cyrilzakka/clinical-trials huggingface dataset:
Internet Supported Group Cognitive Behavior Therapy (CBT) for Hoarding Disorder (HD)

The primary aim is to develop, and test the feasibility and efficacy of, a manual based, cognitive behaviour therapy (CBT) treatment for Hoarding Disorder (HD) delivered in a group format combined with an Internet support system. The investigators' secondary aim is to investigate the neurocognitive profile of the participants before and after treatment in order to explore if the treatment might have an impact on neurocognitive functioning and if certain neurocognitive profiles predict outcome.

For the primary aim, the investigators hypothesize that the treatment will be acceptable to participants and decrease symptoms of hoarding. Regarding the secondary aim, the investigators hypothesize that deficiencies in executive functioning, as measured with a neurocognitive battery, will reduce upon completion of treatment and that baseline executive function will be associated with treatment outcome.


Eligibility Criteria:
* Inclusion criteria:

  * Outpatients
  * Male or female
  * ≥ 18 years of age
  * Currently living in Stockholm county
  * Primary diagnosis of Hoarding Disorder according to DSM-5
  * Signed informed consent
  * Regular access to a computer with Internet and ability to use Internet
  * Access to a mobile phone
  * Able to participate in group sessions
* Exclusion criteria:

  * Current substance dependence or misuse
  * Life time bipolar disorder or psychosis
  * Severe self-rated depressive symptoms (score ≥ 35 on MADRS-S)
  * Suicidal ideation (score \> 4 on item 9 in MADRS-S)
  * Psychotropic medication changes within two months prior to the treatment
  * Other current psychological treatment that could affect hoarding symptoms
  * Has received more than 10 CBT sessions for Hoarding Disorder
Oximeters and Skin Pigment: Impact of Skin Pigmentation on Accuracy of Pulse Oximetry

Finger pulse oximetry SpO2 is widely used to estimate arterial oxygen saturation SaO2. Current Spo2 targets do not take into consideration the many variables that affect that correlation in particular skin pigmentation.

This study aims to evaluate different FDA approved pulse oximeters (Nonin co-pilot, massimo Radical 7, Philips-standard of care monitor, innovo premium iP900BP, nellcor PM1000N, Nano100) with SaO2 reference values obtained by an arterial blood gas in subjects with different skin pigments measured by a skin color scale as well as self-identification of race.

The oximeters that will be evaluated are nonin co-pilot, massimo Radical 7, Philips (standard care), Innovo Premium iP900BP, nellcor PM1000N and USA medical supply Nano100. The sensors used will be reusable digital sensors for all oximeters. Oximeters will have been placed on patients' fingers (3 fingers on each hand) during an initial phase of clinical stability. Due to the impact of the fingers used for SpO2 measurement and bias that might be caused by right hand versus left hand, oximeters will be randomized to different fingers and hands for each patient. Measurements will be made when the SpO2 with the usual oximeter is \<97% as recommended and in the absence of changes of the respiratory parameters in the last 10 minutes. A set of measures that will include all the oximeters tested will be used. Once the oximeters are installed, at least 2 minutes will run out to let the oximeters reach steady state. Then when a standard of care blood gas is obtained, measurements will be taken simultaneously to the drawing of a standard care arterial blood gas by a clinician in the ICU. While the clinician takes the arterial blood gas, a picture will be simultaneously taken of the SpO2 readings shown by each oximeter, in addition to taking vital signs, O2 flow or FiO2.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Patients admitted to the Intensive Care Unit
* Patient has arterial line

Exclusion Criteria:

* No signal with the oximeter
* Missing digits preventing application of all probes simultaneously
* No requirement for arterial blood gases
* Pigmented nails, fake nails, or nail polish
* Methemoglobinemia
* Patient in isolation (multi-resistant bacteria, C-Difficile, COVID-19)
Study to Evaluate Sodium Phenylbutyrate in Pre-symptomatic Infants With Spinal Muscular Atrophy

In this single-center trial, we will evaluate the effects of NaPB on presymptomatic Spinal Muscular Atrophy (SMA) type I (cohort 1)and presymptomatic SMA type II (cohort 2) infants. A variety of outcome measures will be performed at each study visit to follow the course of the disease. Total duration of the study for type I infants will be 18 months, for type II infants, 24 months.

Perform a phase I/II study to evaluate effects of sodium phenylbutyrate (NaPB) in a cohort of presymptomatic infants, predicted to develop either SMA type 1 or SMA type 2 given genotype and family history of an older sibling with the respective SMA type. Primary outcomes: 1) to collect additional safety and pharmacokinetic data in neonates and young infants administered NaPB within the dosing guidelines already in use for urea cycle disorder therapy, and 2) to determine possible benefit of early treatment intervention with regard to status of denervation and functional motor status at specific time points for which we have matched natural history data to perform a comparison between cohorts and between each cohort and participants from our natural history database matched for age, SMN2 dosage and gender.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory documentation of homozygous absence of SMN1 exon 7.
* Confirmation of no more than 3 SMN2 copies for cohort 1; no more than 4 copies for cohort 2.
* Family history of affected sibling with SMA type I for cohort 1 and SMA type II for cohort 2.
* Age ≤ 3 months, cohort 1; Age ≤ 6 months, cohort 2.
* Written informed consent of parents/guardian.
* Laboratory results demonstrating normal values for age.

Exclusion Criteria:

-Evidence of hepatic insufficiency, renal insufficiency, edema with sodium retention, known seizure disorder, urea cycle disorder, cardiac arrhythmia, congenital heart defect, hypertension, significant central nervous system (CNS) impairment, or neurodegenerative or neuromuscular disease other than SMA.

History of allergy/sensitivity to sodium phenylbutyrate (NaPB).

* Use of NaPB within 30 days of study entry.
* Serious illness requiring hospitalization ≤ 14 days prior to study entry.
* Use of medications intended for the treatment of SMA including riluzole, valproic acid, hydroxyurea, oral use of albuterol, NaPB, butyrate derivatives, creatine, growth hormone, anabolic steroids, probenecid, oral or parenteral use of corticosteroids at entry, or agents anticipated to increase or decrease muscle strength or agents with presumed histone deacetylase (HDAC) inhibition within 30 days prior to study entry.
* Unwillingness to travel for study assessments.
CVP-guided Aquapheresis for the Treatment of Acute Congestion in Heart Failure

The number of patients with acute congestion on chronic heart failure is increasing. Ultrafiltration has recently been proposed as an alternative approach for the stabilization of volume balance, especially in patients with imminent diuretic resistance.

There is increasing evidence that ultrafiltration may relief cardiac congestion with lesser effects on blood pressure and activation of renin angiotensin system, respectively . However, recent studies revealed conflicting results: demonstration the superiority of ultrafiltration in comparison to diuretic treatment, and a lack of evidence of benefit, as well as an excess of adverse events with ultrafiltration.

Aquapheresis with adapted ultrafiltration rate guided by central venous pressure is safer than aquaphesis with a constant ultrafiltration with comparable effectiveness


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic heart failure scheduled for LVAD
* Indication for CVVH/Aquapheresis

Exclusion Criteria:

* Renal Disease (GFR \<20 ml / min)
Lung Tumour Volume Database

The main aim is to determine, in patients with locoregional, non-small cell lung cancer (NSCLC) treated by definitive radiotherapy, the influence on survival of the volume of primary tumour, as measured from CT imaging, after adjusting for the effect of the current TNM staging system and other known prognostic factors (especially ECOG performance and weight loss).

Patients with locoregional non small cell lung cancer are registered on study after tumour volumes are outlined by a radiologist and prior to the commencement of any treatment.

All patients must have recorded the volume of disease in the primary tumour (and of involved nodes \> 1 cm diameter) as measured from a CT scan performed according to a standard set of conditions.

Following registration patients are treated with Definitive radiotherapy with or without chemotherapy. Follow-up will occur with the collection of a minimum amount of data every 12 months from the date of registration on study.

Quality Assurance procedures will be implemented with each site that participates in the study.

Eligibility Criteria:
Inclusion Criteria:

Must satisfy ALL of the following

* NSCLC - histological or cytological diagnosis of non-small cell lung cancer
* Intra-thoracic disease - disease is confined to the primary site, with or without intrathoracic lymph nodes
* CT planning - CT imaging of the thorax has been performed as part of the planning procedure
* Definitive radiotherapy - it is planned to give definitive radiotherapy with or without chemotherapy (prior to, during or after radiotherapy). Definitive radiotherapy is defined as 60 Gy in 6 weeks, 50 Gy in 4 weeks or at least the equivalent of either of these. The size of each individual; fraction should not exceed 2.5 Gy.
* Measurable disease - the primary tumour and nodes with maximum diameter greater than 1cm represent measurable disease

Exclusion Criteria:

A patient satisfying ANY of the following is ineligible

* Symptomatic or radiological evidence of metastatic disease
* Prior treatment for non-small cell lung cancer
* Surgical resection is part of initial treatment
* Palliative radiotherapy planned
The Neoadjuvant Treatment Modalities in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (NEO-EC）

The prognosis and safety of patients with locally advanced esophageal squamous cell carcinoma were compared with different neoadjuvant therapy modes in multi-cancer centers in China

Neoadjuvant chemoradiotherapy or neoadjuvant chemotherapy combined with surgery are the main treatment methods for patients with locally advanced esophageal squamous cell carcinoma, but some patients still have local recurrence or distant metastasis after surgery. In the era of immunotherapy, immune checkpoint inhibitor monotherapy or combined chemotherapy has become the first-line and second-line standard treatment for recurrent or metastatic esophageal cancer and has been recommended by NCCN guidelines. However, relevant studies on immunotherapy's participation in neoadjuvant therapy have shown good results, but it is still in its initial stage, and its efficacy needs further research and discussion.Thus, we compared the prognosis and safety of patients with locally advanced esophageal squamous cell carcinoma who received different neoadjuvant therapy before surgery, including neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy, neoadjuvant chemotherapy combined with immunotherapy, and neoadjuvant chemoradiotherapy combined with immunotherapy in several cancer centers in China.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years, male or female;
2. KPS score (KPS) ≥70;
3. Esophageal squamous cell carcinoma confirmed by histopathology;
4. Clinical stage cT1b-4aN+M0,T3-4aN0M0;
5. Surgical resection was performed after 2\~4 cycles of neoadjuvant therapy.
6. Expected survival \> 6 months.

Exclusion Criteria:

1. Have a history of other malignancies (except for cancer in situ that has been cured and other malignancies that have been cured for more than 5 years);
2. There are contraindications of immunotherapy or chemoradiotherapy;
3. Inability to tolerate or refuse surgery;
4. Distant metastasis has occurred;
Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity

The objective of this study is to explore the effects of darifenacin in patients with multiple sclerosis and neurogenic detrusor overactivity. The efficacy, safety and tolerability of darifenacin are already well established in idiopathic detrusor overactivity. Patients with multiple sclerosis and neurogenic detrusor overactivity without detrusor-sphincter-dyssynergia (DSD) will be allocated to darifenacin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple sclerosis for at least 6 months
* Neurogenic detrusor overactivity without DSD
* Symptoms of OAB
* Patients capable of completing the bladder diary
* Patients capable of independent toileting
* Patients able to swallow the study medication in accordance to the protocol
* Body Mass Index \>/= 18,8 kg/qm and \</= 35,0 kg/qm
* documented, dated, written informed consent

Exclusion Criteria:

* Treatment with drugs known to affect mainly the urinary function 14 days prior to starting completion of the baseline diary for Visit 2
* Participation in a bladder-training program
* Low compliance bladder (Compliance \<20 mL/cm H2O)
* DSD, Detrusor hyporeflexia / areflexia and bradykinesia / tremor of the external urethral sphincter
* Indwelling catheter or intermittent self-catheterization
* Patience with post-void residual (PVR) urinary volume \> 200 mL at baseline
* Urinary retention or clinically significant bladder outlet obstruction as detected by the investigator
* Clinically predominant and bothersome stress urinary incontinence
* Neurological diseases other than multiple sclerosis affecting urinary bladder function
* Any urogenital surgery within 12 month prior to Visit 1
* 17 Additional Exclusion Criteria
Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation

The current knowledge of the pathophysiology of allergic contact dermatitis is based on the murine model. In this model, CD8+ T cells are effector cells, and CD4+ T cells regulate the response by limiting the expansion of CD8+ T cells. The goal of this study is to characterize the pathophysiology of contact dermatitis, with patients allergic to para-phenylenediamine (PPD).

We suppose that the CD8+ T cells are the effectors of the allergic contact dermatitis, although the regulator cells belong to the LT CD4+ population. We will test our hypothesis on blood samples, and cutaneous biopsies of patients allergic to PPD.


Eligibility Criteria:
Inclusion Criteria:

For both groups:

* Patients aged from 18 to 65 years old.
* Both genders eligible for study.
* Female participants must use a contraceptive method.
* Feasibility of patch testing.
* Participants must be able to understand and sign the Informed Consent, and comply with all aspects of the protocol.
* Patients must be registered in a social security system or with a health insurance coverage

   First group: allergic patients
* Patients with allergic contact dermatitis to para-phenylenediamine (PPD) based on a history of PPD contact dermatitis and positive PPD patch tests.

   Second group : healthy volunteers
* No history of PPD allergic contact dermatitis, with a negative PPD patch test.

Exclusion Criteria:

* Pregnant or lactating women.
* Evolutive skin disease on the testing zone (lower back).
* Patients with a clinically significant disease (chronic, recurrent or active).
* Systemic corticotherapy or immunosuppressive treatment during the previous month, or local corticoid treatment the week before the patch testing.
* Local or systemic drug use which interacts with the outcome measures.
* Exposure to sun or UV radiations, 15 days before the patch testing.
* Patients deprived of their civic rights, in custody, or subject to a tutorial, judiciary or administrative decision.
* Patients subject to a protection measure.
* Patients in a critical medical situation.
* Patients with a personal situation judged by the investigator as unlikely to be compatible with optimal participation in the study, or which could constitute a risk for the patient.
* Linguistic barrier or psychological profile preventing the patient from signing the consent form.
* Patient still in an exclusion period following the participation in another clinical trial.
* Patients having earned more than 4500€ in indemnities for participation in clinical trials during the previous 12 months, including this study.
Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury

To investigate the renal protective effect of dexmedetomidine in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy

A cytoreductive surgery and hyperthermic intraperitoneal chemotherapy may lead to the renal hypoperfusion, systemic inflammatory response, and oxidative stress. Dexmedetomidine has been known to protect the kidney against inflammation and oxidative stress in diverse clinical settings. It may also enhance a renal perfusion by inhibition of renal sympathoexcitation. We hypothesized administration of dexmedetomidine might protect the kidney in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of malignant tumor with peritoneal metastasis
* Scheduled for elective cytoreduction and hyperthermic intraperitoneal chemotherapy

Exclusion Criteria:

* Preoperative chronic kidney disease stage ≥4 defined by KDOQI ( eGFR \< 30 mL/min/1.73m2)
* Congestive heart failure
* Atrioventricular block \> 1st degree
* Bradycardia \< 45 beat per minute
* History of myocardial infarction within 3 months
* Pregnancy
PET/CT Imaging in COVID-19 Patients

This is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is to evaluate this peptide in patients after infection with SARS CoV2.

The goal of the study is to to acquire 18F-αvβ6-BP PET/CT images in patients diagnosed with SARS CoV2 and to demonstrate the ability of 18F-αvβ6-BP to detect lung damage.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age ≥ 18 yrs
* Diagnosed with SARS CoV2
* Must have 2 sequential COVID negative tests prior to each scan
* Must have no previous lung disease prior to SARS CoV2 infection
* Lung image (Xray or CT) taken during infectious/ diagnosis period
* Will sign the IRB-approved consent form
* Able to remain motionless for up to 30-60 minutes per scan.

Exclusion Criteria:

* Life expectancy \<3 mo
* Women who are pregnant or breast-feeding
* Patients who cannot undergo PET/CT scanning because of weight limits(\>350lbs)
* Lack of availability for follow-up assessments
* Re-infection with SARS CoV2 between scan sessions
* Other active infectious respiratory illness
Improving Outcomes in Underserved Women With GDM

Our objective is to test an innovative approach to improve outcomes among underserved women with gestational diabetes. We ill utilize a multi-lingual, Interactive Voice Response (IVR) -enabled telephone system to facilitate diabetes control and thereby improve pregnancy outcomes. Our hypothesis is that Telemonitoring will improve maternal glycemia, thereby reducing infant birth weights and leading to improved pregnancy outcomes.

Using a step care design, women will be randomized into standard of care or Telemonitoring. In the standard of care group, women will monitor their blood glucose levels four times a day, perform fetal movement counting three times a day and also record insulin doses. The women will record this information in a logbook, which will be reviewed by the medical team at prenatal visits. In the Telemonitoring group, women will receive the standard of care anmd will also transmit their blood glucose and fetal movement information to their health care providers.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of GDM
* 33 or less weeks gestation

Exclusion Criteria:

* multiple gestations
* history of glucose intolerance outside of pregnancy
Study to Compare Reduction in Pain After Surgery With and Without Local Anesthesia During Laparoscopy

This study will help to answer the question, "Does injecting local anesthetic before laparoscopic instrument ports are placed decrease pain after surgery?" Patients participating will be randomly assigned to receive local anesthetic or saline injection at the site of a laparoscopic instrument port as part of their planned surgery. After surgery at 4 and 24 hours the patient will be asked to rate their pain on a simple chart.

The literature is divided on the efficacy of preincisional local analgesia injections at laparoscopic port sites to decrease post operative pain. One reason for this lack of a clear conclusion is the fact that prior studies included small and large port sizes. Many small port sites have little pain associated with them so showing a reduction with medicine is statistically difficult. The investigators have noted that larger, lateral port sites which require fascial closure are the sites that patients consistently note pain at. Our protocol will include the use of 0.25% marcaine injections at all the surgical ports other than the large lateral port used for gynecologic laparoscopy. Patients would then be randomized and surgeons would be blinded as to which patients receive the marcaine or a saline injection at the large lateral port site. Visual analog pain scales will be assessed at 4 and 24 hours after surgery. An additional two arms have been added to include 50 patients randomized to 0.25% marcaine or saline injection just prior to incisional closure in the absence of any preincisional intervention.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing laparoscopic surgery

Exclusion Criteria:

* Cardiovascular instability
* malignancies
* pulmonary conditions incompatible with laparoscopic surgery