cyrilzakka/clinical-trials huggingface dataset:
Single-center Prospective Evaluation of Sickle Cell Patient Care in the CHU Brugmann Emergency Department

Sickle Cell Disease is a serious disease that is life-threatening for patients being homozygous for the SS form or heterozygous for the SC or bthal forms. The CHU Brugmann hospital currently regularly treats about 70 homozygous adult patients and this number is in constant augmentation. The age average of the patients is below 30. The hospital developed a close collaboration with the Queen Fabiola Kids University Hospital to optimize the transition of young sickle cell patients from the pediatric to the adult network.

The emergency care of sickle cell patients remains a source of worry. Even with a correct treatment (Hydroxy-urea or exsanguineous transfusions), patients suffer from frequent sickle cell disease crisis when stress or infection cause hemolysis. The pain level is intolerable and causes emergency hospital admission (2 to 3 crisis per patient per year on average). The crisis are more frequent with poor compliance to the treatments.

There are several obstacles to the rapid and optimal management of these patients:

* fear of causing addiction to heavy pain releaf products (high dosis of morphine)
* lack of biological parameters for the determination of the crisis severity.

The prognostic value of the lactate dehydrogenase (LDH) level in a vaso-occlusive crisis was recently stressed while activation of the coagulation, translated by the elevation of various parameters including the rate of DD dimers, seemed associated with clinical complications. The deleterious role of increased oxidative stress has also been recently demonstrated in patients with sickle cell disease, opening new therapeutic avenues.

This study aims to prospectively evaluate the management of sickle cell patients being admitted in the emergency department for a vaso-occlusive crisis. The level of satisfaction of the patients will be measured.

The investigators will also evaluate the predictive value of several routine biological parameters regarding the severity of the crisis, including the values of nitrous albumin (PNA) as marker of oxydative stress. This last dosage will be made in collaboration with the team of Dr Wayenberg and Pr Bottari in Grenoble.


Eligibility Criteria:
Inclusion Criteria:

* Any sickle cell disease patient being admitted inside the Emergency Department of the Brugmann Hospital for a vaso-occlusive crisis, having signed the informed consent form and being able to fill in the analogic visual questionnaire (EVA).

Exclusion Criteria:

* Patients not being able to sign the informed consent form or fill in the analogic visual questionnaire (EVA)
Addition of Prednisolone and Heparin in Patients Undergoing IVF With Failed IVF Cycles

The addition of heparin and prednisolone increases pregnancy outcome parameters in women undergoing In Vitro Fertilisation (IVF) with failed IVF cycles.


Eligibility Criteria:
Inclusion Criteria:

* personal history of ≥2 failed IVF/ICSI cycles
* age \<45 years
* availability of fresh ejaculate sperm for IVF/ICSI procedures
* confirmation of normal uterine cavity
* presence of good quality (Grade I or II) embryos for transfer

Exclusion Criteria:

* endocrine disorders
* immune disorders
* coagulation disorders
Functional Respiratory Imaging and Orkambi in CF

Open-label study to investigate the effects of Orkambi in CF patients homozygous for the F508del mutation by functional respiratory imaging. Primary endpoints in this study are the changes in Specific airway volumes (siVaw) and Specific Airway resistance (siRaw). A total of 20 ORKAMBI-naive patients with Cystic Fibrosis, homozygous for the F508del mutation will be included in this open label study and will be followed through 3 months of treatment. The treatment will be started after all assessments are performed at visit 1. After the start of the treatment some baseline measurements will be repeated throughout the 3-month treatment period. The patient will be asked to visit the hospital monthly. All study visits should be scheduled around the same time.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of CF (homozygous for the F508del mutation must be present, this should be documented in the medical history).
* Age ≥ 12 years
* FEV1 \> 50%
* Signed informed consent. If patient is a minor, parents/guardians must give written informed consent
* Patient must be on a stable regimen of CF medication for 4 weeks prior to Visit

Exclusion Criteria:

* FEV1 \< 50%
* Anticipated requirement for hospitalization within the next three weeks
* History of pneumothorax within the past 6 months prior to Visit 1
* History of haemoptysis requiring embolization within the past 12 months prior to Visit 1
* Unable or unwilling to complete study visits or provide follow-up data as required per the study protocol
* Has taken Intravenous (IV) antibiotics within the past 4 weeks prior to Visit 1
* Has ongoing exacerbation or Allergic bronchopulmonary aspergillosis (ABPA)
* Pregnant or lactating female
* Posttransplant patients
* Patients with severe hepatic impairment
Long-Term Protection of Vi Antibodies Induced by Bio TCV in Indonesian Population Compared to PQed TCV

Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential. This research aims to determine the long-term immune response after administration of one dose of Bio TCV and PQed TCV vaccines in the population in Indonesia. Research participants will be taken from research participants who complete the Bio TCV (Typhoid 0319) Phase III clinical trial research included in the Main Study Group I.

Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential. Data mainly from Asia, Africa and Latin America show that typhoid fever continues to be a public health problem in many developing countries, with school-age children (aged 5-15 years) disproportionately affected. In some endemic areas, children aged \< 5 years show incidence rates similar to, or exceeding those, of school age children. WHO conservatively estimates the annual global incidence of typhoid fever at 21 million cases, of which 1-4% ends fatally. An estimated 90% of these deaths occur in Asia. Increasing multidrug resistance of S. typhi reduces the effective treatment options, increases treatment costs and results in higher rates of serious complications and deaths.

This research aims to determine the long-term immune response after administration of one dose of Bio TCV and PQed TCV vaccines in the population in Indonesia. Research participants will be taken from research participants who complete the Bio TCV (Typhoid 0319) Phase III clinical trial research included in the Main Study Group I. During the research, participants will make one (1) research visit to the health center for examination and blood sampling. After 5 years of being given the Typhoid vaccine, participants will be contacted by telephone to be given information about the research that will be conducted on you/your child. The research team will ask questions about the willingness to participate in the research. If they agree, a visit will be scheduled to the research site. This research is conducted by the Department of Pediatrics, Cipto Mangunkusumo Hospital, Jakarta, Dr. Soetomo Hospital, Surabaya and PT Bio Farma.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Subject/Parents/legal guardian(s) have been informed properly regarding the study and signed the informed consent form/and informed assent form.
* Subject/parents/legal guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

* History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
The Effect of Conscious Awareness Development Psychoeducation Program Prepared for Caregivers

This study aimed to increase the conscious awareness of caregivers and reduce work stress and compassion fatigue.

This study was planned in an experimental design with pre-test post-test follow-up measurements, experimental and control groups. The universe of the study consisted of care personnel working in institutions affiliated to the Provincial Directorate of Family, Labor and Social Services located in a city center in the east of Turkey. The sample calculation was made using the G-Power program (Experiment 14, Control 14). Since there may be omissions, the experimental group was determined as 20 participants and the control group as 20 participants. In this study, a nine-session training program will be applied to the experimental group. No application will be made to the control group. The conscious awareness development psychoeducation program will be applied once a week and for 90 minutes. Each session will be conducted in line with certain objectives. The sessions will be conducted by the investigator. Ethics committee approval was obtained before starting the study. Institutional permissions and written informed consent will be obtained for the participants. Informed consent will include information about the research and information that will ensure confidentiality.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age,
* Being actively working as a care worker in relevant institutions.

Exclusion Criteria:

* Having received similar training before
* Having been diagnosed with a mental illness
* Wanting to leave the study at any stage.
* Not having attended more than two sessions.
Emotion Regulation and Emotion Perception

The purpose of this study is to assess the impact of a brief, emotion regulation intervention on the ability to perceive other people's emotions.

Decision to close enrollment was made on January 2, 2020.

Eligibility Criteria:
Inclusion Criteria:

1. ages 18-55;
2. have a smartphone and agree to receive text-messages;
3. have difficulty with their relationships or social interactions;
4. high emotion dysregulation, assessed with the Difficulties with Emotion Regulation Scale (DERS)(Gratz \& Roemer, 2004) with scores over 90.

Exclusion Criteria:

1. Current mania;
2. Meets full criteria for any current psychotic disorder;
3. Currently/chronically homeless;
4. Current suicidal ideation;
5. Psychiatric hospitalization within past 6 months;
6. Unable to read, blind or deaf. Our previous study recruited only participants who were currently in treatment, but this study will include both participants who are currently in treatment, as well as those who are not in treatment.
7. high self-reported autistic traits, as assessed by the Autism Spectrum Quotient (Auyeung \& Baron-Cohen, 2012).
Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer

To explore whether there is a significant difference in the cumulative live birth rate and maternal and child health outcomes between cancer patients who undergo or do not undergo fertility preservation before receiving anti-tumor treatment and non-cancer patients who undergo assisted reproductive technology treatment/natural pregnancy.

This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study.

Statistical analysis of the data will be performed.

The number of new cancer cases among Chinese women in 2020 will be 2.09 million, showing a trend in younger age at the time of diagnosis. Incomplete statistics show that 25%\~30% of young breast cancer patients in China Need for fertility preservation. In this study, we want to answer the question: Does fertility preservation affect the prognosis in female cancer patients.

This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study.

If a female tumor patients (focusing on: breast cancer, hematological diseases/lymphoma, gynecological tumors (ovarian borderline tumors, etc.), nasopharyngeal cancer, colorectal cancer, etc.) have a desire to reproduce in the future, she would considered for enrollment. After being admitted into this study, according to the patients'own will, she will receive long term observation or fertility preservation followed by long term observation. Cumulative live birth rate, perinatal and perinatal complications, and offspring health of women who have or have not received fertility preservation before anti-tumor treatment and who have no tumor and who normally receive assisted reproductive technology treatment/natural pregnancy are all recorded, to assess the impact of the current new anti-tumor treatment on female fertility and offspring health.

Eligibility Criteria:
Inclusion Criteria:

1. Tumor confirmed (main focus: breast cancer, hematological disease/lymphoma, gynecological tumor (ovarian cancer), boundary tumors, nasopharyngeal cancer, colorectal cancer, and other tumors that require anti-tumor treatment;
2. Having a desire for future fertility(including women who have already given birth);
3. Age: 20-40 years old (patients planning to freeze their eggs are ≤35 years old, and those planning to freeze their embryos are ≤40 years old);
4. Consent.

Exclusion Criteria:

1. Patients with congenital or acquired uterine abnormalities, severe intrauterine adhesions, and other diseases that have a clear impact on pregnancy;
2. Those with assisted reproductive technology and pregnancy contraindications;
3. Tumors that are not suitable for pregnancy after multidisciplinary discussions on tumor fertility;
4. Clinical diagnosis of POI (premature ovarian insufficiency).
Hands on vs Hands Off for Perineal Laceration

Perineal trauma at the time of vaginal delivery is common, and when the anal sphincter is included, these injuries can be associated with additional morbidity including incontinence, pelvic pain and sexual dysfunction. Techniques studied include hands-on vs hands-off, perineal massage, warm compresses, Ritgen maneuver, and others. It is unclear if a hands-on technique decreases the incidence of perineal trauma compared to a hands-off technique

Different strategies have been adopted in the late first and/or second stage of labor to decrease the incidence of perineal lacerations. These strategies include not only the hands-on technique, but also warm compresses, perineal massage, the use of oil or jelly, the Ritgen maneuver and a new perineal protection device. The review by Aasheim reported a decreased risk of third- and fourth-degree lacerations in the perineal massage group (two studies, RR 0.52, 95% CI 0.29 to 0.94).4 This review also showed a similar reduction in third- and fourth-degree lacerations with warm compresses (two studies, RR 0.48, 95% CI 0.28 to 0.84), but no significant changes with use of a Ritgen maneuver. Additional reviews have evaluated delayed versus immediate pushing, with no significant difference in perineal trauma.

Regarding how the interventions may work, initially the hands-on technique was hypothesized to control the velocity of the crowning process and therefore decrease perineal trauma. Given the fact that the hands-on approach has been found to be possibly associated with more perineal lacerations instead of less, some have proposed that the harm may be caused by the hands-on approach's additional pressure resulting in some perineal ischemia. Moreover, using one intervention (e.g. hands-on) may predispose to use other interventions (e.g. episiotomy), which have themselves been proven to increase perineal trauma.

Perhaps a combination of perineal interventions, such as massage or compresses, with a hands-off approach and avoidance of episiotomy, will prove to show improved perineal outcomes. Larger studies, including evaluation specific for nulliparous subjects, are required to make definitive recommendations for management.

Eligibility Criteria:
Inclusion Criteria:

* Singleton gestations
* Low risk pregnancies
* 37 to 42 weeks of gestations

Exclusion Criteria:

* Multiple gestations
* Preterm birth
A Pilot Randomised Controlled Trial of a Health Champion Intervention

This study is a pilot RCT to evaluate the effectiveness and implementation challenges of an intervention using volunteer 'Health Champions' matched with service users to support service their physical health goals.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old with a serious mental illness (Mood \[affective\] disorders \[F30-F39\], Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders \[F20-F29\]).
* Currently with a Community Mental Health Team (CMHT).
* Want to make changes to their physical health.
* Has capacity to give written informed consent to take part in the project.
* Able to provide a named Care Coordinator or Point of Contact reachable in the event of a health crisis.

Exclusion Criteria:

* • Under 18 years of age

  * Unable to give informed consent
Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs

Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix in the treatment of venous ulcer of the lower limbs.


Eligibility Criteria:
Inclusion Criteria:

1. Signing of the informed consent (IC) after reading the patient information sheet.
2. Over 18 years of both sexes.
3. Active or recurrent venous ulcer in the lower extremity with an area between 5-10 cm2
4. Grade III injury on the Widmer scale.
5. Independence and/or availability to go to the referral center on an outpatient basis.
6. Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3

Exclusion Criteria:

1. Any pathology for which the investigator considers that compression bandaging is contraindicated and/or previous acute deep vein thrombosis (DVT), within the first 10 days from the onset of symptoms.
2. Grade III obesity with a body mass index (BMI) \>40; or underweight patients (BMI \<18.5).
3. Active neoplasia and/or being treated with cytostatics.
4. Patients undergoing radiotherapy treatment in areas close to the lesion.
5. Clinical signs of colonization or local infection of the lesion.
6. Patients with more than one lesion compatible with UV in the same lower limb.
7. Erysipelas.
8. Infectious cellulite.
9. Osteomyelitis.
10. Lymphangitis.
11. Chronic lymphedema.
12. Therapy with corticosteroids or immunosuppressants.
13. Venous ulcer grade I or II on the Widmer scale.
14. Lesions close to possible or diagnosed cancerous lesions.
15. Non-localized wounds in the lower extremities.
16. Ongoing infection and/or sepsis.
17. Critical ischemia in the lower limbs or other venous diseases of unknown origin.
18. Immunocompromised patients.
19. Dependent patients with severe mobility limitations.
20. Dialysis patients.
Diastolic Dysfunction During Conservative Lifestyle Treatment

The Purpose of this study is to 1) investigate prevalence of diastolic dysfunction in patients with morbid obesity attending a conservative lifestyle change program, 2) investigate effects on cardiac function, cardiorespiratory Fitness, body composition, quality of life and cardiovascular risk through the program, 3) investigate feasibility of introducing two different activity monitors throughout the program, and 4) comparing compliance to activity sensor market leader FitBit Application versus Mio Pai Application


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 40 kg/m2 (or BMI \> 35 kg/m2 with comorbidity)
* Stable weight last Three months (≤ 2 kg variation)
* Norwegian speaking
* Smartphone

Exclusion Criteria:

* Other weight reduction treatment, including medication affecting appetite
* Known chronic cardiac condition
* Previous bariatric surgery
* Alcohol or other substitute abuse
* Psychiatric disorder needing treatment, including eating disorders
* Pregnancy or planned pregnancy during project period
Bone Pain Score Validation Initiative

Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness.

Aim of this study is to translate the questionnaire and to examine the psychometric properties of BOMET-QoL-10 in a German population. Correlations with the EORTC QLQ-C30/BM22 at the time of enrolment and throughout the study aim to verify that the BOMET-QoL-10 is reliable, valid and able to detect stabilization or changes in quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults patients (≥ 18 years)
* Diagnosed cancer of the breast, kidney, lung or prostate
* Bone metastases
* Estimated life expectancy of at least 6 months
* Fluent German speaking, reading and writing
* Informed written consent

Exclusion Criteria:

* Patients without bone metastases
* Participation in another study involving questionnaires
* Patients not able to comply with the assessments specified in the protocol
Reducing Indoor Allergen Exposures in Northern Manhattan and the South Bronx

Controlled trial of an intervention to reduce indoor exposures to cockroach allergens among asthmatic children in NYC.


Eligibility Criteria:
Ages 6-18

Doctor-diagnosed asthma

Skin-test reactivity to cockroach antigen

Daily cockroach sitings in home