louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00086034: Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma
Official title: Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Non-Hodgkin's Lymphoma
Keywords: Lymphoma
Non-Hodgkin's Lymphoma
Indolent lymphoma
Relapsed lymphoma
Refractory lymphoma
Motexafin gadolinium
Lead sponsor: Pharmacyclics LLC.
Sponsor class: INDUSTRY
First posted: 2004-06-23
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types
* Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy
* ECOG performance status score either 0 or 1
* Willing and able to provide written informed consent

Exclusion Criteria:

Laboratory values of:

* Platelet count \< 50,000/µL
* AST or ALT \> 2 x the upper limit of normal (ULN)
* Total bilirubin \> 2 x ULN
* Creatinine \> 2.0 mg/dL

and

* Greater than three prior regimens (where a regimen is defined as a treatment for NHL given after disease progression)
* Uncontrolled hypertension
* Known history of porphyria, G6PD deficiency, HIV

Primary outcomes:
measure: Clinical response rate
Secondary outcomes:
measure: Progression-free survival
measure: Duration of clinical response
measure: Safety and tolerability
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: Stanford
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Rochester
country: United States
state: Minnesota
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Brad Kahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02806934: TNF Polymorphism and Implantation Rate
Official title: Tumor Necrosis Factor-308 Polymorphism a Embryo Implantation Rate in Women Undergoing in Vitro Fertilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing intracytoplasmic sperm injection (ICSI) due to male infertility factors

Brief summary: Do TNF-308 and -238 polymorphisms impact the embryo implantation rate after in vitro fertilization (IVF) in women without female infertility factor ?

Detailed description: This study was performed in order to verify whether TNF-308 allele was associated with a higher implantation rate and multiple pregnancy rates in women without known infertility factors after ovarian hyperstimulation with exogenous FSH for IVF

Eligibility criteria: Inclusion Criteria:

* Women
* normal karyotype,
* age under 38 years
* serum follicle-stimulating hormone (Day-3 FSH) levels below 10 UI/l

Exclusion Criteria:

* age under 18 years

Primary outcomes:
measure: Implantation rate by biological test
timeFrame: 20 days after implantation
measure: Implantation rate by ultrasound test
timeFrame: 20 days after implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
affiliation: service d'Endocrinologie
name: Patrick FENICHEL, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04850534: Systemic Inflammation in Liver Cirrhosis
Official title: Evaluation and Prognostic Indications of Systemic Inflammation in Liver Cirrhosis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Keywords: Liver cirrhosis; Systemic inflammation
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2021-04-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of liver cirrhosis with high-risk bleeding esophaogastric varices

Brief summary: Investigate systemic inflammation in liver cirrhosis patients


Eligibility criteria: Inclusion Criteria:

1. Decompensated liver cirrhosis, with endoscopy-verified high-risk esophagogastric varices;
2. Adult patients aged 18-75 years;
3. Willing to anticipate and informed consent form obtained

Exclusion Criteria:

1. History of prior radio-interventional therapy (TIPS or BRTO), liver transplantation, splenectomy, or hepatectomy;
2. Non-sinusoidal cirrhosis (e.g. vascular cirrhosis);
3. Coexistence with advanced hepatocellular carcinoma or other malignancies;
4. Coexistence with severe systemic diseases and less than 3 months of expected survival time;
5. Acute infection within 4 weeks before recruitment;
6. Antibiotic use within 4 weeks before recruitment;
7. Initial antiviral therapy for HBV or HCV within 4 weeks before recruitment;
8. Pregnant or lactating women;
9. Patients resistant to long-term follow-up

Primary outcomes:
measure: Upper Gastrointestinal Bleeding
timeFrame: One Year
measure: Death
timeFrame: One Year
Secondary outcomes:
measure: New or worsening acute decompensation event other than upper GI bleeding
timeFrame: One Year
measure: Liver transplantation/ Transfer to other non-endoscopic therapies
timeFrame: One Year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Cardiology, the Third Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of Gastroenterology, Third Affiliated Hospital of Sun Yar-sen University
name: Bin Wu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00157534: A Study to Evaluate the Safety and Efficacy of Celgosivir in Patients With Chronic Hepatitis C Genotype 1 Infection
Official title: A Phase II, Randomised, Dose-Ranging, Open-Label, Multi-Centre Study to Evaluate the Safety and Efficacy of Celgosivir for 12 Weeks in Patients With Chronic Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C
Celgosivir
HCV
Genotype 1
Lead sponsor: BioWest Therapeutics Inc
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the safety and efficacy of celgosivir for 12 weeks in patients with chronic hepatitis C genotype 1 infection.


Eligibility criteria: Inclusion Criteria:

* The patient must be 18 to 65 years of age, inclusive.
* Primary diagnosis of chronic HCV infection.

Exclusion Criteria:

* Patients who did not respond or relapsed following therapy with interferon.

Primary outcomes:
measure: Safety analysis
Secondary outcomes:
measure: Hepatitis C viral load
Other outcomes:
Locations:
Study officials:
affiliation: BioWest Therapeutics Inc
name: Jim Pankovich
role: STUDY_DIRECTOR
References:
Clinical trial NCT06982534: Clinical Study on the Treatment of Systemic Sclerosis With UTAA91 Injection.
Official title: Clinical Study on the Treatment of Refractory Moderate-to-Severe Active Systemic Sclerosis With UTAA91 Injection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Systemic Sclerosis (SSc)
Lead sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: After signing the informed consent form, eligible subjects will be infused with UTAA91 injection. Blood samples will be collected from the subjects before and after the infusion for the evaluation of pharmacokinetics, pharmacodynamics, immunogenicity, safety, etc.
Primary purpose: TREATMENT

Brief summary: This clinical trial is designed as a single-arm, open-label, single-center investigator-initiated early-phase study, with the primary objective of evaluating the safety of UTAA91 injection in subjects with refractory moderate-to-severe active systemic sclerosis.


Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years (inclusive of the boundary value), with no restriction on gender.
* Expected survival time of ≥3 months.
* Refractory moderate - to - severe active systemic sclerosis that has failed standard treatment or lacks effective therapeutic options.
* Meets the requirements for liver and kidney function, as well as cardiopulmonary function.
* Free from severe psychiatric disorders.
* Able to understand the trial and has signed the informed consent form.

Exclusion Criteria:

* A history of malignant tumors other than relapsed/refractory autoimmune diseases (R/R AID) within 5 years prior to screening.
* Positive results in virology/syphilis tests.
* Severe cardiac diseases or unstable systemic diseases.
* Presence of active or uncontrollable infections requiring systemic treatment, or evidence of central nervous system invasion.
* Pregnant or breastfeeding women, female subjects planning to become pregnant within 2 years after cell infusion, or male subjects whose partners plan to become pregnant within 2 years after their cell infusion.
* Subjects who have received CAR - T therapy or other gene - modified cell therapies prior to screening.
* Subjects who participated in other clinical studies within 1 month prior to screening.
* Other conditions deemed unsuitable for enrollment by the investigator.

Primary outcomes:
measure: Adverse events
timeFrame: About 1 year
Secondary outcomes:
measure: Cmax
timeFrame: About 1 year
measure: Tmax
timeFrame: About 1 year
measure: Disease remission rate
timeFrame: About 3 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT05059834: Feasibility Study for Online Mindfulness for GAD
Official title: Feasibility and Acceptability of an Evidence-based Mindfulness Online Resources for Patients With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Generalized
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 36
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: Method: . Forty patients with general anxiety disorder will be randomized in 1:1 ratio to the online resource plus usual care, and to usual care control group by stratified block randomization. Measurements including 7-item Generalized Anxiety Disorder questionnaire, 9-item Patient Health Questionnaire, Penn State Worry questionnaire, and Five Facet Mindfulness Questionnaire will be made at baseline and at 2-month. Rate of recruitment, drop out and website usage will be collected. All patients in the intervention arm will be interviewed to assess the clarity of the app and user experience. The scores between the two arms will be compared by t-test and the transcripts of the patient interviews will be analysed using thematic analysis


Eligibility criteria: Inclusion Criteria:

* received a diagnosis of GAD in the computerized record system (CMS) in Hong Kong hospital authority
* score ≥10 on the 7-item Generalized Anxiety Disorder scale (GAD-7), signifying active moderate anxiety symptoms
* used any website in prior 12 months
* received stable dose of psychoactive medications in last 2 months

Exclusion Criteria:

* any diagnosed psychotic disorder
* diagnosis of dementia
* any diagnosed substance abuse disorder (except smoking)
* active suicidal ideation (score ≥1 on 9-item Patient Health Questionnaire
* had regular mindfulness meditation practice in last 6 months or had participated in MBSR/MBCT course

Primary outcomes:
measure: recruitment rate
timeFrame: through study completion, an average of 1 year
measure: dropout rate
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: 7-item Generalized Anxiety Disorder questionnaire
timeFrame: baseline and 2-month
measure: 9-item Patient Health Questionnaire
timeFrame: baseline and 2-month
measure: Penn State Worry Questionnaire
timeFrame: baseline and 2-month
measure: Five Facet Mindfulness Questionnaire
timeFrame: baseline and 2-month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of public health and primary care
Study officials:
References:
Clinical trial NCT03876834: Respiratory Training in Patients With Leukemia
Official title: Influence of Respiratory Training on Functional Capacity in Patients With Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Keywords: leukemia
chemotherapy
respiratory training
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 40
Sex: MALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Forty male leukemic patients receiving chemotherapy were selected from National Cancer Institute, They were randomly assigned into two groups. Group (A) included 30 patients who were trained by Inspiratory muscle trainer for 4 weeks ;5 sessions/week and Group (B) included 10 patients as a control group.

The following measures were taken before and after the study period : Maximum voluntary ventilation(MVV) , 2 min walk test, FACT-G questionnaire

Detailed description: Forty male leukemic patients receiving chemotherapy for at least one cycle and their mean ages 37.1 ± 4.89 years.The patients were selected from National Cancer Institute, Cairo ( inpatient ward). The study lasted from March 2018 to June 2018. Patients were randomly assigned into two groups.Group A (30 patients) who received inspiratory muscles training for 4 successive weeks, 5 sessions/week; and Group B (10 patients) acted as a control group on chemotherapy only. Data obtained from both groups regarding (MVV), 2 min walk test and Quality of life questionnaire (FACT-G) were statistically analyzed and compared

Eligibility criteria: Inclusion Criteria:

* male patient with age ranges from 30-50 years
* All patients were leukemic receiving chemotherapy for at least one cycle as a treatment of malignant tumor
* All patients were hemodynamically stable
* All patients were ambulant

Exclusion Criteria:

* lung cancer
* History of any pulmonary disease.
* Metastasis of lungs, ribs, mediastinal structure
* Pulmonary pathology(e.g acute respiratory distress syndrome or exacerbation of chronic obstructive pulmonary disease)
* ruptured ear drum or any other condition of the ear
* High peak airway pressure (barotraumas)
* patients with marked elevated left ventricular end diastolic volume and pressure
* patients with worsening heart failure signs and symptoms

Primary outcomes:
measure: Maximum voluntary ventilation
timeFrame: change from baseline maximum voluntary ventilation at 4 weeks
measure: 2 min walk test
timeFrame: change from baseline 2 min walk test at 4 weeks
measure: FACT-G questionnaire
timeFrame: change from baseline FACT-G questionnaire at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT01028534: Effects of Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea (OSA)
Official title: Comparison of the Effects of Different Antihypertensive Drugs in Patients With Hypertension and Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Hypertension
Keywords: Continuous positive pressure ventilation
Blood pressure
Oxygen desaturation index
Endothelial dysfunction
Patient reported measurement
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2009-12-09
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the effects of different types of antihypertensive drugs (angiotensin II receptor blockers and long-acting calcium channel blockers) in patients with hypertension and obstructive sleep apnea who are not controlled well with their hypertension after continuous positive airway pressure therapy.

Detailed description: Obstructive sleep apnea (OSA) and hypertension have a significant interrelationship, and both disorders are well known risk factors for cardiovascular diseases (CVD). Treating them appropriately may improve the prognosis of the patients. Presently, continuous positive airway pressure (CPAP) therapy is the first-line therapy for OSA, and angiotensin II receptor blockers and long-acting calcium channel blockers for hypertension in Japan. Therefore, in the present study, we wanted to compare the effects of these different types of antihypertensive drugs on the control of blood pressure in patients with OSA whose hypertension is not controlled well after CPAP therapy.

Eligibility criteria: Inclusion Criteria:

* Apnea and hypopnea index of more than 20 /hr, and treated with CPAP
* Uncontrolled hypertension (defined as systolic blood pressure of more than 130 mmHg or diastolic blood pressure of more than 80 mmHg

Exclusion Criteria:

* Cerebrovascular diseases, myocardial infarction, angina pectoris or heart failure within 6 months
* Uncontrolled arrhythmia
* Severe hepatic or renal disorders
* Having poor prognosis disorders such as malignant disorders

Primary outcomes:
measure: Blood pressure
timeFrame: Six months
Secondary outcomes:
measure: Oxygen desaturation index
timeFrame: Six months
measure: Pulse rate
timeFrame: Six months
measure: Endothelial dysfunction
timeFrame: Six months
measure: Sleep quality and sleepiness
timeFrame: Six months
measure: Health-related quality of life
timeFrame: Six months
Other outcomes:
Locations:
city: Kitakyushu
country: Japan
facility: Kirigaoka Tsuda Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
Study officials:
affiliation: Graduate School of Medicine, Kyoto University
name: Kazuo Chin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Graduate School of Medicine, Kyoto University
name: Toru Oga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03364634: Intracranial Pressure After Decompressive Craniectomy
Official title: Intracranial Pressure After Decompressive Craniectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Middle Cerebral Artery Stroke
Intracranial Hemorrhages
Intracranial Hypertension
Keywords: decompressive craniectomy
intracranial pressure
icp
telemetry
telemetric
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients scheduled for a decompressive hemicraniectomy for elevated ICP (e.g. following severe traumatic brain injury) or signs of intracranial herniation (e.g. following cerebral edema in patients with middle cerebral artery infarction).

Brief summary: Observational study to investigate the natural course of intracranial pressure (ICP) after decompressive craniectomy (DC) using long-term telemetric ICP monitoring. Patients will have continuous ICP measurement performed during the admission to the neuro-intensive care unit (NICU) and after discharge weekly measurements sessions will be performed before and after cranioplasty.

Detailed description: Several studies have investigated and documented the effect of DC in lowering ICP in intracranial hypertension following acute brain injuries, e.g. severe traumatic brain injury. But the natural course of ICP in these patients after the acute phase in the NICU has never been investigated. Clinical experience suggests that a DC affects cerebrospinal fluid circulation and ICP, e.g. causing hydrocephalus or subdural hygromas.

The aim of this observational study is to document the natural course of ICP following DC and to investigate the effect of cranioplasty on ICP. This is done by implantation of a telemetric ICP sensor and weekly follow-up monitoring sessions after discharge from the NICU until 1 month after cranioplasty. The monitoring sessions will include standardized body positions to investigate postural ICP changes before and after cranioplasty. The project will also provide experience with telemetric ICP monitoring during the acute phase in a NICU setting.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* scheduled for a decompressive hemicraniectomy for elevated ICP or signs of intracranial herniation

Exclusion Criteria:

* skin damage in the frontal area where the telemetric ICP sensor is implanted
* lack of informed consent from next-of-kin or the patient's general practitioner

Primary outcomes:
measure: Intracranial pressure variations
timeFrame: Weekly monitoring sessions from discharge from the neuro-intensive care unit to 1 month after cranioplasty
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: