louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03183232: Safety and Efficiency of γδ T Cell Against Lung Cancer
Official title: γδ T Cell Immunotherapy for Treatment of Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Keywords: Immunotherapy, γδ T Cell, Lung Cancer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
Collaborators: name: Jinan University Guangzhou
First posted: 2017-06-12
Enrollment: 30
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: In this study, effects of γδT cells on human Lung Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated

Detailed description: Lung tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell and DC-CIK, they will be infused to the patients as an immunotherapy treatment.

NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 \~ 3 weeks.

Therefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.

Eligibility criteria: Inclusion Criteria:

Age: 18-75 Karnofsky performance status \>50 Diagnosis with Lung Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, gd T cells Life expectancy: Greater than 3 months Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

Patients with other kinds of cancer History of coagulation disorders or anemia Patients with heart disease

Primary outcomes:
measure: Relief degree of tumors
timeFrame: 3 months
measure: Progress free survival（PFS)
timeFrame: 1 year
measure: Overall survival（OS）
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biotherapy center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000
name: Jibing Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00150332: Linezolid for the Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus in Japan
Official title: Linezolid (PNU-10766/PNU10766SS) in the Treatment of MRSA Infections in Patients Whose Conventional Therapy Has Failed, or Who Are Intolerant to Conventional Therapy; an Open-label, Multi-center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Nosocomial
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Use of linezolid in patients with methicillin-resistant Staphylococcus aureus infections in Japan


Eligibility criteria: Inclusion Criteria:

* infection due to methicillin-resistant Staphylococcus aureus

Exclusion Criteria:

* hypersensitivity to linezolid

Primary outcomes:
measure: Resolution of infection at the time of completion of therapy
Secondary outcomes:
measure: Adverse events
Other outcomes:
Locations:
city: Kamogawa
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Onga-gun
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Sappopro
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Moriya
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Isahaya
country: Japan
facility: Pfizer Investigational Site
state: Nagasaki
city: Kurashiki
country: Japan
facility: Pfizer Investigational Site
state: Okayama
city: Kurashiki
country: Japan
facility: Pfizer Investigational Site
state: Okayama
city: Suita
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Iruma-gun
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Kodaira
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Hiroshima
country: Japan
facility: Pfizer Investigational Site
city: Hiroshima
country: Japan
facility: Pfizer Investigational Site
city: Kyoto
country: Japan
facility: Pfizer Investigational Site
city: Nagasaki
country: Japan
facility: Pfizer Investigational Site
city: Okayama
country: Japan
facility: Pfizer Investigational Site
city: Okayama
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04970732: Effect of Chewing Gum on Abdominal Distension in Patients After Lumbar Spine Surgery
Official title: A Randomized Controlled Study to Evaluate the Effectiveness of Chewing Gum in Improving Abdominal Distension After Lumbar Spine Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spondylosis
Keywords: Lumbar degenerate diseases
Postoperative management
Abdominal distension
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 50
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: According to chewing gum can promote the recovery of gastrointestinal function, it is used as an intervention measure for patients after lumbar surgery to evaluate the effect of chewing gum on improving abdominal distension of patients after lumbar surgery, so as to provide basis for the application and promotion of chewing gum in lumbar postoperative nursing

Detailed description: In this study, the patients after lumbar surgery were given chewing gum after anesthesia. The exhaust time, defecation time and the incidence of abdominal distension of the two groups were compared, and the significance of chewing gum in improving abdominal distension after lumbar surgery was discussed

Eligibility criteria: Inclusion Criteria:

* The subjects aged 18 years or above were able to chew together;
* Good at listening, speaking, reading and writing;
* Lumbar degenerative disease was definitely diagnosed;
* General anesthesia was used;
* Methods: posterior lumbar decompression, bone graft fusion and internal fixation;
* No history of gum allergy;

Exclusion Criteria:

* None

Primary outcomes:
measure: Physical examination
timeFrame: After surgery to discharge, an average of 4 days
measure: Time points
timeFrame: After surgery to discharge, an average of 4 days
measure: Medication
timeFrame: After surgery to discharge, an average of 4 days
measure: Incidence of abdominal distension
timeFrame: After surgery to discharge, an average of 4 days
Secondary outcomes:
measure: Oral comfort
timeFrame: After surgery to discharge, an average of 4 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05511532: Foot Orthoses & Hallux Limitus in School-age Children
Official title: Analyze the Effectiveness of Plantar Supports in School-age Children With and Without Hallux Limitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hallux Limitus
Keywords: school-age
hallux limitus
plantar pressures
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 51
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The most important pivot of the sagittal plane is in the first metatarsophalangeal joint, which is usually restricted or blocked as a result of alterations in the rest of the planes or as the main cause of secondary compensations.

Detailed description: In the propulsion phase, once the hallux touches the ground, it does not move again until the moment of take-off, so when there is a limitation of the plantar flexion of the hallux, the compensation of this is appreciated in other anatomical locations during gait analysis.

For the propulsion phase to be effective, the first metatarsophalangeal joint must be maximally dorsiflexed.

If any structure or movement is altered, the axis varies. In the hallux, the joint surface on which the movement is performed is reduced and therefore affected at the dorsal level, causing a limitation of the main movement of this joint; dorsiflexion in closed kinetic chain, known as functional hallux limitus.

It is for this reason that it is proposed to study the application of plantar supports to favor the movement of dorsiflexion of the first metatarsophalangeal joint and avoid an early establishment of the hallux limitus.

Eligibility criteria: Inclusion Criteria:

* Interest in participating and completing the phases of the study and signing of the informed consent by the parents. Patients who do not meet any exclusion criteria will be included.

Exclusion Criteria:

* The exclusion criteria will be refusal to sign the informed consent, hypermobility, neurological diseases, previous traumatic history affecting one or both lower extremities, rheumatic pathologies, as well as patients with an angular value of the first metatarsophalangeal joint less than 10º and ankle flexion less than 10º with the knee in extension.

Primary outcomes:
measure: Hallux limitus
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari Universitat de Barcelona
state: Barcelona
city: Molins de Rei
country: Spain
facility: Centre de Podologia CM
state: Barcelona
city: Molins de Rei
country: Spain
facility: Escola Col·legi Pare Manyanet Molins de Rei-Sant Miquel
state: Barcelona
Study officials:
References:
Clinical trial NCT05833932: Suhexiang Pill for Acute Ischemic Stroke: A Registry Study
Official title: Suhexiang Pill for Acute Ischemic Stroke: A Prospective Registry Study of Real-world Data
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Keywords: acute ischemic stroke
traditional Chinese medicine
registry study
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Acute ischemic stroke.

Brief summary: The primary purpose of this study is to investigate the effectiveness and safety of the Suhexiang Pill for patients with acute ischemic stroke in real-world settings.

Detailed description: Suhexiang Pill, a traditional Chinese patent medicine, is widely used in China for acute stroke. However, there is a lack of evidence of its efficacy and safety for acute ischemic stroke in real-world setting. This registry study will recruit 1000 patients who receive Suhexiang Pill treatment after acute ischemic stroke.

Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke within 7 days of symptom onset.
* Age ≥ 18
* Patient who has received Suhexiang Pill treatment
* Patient or legally authorized representative has signed informed consent.

Exclusion Criteria:

* Be allergic to Suhexiang Pill
* Known to be pregnant or breastfeeding.
* With conditions that render outcomes or follow-up unlikely to be assessed.

Primary outcomes:
measure: Proportion of patients independent
timeFrame: 90 days
Secondary outcomes:
measure: National Institute of Health Stroke Scale
timeFrame: The change from baseline to day 10 or discharge.
measure: Glasgow Coma Scale
timeFrame: The change from baseline to day 10 or discharge.
measure: Patient reported outcome
timeFrame: At day 10 or discharge.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03692832: Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease
Official title: Laparoscopic Versus Vaginal Hysterectomy for Benign Gynaecological Disease in Ain Shams University Maternity Hospital: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Gynecological Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare laparoscopic and vaginal hysterectomy in women with benign gynaecological disease in Ain Shams University Maternity Hospital.

Detailed description: The current trial evaluates the performance and short-term postoperative outcomes of these two approaches for hysterectomy in Ain Shams University Maternity Hospital, a major tertiary hospital in Greater Cairo, and one of Egypt's leading centers in terms of provision of public medical service.

Eighty patients with benign indications, with no contraindications to neither laparoscopic nor vaginal approaches, were randomized into two equal groups, to undergo either of the two procedures: LH or VH.

Eligibility criteria: Inclusion Criteria:

* Women undergoing hysterectomy for benign gynaecological disease (e.g., dysfunctional uterine bleeding, adenomyosis, fibroids).

Exclusion Criteria: Women with:

* known tubo-ovarian pathology requiring primary laparotomy, e.g. large adnexal masses
* known neoplasia requiring pelvic lymphadenectomy
* pelvic organ prolapse requiring additional procedures, e.g., uterine procidentia (complete prolapse), enterocoele
* conditions interfering with laparoscopic surgery, e.g. cardio-pulmonary disease, obesity (BMI 30 kg/m2 or more)
* large uteri interfering with vaginal hysterectomy (size \>16 gestational weeks)

Primary outcomes:
measure: Operative time
timeFrame: duration of surgical procedure
Secondary outcomes:
measure: Blood loss
timeFrame: intra-operative
measure: Blood transfusion
timeFrame: 24 hours post-operative
measure: Proportion of successful vaginal opportunistic salpingectomy
timeFrame: intra-operative
measure: Surgical complications
timeFrame: intra-operative
measure: Post-operative pain assessed using visual analogue scale for pain intensity
timeFrame: first 24 hours post-operative
measure: Febrile morbidity
timeFrame: first 24 hours post-operative
measure: Change in serum markers for inflammation
timeFrame: first 24 hours post-operative
measure: Hospital-stay
timeFrame: 1 week
measure: Healthcare costs
timeFrame: 1 week
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Faculty of Medicine
Study officials:
References:
Clinical trial NCT02502032: Effects of Cisatracurium on Sccinylcholine-induced Fasciculations
Official title: Effects of Pretreatment With Different Doses of Cisatracurium on Succinylcholine-induced Fasciculations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fasciculations
Lead sponsor: Yangzhou No.1 People's Hospital
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 87
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the effects of different doses of cisatracurium pretreatment on succinylcholine-induced fasciculations.

Detailed description: Ninety patients scheduled for laparoscopic cholecystectomies were equally randomized into three groups to receive pretreatment of 0.005, 0.01, and 0.02 mg/kg cisatracurium, respectively. General anesthesia was induced 3.5 min later, train of four stimulation was monitored 4.5 min later, succinylcholine 1.5 mg/kg was injected 5 min later, and endotracheal intubation was implemented 6.5 min later. The side effects of cisatracurium, intensity of fasciculations, intubating conditions, time and extent to maximal depression of twitch and time for its recovery to 20% of control value, severity of myalgia at 24 h postoperatively, serum potassium before cisatracurium pretreatments, at intubating time, and 5 min after intubation were recorded.

Eligibility criteria: Inclusion Criteria:

* American Standards Association (ASA) physical status I or II patients scheduled for elective laparoscopic cholecystectomies with tracheal intubation requiring general anesthesia;
* 20 - 65 years old;
* Without acid-base imbalance and electrolyte disturbance;
* With normal hepatic and renal function.

Exclusion Criteria:

* Patients with the contraindications associated with succinylcholine or cisatracurium;
* Patients taking drugs known to alter the action of neuromuscular blockers;
* Patients with a body mass index exceeding 30

Primary outcomes:
measure: Presence of fasciculations
timeFrame: After the injection of succinylcholine for 1.5 minutes
Secondary outcomes:
measure: Side effects of the pretreatment of cisatracurium
timeFrame: From the time of 3 minutes after the pretreatment of cisatracurium for 0.5 minutes
measure: The time to maximal depression of twitch
timeFrame: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
measure: The extent to maximal depression of twitch
timeFrame: From the time of 4.5 minutes after the pretreatment of cisatracurium for two minutes
measure: The grades of endotracheal intubation
timeFrame: At intubating time
measure: The changes of serum potassium
timeFrame: After entering the operating theater till the anesthesia induction, at intubating, and 5 min after intubation
measure: Myalgia at 24 hours postoperatively
timeFrame: At 24 hours postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Yangzhou No. 1 Peoples' Hospital
name: Xin-nong Liu, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04039932: Faith Leaders Advocating for Maternal Empowerment (FLAME)
Official title: Faith Leaders Advocating for Maternal Empowerment (FLAME)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prenatal Care
Maternal Health Services
Perinatal Care
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of Gondar
First posted: 2019-07-31
Enrollment: 18
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized trial assigning facility catchment areas to intervention vs. standard of care
Primary purpose: PREVENTION

Brief summary: In 2015, the average Ethiopian woman had a 1 in 64 lifetime risk of death due to complications of childbirth and 87,414 newborns died before their 28th day of life. Demand for MNCH services, however, remains low in Ethiopia's rural communities most at risk with only 16% of women delivering in a health facility.

The investigator's project responds to the challenge of creating demand for existing MNCH services in rural Ethiopia, which fell short of reaching Millennium Development Goal targets for reducing preventable maternal and neonatal deaths. This study addresses two strategic drivers to prevent maternal mortality identified by USAID including improving individual, household, and community behaviors and norms and increasing equity of access and use of services by the most vulnerable.

The primary objective of the study is to determine the impact of a behavior change intervention that partners Ethiopian Orthodox priests with members of the Health Development Army (HDA) and trains them to conduct maternal health outreach to increase births attended by skilled health personnel among women who attend ≥1 ANC visits.


Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Willing to receive intervention counseling

Exclusion Criteria:

* None

Primary outcomes:
measure: Facility delivery
timeFrame: Through study completion, an average of 18 months
Secondary outcomes:
measure: Any ANC
timeFrame: Through study completion, an average of 18 months
measure: Complete ANC
timeFrame: Through study completion, an average of 18 months
Other outcomes:
Locations:
city: Gondar
country: Ethiopia
facility: University of Gondar
state: Amhara
Study officials:
affiliation: University of Washington
name: Brandon Guthrie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guthrie BL, Tsegaye AT, Rankin KC, Walson JL, Alemie GA. Partnering faith leaders with community health workers increases utilization of antenatal care and facility delivery services in Ethiopia: A cluster randomized trial. J Glob Health. 2021 Oct 30;11:04063. doi: 10.7189/jogh.11.04063. eCollection 2021.