louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00284271: Feasibility and Efficacy of BACOPP-21 for Patients > 60 Years With Intermediate or Advanced Hodgkins Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin´s Lymphoma
Keywords: Hodgkin´s Lymphoma
eldery patients
primary diagnosis
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2006-01-31
Enrollment: 65
Sex: ALL
Minimum age (years): 61
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to test (1) feasibility and efficiancy of new BACOPP regimen and (2) toxicity, overall response and FFTF.


Eligibility criteria: Inclusion Criteria:

* Hodgkin´s lymphoma (histologically proven)
* CS (PS) I and II with one of the risk factors a-d

  1. bulky mediastinal mass (\> 1/3 maximum transverse thorax diameter)
  2. extranodal involvement
  3. ESR \> 50 (A), \> 30 (B-symptoms)
  4. 3 or more lymph node areas involved
* CS (PS) III and IV
* Written informed consent

Exclusion Criteria:

* Leukocytes \<3000/microl
* Platelets \<100000/microl
* Hodgkin´s Disease as "composite lymphoma"
* Activity index (WHO) \< grade 2

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne
Study officials:
affiliation: University of Cologne
name: Andreas Josting, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Halbsguth TV, Nogova L, Mueller H, Sieniawski M, Eichenauer DA, Schober T, Nisters-Backes H, Borchmann P, Diehl V, Engert A, Josting A. Phase 2 study of BACOPP (bleomycin, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone) in older patients with Hodgkin lymphoma: a report from the German Hodgkin Study Group (GHSG). Blood. 2010 Sep 23;116(12):2026-32. doi: 10.1182/blood-2009-11-253211. Epub 2010 Jun 15.
Clinical trial NCT00467571: Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura
Official title: Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Idiopathic Thrombocytopenic Purpura
Helicobacter Pylori Infection
Keywords: chronic idiopathic thrombocytopenic purpura
Helicobacter pylori infection
platelet
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Ramathibodi Hospital
First posted: 2007-04-30
Enrollment: 26
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous studies suggest that chronic idiopathic thrombocytopenic purpura is associated with Helicobacter pylori infection. The objective is to study the effect of Helicobacter pylori eradication on platelet count.

Detailed description: Children with chronic idiopathic thrombocytopenic purpura who have Helicobacter pylori infection are enrolled. Helicobacter pylori infection is diagnosed by urea breath test. Patients who have Helicobacter pylori infection will be randomized into 2 groups: control and treatment groups. The treatment group will receive 2 antibiotics and proton-pump inhibitors for 14 days for eradication of infection. Repeated urea breath test at week 6-8 after treatment. Blood tests for platelet count will be performed every month for 6 months in both groups. Platelet count at 6 months in both group will be compared.Blood for platelet antibody will be performed at 3 and 6 months. Control group will receive treatment for Helicobacter pylori at the end of the study.

Eligibility criteria: Inclusion Criteria:

* Children who was diagnosed as chronic ITP, defined by platelets below 100,000/uL for more than 6 months without identified causes.
* 13C-urea breath test (UBT) was performed for diagnosis of Helicobacter pylori infection.

Exclusion Criteria:

* Patients who had a previous treatment for H. pylori infection.

  * Patients require prednisolone more than 0.5 mg/kg/day

Primary outcomes:
measure: platelet count
timeFrame: 6 months
Secondary outcomes:
measure: platelet antibody after treatment of Helicobacter pylori infection, compared with control group (no treatment of Helicobacter pylori)
timeFrame: 6 months
measure: platelet count
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Ramathibodi Hospital, Mahidol University
Study officials:
affiliation: Faculty of Medicine Ramathibodi Hospital, Mahidol University
name: Suporn Treepongkaruna, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05211271: Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia
Official title: Evaluating Thermal Ablation in the Treatment of Cervical Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Neoplasia
Keywords: cervical neoplasia
treatment
thermal ablation
longitudinal study
LMIC
Lead sponsor: International Agency for Research on Cancer
Sponsor class: OTHER
Collaborators: name: Kamenge University Hospital, Burundi University, Burundi
First posted: 2022-01-27
Enrollment: 86
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Longitudinal study in Burundi to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.

Detailed description: The study population consisted of women with an abnormal VIA test or an abnormal colposcopy examination. A total of 86 women with lesions eligible to ablative treatment were counselled and treated by thermal ablation. Informed consent was signed by each participant. Just after treatment, they were inquired about the level of pain during the procedure, and their level of satisfaction with the treatment. They were followed-up at 6 weeks for any complication and re-assessed by VIA and colposcopy at 12 months for any persistent or recurrent lesion and for any adverse event.

Eligibility criteria: Inclusion Criteria:

* Women residing in Burundi and referred to the tertiary hospital after a positive VIA test

Exclusion Criteria:

* Lesion occupying the 4 quadrants of the cervix
* Not visible squamous columnar junction (not Type 1 TZ)
* Vaginal or endocervical lesion
* Lesion subjective of cervical cancer

Primary outcomes:
measure: Cure rate based on VIA and colposcopy assessment
timeFrame: 1 year
measure: Acceptability of thermal ablation
timeFrame: 6 weeks
measure: Acceptability of thermal ablation
timeFrame: At day 1
measure: Safety of thermal ablation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bujumbura
country: Burundi
facility: Kamenge University Hospital
Study officials:
affiliation: Kamenge University Hospital, Burundi University, Bujumbura, Burundi
name: Sylvestre Bazikamwe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Agency for Research on Cancer
name: Catherine Sauvaget, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sauvaget C, Bazikamwe S, Lucas E, Ndayikengurukiye A, Harerimana S, Barango P. Evaluation of effectiveness, acceptability and safety of thermal ablation in the treatment of cervical neoplasia in Burundi. Int J Cancer. 2022 Oct 1;151(7):1120-1126. doi: 10.1002/ijc.34117. Epub 2022 Jun 3.
Clinical trial NCT00463671: Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation
Official title: The Relation Between Hyperbaric Oxygen, Oxidative Stress, NO Bioavailability and Tissue Oxygenation in Diabetic Patients Suffering From Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcers
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hyperbaric oxygen therapy (HBOT) increases tissue oxygenation and serves as an adjunct therapy for diabetic wounds. However, some patients have insufficient increase or even paradoxical decrease in tissue O2 due to vasoconstriction. The aim of the present study was to investigate the pathophysiology responsible for the different consequences of HBOT and to evaluate the effect of N-acetylcysteine (NAC) on these changes.

Methods: Prospective, randomized, cross-over trial including fifty diabetic patients with non-healing ulcers. All patients had two HBOT (100%oxygen, 2ATA) with NAC at the first or the second evaluation. At the beginning and at the end of each evaluation, ulcer oxygenation and plasma levels of malondialdehyde (MDA), total anti-oxidant status (TAOS) and nitric oxide (NO) were measured. Patients with ulcer oxygenation above 200mmHg, were subjected to complete HBOT protocol.


Eligibility criteria: Inclusion Criteria:

* diabetic patients, aged 18 years or older, with non-healing foot ulcers

Exclusion Criteria:

* Patients with macrovascular disease amenable for revascularization with more than 70% obstruction in femoral artery (evaluated by US doppler) were excluded from the study. Similarly, patients with a documented allergy to NAC, liver cirrhosis or those receiving NAC for other indications were excluded. Finally, patients with chest pathology incompatible with pressure changes, patients with inner ear disease, or those suffering from claustrophobia were excluded.

Primary outcomes:
measure: The aim of the present study was to investigate whether changes in oxidative stress and NO bioavailability are responsible for the different effects of HBOT on tissue oxygenation in diabetic patients suffering from foot ulcers.
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: The Institute of Hyperbaric Medicine and Wound Care Clinic
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: Shai Efrati, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04456452: Study of Ampion for the Treatment of Adult COVID-19 Patients Requiring Oxygen Supplementation
Official title: A Randomized Controlled Trial to Evaluate the Safety of Intravenous Ampion™ in Adult COVID-19 Patients Requiring Oxygen Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: Ampio Pharmaceuticals. Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 randomized study to evaluate the safety, tolerability and efficacy of IV Ampion in improving the clinical course and outcomes of patients hospitalized with COVID-19 infection who require supplemental oxygen.


Eligibility criteria: Inclusion Criteria:

1. Male or female, 18 years to 89 years old (inclusive).
2. Hospitalized and diagnosed with COVID-19, as evaluated by PCR test confirming infection with SARS-COV-2.
3. Patient is receiving supplemental oxygen (e.g. oxygen saturation (SpO2) \<88%, labored breathing, increased respiratory rate, dyspnea on rest or exertion).
4. A signed informed consent form from the patient or the patient's legal representative must be available.

Exclusion Criteria:

1. In the opinion of the clinical team, progression to death is imminent and inevitable, irrespective of the provision of treatments.
2. Patient has severe chronic obstructive pulmonary disease (COPD), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.).
3. Patient is on chronic immunosuppressive medication.
4. As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study.
5. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
6. Patient has known pregnancy or is currently breastfeeding.
7. Participation in another clinical trial.
8. Baseline QT prolongation.

Primary outcomes:
measure: Incidence and severity of adverse events
timeFrame: Primary endpoint at day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
Study officials:
References:
Clinical trial NCT01868152: The Realtime Detection for Prediction of Opioid Analgesic
Official title: Study of Prediction of Opioid Analgesic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Individuality
Keywords: sufentanil
individual variation
pain threshold
narcotrend index
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2013-06-04
Enrollment: 131
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese female patients receiving elective surgery under general anesthesia

Brief summary: This study aimed to find a quick and timely way to predict the individual variation of efficacy of opioid analgesic during the operation and postoperative analgesia in Chinese patients undergoing elective surgeries. Methods: female patients receiving elective surgery under general anesthesia were recruited into this study. At the time of routine intravenous anesthetic induction we observe the efficacy of opioid analgesic including analgesic effect, effects on Narcotrend index, sedative effect, effects on respiratory system, and aslo effects on cardiovascular system. Then we record the consumption of of opioid analgesic during the operation and postoperative analgesia. Also we record the side effect of the opioid analgesic.

Detailed description: Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.

Eligibility criteria: Inclusion Criteria:

* Aged 20-65 years
* Anesthesiologists (ASA) physical status I or II;
* Within ±20% of ideal body weight;
* Agreed to participate the research

Exclusion Criteria: •History of chronic pain;

* Psychiatric diseases;
* Diabetes mellitus;
* Severe cardiovascular diseases;
* Kidney or liver diseases;
* Alcohol or drug abuse (according to the criteria of DSM-IV);
* Pregnancy or at lactation period;
* Disagree to participate to the research

Primary outcomes:
measure: Rangeability of pressure pain threshold
timeFrame: 8 months
Secondary outcomes:
measure: Rangeability of Narcotrend index
timeFrame: 8 months
measure: Rangeability of Ramsay Sedation Scale
timeFrame: 8 months
measure: Rangeability of respiratory frequency
timeFrame: 8 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Zhang Xianwei, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02505152: Percutaneous Transhepatic Intrahepatic Portosystemic Shunt for Treatment of Portal Vein Occlusion With Symptomatic Portal Hypertension After Splenectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension, Portal
Portal Vein, Cavernous Transformation Of
Keywords: Hypertension, Portal
Portal Vein, Cavernous Transformation Of
Portosystemic shunt
Radiology, Interventional
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the values of percutaneous transhepatic intrahepatic portosystemic shunt for treatment of portal vein occlusion with symptomatic portal hypertension after splenectomy.


Eligibility criteria: Inclusion Criteria:

* All patients with portal hypertension who have the history of splenectomy and have enough image information to confirm occlusion of portal vein

Exclusion Criteria:

* Patients with known severe dysfunction of heart, lung, brain, kidney and other vital organs

Primary outcomes:
measure: No gastrointestinal rebleeding in 1 month after interventions
timeFrame: 1 month
measure: Ascites disappear in 1 month after interventions
timeFrame: 1 month
Secondary outcomes:
measure: Whether the shunt is patent after interventions in 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Radiology
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zaibo Jiang, MD.
role: STUDY_CHAIR
References:
Clinical trial NCT04644952: The Rise in Robotic Atypical Segmentectomies
Official title: The Rise in Robotic Atypical Segmentectomies: A Large Cancer Center Experience
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent a lung resection from 2004 to 2019

Brief summary: This study investigates the increased rate of robotic atypical segmentectomies. Segmentectomy refers to removing a section of a lobe of the lung. Reviewing patients' data retrospectively may help researchers determine whether robotic surgery has led to an increase in atypical segmentectomy.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the rate of increase in robotic segmentectomies performed at our institution per year.

II. To evaluate the rate of typical and atypical segmentectomies performed at our institution per year.

III. To characterize the differences in robotic versus other types of resections such as open and VATS (video-assisted thoracic surgery).

OUTLINE:

Patients' medical records are reviewed retrospectively.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent a lung resection from 2004 to 2019

Primary outcomes:
measure: Rate of change in robotic segmentectomies
timeFrame: Up to 2 years
measure: Rate of typical and atypical segmentectomies
timeFrame: Up to 2 years
measure: Differences in robotic versus other types of resections such as open and video-assisted thoracic surgery
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David C Rice
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01228552: The Efficacy and Safety of Intra-oral Topical Ketoprofen for the Treatment of Acute Migraine
Official title: A Randomized Double Blind, Placebo Controlled Phase III Trial to Determine the Efficacy and Safety of Topical Intra-oral Ketoprofen for the Treatment of Acute Migraine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Migraine Disorders
Migraine Headache
Migraine
Acute Migraine
Keywords: Acute Migraine Treatment
Migraine Treatment
Migraine
Headache
Treatment
Lead sponsor: Behar, Caren, M.D.
Sponsor class: INDIV
First posted: 2010-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of intra-oral topical ketoprofen for the treatment of acute migraine.


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of Migraine as per IHS with aura
* Established diagnosis of Migraine as per IHS without aura
* At least 2 migraines per month
* At least 18 years of age

Exclusion Criteria:

* Pregnancy or Lactation
* Other Headache Conditions including basilar, hemiplegic, or ophthalmoplegic migraines
* Chronic Daily Headache
* Allergy or Sensitivity to NSAIDs
* Other Severe Medical Conditions including GI bleeding, blood dyscrasias, thrombocytopenia

Primary outcomes:
measure: Pain relief (defined as at least 2 graded reduction in a 5-grade scale) at 120 minutes post-treatment
timeFrame: Within 240 minutes post-treatment
Secondary outcomes:
measure: Pain free status at 30, 60, 120, and 240 minutes post-treatment based on headache severities reported in patient's journals
timeFrame: Within 240 minutes post-treatment
measure: Pain relief at 30, 60, and 240 minutes post-treatment based on headache severities reported in patient's journals
timeFrame: Within 240 minutes post-treatment
measure: Relief of Photophobia at 30, 60, 120, and 240 minutes post-treatment
timeFrame: Within 240 minutes post-treatment
measure: Relief of Phonophobia at 30, 60, 120, and 240 minutes post-treatment
timeFrame: Within 240 minutes post-treatment
measure: Relief of Nausea at 30, 60, 120 and 240 minutes post-treatment
timeFrame: Within 240 minutes post-treatment
measure: Relief of Vomiting 30, 60, 120 and 240 minutes post-treatment
timeFrame: Within 240 minutes post-treatment
measure: Need for Rescue Medication between the time of dosing to 240 minutes
timeFrame: Within 240 minutes post-treatment
Other outcomes:
Locations:
city: Valhalla
country: United States
facility: New York Medical College
state: New York
Study officials:
affiliation: New York Medical College
name: Caren Behar, MD
role: PRINCIPAL_INVESTIGATOR
References: