louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00027430: Androgen Replacement Therapy in Women With Hypopituitarism
Official title: TheraDerm Administration in Women With Hypopituitarism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypopituitarism
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2001-12-07
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to determine whether testosterone replacement with TheraDerm can improve bone density, mood, sex drive, thinking, and distribution of body fat and muscle mass in women with hypopituitarism.

Detailed description: Patients will be randomized into 2 groups to receive testosterone replacement therapy or placebo. Group 1 will receive 2 testosterone patches and estrogen pills for 12 months. Group 2 will receive 2 placebo patches and estrogen pills for 12 months. Changes in bone density, bone metabolism markers, body composition, libido, and quality of life will be compared in the women receiving testosterone replacement therapy with that of the women receiving placebo.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: Inclusion criteria:

* Hypogonadism and/or hypoadrenalism of central origin
* Testosterone or free testosterone level below the median for age-matched normal controls
* Prior estrogen preparation for at least 6 months

Exclusion criteria:

* Any disease known to affect bone metabolism, including untreated hypothyroidism or hyperthyroidism
* Change in thyroid hormone dose in the last 3 months
* Untreated Cushing's syndrome
* Renal failure
* Alcoholism
* Anorexia nervosa
* Prior use of medication known to affect bone metabolism (e.g., supraphysiologic doses of glucocorticoids, phenytoin, bisphosphonates, or calcitonin) within the past 3 months
* Pregnant or nursing
* Uncontrolled hypertension
* ALT greater than 3 times upper limit of normal
* Serum creatinine greater than 2 times the upper limit of normal
* Any contraindication to estrogen therapy, including history of breast cancer or undiagnosed uterine bleeding
* Concurrent growth hormone replacement therapy, if patient has been receiving it for less than 2 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Anne Klibanski, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin E, McCabe E, Newton-Cheh C, Bloch K, Buys E, Wang T, Miller KK. Effects of transdermal testosterone on natriuretic peptide levels in women: a randomized placebo-controlled pilot study. Fertil Steril. 2012 Feb;97(2):489-93. doi: 10.1016/j.fertnstert.2011.11.001. Epub 2011 Dec 2.
Clinical trial NCT00787930: Bipolar Disorder in Late Life
Official title: Bipolar Disorder in Late Life (Evaluation of MRI Hyperintensities and DTI in Bipolar Disorder)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: BPD
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2008-11-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects recruited from the adult inpatient and outpatient psychiatric clinics at Duke University Medical Center and John Umstead Hospital (Butner, NC).

Brief summary: The purpose of this study is to look at certain structural changes in the brain in people with bipolar disorder or those with a history of Bipolar disorder.

Detailed description: Individuals with bipolar disorder or those with a history of bipolar disorder may have certain structural changes in their brain. The purpose of this study is to look at those changes, as well as the assessment of risk factors for bipolar disorders, involving both social and psychological aspects of behavior, age, education, marital relations, nutrition, physical activity, etc., compared with persons not having bipolar disorder. These changes in the brain will be measured by Magnetic Resonance Imaging (MRI).

Eligibility criteria: Inclusion Criteria:

1. DSM-IV diagnosis of bipolar Disorder, Manic and mixed episodes.
2. 18 years of age and older, male or female, any race.
3. Capacity to give informed consent and follow study procedures.

Exclusion Criteria:

1. History of alcohol/drug dependence
2. Any metal or pacemaker in the body which precludes MRI
3. Pregnancy
4. Dementia or other primary psychiatric disorders including substance abuse/dependence, anxiety disorders, schizophrenia
5. For controls, numbers one through four above as well as any history of depression or the use of antidepressants

Primary outcomes:
measure: Boyko DWM Hyperintensity Value >2 in Subjects Who Received Acute Treatment for Mania
timeFrame: 3 weeks
measure: Boyko DWM Hyperintensity Value >2 in Subjects Who Received Continuation Treatment
timeFrame: 12 months
Secondary outcomes:
measure: Boyko Subcortical (SC) Hyperintensity Value >2 in Subjects Who Received Continuation Treatment
timeFrame: up to 12 months
measure: fa LOFC in Subjects Who Received Continuation Treatment
timeFrame: up to 12 months
measure: fa ROFC in Subjects Who Received Continuation Treatment
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: John L Beyer, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04552730: Nerve Growth Factor for the Treatment of Cornea Disease
Official title: Observational Study of Cenegermin-bkbj in the Treatment of Limbal Stem Cell Deficiency Associated With Neurotrophic Keratopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurotrophic Keratitis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 5
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: Adults. Both sexes will be recruited. Any ethnic background, as long as they meet the inclusion criteria.

Brief summary: To determine the efficacy and safety of nerve growth factor in the treatment of limbal stem cell deficiency (LSCD) associated with neurotrophic cornea.

Detailed description: This is a prospective open-label pilot study evaluating the role of cenegermin-bkbj for the treatment of LSCD with associated neurotrophic keratopathy. Patient diagnosed with LSCD with neurotrophic cornea who have failed conventional treatment such as artificial tears are enrolled in the study after a 2 week washout period. Patient are then treated with cenegermin-bkbj over an 8 week period.

Eligibility criteria: Inclusion Criteria:

Patients diagnosed with LSCD and neurotrophic cornea confirmed by testing with Cochet-Bonnet aesthesiometer

Exclusion Criteria:

1. Active ocular infection
2. Anticipated need for bandage contact lens, amniotic membrane graft, or tarsorrhaphy during the study period
3. Unable to discontinue the use of contact lens
4. Visual acuity worse than 20/200 in the better eye

Primary outcomes:
measure: Size of abnormal epithelium
timeFrame: Baseline, week 8
Secondary outcomes:
measure: Number of patients with resolution of epithelial defect if present prior to treatment
timeFrame: Baseline, week 8
measure: Cornea sensation
timeFrame: Baseline, week 8
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Christopher N Ta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arboleda A, Ta CN. Observational study of cenegermin for the treatment of limbal stem cell deficiency associated with neurotrophic keratopathy. Ther Adv Ophthalmol. 2022 Nov 4;14:25158414221134598. doi: 10.1177/25158414221134598. eCollection 2022 Jan-Dec.
Clinical trial NCT02988830: Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago
Official title: Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Subcutaneous stimulation
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 19
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 aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in chronic lumbago after 12 months of treatment.


Eligibility criteria: Inclusion Criteria:

* patients over 18 years old
* Having given their non-opposition
* Affiliated to a national insurance scheme or beneficiary
* Suffering for more than a year from a chronic, invalidating lumbago that is refractory in several lines of treatments

Exclusion Criteria:

* patients with lumbago that can be surgically handled or which justified a medullary stimulation
* having been operated for the rachis for less than 6 months;
* which cannot for cognitive or cultural reasons contribute to the planned evaluations and to the management of the material (remote control);
* for who the investigator can plan that they cannot be followed during one year from the date of the setting-up (non-observance, planned moving, etc.);
* which present psychological, local or general contraindications to the setting-up of a neurostimulation device (Impossibility to stop anticoagulants or aggregation inhibitors, disturb of the hemostasis, cutaneous infection change on the site of setting-up)
* MRI planned within the next year
* pregnant or breast-feeding women.

Primary outcomes:
measure: Average pain per day on visual analogical scale
timeFrame: 12 months
Secondary outcomes:
measure: Douleur neuropathique 4 (DN4) score
timeFrame: 12 months
measure: Average pain per day on visual analogical scale
timeFrame: 15 days
measure: OSWESTRY DISABILITY INDEX
timeFrame: 12 months
measure: 36-Item Short Form Health Survey score (SF 36)
timeFrame: 12 months
measure: DALLAS self-questionnaire
timeFrame: 12 months
measure: Tampa scale
timeFrame: 12 months
measure: Questionnaire Hospital Anxiety and Depression scale (HAD)
timeFrame: 12 months
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 12 months
measure: Coping strategies questionnaire (CSQ)
timeFrame: 12 months
measure: Fear Avoidance Belief Questionnaire (FABQ)
timeFrame: 12 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hôpital Foch
name: Marie Christine DJIAN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Foch
name: Bechir Jarraya, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05860530: Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers
Official title: Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the pharmacokinetic characteristics and bioequivalence of two olaparib tablets in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.


Eligibility criteria: Inclusion Criteria:

* Had BMI 18.0 kg/m\^2, and weight ≥ 50 kg for male, or ≥ 45 kg for female
* Patients who were on olaparib treatment, had epithelial ovarian, fallopian tube, or primary peritoneal cancer, or were eligible for olaparib treatment judged investigators
* Had ECOG performance status 0-1
* Had life expectancy \>12 weeks
* Had Adequate organ function or clinically irrelevant abnormal result
* Agreed to use adequate contraception from 14 days before treatment initiation to 6 months after last dose

Exclusion Criteria:

* Allergic to any component of study drugs
* Had central nervous system metastases (stable and asymptomatic metastases were acceptable)
* Had other malignancy within 5 years
* Had disease affecting swallow or absorption
* Received major surgery within 1 month before study drug administration
* Had major disease
* Had continuous grade 3-4 adverse event
* Had drug abuse
* Had (suspected) pneumonitis
* Participated in other clinical trial of drug or device within 1 month
* Lost or donated blood \> 200 mL or received blood transfusion within 1 month
* With average alcohol consumption \> 14 units/week or cigarette consumption \> 20/day within 1 month
* Positive for human immunodeficiency virus, hepatitis B, C, or syphilis test
* Received strong or moderate CYP3A inducer or inhibitor within 3 half-lives of the drug
* Consumed grape fruit juice, or other food or beverage containing caffeine or xanthine
* For female, pregnant or breastfeeding

Primary outcomes:
measure: Cmax,ss
timeFrame: Day 7
measure: AUC0-τ
timeFrame: 0-12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
Study officials:
References:
Clinical trial NCT01161030: Almonds and Diabetes Management
Official title: Almond Ingestion at Meal-time Reduces Postprandial Glycemia and Chronic Ingestion Reduces Hemoglobin A1c in Individuals With Well-controlled Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2010-07-13
Enrollment: 32
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This trial examined the impact of acute and chronic almond ingestion on indicators of glucose control (postprandial glycemia and hemoglobin A1c). Hypotheses:

1. Almonds will stimulate the secretion of GLP-1 in healthy adults and in adults with T2D The investigators were not able to demonstrate a relationship between GLP-1 secretion and almond consumption. Individuals with T2D were characterized with significantly greater GLP-1 secretion than the non-diabetic control subjects.
2. Acute ingestion of almonds will decrease the postprandial glycemia and insulinemic responses in healthy controls and in individuals with T2D The investigators data support the hypothesis: almond consumption by individuals with T2D did attenuate postprandial glycemia; however, almond consumption did not alter glycemia in non-diabetic control subjects
3. Chronic almond ingestion for 12 weeks will reduce fasting glucose (FG) and A1c concentrations in individuals with T2D The investigators data demonstrated modest beneficial effect of almond consumption on A1c in individuals with T2D. Almond consumption was also associated with modest weight loss as compared to the control treatment (low fat cheese sticks).


Eligibility criteria: Inclusion Criteria:

* 12 subjects with diagnosed T2D for at least 1 year and 12 healthy individuals without T2D will be recruited for the acute almond trial.
* 24 subjects with diagnosed T2D for at least 1 year will be recruited for the chronic almond trial.
* Subjects from the campus population and nearby communities will be recruited to participate in these trials.
* Men and women must be willing to comply with the experimental protocol including the restriction of nut consumption:

  * subjects recruited for the acute almond study must agree not to consume any nuts or nut butters for 1-week prior to and during the 2-week trial
  * participants in the chronic almond study must agree not to consume nuts or nut butters more than 2 times per week during the 12 week trial.
* Participants must have a body mass index (BMI) from 20 to 35 kg/m2 and are aged 30 to 70 years.
* Subjects with T2D may take oral hyperglycemic agents.

Exclusion Criteria:

* Insulin use
* History of a peanut allergy
* Chronic or unresolved disease
* Current smoking habit
* Pregnant or lactating
* Medication use that may impact incretin secretion. \[Incretins are gastrointestinal hormones secreted at meal-time.\]

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05803330: Study of Alpha-blockers Alone During Preoperative Preparation in Patients With Pheochromocytoma
Official title: Clinical Study of Abandonment of Intravenous Volume Expansion After Preoperative Use of α-blockers in Patients With Adrenal Pheochromocytoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adrenal Pheochromocytoma
Hemodynamic
Lead sponsor: Handan First Hospital
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study of the relationship between hemodynamic stability and preoperative intravenous rehydration in patients with pheochromocytoma

Detailed description: All patients were subclassified into either the hemodynamic stability group (HS group) or the hemodynamic instability group (HU group) according to whether intraoperative hemodynamic instability occurred. Differences in data between the two groups were examined, and the risk factors for intraoperative hemodynamic instability were analyzed using logistic regression.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of adrenal pheochromocytoma Must be able to swallow tablets

Exclusion Criteria:

