louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02090582: H.O.P.E: Helping Ovarian Cancer Patients Cope
Official title: Pilot Study on H.O.P.E: Helping Ovarian Cancer Patients Cope During Disease Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platinum-resistant Ovarian Cancer
Recurrent Ovarian Cancer
Palliative Care
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test the effect of the gynecologic oncologists with palliative care specialist collaboration (GO-PC) intervention on patient quality of life.

Detailed description: Eligible patients include women diagnosed with platinum-resistant ovarian cancer or recurrent ovarian cancer cancer. All patient participants will complete two quality of life (QOL) questionnaires and a cost-diary documenting their health care experience at time of consent and every 12 weeks thereafter. Consenting care givers will also be asked to complete two questionnaires to asses the impact of structured palliative care on them every 12 weeks.

Patients will be assigned to two arms randomly: 1) usual care or 2) structured palliative care. The primary endpoint is quality of life. A two-sided Chi-square test will be used to compare the proportion of patients who have improved quality of life after treatment between control arm and intervention arm. The average value of multiple scores after treatment will be used to compare with the baseline score before treatment for each question in the standard questionnaire.

Eligibility criteria: Inclusion Criteria:

* Platinum-resistant ovarian cancer or recurrent ovarian cancer
* Ability to read and respond to questions in English

Exclusion Criteria:

* Platinum-sensitive recurrent ovarian cancer without a significant clinical event
* Existence of co-morbid disease, which in the opinion of the investigator prohibits participation in the protocol

Primary outcomes:
measure: Quality of Life (Functional Assessment of Cancer Therapy for Ovarian Cancer and Functional Assessment of Chronic Illness Therapy for Palliative Care)
timeFrame: Every 12 weeks for a maximum of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Paula S Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01873482: Traditional African Healing Ceremony in a U.S. Population
Official title: Traditional African Healing Ceremony in a U.S. Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Fatigue Syndrome
Anxiety
Depression
Cancer
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 17
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pre-agricultural societies almost universally used healing ceremonies that involved reverence, rhythm and dance in the presence of a healer. It is believed that we are "wired" for such experiences and they foster an integrative mode of consciousness similar to that of mindfulness based stress reduction, which has been shown to have therapeutic effects in a variety of conditions. Collaborator Ava Lavonne Vinesett of the Duke Dance Program has developed a healing ceremony based in sub-Saharan African traditions. The investigators plan is to have 25 subjects with a variety of clinical conditions participate in this ceremony. Subjects will then be asked to write a commentary about their experience and to participate in a focus group discussion. It is anticipated that the study will give us some idea of how promising this approach would be and what kinds of patients might benefit. Safety issues are minimal and include the possibility of injury (though the dancing is not strenuous) and psychological distress.


Eligibility criteria: Inclusion Criteria:

* Age 25 to 65 with one of the diagnoses listed above or with 8 visits to their provider in the last year and with no diagnosis of chronic illness.

Exclusion Criteria:

* physical disability making participation difficult and previous experience with a similar ceremony, for instance while growing up in Africa.

Primary outcomes:
measure: Report from each participant as to whether they found the experience positive, neutral or negative.
timeFrame: During the first hour after the intervention
Secondary outcomes:
measure: written narrative of experience
timeFrame: During the first hour after the intervention
Other outcomes:
measure: Encounter group discussion
timeFrame: During the first hour after the intervention
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Kenneth Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01374282: Post Marketing Surveillance Study of Cuprimine
Official title: Post Marketing Surveillance Study of Cuprimine (MK-0172-001)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Scleroderma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-06-15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Cuprimine (penicillamine) was made available in the Philippines by the Sponsor under a Compassionate Special Permit issued by the Bureau of Food and Drugs. Physicians were able to request the drug for their patients from the Sponsor. A Clinical Study Report form was completed for each purchase of Cuprimine.


Eligibility criteria: Inclusion Criteria:

- None

Exclusion Criteria:

- None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01687582: Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients
Official title: Clinical and Histopathological Effect of GLP-1 Analogs on Psoriasis in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Psoriasis
Keywords: type 2 diabetes
psoriasis
exenatide
liraglutide
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 20
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 aim of the study is to evaluate after 4 to 6 months the effects of a GLP-1 analog treatment on psoriatic skin lesions in patients with type 2 diabetes.

Detailed description: The objective of this study is to analyse short and medium-term efficacy on clinical, immunological and histopathological parameters of a GLP-1 receptor agonist on moderate to severe psoriasis plaques in a group of patients with type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients treated with oral anti-hyperglycaemic agents and/or insulin and presenting stable psoriasis plaques for at least one year, which failed to respond to previous systemic and/or topical treatments.

Exclusion Criteria:

* Type 1 diabetes
* Secondary diabetes
* Liver, renal or pancreatic disease
* Previous treatment with GLP-1 agonist or DPP-4 inhibitors agents

Primary outcomes:
measure: Improvement of PASI score
timeFrame: 4 to 6 months
Secondary outcomes:
measure: Evolution of BMI (body mass index)
timeFrame: 4 to 6 months
measure: Evolution of immunological data
timeFrame: 4 to 6 months
measure: Evolution of histopathological data
timeFrame: 4 to 6 months
measure: Evolution of glycaemic control
timeFrame: 4 to 6 months
measure: Evolution of routine laboratory measures
timeFrame: 4 to 6 months
measure: Evolution of BMI
timeFrame: 4 to 6 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Martin Buysschaert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buysschaert M, Tennstedt D, Preumont V. Improvement of psoriasis during exenatide treatment in a patient with diabetes. Diabetes Metab. 2012 Feb;38(1):86-8. doi: 10.1016/j.diabet.2011.11.004. Epub 2012 Jan 9.
citation: Hogan AE, Tobin AM, Ahern T, Corrigan MA, Gaoatswe G, Jackson R, O'Reilly V, Lynch L, Doherty DG, Moynagh PN, Kirby B, O'Connell J, O'Shea D. Glucagon-like peptide-1 (GLP-1) and the regulation of human invariant natural killer T cells: lessons from obesity, diabetes and psoriasis. Diabetologia. 2011 Nov;54(11):2745-54. doi: 10.1007/s00125-011-2232-3. Epub 2011 Jul 9.
Clinical trial NCT02124382: Living Donor Liver Transplantation in Children
Official title: Living Donor Liver Transplantation in Children: Surgical and Immunological Results in 250 Recipients at Université Catholique de Louvain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Liver Transplanted Recipients
Healthy Donors
Keywords: liver failure
liver malignancy
metabolic diseases
Pediatric liver transplanted recipients and their healthy donors
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 500
Sex: ALL
Maximum age (years): 57
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 250 pediatric living donor liver transplant recipients 250 corresponding adult living donors

Brief summary: Evaluate the outcome of pediatric living donor liver transplantation (LDLT) regarding portal vein reconstruction, ABO-compatibility and impact of maternal donation on graft acceptance.

Detailed description: Data from 250 pediatric LDLT recipients (and their donors), transplanted at Cliniques universitaires Saint-Luc between July 1993 and June 2012, were collected retrospectively using electronic data files. Results were analysed according to ABO matching and portal vein complications. Uni- and multi-variate analysis was used to study the impact of immunosuppression, gender match and maternal donation on acute rejection rate.

Eligibility criteria: Inclusion Criteria:

* Children receiving a living donor liver transplant
* Adult living donors

Exclusion Criteria:

* No one

Primary outcomes:
measure: Patient and graft survival
timeFrame: 10 years
Secondary outcomes:
measure: Portal vein complications
timeFrame: 10 years
Other outcomes:
measure: Graft rejection free survival
timeFrame: 10 years
Locations:
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Raymond Reding, Md-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05452382: Surgical Outcome and Predictors of Overall Survival of Stage I-III Appendiceal Adenocarcinoma
Official title: Surgical Outcome and Predictors of Overall Survival of Stage I-III Appendiceal Adenocarcinoma; a National Cancer Database Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Appendiceal Cancer
Lead sponsor: Mansoura University
Sponsor class: OTHER
Collaborators: name: Cleveland Clinic Florida
First posted: 2022-07-11
Enrollment: 2607
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage I-III appendiceal adenocarcinoma

Brief summary: A few studies investigated the predictors of overall survival in appendiceal adenocarcinoma. A SEER database analysis of 1404 patients with appendiceal adenocarcinoma found that older age, T4 tumors, N1-2 stage, poorly differentiated carcinoma, and distant metastasis were significantly predictive of poorer survival. Another small single-center study including 49 appendiceal cancer patients reported female gender and low-grade adenocarcinoma to be associated with increased overall survival. However, these previous analyses did not take into account some important prognosticators of survival such as patients' comorbidities and functional status, pathologic parameters such as lymphovascular invasion, and adjuvant systemic treatment. Therefore, we used the National Cancer Database (NCDB) to conduct a comprehensive analysis of the predictors of overall survival after surgical treatment of stage I-III appendiceal adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* patients with non-metastatic appendiceal adenocarcinoma who underwent surgical resection

Exclusion Criteria:

* Patients with other pathologic types of appendiceal cancer
* Patients with clinical stage IV or unknown stage
* Patients who did not undergo surgery, underwent local excision, or had unknown/non-specified surgery

Primary outcomes:
measure: Overall survival
timeFrame: 60 months
Secondary outcomes:
measure: Positive resection margins
timeFrame: Immediate postoperative
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Flroida
state: Florida
Study officials:
References:
Clinical trial NCT03781882: Local Injection of PRP During Repair of Disrupted Surgical Wounds
Official title: Local Injection of Autologous Platelet Rich Plasma During Repair of Disrupted Surgical Wounds at Obstetrics and Gynecology Department: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Role of Platelet Rich Plasma in Wound Healing
Keywords: Platelet rich plasma
disrupted wounds
Obstetrics and Gynecology
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 220
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All cases with disrupted surgical wounds admitted at Obstetrics and Gynecology departments
Primary purpose: TREATMENT

Brief summary: Patients with disrupted wounds will either managed as usual or managed by Platelet rich plasma local infiltration in the wound edges

Detailed description: The patients with disrupted surgical wounds will be cleansed, debrided and closed with infiltration of platelet rich plasma in one group and the other group will be closed without infiltration of Platelet rich plasma

Eligibility criteria: Inclusion Criteria:

* Disrupted surgical wounds after cesarean sections and other gynecological operations
* Body mass index 18-25
* Hemoglobin \> 10.5gm/dl
* Albumin \>3.5gm/dl

Exclusion Criteria:

* Medical disorders asDiabetes mellitus (DM), Liver disease or systemic lupus erythymatosus (SLE)
* Patient on corticosteriod therapy
* Thrombocytopenia
* Coagulation disorders

Primary outcomes:
measure: Complete wound healing
timeFrame: 30 days
measure: Duration of hospital stay
timeFrame: 30 days
Secondary outcomes:
measure: Failure of complete wound healing
timeFrame: 30 days
measure: Need fo tertiary suture
timeFrame: 30 days
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ayman Shehata Dawood
Study officials:
References:
Clinical trial NCT00982982: Effects of Delta-9-THC and Iomazenil in Healthy Humans
Official title: Gamma-Amino Butyric Acid (GABA) Deficits and Vulnerability to Cannabinoid-Induced Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Schizophrenia
Mental Disorders
Psychotic Disorders
Keywords: Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Cannabis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to examine the combined effects of delta-9-tetrahydrocannabinol (∆-9-THC or THC) and iomazenil on thinking, perception, mood, memory, attention, and electrical activity of the brain (EEG). THC is the active ingredient of marijuana, cannabis, "ganja", or "pot". Iomazenil is a drug that works opposite to drugs like valium. The purpose of this study is to determine whether the administration of iomazenil will alter the effects of THC.


Eligibility criteria: Inclusion Criteria:

* Exposed to cannabis at least once in their lifetime

Exclusion Criteria:

* Cannabis naïve
* History of hearing deficit

Primary outcomes:
measure: Clinician Administered Dissociative Symptoms Scale
timeFrame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
measure: Positive and Negative Symptom Scale
timeFrame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
measure: Visual Analog Scale
timeFrame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
measure: Auditory Verbal Learning Test
timeFrame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
measure: Perceptual Aberration Scale
timeFrame: On each test day at: baseline, +10min after infusion, +70min, +150min, +240min
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University Medical School
name: Deepak C D'Souza, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00560820: Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload
Official title: Phase I Study to Examine the Effect of Deferasirox on Renal Hemodynamics in β-thalassemia Patients With Transfusional Iron Overload
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: β-thalassemia
Transfusional Iron Overload
Keywords: β-thalassemia
transfusional iron overload
renal function
renal biomarkers
deferasirox
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-11-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the effect of deferasirox on renal hemodynamics by determining glomerular filtration rate (GFR), renal plasma flow (RPF) and filtration fraction (FF).


Eligibility criteria: Inclusion criteria:

* Male or female patients ≥ 18 years of age without prior history of deferasirox treatment
* β-thalassemia patients receiving regular transfusions every 2-5 weeks
* Transfusion history of ≥ 20 units of packed red blood cells

Exclusion criteria:

* Abnormal renal function at baseline
* ALT greater than 5 x ULN at screening
* Patients with underlying cardiac disease requiring continuous iron chelation therapy

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Effect of deferasirox on renal hemodynamics in patients with β-thalassemia and transfusional iron overload.
timeFrame: Once a month
Secondary outcomes:
measure: Effect of deferasirox on standard markers of renal function
timeFrame: Once a month
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Novartis Investigative Site
state: CA
city: Genova
country: Italy
facility: Novartis Investigative Site
state: GE
city: Orbassano
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Piga A, Fracchia S, Lai ME, Cappellini MD, Hirschberg R, Habr D, Wegener A, Bouillaud E, Forni GL. Deferasirox effect on renal haemodynamic parameters in patients with transfusion-dependent beta thalassaemia. Br J Haematol. 2015 Mar;168(6):882-90. doi: 10.1111/bjh.13217. Epub 2014 Nov 17.
Clinical trial NCT06156020: Outcome Analysis of Endoscopic Resection of Pituitary Adenomas
Official title: Analysis of Operative Outcomes Following Endoscopic Resection of Pituitary Adenomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pituitary Adenoma
Keywords: pituitary adenoma
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this prospective study is to learn about the operative outcomes in patients with pituitary adenoma who receive endoscopic resection.

The main question it aims to answer is:

• What are the outcomes of patient following endoscopic resection? including visual, hormonal, survival, and functional outcomes.

Participants' data including clinical history, laboratory data, radiographic images, intraoperative videos will be evaluated and analyzed.


Eligibility criteria: Inclusion Criteria:

* Adult patient
* Pathological diagnosis of pituitary adenoma
* Underwent endoscopic endonasal resection

Exclusion Criteria:

* Age \< 18 or \> 80 years
* Non-pituitary adenoma pathologies
* Underwent non-endoscopic surgery

Primary outcomes:
measure: Visual field
timeFrame: 6 months
measure: Diabetes insipidus
timeFrame: 6 months
measure: Cortisol level
timeFrame: 6 months
measure: Thyroid hormone level
timeFrame: 6 months
measure: Prolactin level
timeFrame: 6 months
measure: IGF-1 level
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References: