louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00956033: Skin Biopsies in Chemotherapy-Induced Neuropathy
Official title: Skin Biopsies in Chemotherapy-induced Neuropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Peripheral Neuropathy
Keywords: Cancer
Peripheral Neuropathy
Bortezomib
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with multiple myeloma receiving bortezomib in a large university hospital

Brief summary: Neuropathy is a common side effect of chemotherapeutics used for the treatment of multiple myeloma, including vincristine, thalidomide and bortezomib. The neuropathy induced by these drugs is often preferentially small fiber. Small fiber neuropathies are difficult to diagnose and quantify using conventional electromyography. Determining intra-epidermal nerve fiber density (IENFD) in skin biopsies from diabetes and AIDS patients has been shown to be a more sensitive and more specific ancillary investigation to establish the diagnosis of small fiber neuropathy. In this study the investigators aim to establish the sensitivity of IENFD measurements in skin biopsies from patients with multiple myeloma treated with bortezomib.


Eligibility criteria: Inclusion Criteria:

* Patients with multiple myeloma receiving bortezomib

Exclusion Criteria:

* Patients not able to provide informed consent
* Patients with coagulation disturbances or immunocompromised patients

Primary outcomes:
measure: intraepidermal nerve fiber density/pain intensity
timeFrame: one timepoint, i.e. date of skin biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC, Centrumlocatie en Daniel den Hoed
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Joost L Jongen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05535933: HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II/III Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of HMPL-523 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Warm Antibody Autoimmune Hemolytic Anemia
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2022-09-10
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA

Phase III Studies: Confirmation of Efficacy safety and of HMPL-523 in Adult Patients With wAIHA

Detailed description: Phase II Study: the proportion of patients with overall Hb response by Week 24

Phase III study: the proportion of patients who achieve a durable response by Week 24

Eligibility criteria: Inclusion Criteria:

1. Voluntarily signed the informed consent form (ICF);
2. Males or females aged 18 to 75 years;
3. Patients diagnosed with primary wAIHA or secondary wAIHA whose underlying diseases are stable;
4. Organs in good function.

Exclusion Criteria:

1. Patients with other types of AIHA other than wAIHA;
2. Patients with secondary wAIHA with unstable underlying disease;
3. Patients with drug-induced secondary wAIHA;
4. Patients with infections requiring systemic treatment;
5. Patients previously treated with Syk inhibitors (e.g., fostamatinib);
6. Patients with known allergy to the active ingredients or excipients of the study drug;
7. Patients with serious psychological or mental disorder;
8. Alcoholic or drug abuser;
9. Female patients who are pregnant and lactating.

Primary outcomes:
measure: Phase II: overall Hb response rate
timeFrame: 24Weeks
Secondary outcomes:
measure: Phase III: Durable Hb response rate
timeFrame: 24Weeks
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Gansu
city: Nanchang
country: China
facility: The First affiliated hospital of nanchang uiversity
state: Jiangxi
city: Changchun
country: China
facility: Bethune First Hospital Of Jilin University
state: Jilin
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Tianjin
country: China
facility: Hematology Hospital of Chinese Academy of Medical Sciences
Study officials:
affiliation: offices director
name: Fengkui Zhang, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04022733: Remifentanil in Deep vs Moderate Neuromuscular Blocks During Surgical Pleth Index-guided Anesthesia for Laparoscopic Herniorrhaphy
Official title: A Double-blind, Randomized Study to Compare the Remifentanil Requirements in Deep Versus Moderate Neuromuscular Blocks During the Surgical Pleth Index-guided Analgesia in Patients Undergoing General Anesthesia for Laparoscopic Herniorrhaphy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia Abdominal Wall
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 134
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to compare the remifentanil requirements in deep versus moderate neuromuscular blocks during the surgical pleth index -guided anesthesia in patients undergoing laparoscopic herniorrhaphy.


Eligibility criteria: Inclusion Criteria:

* laparoscopic hernia repair

Exclusion Criteria:

* patients refusal, hyperbilirubinemia, chronic pain, opioid abuse, infection, and peripheral disease

Primary outcomes:
measure: Remifentanil Infusion Rate
timeFrame: from pneumoperitoneum to removal of laparoscope, an average of 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
state: Gyeonggido
Study officials:
References:
Clinical trial NCT06106633: Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization
Official title: Pain Reduction and Ovarian Perfusion Following Uterine Fibroid Embolization Via Pressure-Enabled Drug Delivery With the TriNav Infusion System (PEDD-UFE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Uterine Bleeding
Uterine Fibroid
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: TriSalus Life Sciences, Inc.
First posted: 2023-10-30
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.

Detailed description: Uterine fibroids are the most common tumor type in women of reproductive age and may be associated with abnormal menstrual bleeding, pain, sub-fertility, and diminished quality of life. For women interested in uterine preservation who want to derive adequate relief from medical management, uterine fibroid embolization (UFE) is a treatment option. The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.

Eligibility criteria: Inclusion Criteria:

1. Female, aged \>18 years.
2. Prior clinical decision for treatment by UFE.
3. One or more enhancing intramural, submucosal or subserosal fibroids on MRI.
4. Having either bulk symptoms or menorrhagia.

Exclusion Criteria:

1. Absolute contraindication to contrast-enhanced MRI.
2. Current pregnancy.
3. Known history of adenomyosis.
4. Diagnosis of pelvic inflammatory disease.
5. Diagnosis of endometriosis.
6. Post-menopausal (no menses \>12-months).
7. Diagnosed gynecologic malignancy.
8. Prior uterine fibroid embolization treatment.
9. \>50% volume of non-enhancing fibroids.
10. Prior oophorectomy
11. GnRH agonist therapy within 6-months or GnRH antagonist therapy within 1-month prior to entering the study.
12. Target uterine vasculature not suitable for treatment with the TriNav Infusion System.
13. Allergy or intolerance to dilaudid.
14. Lack of ovarian perfusion on baseline MRI.

Primary outcomes:
measure: Pain Reduction
timeFrame: 6 months
Secondary outcomes:
measure: ovarian perfusion
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Dania Daye, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05192733: PRICE Survey Of Extubation Following Infratentorial Craniotomy
Official title: An International, Multisociety Practice Survey Of Extubation Following Elective Infratentorial Craniotomy In Adult Neurosurgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infratentorial Neoplasms
Keywords: Airway Extubation
Prediction
Prevalence
Survey
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: Hervé Quintard
name: Torstein Meling
name: Nicolai Goettel
name: Lien Jakus
name: Camille Levy
First posted: 2022-01-14
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians involved in delivering care to neurosurgical patients: neuroanesthesiologists, neurosurgeons, neurocritical care specialists

Brief summary: The PRICE study primarily aims to identify predictors of early extubation following elective infratentorial craniotomy in adults. It also aims to (i) measure the rate of early extubation in different clinical settings; and (ii) study how the decision to extubate early is made and communicated in clinical practice. The first phase of the study (PRICE1) is a brief online survey addressed to physicians in charge of neurosurgical patients (neuroanesthesiologists, neurosurgeons, neurocritical care specialists) in multiple countries.


Eligibility criteria: Inclusion Criteria:

* Physician actively involved in delivering care to neurosurgical patients
* Physician formerly involved in delivering care to neurosurgical patients

Exclusion Criteria:

* Has already completed the survey

Primary outcomes:
measure: Prevalence of early extubation
timeFrame: 3 months
Secondary outcomes:
measure: Inventory of perceived main predictors of early extubation
timeFrame: 3 months
measure: Personnel perceived to make the decision to extubate early
timeFrame: 3 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
References:
citation: Cata JP, Saager L, Kurz A, Avitsian R. Successful extubation in the operating room after infratentorial craniotomy: the Cleveland Clinic experience. J Neurosurg Anesthesiol. 2011 Jan;23(1):25-9. doi: 10.1097/ANA.0b013e3181eee548.
citation: Cai YH, Wang HT, Zhou JX. Perioperative Predictors of Extubation Failure and the Effect on Clinical Outcome After Infratentorial Craniotomy. Med Sci Monit. 2016 Jul 12;22:2431-8. doi: 10.12659/msm.899780.
Clinical trial NCT01894633: Study of Whole-brain Irradiation With Chloroquine for Brain Metastases
Official title: Phase II Randomized, Double Blind, Placebo Controlled Study of Whole-brain Irradiation With Concomitant Daily-dose Chloroquine for Brain Metastases.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Brain Metastasis
Keywords: Prophylactic Cranial Irradiation
Metastasis
Cloroquine
Lead sponsor: Instituto Nacional de Cancerologia de Mexico
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 73
Sex: ALL
Minimum age (years): 46
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and purposes:Chloroquine (CLQ), an antimalarial drug, has a lysosomatrophic effect associate with increase the sensibility of Radiation through leakage of hidroliticenzimes, increase of apoptosis, autophagy mediated by lysosomalhidrolases and increase of oxidative stress "in vitro". In this phase II study we evaluated the efficacy and safety as radiosensitizing of the Chloroquine plus concomitant 30 Gray (Gy) of Whole-brain irradiation (WBI)in patients with brain metastases (BM) from solid tumors.

Detailed description: Seventy-three eligible patients were randomized. Thirty-nine patients received WBI (30 Gy in 10 fractions over 2 weeks) concomitant with 150 mg of CLQ for 4 weeks (the CLQ group). Thirty-four patients received the same schedule of WBI concomitant with a placebo for 4 weeks (the control arm). All the patients were evaluated for quality of life (QoL) using the EORTC QLQ-C30 questionnaire (Mexican version) before beginning radiotherapy and one month later.

Eligibility criteria: Inclusion Criteria:

* 18 to 80 years of age
* At leat one brain metastasis MRI
* KPS 70 or more
* RTOG-RPA I or II
* Basic Laboratory requirements

Exclusion Criteria:

* Candidates for radiosurgery, neurosurgery
* Patients treated with radiotherapy before entered to the study

Primary outcomes:
measure: Overall Response Rate
timeFrame: Every third month after randomization until 24 months follow-up. Measured by brain MRI
Secondary outcomes:
measure: Central Nervous System Progression Free Survival
timeFrame: From time to progression to 24 months follow up
Other outcomes:
measure: Quality of life in brain metastases
timeFrame: The quality of life questionnaires were completed 1 day before radiotherapy began and 1 month later.
Locations:
city: Mexico DF
country: Mexico
facility: Instituto Nacional de Cancerologia
state: DF
Study officials:
affiliation: Instituto Nacional de Cancerologia, Columbia
name: Oscar Arrieta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02856633: Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station
Official title: Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infection
Diabetes Mellitus
Atrial Fibrillation
OSA
COPD
Pneumonia
Acute Otitis Media
Leukocytosis
Iron Deficient Anemia
Hypertension
Healthy Volunteers
Lead sponsor: Cloud DX Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult subjects with urinary tract infection, diabetes mellitus, atrial fibrillation, sleep apnea, COPD, pneumonia, acute otitis media, leukocytosis, anemia, or hypertension will be recruited to participate in this observational study from Oakville-Trafalgar Memorial Hospital.

Brief summary: The study objective is to satisfy the testing requirements for the Qualcomm Tricorder XPRIZE Competition. This requires an oversight model using the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station to continuously monitor the patient's five core vital signs and to detect the health conditions required by the competition.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 65 years of age.
* English speaking
* Established diagnosis of one of the thirteen required conditions with evidence in Medical Record.

Exclusion Criteria:

* Lack of patient consent
* Has pacemaker or internal medical device
* Pregnancy
* Concurrent enrollment into a clinical trial that may affect subject treatment
* Age less than 18 or over 65
* Physical disabilities affecting vision (eyeglasses or contact lenses will be allowed), manual manipulation, or use of a computer or mobile device

Primary outcomes:
measure: Successful diagnosis of patient's condition by Vitaliti software as compared to patient's Medical Record
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Oakville
country: Canada
facility: Oakville Trafalgar Memorial Hospital
state: Ontario
Study officials:
affiliation: Oakville Trafalgar Memorial Hospital
name: Sonny Kohli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01416233: Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
Official title: Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orbital Fat Atrophy
Keywords: autologous
fat
orbit
atrophy
cannula
Lead sponsor: Fox, Donald Munro, M.D., P.C.
Sponsor class: INDIV
First posted: 2011-08-12
Enrollment: 6
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: After enucleation or evisceration with placement of a dermis fat graft or integrated orbital implant as a primary procedure, there can be secondary loss of orbital fat volume causing regression of periocular tissue and malpositioning of the cosmetic shell. Current techniques for correction require open surgery to place a sheet/block of biocompatible material or a macroaggregate of fat into the orbit to augment orbital volume for permanent correction. Alternatively, hyaluronic acid-base fillers (Restylane, Radiesse) have been injected, but these have proved to be temporary. The current study seeks to show that a permanent augmentation of orbital volume can be achieved using a closed cannula injection of autologous fat.

Detailed description: To date, 5 subjects have completed fat injections and 4/5 have acquired complete sets of 3 MRIs each. Data analysis has begun. The study has been extended to include 5 more subjects (total 10) to increase the number of data for analysis.

To date, the protocol has been expanded to include 10 subjects of which 6/10 have completed fat injections. The study period has been extended to include MRIs at 2 and 5 years after injection.

Eligibility criteria: Inclusion Criteria:

* Subjects who have developed secondary orbital fat atrophy after enucleation/evisceration with or without dermis fat grafting
* standard sphere or integrated orbital implantation
* phthisis bulbi are candidates

Exclusion Criteria:

* class 3 or greater anesthesia risk
* infection
* inability to follow study protocol

Primary outcomes:
measure: Autologous Augmentation of Orbital Volume Using a Closed Cannula Technique
timeFrame: 1-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
Study officials:
References:
Clinical trial NCT05477433: Psychiatric Disorders Related to Diabetes Mellitus Type 1
Official title: Psychiatric Disorders Related to Diabetes Mellitus Type 1 Among Adolescents in Egypt
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes Mellitus Type 1
Adolescents
Psychiatric Disorders
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 140
Sex: ALL
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be screening for adolescents with diabetes mellitus

Brief summary: The most common endocrine illness in children and adolescents is type 1 diabetes. It is distinguished by a lack of insulin synthesis and necessitates daily insulin injections to keep glucose levels under control. As a result, there are numerous medical approaches to its management, such as levels of glycosylated haemoglobin (HbA1c) as a marker of glycemic control during the previous three months and monitoring of blood glucose levels, which affect the patient's mental health and quality of life. Type 1 diabetes complications and poor quality of life are widespread. Diabetes therapy is difficult during puberty and adolescence. Adolescents with T1D have poor metabolic control and a higher rate of acute complications. Because the onset of adolescence is frequently associated with decreased adherence to therapy and an increased risk of psychological illnesses.


Eligibility criteria: Inclusion Criteria:

1. Both males and females were included.
2. Age ranges from 10 to 19 years.
3. Willing of the parents or the caregivers to participate in the study.
4. Duration of T1DM of at least 1 year.

Exclusion Criteria

1. Adolescents with an intelligence quotient below 70.
2. Adolescents with a history of substance use or psychiatric disorders.
3. Adolescents with medical or other neurological conditions.

Primary outcomes:
measure: Measure frequency of sleep problems with diabetes mellitus type 1
timeFrame: through study completion, an average of 1 year
measure: Measures frequency of psychiatric problems with diabetes mellitus type 1
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: