cyrilzakka/clinical-trials huggingface dataset:
Rare Group Problem Management Plus

Participants are being asked to be in the study if they are the parent or legal guardian of a child (\>1 year or \<18 years old) with a rare condition.

The group based psychoeducational intervention is called Rare Group Problem Management Plus.

Rare Group PM Plus may help adults with practical and emotional problems. It is a group program (there will be other men or women with similar problems) It happens once a week for 5 weeks (each session lasts 90 minutes)

Participants will complete assessments before they start Rare Group PM+. Participants will also complete the same assessments within a few weeks of completing Rare Group PM+. Assessments should only take one hour.

Study visits are by Telemedicine. Participants will need a smart phone or tablet. If they do not have a smart phone or tablet, the study team will help with this.

Participants will not receive any materials or money or medication.

Participants are being asked to be in the study because they are the parent or legal guardian of a child (infancy up to 21 years old) with a rare condition.

The group based psychoeducational intervention is called Rare Group Problem Management (PM) Plus intervention.

Rare Group PM Plus may help adults with practical and emotional problems It is a group program (there will be other men or women with similar problems) It happens once a week for 5 weeks (each session lasts 90 minutes)

Investigators will be recruiting for 3 groups of 10 families each, for a total of 30 families who will participate in this study from Children's National Hospital.

There are 7 study visits.

Study Timeline:

Study visit 1: Assessment-Before Group PM+ Study visit 2: Session 1-Managing Stress Study visit 3: Session 2-Managing Problems Study visit 4: Session 3-Get Going, Keep Doing Study visit 5: Session 4-Strengthening Social Support Study Visit 6: Session 5-Staying Well and Looking Forward Study Visit 7: Assessment within 2 weeks after complete Group PM+

Sessions will occur over Zoom Telehealth and facilitated by a licensed clinical psychologist and a genetic counselor trainee.

Investigators will use chi-square tests and Fisher's exact test to measure changes from baseline to 2 weeks post-intervention. Investigators will also collect qualitative data on what participants liked about the intervention, what they did not like, and what they think will improve the intervention.

Eligibility Criteria:
Inclusion Criteria:

* • Family caregiver aged 18 years or older of a child with a rare disease from infancy to age 21 years.

  * Understands and speaks English or Spanish. Reading or health literacy is not required.
  * Signed consent.
  * Signed waiver of assent for child.

Exclusion Criteria:

* Family caregiver is under the age of 18 years.
* Child with the rare disease is over the age of 21 years.
* Family caregiver is actively suicidal, homicidal, or psychotic.
* Family caregiver is impaired (cognitively or by drugs or alcohol).
* Family caregiver has a low level of distress.
Effect of Regorafenib on Digoxin and Rosuvastatin in Patients With Advanced Solid Malignant Tumors.

Evaluate the effect of regorafenib on the pharmacokinetics of digoxin (P-gp substrate : P-glycoprotein) and rosuvastatin (BCRP substrate: Breast cancer resistant protein) by comparing their Area under time curve (AUC(0-24)) and maximum drug concentration (Cmax) on Day -7 and Cycle 1 or Cycle 2 Day 15 of regorafenib in cancer patients


Eligibility Criteria:
* Inclusion Criteria:
* The following criteria apply to ALL patients starting the study treatment:

  * Patients with histologically confirmed, locally advanced or metastatic solid tumors refractory to standard therapy or in whom regorafenib is considered a standard treatment.
  * Male or Female Caucasian patients \>/= 18 years of age
  * Women of childbearing potential and men must agree to use adequate contraception before entering the program until at least 8 weeks after the last study drug administration.
  * Life expectancy of at leat 12 weeks
  * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  * Adequate bone marrow and liver function
  * Estimated creatinine clearance (CLcr) ≥ 30 mL/min as calculated using the Cockroft-Gault (C-G) equation.
  * Thyroid Stimulating Hormone(TSH) within normal ranges.
* The following inclusion criteria apply to Group A (digoxin + regorafenib) patients ONLY:

  * Potassium, magnesium and calcium blood levels within normal range according to the local laboratory.
* The following inclusion criteria apply to Group B (rosuvastatin + regorafenib) patients ONLY:

  * Signed genetic informed consent. Patients must be able to understand and willing to sign the written informed consent intended to screen for BCRP and OATP1B1 polymorphisms.
* Exclusion Criteria:
* For ALL patients
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.
* Non-healing wound, skin ulcer, or bone fracture.
* Ongoing or active infection.
* Other anticancer treatment.
* Patients unable to swallow oral medications
* For Group A (digoxin + regorafenib):

  * Family history of sudden cardiac death.
* For Group B (rosuvastatin + regorafenib):

  * Patients with porphyria.
  * Patients with intestinal or urinary obstructions.
Physical Activity Levels of Parents of Children With Cystic Fibrosis- (PHACTS-CF)

This study will investigate if parental physical activity levels, assessed by providing a physical activity questionnaire to parents of children aged 6-16 with Cystic Fibrosis (CF), is associated with their child with CF's physical activity levels. Children's activity levels will be taken from electronic records where a questionnaire is routinely given at annual reviews to analyse this. Parental activity levels will also be compared against adherence to nebulisers as a proxy for adherence to treatment, this data is again in the electronic records of patients and is collected at annual reviews.


Eligibility Criteria:
Inclusion Criteria:

1. Parents of Children aged 5-16 years.
2. Under the care of Cambridge University Hospitals CF team
3. Confirmed Cystic Fibrosis diagnosis
4. Uses an ineb as main nebulizer delivery device.
5. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1. Parents of CYP diagnosed with a CF screen positive inconclusive diagnosis (SPID).
2. If not yet doing lung function.
3. If has any other self-identified physical disability which may limit physical activity.
Debunking Myths About Contraceptive Safety Among Women in Kingston, Jamaica

The primary hypothesis is that the intervention video - based on strategies from cognitive psychology - can correct women's misinformation about long-acting reversible contraception (LARC) and result in higher use of LARC. While there are no direct benefits to participants from being in the study, the research could benefit women in general by providing evidence to help prevent unintended pregnancy. Unlike many interventions that are not feasible for scaling up once shown to be effective in changing people's behavior, the proposed intervention has been carefully designed to impose a low burden to clinic staff and require few resources for translating to wider use. Thus, the investigators expect the intervention to have high potential for influencing clinical care and research for addressing the overall goal of reducing unintended pregnancy.

The investigators will conduct a randomized trial (RT) of consenting adult women (N=220) to test the effectiveness of the final intervention video.

Participants in the RT will complete the "Enrollment Questionnaire" and then will be randomized to either watch a short video on 1) debiasing about LARC safety (intervention arm; n=110) or 2) vector control (control arm; n=110) (Figure 2). Participants then will have the option of receiving routine contraceptive services that follow standard care. After three months, trained interviewers will contact participants to administer the short "Follow-up Questionnaire" via telephone. To corroborate participant reporting of contraception use during follow-up, the investigators also will extract data on LARC use from participant medical records.

Eligibility Criteria:
Inclusion Criteria:

* present at the Comprehensive Health Centre;
* 18-25 years of age; and
* sexually active (defined as ≥1 penile-vaginal act in past month);

Exclusion Criteria:

* known to be pregnant;
* sterilized;
* breastfeeding;
* currently using the IUD or implant; or
* want pregnancy in the next 12 months
Digital Data in Mental Health Therapy

The Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment intends to better understand how digital data, social media, and electronic communication can be used in mental health therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Between 18-65 years of age
2. Primarily English speaking (for language analysis)
3. Willing to share at least one digital data source this includes Facebook, Google searches, YouTube searches, or screen time by downloading a free application (app) on their smartphone.
4. Regular activity viewing and posting on social media sites, defined as once a month posting
5. Has a mental or behavioral health provider and/or has a provider from the Philadelphia Society of Clinical Psychologists and currently enrolled in mental or behavioral therapy
6. Attends therapy at least once a month and intends to remain in therapy for the next three months
7. Willing to share dashboard with their behavioral health provider
8. Able to provide informed consent
9. Owns a smartphone
10. If the patient downloads an app, they are willing to download and keep an app on their phone for 3 months

Exclusion Criteria:

1. Under 18 years of age
2. Non-English speaker
3. Patient is in severe distress, e.g. respiratory, physical, or emotional distress
4. Patient is intoxicated, unconscious, or unable to appropriately respond to questions
5. Not currently enrolled in mental therapy
6. Not expected to remain in mental therapy for the next three months
7. Not a regular social media poster, or does not use Facebook and/or Instagram and/or not willing to share
8. Unwilling to share social media summary dashboard with behavioral health provider
9. Patient with diagnosed psychosis
10. Does not own a smartphone
11. Unwilling to download and keep an app on their phone for 3 months
Capnography During ERCP

In the study the value of capnography for avoiding complications during sedation for ERCP is evaluated.

In this randomized controlled trial the utility of capnography gets evaluated. Hypoxemia may occur during sedation with midazolam and propofol. Whether hypoxemia may be prevented by an additional capnographic monitoring is subject of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age\>=18
* Scheduled for colonoscopy with midazolam and propofol sedation

Exclusion Criteria:

* No informed consent
* ASA V
* Pregnancy
* Prexisting hypotension, bradycardia or hypoxemia
A Study on the Angioarchitecture of Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is one of the commonest solid malignancies in Hong Kong as well as globally. Transarterial therapy has been playing an important role in the treatment algorithm for patients with HCC. The primary purpose of transarterial therapy is eradication of the viability of the targeted tumors. The treatment outcomes have been variable among the various treatments, in general, there is still much room for improvement, especially for large size tumors. From the studies on Transarterial chemoembolization (TACE), it is known that the treatment outcome is affected by the nature and the formulation of therapeutic agents that are delivered, which is related to the angioarchitecture of the tumor. Knowledge on the angioarchitecture of HCC is essential for the understanding of the requirements for effective transarterial treatment of HCC. This prospective study is aimed to study the angioarchitecture of HCC.

Embolization is performed within 2 weeks before the scheduled date of partial hepatectomy. The purpose of the timing is two folded, it allows observation of the embolization effect to be differentiated among the various embolic agents, it also allows time for the patient and the liver to recover from the embolization.

The patient then receives partial hepatectomy within 2 weeks unless the result of liver function tests shows contraindication to surgery, in which case the liver function test is further evaluated on a weekly basis until the findings are acceptable, and surgery is scheduled accordingly.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years
2. HCC suitable for partial hepatectomy
3. Child-Pugh A or B cirrhosis
4. Eastern Cooperative Oncology Group performance score 0 or 1
5. Barcelona clinic liver cancer (BCLC) staging A or B
6. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology
7. Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions)

Exclusion Criteria:

1. Previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
2. Evidence of tumor invasion of portal vein or hepatic vein
3. History of acute tumor rupture presenting with hemo-peritoneum
4. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
5. Serum creatinine level \> 150umol/L
Lenalidomide Observational Study in Patients With Mantle Lymphoma in Relapse/Refraction. Spanish Programme RRMCL Results.

This is a multicentric, observational and retrospective study of the use of lenalidomide in patients with relapsed or refractory mantle cell lymphoma that are included in the RRMCL spanish program.

The lenalidomide effectiveness and tolerability data will be retrospectely collected until the 30 of April 2018.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old.
* Diagnosed with relapsed or refractory mantle cell lymphoma verified by a tissue biopsy.
* Treated with monotherapy or combination of lenalidomide.
* Not candidate for any of the therapeutic options approved until that date for this disease.
* Not candidate or unable to be included in any clinical trial due to availability or geographical difficulty.
* Registered in the RRMCL spanish program.

Exclusion Criteria:

* ECOG \> 2.
* Patients with uncontrolled comorbidities.
* Blastoid variant.
* Central nervous system tumor infiltration.
* HIV, HBV and/or HCV active infection.
* Radiotherapy concomitant treatment or that have received radiotherapy in the previous 30 days to the beginning of the first cycle of lenalidomide.
* Diagnosed with other active solid tumor except for basal cell carcinoma skin cancer.
* Patients that haven´t completed at least one complete cycle of the treatment.
Use of a New Method for the Microbiological Diagnosis of Severe Corneal Infection

Microbial keratitis is a severe and often blindness-inducing pathology which represents today the first reason for long-term hospitalization (more than 5 days) in ophthalmology. Its diagnosis is clinical and leads to an immediate hospitalization in the presence of serious criteria (Mackie classification). The entire process of microbiological diagnosis requires several days before etiological confirmation and therefore delays the initiation of targeted therapy.

Recently, new PCR systems allowing the detection of 18 to 27 pathogens in 75 minutes have been developed. Their use could thus be transposed to ophthalmology by adapting the microbiological diagnostic technique to samples currently taken by swabbing the cornea.

The investigators will compare their diagnosis performance versus conventional methods on patients who suffered for a microbial keratitis with severity criteria.

46 patients enrolled for severe infectious keratitis will be recruited in the department of Ophthalmology, Robert Debré Hospital, Reims, France. The study will be composed by 2 groups. The first, also called "before group" will contain 23 patients who were anteriorly hospitalized for a severe infectious keratitis in our hospital unit. They received standard microbiological diagnosis methods: Direct microscopic examination with Gram stain, bacterial and fungal cultures, viral and amoebic polymerase chain reaction \[PCR\]).

The second, also called "after group" will enroll patients who suffer for a severe infectious keratitis (prospective group). Each patient will benefit a complete ophthalmologic examination, corneal scrapping and swabbing for standard microbiological diagnosis methods along with another corneal swabbing sample for the use of two different FilmArray® PCR systems identified as "ME" for Meningitis-Encephalitis and "BCID" for Blood Culture Identification.

