louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03260439: Tramadol in Penial Block Does it Improve Efficiency of Postoperative Analgesia in Circumcision
Official title: Doses Tramadol With Bupivacaine in Penial Block Improve Efficiency of Postoperative Analgésia in Children in Circumcision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tramadol - Anesthetics- Child - Circumcision
Keywords: tramadol-penile block -circumcision surgery-anesthesia-child
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 106
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled and double blind assignment
Primary purpose: OTHER

Brief summary: After the consent of the local ethics committee and informed consent of the parents, we conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December 2014, including one to eight year olds, ASA I or II and Programmed for circumcision.We collected 53 children in each group.

Detailed description: After the consent of the local ethics committee and informed consent of the parents, we conducted a prospective randomized, double-blind study, from 30 June 2014 to 31 December 2014, including one to eight year olds, ASA I or II and Programmed for circumcision. Anesthesia was induced with sevoflurane at 8% and maintained by the same agent at 2%. The children were randomized to 2 groups (n = 53 in each group) to receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with either tramadol 2mg / Kg (G1: GroupBT ) Or saline serum at the same volume (G2: Group B or control). Postoperative analgesia was assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO hour at home, by the number of analgesic inThe hospital and at home, and by the time of the first demand analgesic.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II
* Were scheudled to circumcision surgery
* Performed by experenced surgeon under general anesthesia

Exclusion Criteria:

* children with full stomach
* A history of gastric reflux
* A history of cardiovascular or neuromuscular disease
* Allergies to the study drugs

Primary outcomes:
measure: Postoperative analgesia
timeFrame: from awake until 60 min after emergence
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: University Hospital of Fattouma Bourguiba
state: Monastir- Tunisia
Study officials:
affiliation: University Hospital of Fattouma Bourguiba Monastir TUNISIA
name: leila Mansali Stambouli, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kargi E, Isikdemir A, Tokgoz H, Erol B, Isikdemir F, Hanci V, Payasli C. Comparison of local anesthetic effects of tramadol with prilocaine during circumcision procedure. Urology. 2010 Mar;75(3):672-5. doi: 10.1016/j.urology.2009.06.108. Epub 2009 Oct 24.
Clinical trial NCT03763539: Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value
Official title: Ultraslow Full-power SWL Versus Slow Power-ramping SWL in Stones With High Attenuation Value
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stones
Keywords: renal stones
SWL
High density stones
Ultraslow SWL
Slow SWL
Ramping
Pause
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 196
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: Ultraslow full-power SWL versus slow power-ramping SWL in stones with high attenuation value

Detailed description: To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL.

Eligibility criteria: Inclusion Criteria:

* single renal stone less than or equal to 3 cm (2 cm for lower calyceal stones)
* radio-opaque stone
* high attenuation value (≥ 1000 HU) stone

Exclusion Criteria:

* Abnormal renal anatomy
* renal insufficiency
* solitary kidney
* coagulopathies
* uncontrolled hypertension
* renal artery or aortic aneurysm
* active urinary tract infection
* pregnancy
* severe skeletal malformations (spinal deformity) precluding proper stone localization
* skin to stone distance (SSD) \> 11 cm
* BMI \> 30 Kgm/m2

Primary outcomes:
measure: stone free rate
timeFrame: 3 months following last session of SWL
Secondary outcomes:
measure: Complications
timeFrame: 1 year following last session of SWL
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef Hospitals
state: Outside U.S./Canada
Study officials:
affiliation: Beni-Suef University
name: Ahmad Aref Al-Dessoukey, Ass. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02787239: Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and Rituximab in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: B-cell Non Hodgkin's Lymphoma
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2016-06-01
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multicenter, Randomized, Double-blind, Parallel, Phase III Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and MabThera in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL


Eligibility criteria: Inclusion Criteria:

* Untreated CD20-positive DLBCL confirmed.
* IPI score of 1 to 2, Stage I \~ IV, Score 0 needs to accompanied by bulky disease, which is defined as the presence of a tumor mass with a diameter of more than 7.5 cm.
* ECOG performance status of 0 to 2.
* More than 6 months life expectancy.
* At least one measurable lesion: For nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; For extranodal tumor mass, more than 1.0 cm in the long axis.
* 18 years to 70 years; Male or female patients.

Exclusion Criteria:

* Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins.
* Known allergic reactions against any component of CHOP regimen.
* Previous treatment for NHL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, monoclonal antibody therapy or surgical treatment (excluding lymph node biopsies and surgical resection for non-lymphoma lesions).
* History of cytotoxic drugs treatment or anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis).
* Prior use of any monoclonal antibody within 3 months.
* Primary central nervous system(CNS) lymphoma, secondary CNS involvement, grey zone lymphoma (GZL) between burkitt and DLBCL, primary effusion lymphoma, plasmablastic lymphoma, primary cutaneous DLBCL, anaplastic lymphoma kinase(ALK) positive DLBCL or transformed lymphoma.

Primary outcomes:
measure: Percentage of Participants With Overall Response Rate (ORR)
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
References:
citation: Shi Y, Song Y, Qin Y, Zhang Q, Han X, Hong X, Wang D, Li W, Zhang Y, Feng J, Yang J, Zhang H, Jin C, Yang Y, Hu J, Wang Z, Jin Z, Su H, Wang H, Yang H, Fu W, Zhang M, Zhang X, Chen Y, Ke X, Liu L, Yu D, Chen G, Wang X, Jin J, Sun T, Du X, Cheng Y, Yi P, Zhao X, Ma C, Cheng J, Chai K, Luk A, Liu E, Zhang X. A phase 3 study of rituximab biosimilar HLX01 in patients with diffuse large B-cell lymphoma. J Hematol Oncol. 2020 Apr 16;13(1):38. doi: 10.1186/s13045-020-00871-9.
Clinical trial NCT06696339: Assessment of Heart Rate Measurement Accuracy for the PreemptiveAI SDK in Adults
Official title: Collection of Fingertip Video for Determination of Heart Rate
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Rate in the General Public
Lead sponsor: PreemptiveAI, Inc
Sponsor class: INDUSTRY
First posted: 2024-11-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 60 participants, up to 125 participants. Participants will be recruited to meet the following demographics goals:

* Sex assigned at birth - a minimum of 25 male and 25 female participants
* Age - a minimum of 10 participants in each age bin: 18-30, 30-65, 65+
* BMI - a minimum of 5 participants in each bin: 0-25, 25-30.0, 30.0+
* Skin tone (Fitzpatrick scale) - a minimum of 10 participants in each bin: Type 1/2, Type 3/4, Type 5/6
* Heart Rate - a minimum of 5 participants with average heart rate \< 60 bpm and \>100 bpm

Brief summary: The goal of this clinical trial is to assess the accuracy of the PreemptiveAI SDK to measure heart rate for adults as compared to an FDA-approved ground truth device.

Participants will:

* Complete a demographics and health history survey
* Apply and wear ground truth equipment such as a pulse oximeter and ECG
* Measure their heart rate 8 times with 4 different smartphones using the PreemptiveAI SDK


Eligibility criteria: Inclusion Criteria:

* Adults with both normal and abnormal heart rates

Exclusion Criteria:

* Under 18 years of age
* Unable to speak and read English
* Deemed not suitable to participate by Investigator due to cognitive impairment, acute illness, or serious physical or mental health condition
* Essential tremor in left or right hand
* Raynaud's disease
* Severe calluses on left or right index finger
* Unable to produce a heart rate measurement due to low signal quality during the training phase (i.e. low perfusion, unable to hold hand steady, etc)

Primary outcomes:
measure: Heart Rate Error
timeFrame: At single site visit, measured across 8 repetitions within a 1-hour period
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Paul Allen Institute for Artificial Intelligence
state: Washington
Study officials:
References:
Clinical trial NCT06788639: A Study of Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting
Official title: Non-interventional Cohort Study of Patients Treated With Liso-cel (Lisocabtagene Maraleucel) for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in the Post-Marketing Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Keywords: Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Lead sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor class: INDUSTRY
First posted: 2025-01-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adults with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that are being treated with lisocabtagene maraleucel and are registered within the Center for International Blood and Marrow Transplant Research (CIBMTR) registry.

Brief summary: The purpose of this study is to characterize the long-term safety of lisocabtagene maraleucel (liso-cel), focusing on patients treated in the chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities


Eligibility criteria: Inclusion Criteria:

• Participants must have been treated in the post-marketing setting with ≥1 infusion of lisocabtagene maraleucel used for the treatment of relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) within the approved indication and dosage per the United States Prescribing Information (USPI) and product specifications approved for commercial release in the USA

Exclusion Criteria:

* Participants known to be participating in investigational studies at the time of lisocabtagene maraleucel infusion
* Patients treated with non-conforming CAR T-cell product

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: Up to 15 years
Secondary outcomes:
measure: Complete remission rate (CRR
timeFrame: Up to 15 years
measure: Overall response rate (ORR)
timeFrame: Up to 15 years
measure: Progression-free survival (PFS)
timeFrame: Up to 15 years
measure: Overall survival (OS)
timeFrame: Up to 15 years
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Center for International Blood and Marrow Transplant Research (CIBMTR)
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03181139: Efficacy of Enhanced Recovery After Surgery Pathway for Total Mastectomy
Official title: Efficacy of Enhanced Recovery After Surgery Pathway for Total Mastectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mastectomy
Breast Cancer Female
Keywords: Enhanced Recovery after Surgery (ERAS)
Fast-track surgery
Pec Blocks
Mastectomy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Mount Zion Health Fund
First posted: 2017-06-08
Enrollment: 386
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients at UCSF Mount Zion hospital who were scheduled for total mastectomy

Brief summary: Retrospective analysis of pre and post-Enhanced Recovery after Surgery for Total mastectomy pathway implementation.

Detailed description: Retrospective analysis of pre- and post-Enhanced Recovery after surgery for total mastectomy pathway implementation in patients at Mount Zion Hospital. We examined perioperative opioid consumption, pain scores, post-operative nausea and vomiting, benzodiazepine use, length of stay for the time period before and after implementation of an Enhanced Recovery after Surgery pathway for Total mastectomy. Pathway features included preoperative acetaminophen and gabapentin, minimizing opioids, postoperative NSAIDs, Pecs blocks, and aggressive postoperative nausea and vomiting prophylaxis.

Eligibility criteria: Inclusion Criteria:

* female patients at least 18 years old undergoing total skin sparing mastectomy at University of California San Francisco Mount Zion hospital

Exclusion Criteria:

* patients undergoing concurrent bilateral salpingo-oophorectomy, flap reconstruction

Primary outcomes:
measure: perioperative opioid consumption
timeFrame: through study completion (average of 1 year)
Secondary outcomes:
measure: Post-operative nausea and vomiting (PONV)
timeFrame: through study completion (average of 1 year)
measure: postoperative benzodiazepine use
timeFrame: through study completion (average of 1 year)
measure: Length of stay (LOS)
timeFrame: through study completion (average of 1 year)
measure: Pain score
timeFrame: through study completion (average of 1 year)
measure: Surgery duration
timeFrame: through study completion (average of 1 year)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04001439: FEcal Microbiota Transplantation
Official title: FEcal Microbiota Transplantation for MAjor Depression in Schizophrenia (FEMADSZ)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression in Schizophrenia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 3088
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
Intervention model description: All patients will receive 30 microbiota capsules in take proceded by bowel lavage by 4 liters macrogo solution.
Primary purpose: OTHER

Brief summary: The primary objective will be to evaluate effectiveness, safety and acceptability of FMT on depressive symptoms at 2 months follow-up in SZ patients with resistant MD.

Detailed description: Background. Major Depression (MD) will move into the first place of cause of the global burden of disease by 2030. Conventional treatments (antidepressants) are only partly effective with frequent side effects. More specifically, MD is underdiagnosed and undertreated in schizophrenia (SZ) despite its high impact on prognosis and quality of life in SZ patients. Even when treated, 44% of the patients remain major depressed under conventional antidepressants.

FEMADSZ makes the hypothesis that this is due to the fact that the source of MD relies outside the brain, in the gut microbiota. The associations between microbiota disturbances are now well demonstrated in rodent models (\>60 studies) and indirect data in humans clearly suggest that the microbiota hypothesis of MD is the most promising track in psychiatry. The primary objective will be to evaluate effectiveness, safety and acceptability of FMT on depressive symptoms at 2 months follow-up in SZ patients with resistant MD. Methods: This is a pilot, single-arm, prospective, open-label proof-of-concept trial, including SZ patients with resistant MD. Fifteen patients will be enrolled and administered a Fecal Microbiota Transplantation. The main outcome measure will be depressive score at 2 months, adverse events and acceptability. Each patient will receive a FDG-PET scan, a routine blood draw and a metagenomic microbiota analysis before and after intervention. Expected results. This pilot study will help determining the effectiveness of FMT and the neurobiologic and microbiologic mechanisms associated with response to treatment.

Eligibility criteria: Inclusion Criteria:

* patients aged 18 to 65 years
* with the current diagnosis of shizophrenia

Exclusion Criteria:

* history of lifetime FMT
* History of gut surgery

Primary outcomes:
measure: myoglobin concentration
timeFrame: 2 moths
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04365439: Convalescent Plasma for COVID-19
Official title: Convalescent Plasma for the Treatment of Moderate-severe COVID-19: A Proof-of-principle Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Plasma Therapy
COVID
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this proof of concept study is to provide COVID-19 convalescent plasma to patients with moderate to severe COVID-19 and assess:

* the titer of anti-COVID-19 antibodies in the donors and in the patients before and after treatment;
* the in-depth analysis of immunological parameters in the donors and in recipient before and after treatment;
* the impact of plasma transfusion on the reduction of viral load and inflammation
* safety and tolerability
* clinical efficacy


Eligibility criteria: Inclusion Criteria:

* Hospitalized adult patients 18 - 75 y.o. with confirmed COVID-19 infection by nasopharyngeal swab;
* radiologically confirmed pneumonia;
* SpO2 \> 92o/o and \< 96% (room air);
* ongoing thromboembolic prophylaxis.

Exclusion Criteria:

* Participation to another COVID-19 trial;
* severe COVID-19 disease (SpO2 \< 93o/o in room air);
* severe allergic transfusion reactions or anaphylaxis in the patient history;
* documented lgA deficiency;
* unstable heart disease with signs of circulatory overload;
* malignancies or other concomitant diseases with poor short-term prognosis;
* pregnancy.

Primary outcomes:
measure: Titers of anti-SARS-CoV-2 antibodies in the plasma derived from convalescent donors
timeFrame: At plasma donation
measure: Change in titers of anti-SARS-CoV-2 antibodies in patients' plasma
timeFrame: Change from baseline at day 21
measure: Change in inflammatory cytokines concentration (e.g. IL-6, HMGB1)
timeFrame: Change from baseline at day 7
measure: Viral load decay in the recipient after plasma transfusion with semiquantitative assessment of nasopharyngeal swabs
timeFrame: Change from day of diagnosis at day 1
Secondary outcomes:
measure: Number of patients with improvement in the 7-points Ordinal Scale
timeFrame: At day 7
measure: Proportion of patients with adverse events, severity of adverse events
timeFrame: At day 21
Other outcomes:
Locations:
city: Locarno
country: Switzerland
facility: Ospedale Regionale Locarno
state: Ticino
Study officials:
affiliation: Servizio Trasfusionale, Lugano
name: Stefano Fontana, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
Clinical trial NCT06914739: Application of Health Empowerment Theory to Enhance Health Empowerment Levels and Self-Health Management Ability Among Older Migrants: A Randomized Controlled Trial
Official title: Application of Health Empowerment Theory to Enhance Health Empowerment Levels and Self-Health Management Ability Among Older Migrants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Self-management
Lead sponsor: Huzhou University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 66
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aimed to evaluate the effectiveness of a theory-based health self-management program in empowering older migrants to manage their health. This study used a single-blind, randomized controlled trial design. A comparison was conducted between the experimental and control groups in terms of pre-test and post-test levels of health empowerment and health self-management abilities.


Eligibility criteria: Inclusion Criteria:

* (1) age 60 years or older; (2) residing in thelocal area for a minimum of six months; (3) agreement to participate in the study and willingness tosign the informed consent form; and (4) possessing a clear sense of autonomy and the ability tounderstand and engage with the content of the study intervention activities.

Exclusion Criteria:

* (1) absencefrom two consecutive lectures or group activities without prior notification and (2) voluntary withdrawal from the study at the participant's request.

Primary outcomes:
measure: health empowerment level
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: self-health management ability
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Huzhou
country: China
facility: Huzhou University
state: Zhejiang
Study officials:
References: