cyrilzakka/clinical-trials huggingface dataset:
Telemedicine vs. Face-to-Face Cancer Genetic Counseling

Cancer genetic counseling (CGC) has been found to have "substantial" benefits for individuals with breast cancer and their family members; it has been deemed by multiple organizations as "standard of care" for women with breast cancer and their relatives. Unfortunately, there is a disparity in access to CGC, especially among women who live in rural and underserved areas. In North Carolina, only two cancer genetic counselors practice in rural clinics - each only for a few days per month. Therefore, in an effort to make CGC more widely available in a timely manner, we propose to test provision of counseling through telemedicine (TM), in which a patient and health care provider communicate with each other using videoconferencing. In 4 rural oncology clinics, we will implement low-cost TM and compare satisfaction and cost-effectiveness between groups of women designated to have their CGC session by TM or FTF. We'll use a validated measure to assess satisfaction by a phone survey one week after the CGC appointment; cost-effectiveness will be measured at project's end by calculating length of wait time for appointment and costs of equipment, labor, and mileage. Study hypothesis: TM is as satisfactory as FTF counseling and is a more cost-effective way to provide this beneficial service.


Eligibility Criteria:
Inclusion Criteria:

* Individuals referred for cancer genetic counseling (e.g., by medical oncologist, primary care physician or self) in one of 4 oncology clinics: Gibson Cancer Center in Lumberton, NC; Scotland Cancer Treatment Center in Laurinburg, NC; Johnston Cancer Center in Smithfield, NC; and Maria Parham Cancer Center in Henderson, NC.
* Willing to be randomized to receive counseling via telemedicine or face-to-face.

Exclusion Criteria:

* Referred for cancer genetic counseling from any clinic other than the 4 listed above.
* Unwilling to be randomized to receive counseling via telemedicine or face-to-face.
Investigation of the Effectiveness of CoronaVac Vaccine in Cancer Patients With Active Chemotherapy and Comparison With Healthy People.

This study aimed to investigate the effectiveness of CoronaVac vaccine, which is more than 90% protective in healthy people, in cancer patients receiving active chemotherapy. In this study, to collect information to measure the amount of antibodies produced by the vaccine in the blood of volunteers with the CoronoVac vaccine and to compare it with healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Group 1

  1. 18 years old and above
  2. Having completed two doses of CoronoVac vaccine on time
  3. Those with a pathological diagnosis of breast cancer or lung cancer
  4. Being the first dose of vaccine during active chemotherapy period
  5. Ecog performance score 0-1
  6. Patients who signed the informed voluntary consent form
* Group 2

  1. Over 18 years old
  2. Ecog performance score is 0-1
  3. Those who have completed 2 doses of coronovac vaccine within the recommended period
  4. Volunteer who signed the informed consent form

Exclusion Criteria:

* For all groups

  1. Being confirmed or suspected covid-19 before vaccination
  2. Symptomatic covid-19 infection
  3. Being addicted to alcohol or drugs
  4. Having a fever of 37.8 ° C as a suspect before vaccination
  5. Aspleni
Assessment and Monitoring of Patients in Medium-term Heart Transplant Candidates Undergoing Low-intensity Exercise

Objectives: To study the behavior and cardiovascular safety protocol to the front low-intensity exercise in patients with heart failure (HF) severe, awaiting heart transplantation. Methods: The investigators studied 21 patients with severe HF on the list for a heart transplant at the University Hospital of UNIFESP. After evaluation, patients underwent exercise protocol with six stages of exercise (1. upper limbs, 2. inferiors, 3. walk 35 m, 4. ½ flight of stairs, 5. walk 200 m 6. a flight of stairs) with intensity between 2-6 metabolic equivalents. These also were followed for an average period of 17 months as the clinical complications and death. Results: From the patients studied, three were not able to perform the full protocol, and the variables body mass index, maximal inspiratory and expiratory pressure measurement (Pimáx and Pemáx, cmH2O) and number of previous admissions, showed the most divergent behavior of the sample studied. A greater increase in heart rate, double product and scale of perceived exertion during step 5 was observed during the protocol. Blood pressure levels showed little change between stages, and there was no arrhythmias incidence increase (kappa = 0.552) compared to effort. A positive correlation scale was perceived in exertion walking distance of 200m, with systolic blood pressure (r = 0.4, p = 0.02). Overall observed lower values of maximal inspiratory pressure and increased blood pressure and elevated heart rate in patients with death outcome. Conclusion: Cardiovascular behavior against exercise protocol was well tolerated and safe, but suggests need for monitoring. Information collected at initial clinical evaluation associated with decompensation and death, and may help stratify these patients.


Eligibility Criteria:
Inclusion Criteria:

* heart failure severe, awaiting heart transplantation

Exclusion Criteria:

* decompensated heart failure
* vasoactive drugs
* unstable angina
* severe stenosis or insufficiency valvular
* recent surgery
* morbid obesity
Chidamide in Patients With Recurrent and Refractory Diffuse Large b

A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

This is a prospective, multicenter, observational investigator-initiated clinical study. The subjects were adults (18 years of age and older) diagnosed with relapsed/refractory diffuse large B-cell lymphoma who will begin cR2 therapy at the time of enrollment. Patients were required to complete a visit every 4 weeks, lasting 24 weeks from the first dosing of the study protocol. The first visit was considered an enrollment visit. The specific dosage of cR2 will be determined according to the standard clinical practice of the treating physician. Participation in the study did not affect treatment decisions. Patients who could not continue with the cR2 regimen would terminate the visit early and then withdraw from the study. According to the data collected from the experiment, the safety and effectiveness of the research scheme were analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
2. Age 18 and above, no gender limitation;
3. Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
4. Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion \> 1cm;
5. The serum pregnancy test of female subjects of childbearing age was negative;
6. Understand the test procedure and content, and sign the informed consent voluntarily.

Exclusion Criteria:

1. The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
2. Age 18 and above, no gender limitation;
3. Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
4. Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion \> 1cm;
5. The serum pregnancy test of female subjects of childbearing age was negative;
6. Understand the test procedure and content, and sign the informed consent voluntarily.
Evaluation of PSMA-PET and mpMRI in High-risk Prostate Cancer - Using Histopathologic Validation

In this trial the connection between image properties (mpMRI and PSMA-PET) and tissue properties (molecular and histopathology) will be investigated in order to improve diagnostics and image-based treatment guidance of prostate cancer.

Open, non-randomized, prospective multi-center trial, with consecutive recruiting, between Skåne University hospital and Umeå University Hospital.

High-risk prostate cancer patients referred for radical prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed prostate cancer planned to be treated with radical prostatectomy
2. PSMA-PET/CT conducted as part of the clinical management for the existing prostate cancer.
3. ≥4 weeks since last biopsy of the prostate
4. One or more of the following criteria

   1. cT3, or high suspicion of extra prostatic growth on mpMRI
   2. Gleason score ≥8
   3. PSA 20-49 ng/ml
5. \>18 years
6. Given a written consent to participate in the trial

Exclusion Criteria:

1. Non-MR-safe implants or another contraindication to MRI or PET
2. Claustrophobia
3. Unfit for MRI or PET/MRI examination for any other reason, e.g., back pain
4. WHO PS \>1
5. Patients treated with neoadjuvant/concomitant anti-testosterone treatment (surgical or medical castration or anti-androgens)
6. TUR-P within 6 months
7. Metastatic disease in skeleton, parenchymal organs, or lymph nodes outside the pelvis.
8. Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour.
9. Creatinine clearance \< 30ml/min (acc. to http://www.fass.se/LIF/produktfakta-/kreatinin.jsp)
10. Tinnitus or severe hearing loss
The Effect of Remifentanil on Established Capsaicin-Induced Hyperalgesia in Human Volunteers

Treatment of chronic pain is a major clinical challenge since chronic pain is frequent and leads to deterioration of quality of life. An injury or wound can lead to long term changes in the nervous system that make the skin more sensitive at and near the injury; this is termed hyperalgesia and occurs through long term depotentiation (LTP), i.e., a change in the synaptic interaction between neurons.

Opioids are the gold standard for the symptomatic therapy of moderate to severe pain. Now, in animal studies the investigators have discovered previously unrecognized effects of opioids.

Intradermal injection of capsaicin (injection of pepper extract into the skin) is an established pain model in humans. The investigators want to test the influence of remifentanil, an ultra-short acting opioid, on hyperalgesia observed after intradermal capsaicin in human volunteers in a double blind cross-over prospective active placebo controlled clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 15th and 85th percentile
* Normal findings in the medical history and physical examination
* Drug free for 1 week prior to the study day

Exclusion Criteria:

* Regular use of medication especially analgesics
* Abuse of alcoholic beverages, drug abuse
* History of asthma
* Participation in a clinical trial in the 2 weeks preceding the study
* Symptoms of a clinically relevant illness in the 2 weeks before the first study day
* Resting systolic blood pressure \> 135 mmHg or diastolic blood pressure \> 85 mmHg
* Acute skin diseases like sunburn on the relevant areas or skin lesions
* Pregnancy or breast feeding
Assessment of the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in the Serum of Infants and Toddlers, Following Administration of IPV (Inactivated Poliovirus Vaccine)-Containing Vaccines

This study aims to analyse the serologic response to PCV-1 in the PEDIARIX® \[GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine\] and KINRIX® (GSK Biologicals' Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) vaccine products. The samples have been collected at pre-determined time points from a subset of subjects who participated in selected studies \[217744/085 and 213503/048\] conducted in the United States.

Serum samples from the previously conducted clinical trials (217744/085 and 213503/048) are used in this study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects enrolled previously in randomized, open and multicentre studies \[217744/085; 213503/048\].
* Subjects aged 6 months to 6 years at last dose vaccinated with either DTaP-HepB-IPV vaccine or separately administered DTaP, HepB, and IPV vaccines or DTaP-IPV vaccine or separately administered DTaP and IPV vaccines.
* Subjects for whom sufficient residual volume of the pre and post vaccination blood samples is available.

Exclusion Criteria:

* Not Applicable
Inflammation and Cell Maturation in Preterm Delivery Placentas - in Vitro and in Vivo Effect of Progesterone

The aim of this study is to investigate the In Vitro and In Vivo effect of progesterone on immature myeloid cells (IMC), inflammation characteristics and maturation into dendritic cells (DC).


Eligibility Criteria:
Inclusion Criteria:

* Placentas from term and preterm deliveries
* Singleton pregnancy
* Consent to participate

Exclusion Criteria:

* Pregnancies with obstetric complications
* Multiple gestation
* Maternal illness or fetal malformation known pre-delivery
Prevention of Retinal Non-perfusion in Central Retinal Vein Occlusion by Hydroxycarbamide Treatment.

The central retinal vein occlusion (CRVO) is a major cause of ocular morbidity, depending in particular on the occurrence and extent of retinal ischemia by capillary occlusion. There is no effective systemic treatment of this condition. An increase in the adhesion of erythrocytes to vascular endothelium was observed for patients with CRVO, correlated with overexpression of membrane phosphatidylserine

introduction : The central retinal vein occlusion (CRVO) is a major cause of ocular morbidity, depending in particular on the occurrence and extent of retinal ischemia by capillary occlusion. There is no effective systemic treatment of this condition. An increase in the adhesion of erythrocytes to vascular endothelium was observed for patients with CRVO, correlated with overexpression of membrane phosphatidylserine.

Hypothesis : Hydroxycarbamide (HC) by reducing the erythrocyte adhesion to the endothelium may prevent or delay the onset of retinal capillary non-perfusion in patients with CRVO.

Primary objective: To assess the efficacy at 3 months of treatment with HC on retinal capillary perfusion in patients with a recent CRVO.

Secondary Objectives: To evaluate the safety of the treatment, the efficacy to 6 months on retinal perfusion of the treatment with HC (HC peak effect on the red cell adhesion in vitro), and the biological effects of HC, in particular on adhesion to endothelium and erythrocyte hemorheological parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes of at least 45 years of age.
* with social protection
* Presenting CRVO for less than 1 month duration
* With a decrease of visual acuity and with the best corrected visual acuity lower than 6/10 (73 ETDRS letters)
* Signature of informed consent

Exclusion Criteria:

* predictable lack of compliance to the protocol
* monophtalmic patient or any ocular history or condition that could interfere with the study course or results interpretation.
* active systemic disease
* sickle cell disease
* myeloproliferative disease
* myelosuppression
* kidney or liver insufficiency
* ongoing treatment with hydroxycarbamide or anticoagulant
* Pregnancy, breast-feeding, no efficient contraception (for both sexes)
* wish of paternity (for males of al least 45 years of age)
Smartphone App Impact on Oral Hygiene in Orthodontics

This study aimed to compare changes in gingival index (GI), plaque index (PI), and gingival bleeding index (GBI) values in fixed orthodontic patients. Participants were classified into two groups based on their oral hygiene: those using the Dentabuddy app for oral hygiene improvement and those receiving assistant-led toothbrushing training.

Will the use of the Dentabuddy application lead to differences in oral hygiene levels? Can adolescents effectively utilize the program? Participants will compare the effectiveness of the smartphone application with a group receiving traditional oral hygiene motivation.

Participants:

Will use the program according to the designated time intervals. Will attend their appointments regularly.

The Dentabuddy application is a free oral hygiene improvement tool available for download on the Google Play Store. This study will include 60 patients aged 12-18 years who have been undergoing fixed orthodontic treatment for at least six months. Patients will be classified into good, fair, and poor oral hygiene groups based on the Simplified Oral Hygiene Index (OHI-S), assessed by the second researcher. Using the Research Randomizer website, participants will be randomly assigned to either the Dentabuddy group or the assistant-supported training group.

Gingival Index (GI), Plaque Index (PI), and Gingival Bleeding Index (GBI) values will be recorded at baseline, after one month, and after three months. These data will be compared between groups. Additionally, at the end of three months, participants will be asked to demonstrate the brushing technique they were taught using a bracketed model. Those meeting specific criteria will be classified as having successfully demonstrated the brushing technique.

Eligibility Criteria:
Inclusion Criteria:

* no missing teeth,
* no systemic diseases or medications,
* complete permanent dentition,
* ability to maintain personal oral hygiene

Exclusion Criteria:

* dental treatment affecting oral hygiene
Aspergillus and Chronic Obstructive Pulmonary Disease Evolution

This is a prospective multicenter cohort study which includes all consecutive COPD patients who come for a visit in one the participating pneumologist. They will have to do a sputum and to complete some questionnaries. Questionnaries will be redone by phone after 1 and 3 months and during the visit after 6 months. We will correlate aspergillus presence in sputum with quality of life (QoL), and COPD symptoms evaluated by questionnaires.

Aspergillosis disease is a growing problem. These diseases are not yet uncommon in chronic obstructive pulmonary disease patients. (COPD).

Aspergillosis disease are very difficult to be diagnosed or treated. Isolation of aspergillus in sputum of patients is not always responsible of a real disease. Need of treatment is discussed. That is why, we will conduct a prospective cohort study to evaluate aspergillus rate in respiratory samples of COPD patients (GOLD stage III or IV)

Eligibility Criteria:
Inclusion Criteria:

* COPD patients GOLD stage III and IV

Exclusion Criteria:

* Cystic fibrosis
* Pulmonary fibrosis
* hematological malignancy
* known aspergilloma
* allergic bronchopulmonary aspergillosis
The Impact of Myasthenia Gravis in the Real World

An international, non-interventional, prospective, community recruited, longitudinal, lifestyle study which aims to collect Real-World Evidence (RWE) from people living with myasthenia gravis (MG) in order to map the disease's natural history, its burden on patients and their families, its treatment, as well as its medical, social and pharmacoeconomic impact.

Data was collected from people with MG using the MyRealWorld™ RWE platform , developed by the healthcare digital research company, Vitaccess. Participants downloaded a 'bring your own device' (BYOD) study app, MyRealWorld™ MG, onto their smartphones, which they used to enter data and complete surveys about their MG.

Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 18 years and over) with any stage and any subtype of myasthenia gravis disease
* Resident in Belgium, Canada, France, Germany, Italy, Japan, Spain, the UK, the USA, or Denmark

Exclusion Criteria:

* No specific exclusion criteria
Weaning is Winning? (WeWin Study)

We propose a multicenter prospective study on pediatric patients with intestinal failure (IF) who weaned off parenteral nutrition (PN).

Children with IF depend on PN. This is associated with frequent and various complications such as metabolic bone disease, micronutrient deficiencies and abnormal body composition. Due to advancements in care, many patients with IF are able to wean off PN; they are so called PN graduates. It is currently not well known how often complications do occur after weaning off PN, and which patients are at highest risk of developing these complications.

Eligibility Criteria:
Inclusion Criteria:

* Parenteral Nutrition graduates for at least 1 year, with a history of intestinal failure.
* Age \<18 years at time of inclusion.

Exclusion criteria:

* No consent provided.
Effects of Lumbar Repositioning Feedback and Transversus Abdominis Training on Lumbar Propricption in Patients With Chronic Mechanical Low Back Pain

This study is conducted to answer the following question: What is the effect of lumbar repositioning feedback and transverses abdominis training on lumbar proprioception in patients with chronic mechanical low back pain?

Chronic low back pain is a chronic pain syndrome in the lower back region, lasting for at least twelve weeks. Chronic low back pain represents the leading cause of disability worldwide and is a major welfare and economic problem. Low back pain represents a major social and economic problem. The prevalence of chronic low back pain is estimated to range from fifteen to forty-five percent in French healthcare workers. Low back pain symptoms can derive from many potential anatomic sources, such as nerve roots, muscle, fascial structures, bones, joints, intervertebral discs, and organs within the abdominal cavity. Moreover, symptoms can also spawn from aberrant neurological pain processing causing neuropathic low back pain. Low back pain has been associated with motor control dysfunction. Indicators of this dysfunction include decreased contraction of the transversus abdominis and multifidus muscles, the reduced cross-sectional area of the multifidus, and fat infiltration. An association of chronic low back pain with altered muscle recruitment patterns and transversus abdominis activation delay was also found, as well as increased back muscle fatigue and altered kinematic patterns in the hips and lumbar area.

This was further supported in two recent systematic reviews that reported that proprioception deficits were found in patients with chronic low back pain compared to healthy controls

Eligibility Criteria:
Inclusion Criteria:

* Patients with CMLBP referred from orthopedic surgeon with no radicular pain
* Their age is ranged between 35-55 years old (Martim etal.,2008)
* BMI 24-28 kg/m2

Exclusion Criteria:

* Patients who have a history of diabetic peripheral neuropathies
* Patients who have a history of sciatica
* Spinal or lower limb deformity or any pathology within the spine.
* Patients who have neurological disorders
* Patients who have a history of previous lumbar surgery
* Patients who have visual problems