Bilateral or multiple pheochromocytomas. Ectopic pheochromocytoma

Primary outcomes:
measure: intraoperative mean arterial pressure
timeFrame: During surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Handan First Hospital
name: kunwu yan, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meijs AC, Snel M, Corssmit EPM. Pheochromocytoma/paraganglioma crisis: case series from a tertiary referral center for pheochromocytomas and paragangliomas. Hormones (Athens). 2021 Jun;20(2):395-403. doi: 10.1007/s42000-021-00274-6. Epub 2021 Feb 11.
citation: Challis BG, Casey RT, Simpson HL, Gurnell M. Is there an optimal preoperative management strategy for phaeochromocytoma/paraganglioma? Clin Endocrinol (Oxf). 2017 Feb;86(2):163-167. doi: 10.1111/cen.13252. Epub 2016 Oct 24.
citation: Randle RW, Balentine CJ, Pitt SC, Schneider DF, Sippel RS. Selective Versus Non-selective alpha-Blockade Prior to Laparoscopic Adrenalectomy for Pheochromocytoma. Ann Surg Oncol. 2017 Jan;24(1):244-250. doi: 10.1245/s10434-016-5514-7. Epub 2016 Aug 25.
citation: Bihain F, Nomine-Criqui C, Guerci P, Gasman S, Klein M, Brunaud L. Management of Patients with Treatment of Pheochromocytoma: A Critical Appraisal. Cancers (Basel). 2022 Aug 9;14(16):3845. doi: 10.3390/cancers14163845.
Clinical trial NCT02091830: Non-surgical Treatment of Knee Osteoarthritis - a Comparison of Effects in 2200 Patients
Official title: Non-surgical Treatment of Knee Osteoarthritis - a Comparison of Effects in 2200 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 2262
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: 2200 patients with knee osteoarthritis not eligible for at total knee arthroplasty

Brief summary: The purpose of this study is to assess whether radiographic osteoarthritis severity (OA; Kellgren-Lawrence scale) is associated with self-reported improvement in pain after non-surgical treatments (physiotherapy, pain killers, injection, other treatments).

The hypothesis is that radiographic OA severity is inversely associated with self-reported improvement.


Eligibility criteria: Inclusion Criteria:

* Not eligible for at total knee arthroplasty

Exclusion Criteria:

* Ipsilateral knee arthroplasty

Primary outcomes:
measure: Self-reported improvement
timeFrame: 2-5 years after consulting orthopedic surgeon
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Orthopedic Surgery
Study officials:
affiliation: Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital, Denmark.
name: Michael Rathleff, MSc
role: STUDY_CHAIR
affiliation: Department of Mathematical Sciences, Aalborg University
name: Mikkel M Andersen, MSc
role: STUDY_CHAIR
affiliation: Department of Orthopedic Surgery
name: Ole Simonsen, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthopedic Surgery
name: Christina A Derosche, BSc
role: STUDY_CHAIR
affiliation: Department of Orthopedic Surgery
name: Signe B Pedersen
role: STUDY_CHAIR
affiliation: Orthopedic Surgery Research Unit + Department of Health Science and Technology, Aalborg University
name: Søren T Skou, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT00960830: Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety
Official title: Mirtazapine Reduces ICD Appropriate Shocks in Cardioverter Implanted Patients With Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Universidad Nacional de Rosario
Sponsor class: OTHER
First posted: 2009-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 87
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate if the use of antidepressant medication in depressed patients with implantable cardioverter defibrillator reduces the number of ICD's shocks as it improves depressive affect.

Detailed description: episodes of arrhythmia remain present even after icd implantation, this is specially true in depressed patients. it is hypothesized that improving mood state by means of an antidepressant drug . namely mirtazapine. could be responsible of alleviating the number of appropriate shocks delivered by the cardioverter. this could be due to a direct effect of the drug itself or an indirect effect of improving anxious and depressive affect. the mood and anxiety state are measured with the HADS scale

Eligibility criteria: Inclusion Criteria:

* cardioverter implanted patients
* depression
* anxiety

Exclusion Criteria:

* heart failure
* other diseases reducing physical fitness

Primary outcomes:
measure: number of implantable cardioverter defibrillator shocks
timeFrame: one year
Secondary outcomes:
measure: improvement of depression
timeFrame: one year
Other outcomes:
Locations:
city: San Nicolas
country: Argentina
facility: Cl Sn Nicol
state: Bs As
Study officials:
affiliation: facultad de psicologia
name: daniel jl serrani, MD
role: PRINCIPAL_INVESTIGATOR
References: