louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00752778: Magnetic Resonance Imaging (MRI) Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri
Official title: MRI Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: MRI, PET scan
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2008-09-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the diagnosis value of MRI and positon emission tomography (PET) scan for studying macrophagic infiltration and other brain modification in multiple sclerosis (MS) patients treated with Natalizumab (Tysabri).


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with MS
* Treatment with Tysabri planned

Exclusion Criteria:

* Allergy to Tysabri or MRI contrast products
* Pregnancy

Primary outcomes:
measure: Number of enhanced lesions on MRI before and after treatment. PET scan modification in brain (in enhanced lesions and in the whole brain).
timeFrame: At baseline and after 3 months of treatment.
Secondary outcomes:
measure: Correlation with relapses.
timeFrame: During the 3 months of treatment and the 3 following months.
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Neurologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Service de Médecine Nucléaire, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
city: Strasbourg
country: France
facility: Service de Radiologie 2, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Jérôme DE SEZE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02886078: Dorsal Versus Volar Approach for CapFlex-PIP© Implantation
Official title: Dorsal Versus Volar Approach for CapFlex-PIP© Implantation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach.

This is a randomized controlled trial including 70 patients with PIP OA indicated for CapFlex arthroplasty.

Detailed description: The CapFlex-PIP© implant is a modular gliding surface proximal interphalangeal (PIP) joint prosthesis. For implantation, there are two approaches available: The dorsal central split approach according to Swanson and the volar approach described by Simmen.

Our experiences and data from our prospective registry indicate, that the active extension of the PIP joint is better after the dorsal approach, but sometimes related with hyperextension of the PIP joint and secondary swan-neck deformity. Extension is supposed to be better after the volar approach, but associated with active and passive extension lag. Evidence of theses experiences will assist the surgeon in the preoperative planning to select the appropriate approach according to the patient's needs.

The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach.

This is a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Indication for CapFlex-PIP© arthroplasty
* Patient aged 18 years and over
* Informed Consent as documented by signature

Exclusion Criteria:

* Revision surgery
* CapFlex-PIP© arthroplasty at the thumb IP joint
* Major surgery at the same finger (e.g. DIP arthrodesis)
* Ulnar/radial deviation of the PIP joint \> 15°
* Patients in which a reconstruction of the collateral ligaments has to be performed
* General medical contraindication to surgery
* German language barrier to complete the questionnaires
* Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
* Pregnancy
* Surgery not planned by Dr. Herren, Dr. Schindele or Dr. Bodmer
* Legal incompetence

Primary outcomes:
measure: Active extension of the PIP joint measured with a goniometer
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Subjective function using the Brief Michigan Hand Questionnaire (briefMHQ)
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Schulthess Klinik
Study officials:
References:
Clinical trial NCT03480178: Renal Anemia Refractory to Erythropoietin
Official title: Renal Anemia Refractory to Erythropoietin
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ESRD
Renal Anemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. The investigators choose 50 uraemic patients on hemodialysis randomly and receiving Epo.among those admitted to nephrology ward and out Patient clinic of the department of internal medicine of Assiut University Hospital.
2. Follow up of patients for 6 months with CBC every month.
3. Searching for number of patients among this 50 who have failure to correct the anemia with Epo. (100IU /Kg / week- SC ) For target HB 11 gm.
4. Effect of bleeding, infection and malnutrition.
5. Scaring for the possible underling cause of anemia refractory to Epo. Clinically, laboratory at the end of study period.

Brief summary: This study evaluates the renal anemia refractory to Epo . in hemodialysis patients. all of participants will receive Epo. and identify various factors contributing to etiology of renal anemia in Epo- resistant patients.

Detailed description: Chronic kidney disease (CKD) is considered a public health problem worldwide with high incidence and prevalence rates.Anemia is one of the most frequent early complication of CKD. The main cause is erythropoietin (EPO) deficiency due to impaired kidney function However, other causes should be considered when the severity of anemia is inconsistent with the decrease in renal function; when there is evidence of iron deficiency or matching decreases in hemoglobin, leukopenia and/or thrombocytopenia are also found

Eligibility criteria: Inclusion Criteria:

* Patients greater than or equal to 18 years old with CKD on hemodialysis

Exclusion Criteria:

1. - Evidence of infections especial of vascular access .
2. - malnutrition and manifestation of iron, B12, folate and protein deficiency .
3. - any underling cause as;

   * Hematologic malignances -Hemolytic anemia -
   * Aplastic anemia (infection and/or bleeding with anemia)
   * Solid tumors
   * Bleeding (skin ,mucosal ,orificial)
   * Evidence of mineral bone disease (CKD-MBD)
   * Others

Primary outcomes:
measure: Renal anemia refractory to erythropoietin
timeFrame: 1 months
Secondary outcomes:
measure: Renal anemia refractory to erythropoietin
timeFrame: 6MONTHS
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07023978: on General Well-being, Anxiety, and Physical Activity in Pregnant Women
Official title: Effects of Qigong on General Well-being, Anxiety, and Physical Activity in Pregnant Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 60 pregnant women will be randomly divided into 2 groups. Participants in the control group will be given pregnancy counseling that includes only nutrition, walking (3 days a week for 30 minutes), and breathing exercises, and will be called for 1st, 2nd and 3rd month check-ups. In addition to pregnancy counseling, the Qigong group will receive 2 Qigong training sessions, one via Zoom and one face-to-face, and then the training videos of each exercise will be sent via WhatsApp. Paricipants will be asked to do the Qigong exercises at home for 30 minutes, 3 days a week for 12 weeks. These participants will be called for 1-month, 2-month and 3-month check-ups. Blood pressure and sugar measurements will be recorded at the first visit, 1st month, 2nd month and 3rd month check-ups, and patients will also be evaluated with the Pregnancy Physical Activity Questionnaire, Pregnancy Stress Assessment Scale, Pregnancy-related Anxiety Scale, Pregnancy Exercise Self-Efficacy Questionnaire. After the recruitment period the results will be evaluated statistically.


Eligibility criteria: Inclusion Criteria:

* Pregnant women between the ages of 18-40 who have a new pregnancy detected by USG
* Pregnant women whose pregnancy week is compatible with fetal development, who do not have any problems and who will not have any problems exercising

Exclusion Criteria:

* Those with risky pregnancies (cervical dilation, bleeding, premature membrane rupture, etc.) \*\&lt;18 and \&gt;40 years old pregnant women

  * Those with cardiovascular disease or hypertension
  * Those with uncontrolled diabetes
  * Those with uncontrolled thyroid disease
  * Those with a previous risky pregnancy or a complication
  * Those with an operation, metabolic bone disease or joint limitation that will prevent them from exercising
  * Those who are included in another pregnancy counseling or physical activity program
  * Those who do not give their consent for the study, do not come to regular pregnancy check-ups or have incomplete information will be excluded from the study.

Primary outcomes:
measure: Blood Glucose Values
timeFrame: 2 minutes
measure: Pregnancy Physical Activity Questionnaire,
timeFrame: 10 minutes
measure: blood pressure value
timeFrame: 2 minutes
Secondary outcomes:
measure: The 30-item Pregnancy Stress Rating Scale (PSRS)
timeFrame: 10 minutes
measure: Pregnancy-related anxiety scale
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Home adress of the principal investigator
Study officials:
References:
Clinical trial NCT05496478: Assesment of Complications and Surgery Timing in Postcovid Thoracotomy Patients: Single Center Experience
Official title: Assesment of Complications and Surgery Timing in Postcovid Thoracotomy Patients: Single Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracotomy
Keywords: Thoracotomy
covid infection
complication
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: post-covid patients undergoing thoracotomy

Brief summary: Covid-19 infection has caused delay in many surgeries. Besides Covid -19 infection may be a potential problem in especially major surgeries such as thoracotomies. Surgery timing, complications, intensive care unit stay and vaccination status are important issues that should be learned from post-covid cases.The aim of the study is to learn lessons from post-covid thoracotomy cases.

Detailed description: Patients who had covid-19 infection before thoracotomy were assessed by their datas, Postoperative complications, intensive care unit stay, vaccine status, time period between covid infection and surgery were collected from patients' files and statistical analysis performed.

Eligibility criteria: Inclusion Criteria:

* undergoing thoracotomy
* had covid infection before surgery

Exclusion Criteria:

* age under 18
* missing data

Primary outcomes:
measure: number of patients who had postoperative complication
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
state: Cankaya
Study officials:
affiliation: Ankara University
name: CIGDEM YILDIRIM GUCLU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06682078: Disorders of Sexual Development and Gonadal Tumor Risk
Official title: DEV-GEN-RiTuGo - Assessment of Individual Gonadal Tumor Risk in Patients With Disorders of Sexual Developpment According to the Etiology.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorders of Sexual Development
Keywords: surgery
pediatrics
Urology
Endocrinology
Gonadoblastoma
Dysgerminoma
neoplasms
gonadal tissue
sexual development
oncology
gonadal dysgenesis
androgen-insensitivity syndrome
testicular regression syndrome
anti-mullerian hormone
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent gonadectomy for Disorders of Sexual Development between 1990 and 2022, followed by Dr. Daniela Gorduza in the Pediatric Uro-Visceral Surgery Department of the hospital Femme-Mère-Enfant.

Brief summary: Disorders of Sexual Development are rare and represent a spectrum of heterogeneous pathologies. The risk of developing a malignant gonadal germ cell tumor (MGCT) exists and varies according to the etiology.

The indication for prophylactic gonadectomy must be modulated and discussed for all patients. It is essential to assess each patient's individual risk.

The aim of our study is to assess gonadal tumor risk in patients with Disorders of Sexual Development according to etiology

The primary objective is to evaluate tumor risk and the indication for gonadectomy in cases of Disorders of Sexual Development according to etiology.

The secondary objectives are to evaluate the timing of gonadectomy, to monitor changes in practice over time, and to assess the contribution of imaging and/or biological tests to tumor detection.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent gonadectomy for variation in genital development between 1990 and 2022.
* Pathological anatomy examination in Lyon
* With clinical data
* With karyotype
* 3 categories:

  * with genetic diagnosis
  * without genetic diagnosis because searched but not found
  * without genetic diagnosis because not searched

Exclusion Criteria:

* Biopsies without gonadectomy
* Fetus
* Operated outside the period 1990-2022
* Lack of clinical data
* No karyotype

Primary outcomes:
measure: Presence or absence of gonadal tumor lesion after gonadectomy, in case of Disorders of sexual development (DSD) according to anatomo-pathological analysis.
timeFrame: The outcome measure will be assessed and the datas reported for each patient will be collected, from birth until the study completion date, or by default until the date of death from any cause. Datas will be collected during the 10 months of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Chirurgie uro-viscérale pédiatrique
Study officials:
References:
Clinical trial NCT03247478: Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure
Official title: Computed Tomography (CT) Reconstruction for Axillary Lymph Node Structure: a Prospective Observational Study Evaluating Response in Axillary Lymph Nodes of Breast Cancer After Neoadjuvant Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Breast Cancer
Keywords: Computed tomography (CT) reconstruction
axillary lymph node status
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 160
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Invasive breast cancer with axillary lymph node metastasis: stage N1-2.

Brief summary: This is a prospective, single-center, non-randomized, non-controlled observational study.

Detailed description: The negative predictive value of ultrasound for lymph node with neoadjuvant chemotherapy is low, magnetic resonance imaging (MRI) or PET/CT did not significantly improve specificity to axillary lymph node. The aim of this study is to determine performance of computed tomography (CT) reconstruction on evaluation of lymph node status after neoadjuvant chemotherapy in breast cancer patients.

Eligibility criteria: Inclusion Criteria:

* Invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB).
* Underwent computed tomography (CT) reconstruction for assessment of axillary lymph node status before and after neoadjuvant chemotherapy (NAC).
* Attend the study voluntarily, sign the informed consent.

Exclusion Criteria:

* Contradiction for adjuvant chemotherapy.
* Contradiction for proceeding surgery.

Primary outcomes:
measure: Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy.
timeFrame: within 6 weeks after obtaining the post-surgery pathological results
Secondary outcomes:
measure: Rreceiver operating characteristic (ROC) curve analysis
timeFrame: within 6 weeks after obtaining the post-surgery pathological results
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Li-ze Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04765878: RespirAq Humidifier Usability During Invasive Ventilation
Official title: RespirAq Humidification During Post-operative Invasive Mechanical Ventilation in Scheduled Cardiothoracic Surgical Patients: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Ventilation
Lead sponsor: Auckland University of Technology
Sponsor class: OTHER
Collaborators: name: Ministry of Business, Innovation and Employment
name: Waikato District Health Board
First posted: 2021-02-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to capture preliminary safety and effectiveness information on a near-final humidifier device design and to provide data for more extensive research, if required. This feasibility study will investigate the following: process, resources, management, and scientific aspects of delivering humidification by the RespirAq humidifier device in ventilated patients.


Eligibility criteria: Inclusion Criteria:

Patients scheduled for coronary artery bypass surgery (CABG) will be recruited before their surgical procedure at the Waikato district health board during February, March, and April of 2021.

Exclusion Criteria:

* Age \<18 years
* Have any other condition which, at the investigator's discretion, is believed may present a safety risk or impact the feasibility of the study or the study results
* Patients admitted for emergency CABG surgery
* Unable to provide written informed consent before surgery
* Patients who would be contra-indicated to HME humidification devices

Primary outcomes:
measure: Temperature
timeFrame: max 24 hours
measure: Humidity
timeFrame: max 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Auckland University of Technology
name: Melanie Moylan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04452578: Hepatitis C Virus (HVC) Positive Heart Grafts in HCV Negative Recipients
Official title: Pilot Investigation Using HCV Positive Heart Grafts in HCV Negative or Previously Successfully Treated Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: HCV
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV negative heart recipients who are currently listed.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 18 and older
* Active on the transplant list
* Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
* HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
* Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject
* Patients listed for multiple organ transplant (heart and kidney or heart and liver) can be included based on agreement of non-cardiac organ transplant team

Exclusion Criteria:

* Participants co-infected with HIV
* Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
* Known allergies or hypersensitivity to DAA or ribavarin
* Pregnancy and/or actively breastfeeding

Primary outcomes:
measure: Patient Survival Rate
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Transplant Institute
state: California
Study officials:
References: