense temozolomide regimens（one-week on/one-week off regimen versus continuous dose-intense regimen）in patients with glioblastoma at first relapse.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must have histopathologically-confirmed, supratentorial, glioblastoma.
2. Participants must have received first-line treatment regimen consisting of RT plus concomitant temozolomide followed by adjuvant temozolomide.
3. Participants must be first recurrence or progression of glioblastoma after first-line treatment regimen.
4. Participants must have demonstration of recurrent disease on MRI following prior therapy.
5. Participants must have bi-dimensionally measurable disease with a minimum measurement of 1 cm in one dimension on MRI performed within 14 days prior to first treatment. If receiving corticosteroids, participants must be on a stable or decreasing dose of corticosteroids for at least 5 days prior to baseline MRI.
6. Participants must have developed progressive disease after receiving prior therapy and must have an interval of at least 12 weeks from the completion of radiation and concomitant temozolomide therapy to study entry (unless progressive tumor growth is outside the radiation field or there is histopathological confirmation of recurrent tumor)
7. Age 18-75 years old.
8. Life expectancy of at least 12 weeks.
9. Karnofsky performance status at least 60
10. Participants must be able to adhere to the dosing and visit schedules, and agree to record medication times, concomitant medications, and adverse events (AEs) accurately and consistently in a daily diary.
11. 20 paraffinsections of glioblastoma tissue must be available.
12. Participants must have normal organ and marrow function as defined below: leukocytes \>4.0×10\^9/L，platelets \>100×10\^9/L，Hemoglobin \> 10 g/dl，Serum creatinine\< 1.5-fold upper normal range，AST and ALT \<2-fold upper normal range, Alkaline phosphatase \< 3-fold upper normal range.
13. Female and male subjects of childbearing potential must agree to use a medically accepted method of adequate contraception.

Exclusion Criteria:

1. Treatment with any chemotherapy other than temozolomide prior to enrollment.
2. Progressive or recurrent glioblastoma documented by MRI earlier than 12 weeks after completion of radiotherapy.
3. History of any other cancer.
4. HIV infection.
5. Women who are pregnant or breast feeding.
Compassionate Use of Ibalizumab for the Treatment of HIV Infection

Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into CD4+ lymphocytes. Ibalizumab has completed phase I and II clinical studies in HIV-negative and HIV-infected individuals showing safety and efficacy for suppressing HIV replication.

1. Ibalizumab is a humanized immunoglobulin G monoclonal antibody directed against a human T-cell receptor (CD4) and thus suppresses HIV replication by blocking entry of HIV into CD4+ lymphocytes. Ibalizumab is in the pipeline for FDA approval to treat HIV infection. Phase I and II clinical studies have been completed in HIV-negative and HIV-infected individuals showing safety and efficacy for suppressing HIV replication.
2. Use of this medication requires that a single patient IND be obtained from the FDA for each patient requiring ibalizumab. An individual use IND has been approved by the FDA for one patient on treatment through this protocol; The IND number is 114515. The manufacturer of ibalizumab (TaiMed Biologics, Inc) will ship the drug directly to the Denver Health pharmacy.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a diagnosis of HIV-infection with resistance or intolerance to currently available antiretroviral medications available in the United States or in whom additional drugs need to be added to their regimen because of inadequate response to existing therapy
* Patients with HIV infection that is expected to be sensitive to dolutegravir and ibalizumab
* Patients who do not qualify for or who are otherwise ineligible for clinical trials of medications not currently approved for treatment of HIV infection in the U.S.

Exclusion Criteria:

* Patients who are allergic to or have had a severe adverse reaction to dolutegravir or ibalizumab in the past.
* Age \<18 years or \>89 years
* Women may not be pregnant
* Prisoners and decisionally challenged patients will be excluded
Effects of Brain Stimulation During a Daytime Nap on Memory Consolidation in Older Adults

The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory representations. This impact of sleep on memory performance can be additionally enhanced by exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the frequency range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in young, healthy subjects. If older adults that commonly experiencing cognitive decline, including long-term retention of declarative memory - benefit from transcranial slow oscillatory stimulation (tSOS) during sleep in the same way has not been studied so far. The primary goal of the study is therefore to investigate the impact of oscillating current stimulation (tSOS) during a daytime nap on declarative memory consolidation in older adults.


Eligibility Criteria:
Inclusion Criteria:

* age: 50-90 years
* right handed
* inobtrusive neuropsychological examination

Exclusion Criteria:

* untreated severe internal or psychiatric diseases
* epilepsy
* other severe neurological diseases eg., previous major stroke, brain tumour
* dementia
* contraindications to MRI
Photo Biostimulation and Spasticity in Cerebral Palsy

the current study will address the spasticity in calf muscle secondary to cerebral palsy in children. As the spasticity can inversely affect muscle contraction, joint function, and consequently the function and quality of life, the current study will investigate the effect of adding photobiostimulation therapy to standard physiotherapy on muscle tone, ankle range of motion, gross motor function, plantar surface of the affected foot, and quality of life in patients with spastic cerebral palsy

spasticity is one of the common complications associated with upper motor neuron injuries such as cerebral palsy. it can affect the normal developmental process of the child as it restricts muscle performance, limit range of motion, decrease function, and affect the ability to engage in daily activities.

the current study will include 2 groups of children having spastic cerebral palsy. these groups will be randomly distributed to the experimental group (receive standard physiotherapy treatment plus photo biostimulation therapy on related acupuncture points) and the control group will receive a standard physiotherapy program.

the duration of the intervention will be 1 month, 3 sessions per week. the outcome measures will be assessed at baseline, at the end of the intervention ( after 4 weeks of treatment), and at 3 months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* age between 8 and 14 years,
* who had a diagnosis of spastic cerebral palsy by a pediatrician, with at least one spastic - muscle in the extremities,
* grades 1 -4 on Gross Motor Function Classification System
* score 1 on the Modified Ashworth Scale (MAS)
* the ability to walk alone or with assistance
* whose parents/guardians sign the informed consent form,
* who were willing to complete the study.

Exclusion Criteria:

* patients with anatomical disorders,
* patients who received a botulinum toxin injection in the calf muscle during the last six months
* surgery in the lower extremity during the previous year
* severe associated neurological diseases such as epilepsy
* poor nutritional status,
A Prospective, Open Label Study Evaluating JUVÉDERM® VOLBELLA With Lidocaine Treatment for the Correction of Skin Depressions in the Infra-orbital Area

A prospective, open label, study evaluating JUVÉDERM® VOLBELLA with lidocaine treatment for the correction of skin depressions in the infra-orbital area (under the eyes)


Eligibility Criteria:
Inclusion Criteria:

* Has Grade \> 0 at screening within each eye (bilateral skin depression in the infra-orbital area), as evaluated by the Evaluating Investigator (EI) using AIRS
* Agree to refrain from undergoing other antiwrinkle/volumizing treatments in the upper two-thirds of the face (eyebrow to cheeks/cheekbones) for the duration of the study

Exclusion Criteria:

* Has undergone cosmetic facial procedures \[e.g., face-lift, or other surgeries which may alter the appearance of the infra-orbital area (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures), tissue augmentation with dermal fillers or fat injections, or mesotherapy\] anywhere in the face, or Vistabel® cosmetic injections in the peri-orbital area, within 6 months prior to entry in the study or be planning to undergo any of these procedures at any time during the study. NOTE: Prior treatment with HA fillers and/or collagen is allowed, provided the treatment was administered more than 12 months prior to study entry
* Has undergone volumizing of the mid face within 12 months prior to study entry
* Has ever received semi-permanent fillers or permanent facial implants (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the infra-orbital area, or be planning to be implanted with any of these products at any time during the study
* Have a history of skin cancer
* Have a history of hypertrophic scarring
* Have a subcutaneous retaining structure on the face (e.g., meshing, gold strand)
The Effect of Orally Administered L- Arginine on Quadriceps Strenght in Healthy Smokers

The study will investigate changes in certain locomotor parameters as early predictors of disease in smokers who are prone to develop chronic obstructive pulmonary disease (COPD).

The research will include about 150 respondents aged 40-65, smokers and non-smokers, and will be conducted at the Special Hospital for Medical Rehabilitation 'Daruvarske toplice'. All patients will make spirometry and the Tiffeneau-Pinelli index (ratio of forced expiratory volume in 1 second - FEV1 and forced vital capacity FVC).

All patients will be maesured: body weight, height, BMI (body mass index), waist circumference, pulse (cp), saturation (SpO2), blood pressure, respiratory index and thoracic spine mobility index measured. The thickness of the skin fold will be measured on the abdomen with a caliper and on the measuring device for the analysis of body mass composition - Gaia, the percentage of muscle and fat tissue will be determined for each patient, as well as the analysis of body mass composition. All patients will do a 6-minute walk test and the patient's cardiorespiratory and muscular ability will be tested on a bicycle erogometer, the values of maximal oxygen uptake (VO2 max) and pulse (cp) will be recorded and the patient's fitness status determined. Each patient will estimate dyspnea intensity from 1 -10 before and after a 6-minute walk test and before and after a bicycle ergometer according to the Borg's dyspnea scale. The strength test of the the quadriceps muscle, will be measured in all patients on the Biodex isokinetic device. Quadriceps strength testing will be performed on 2 occasions. On one occasion without medication, except those that the patient may take permanently, and on the other 90 minutes after the patient takes 1 tbl of L - Arginine 500 mg on mouth to an empty stomach ,in order to monitor the possible increase in quadriceps strength. All patients who are smokers will have recorded : the age of onset of smoking, the year of smoking experience and the average number of cigarettes smoked per day. All patients will complete the CAT, IPAQ and DASS-21 questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* aged 40-65
* smokers and non-smokers, All patients will make spirometry and the Tiffeneau-Pinelli index (ratio of forced expiratory volume in 1 second - FEV1 and forced vital capacity FVC)\> 75% of the predictive value will be taken as an inclusion criteria.

Exclusion Criteria:

* FEV1 / FVC \<75%,
* inflammatory rheumatic diseases,
* malignancies,
* acute and severe heart or lung disease,
* unregulated hypertension,
* patients who have undergone major surgery in the past year,
* patients with implanted hip, knee or ankle prosthesis, will be excluded from the study.
Roll for Intervention - TBI Group Treatment

Communication group intervention for individuals with Traumatic Brain Injury based on INSIGHT protocol (Keegan et al, 2020) with roll playing game focus

Individuals with TBI recruited to participate in a study about applying INSIGHT protocol to a virtual roll playing game environment. The game 'monsters of the week' will be used to administer the cognitive-communication ingredients outlined by INSIGHT (Keegan et al 2020) and progress towards social communication goals will be documented throughout the course of participating in the roll playing campaign (7-8 weeks - meeting 2 hours each week). The individuals without neurological disorders will follow the same protocol.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe TBI more than 1 year ago

Exclusion Criteria:

* other neurological diagnoses prior to TBI
Videolaryngoscopic Intubation and Difficult Airway Classification

Primary aim of this study is to identify independent factors associated with difficult videolaryngoscopic intubation in patients undergoing oral and maxillofacial (OMF) or ear, nose and throat (ENT) surgery. Furthermore, this study intends to assess the diagnostic value of preoperative flexible nasal videoendoscopy to predict difficult videolaryngoscopic intubation in these patients.

Difficult endotracheal intubation is a major reason for anesthesia related adverse events. Videolaryngoscopy has become an important part of the anesthesiological standard of care for difficult airway management in the past decades. Still, medical preconditions, as well as procedural and technical factors related with difficult videolaryngoscopy have not been systematically investigated, and a standardized comprehensive classification system for the severity of videolaryngoscopic intubation has yet to be specified. The primary objective of this study is to identify independent factors associated with difficult videolaryngoscopic intubation in patients undergoing ENT or OMF surgery.

Patients with conditions of the ENT and OMF spectrum have a predisposition for difficult airway management and are at high risk for adverse events during endotracheal intubation. However, current recommendations for preoperative screening for difficult intubation rarely consider space consuming lesions of the laryngopharyngeal region. Comprehensive data identifying the predictive value of preoperative flexible nasal videoendoscopy as a diagnostic measure to anticipate difficult airway management still lack. Thus, secondary aim of this study is to evaluate the diagnostic value and clinical significance of preoperative flexible nasal videoendoscopy to predict difficult videolaryngoscopic intubation in these patients.

Study design:

The investigators conduct a prospective observational study, which includes 400 patients with predicted difficult airway and confirmed indication for flexible nasal videoendoscopy and videolaryngoscopic intubation undergoing ENT or OMF surgery.

Procedural and surgical data as well as medical preconditions will be assessed systematically. The handling anesthetist and two independent observers will be surveyed (structured questionnaire) in order to assess procedural and technical factors related with videolaryngoscopic intubation.

Eligibility Criteria:
Inclusion criteria:

* 18 Years and older
* Patients scheduling for ENT or OMF surgery under general anesthesia with requirement of endotracheal Intubation
* Risk of difficult airway management with confirmed indication for videolaryngoscopic intubation

Exclusion criteria:

* No consent given
* Pregnancy
Correlation Between the Incidence of COVID-19 in Nursing-homes and the Profile of Nursing Homes in the French Alps

Since the beginning of the COVID-19 outbreak in France, nursing homes (NH) have been heavily affected. In this study, the investigators want to evaluate the factors associated with the occurrence of COVID-19 epidemic clusters within the nursing homes in the French Alps

In France, between 1st of March and 29th of June 2020, the situation of NH was critical, with a total of 5,203 outbreaks (≥ 1case), of which 651 (13%) occurred in the Auvergne-Rhône-Alpes (ARA) area. In the ARA area, 3,885 residents of NH were confirmed cases (positiveness of the polymerase chain reaction (PCR) or of the serology testing), of which 1,772 (46%) subsequently died. To manage this crisis, the French government decided to first, ban the visits to residents and to reinforce hygiene measures targeting care workers, and secondly, of a national lock down. In the same time, shortage of personal protective equipment (PPE) had happened worldwide.

In this context, one can hypothesize that the occurrence of outbreaks and its spread among the residents of NH would have been initiated by the staff members. Nonetheless, the implementation of local actions might have been efficient to mitigate the epidemic, while on the other hand, shortage of PPE might have worsen the epidemic.

Therefore the investigators aimed to investigate the relationship between the occurrence of outbreak in residents and in staff members of nursing home, as well as the factors influencing this relationship, using data from a multicentric cross-sectional survey conducted in the French Alps, a part of ARA area.

Eligibility Criteria:
Inclusion Criteria:

* Hospital based NH in the French Alps
* Non Hospital based NH in the French Alps
* Study participation agreement from the NH's managers

Exclusion Criteria:

* Refusal of the NH's managers to participate
Study on the Long-Term Risk of Recurrence of Anoperineal Fistula in Crohn's Disease

This research aims to evaluate the long-term recurrence risk of perianal fistulas in Crohn's disease patients who have undergone treatment with anti-TNF therapy and seton drainage.The research seeks to identify factors influencing recurrence and assess the long term effectiveness of these treatments in preventing fistula recurrence. This study will provide insights that could enhance treatment strategies and improve patient outcomes.

Scientific Justification :

● Perianal fistulas are a common and challenging complication of Crohn's disease, significantly impacting patient quality of life. Infliximab, an TNFα antagonist has shown its efficacy in inducing remission of these fistulas. Seton drainage is often used alongside anti-TNF therapy to promote fistula healing and prevent abscess formation. However, data with long term follow up are still lacking on the impact of these treatments. Understanding the long-term outcomes of these combined treatments is crucial for optimizing therapeutic strategies and improving patient management.

Treatment Strategy :

● The treatment involves administering infliximab to control inflammation and promote fistula closure, along with seton drainage to maintain fistula patency and prevent abscesses, ensuring continuous drainage and reducing infection risk.

Follow-up Description :

● Patients are monitored retrospectively through medical records for a period ranging from several months to years, assessing recurrence rates and potential predictors of recurrence. Follow-up includes regular clinical evaluations, biological evaluations (blood test and fecal calprotectin), colonoscopy, imaging studies such as MRI, and patient-reported outcomes to gather comprehensive data on the long-term efficacy and safety of the combined treatment approach.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Crohn's disease
* drainage of an anal fistula with seton combined with the initiation of anti-TNF alpha treatment
* Patient who was treated in the digestive center of the Toulouse University Hospital for drainage of an anal fistula between January 1, 2000 and December 31, 2010

Exclusion Criteria:

Patient followed less than 6 months after seton drainage
Clinical and Biological Characteristics of Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a common and debilitating skin disease that is poorly understood and understudied. As a result, little is known about disease prognosis and few effective treatments exist for this condition. This prospective observational cohort study aims to comprehensively characterize the clinical and biological features of HS. The results of this research will provide a basis for the development of an HS clinical classification system and identification of potential treatments for HS.


Eligibility Criteria:
Hidradenitis Suppurativa Patients

Inclusion Criteria:

1. Age 13 years or older
2. Diagnosis of HS clinically-confirmed by a physician

Exclusion Criteria:

1. Inability to give informed consent or have a parent/guardian who is able and willing to give informed consent.

Healthy Volunteer

Inclusion Criteria:

1. No history of chronic skin conditions
2. No recent history of antibiotic use

Exclusion Criteria:

1. Inability to give informed consent or have a parent/guardian who is able and willing to give informed consent.