The investigators hypothesize that the use of rapid multiplex PCR tests for the microbiological diagnosis of severe corneal infections could in the future prove to be more efficient than the current diagnostic strategy, on the one hand, by shortening the time to identify the pathogen and therefore to implement a targeted treatment, and on the other hand, by systematically searching for a large number of pathogens well beyond those targeted today. In addition, the benefits of this technique applied to ophthalmology could improve the long-term visual prognosis, reduce the length of hospitalization and therefore the diagnostic and management costs of these patients.

Eligibility Criteria:
Inclusion criteria:

* Over 18 years old
* With social security affiliation
* Willing to participate this study
* Hospitalized in our department for severe infectious keratitis

Non-inclusion criteria:

* Any prior (48 hours) or concomitant treatment with local or systemic antibiotherapy at time of corneal scrapping and swabbing
* Patient not covered by the French Health Insurance
* Unable to give informed consent
Activity Modeling in Birth Room

At this time, two methods exist to calculate a pregnant woman's presumed delivery date (DPA) : one adds 280 days to last menstruation date (Naegele rule), other estimates early pregnancy's date by imagery and adds 270 days. Unless pathology requires a trigger, this DPA estimated a early pregnancy is not re-estimated. These methods are simple and arbitrary : Mongelli and al. in 1996 found that out of nearly 40 000 unique pregnancies, only 4% give birth at determined DPA by echography and 70% at more or less 5 days. Jukic and al. in 2013 they estimate a natural variation of 37 days between pregnancy durations. Face of these poor performances, the calculating DPA method seems to be open to improvement.

Thus, the DPA calculation formula does not take into account the individual patients characteristics (age, occupation, antecedents ...), nor the follow-up data collected during pregnancy. Jukic and al. in 2013 propose a first model with some individual characteristics and medical measures (period between ovulation and early pregnancy, hormone peak) to refine the estimation. Their study gives promising results but their small patients number (a hundred) does not allow them to detect all interactions. Moreover, their method calculation is not dynamic, i.e it does not refine the DPA as pregnancy progresses. To our knowledge, no studies developing an evolutionary model over time for the DPA exist. However, objectives of a more accurate estimate of expected date are multiple and important. The investigators will mention here the two main ones :

* A better understanding of mecanisms leading to early labour or abnormally long gestation in order to anticipate patients at risk
* A better material and human needs anticipation, allowing a more efficient organization more adapted to activity and a care of each parturient in optimal conditions.

Our study will focus on predictive model elaboration of pregnancy duration that will evolve as the pregnancy progresses and new data collected. The investigators are considering a machine learning methodology by patient's medical record computerization at the Groupe Hospitalier Paris Saint-Joseph (GHPSJ) since early 2016. Thus, for patients who gave birth from end of 2016, the investigators have a large amount of information on their pregnancy and follow-up on hospital servers, which motivates an automatic approach based on massive data analysis.

This study thus intends to implement advanced techniques in Machine Learning (Online Learning, Support Vector Machine ...) to advance a powerful calculation model.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 18 years old
* Patient who gave birth at GHPSJ maternity between 01/01/2017 and 02/28/2018

Exclusion Criteria:

* Patient who expressed her opposition to participate in the study
* Patient under guardianship or curatorship (unless consent is provided)
* Patient who gave birth at less than 32 weeks amenorrhea
* Pregnancy marked by MFIU (fetal death in utero)
Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study

A0081256 is a prospective, open-label, multi-centre European study designed to raise awareness and enhance the diagnosis of patients with chronic low back pain with a neuropathic pain component in primary care who are refractory to standard analgesic therapy and/or one treatment for neuropathic pain and evaluate the effectiveness and tolerability of pregabalin in this population. The impact of pregabalin on analgesia, patient satisfaction with treatment, patient anxiety and depression, sleep interference, physical functioning and work productivity will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have low back pain with a neuropathic pain component between 3 months and 12 months duration prior to entering the study.
* Patients must have a score of at least 19 on the PainDetect questionnaire and at least 4 on the Standardized Evaluation of Pain (StEP) scale at screening.
* Patients must have a mean pain numerical rating scale (NRS) score of 4 or more during the one week screening period.
* Patients must have failed to respond to standard analgesic therapy (e.g. non-steroidal anti-inflammatory drugs \[NSAIDs\]) and/or one treatment for neuropathic pain (e.g. tricyclics, serotonin-norepinephrine re-uptake inhibitors \[SNRIs\]) prior to entering the study).

Exclusion Criteria:

* A diagnosis of depression or a Hospital Anxiety and Depression Scale (HADS) score of \> 15 on the depression sub-scale only.
* Patients with a history of renal impairment or who have reduced renal function at baseline (Creatinine Clearance \< 60 mL/min).
* Patients who have previously taken pregabalin or gabapentin within 6 months prior to entering the study.
* Patients who have undergone previous surgery for back pain.
* Patients who are using high doses of opioid medication (morphine \> 60 mg per day).