louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00000390: Antidepressant Treatment of AIDS Related Depression.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: Adult
Acquired Immunodeficiency Syndrome
Depression
Female
Human
Imipramine
Male
Middle Age
Acquired Immunodeficiency Syndrome -- *complications
Depression -- *drug therapy
Depression -- etiology
Imipramine -- *therapeutic use
Lead sponsor: National Institute of Mental Health (NIMH)
Sponsor class: NIH
First posted: 2000-01-18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Primary purpose: TREATMENT

Brief summary: To test the effectiveness treating AIDS related depression with imipramine hydrochloride.

Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status.

This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over phase in which placebo non responders are entered into an open-label study and given imipramine hydrochloride.

Detailed description: To test the effectiveness treating AIDS related depression with imipramine hydrochloride.

Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status.

This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over phase in which placebo non responders are entered into an open-label study and given imipramine hydrochloride.

Eligibility criteria: Inclusion Criteria:

* Patient must be ambulatory and relatively good health. Even if unable to work at least able to partially care care for self and not demented.
* May have been alcoholic or drug abuser 6 months previous.
* Unspecified
* CD4 Unspecified.

Exclusion Criteria:

* Non ambulatory patients or those requiring extensive help in self care are excluded.
* Non ambulatory patients or those requiring extensive help in self care are excluded.
* Current alcohol or drug abuse.
* Unspecified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Hosp - Cornell Med Ctr
state: New York
Study officials:
name: Frances A
role: STUDY_CHAIR
name: Manning D
role: STUDY_CHAIR
References:
Clinical trial NCT03021590: Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori
Official title: Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Helicobacter Pylori Gastrointestinal Tract Infection
Keywords: Helicobacter pylori
Helicobacter Infections
Proton Pump Inhibitors
sequential therapy
Clarithromycin
Tinidazole
Lead sponsor: Damascus Hospital
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 0
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: Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on the Eradication of Helicobacter Pylori in Syrian population


Eligibility criteria: Inclusion Criteria:

-Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods: I-Positive rapid urease test (CLOtest). II-Histologic evidence of H. pylori by modified Giemsa staining. III-Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.

Exclusion Criteria:

* Children and teenagers aged less than 18 years.
* Previous eradication treatment for H. pylori.
* Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
* History of gastrectomy.
* Gastric malignancy, including adenocarcinoma and lymphoma,
* Previous allergic reaction to antibiotics (Amoxicillin, Tinidazole , Levofloxacin) and prompt pump inhibitors (Es-omeprazole).
* Contraindication to treatment drugs.
* Pregnant or lactating women.
* Severe concurrent disease. Liver cirrhosis. Chronic kidney disease.
* Patients who cannot give informed consent by himself or herself.

Primary outcomes:
measure: Helicobacter pylori Eradication rate
timeFrame: 6 weeks after eradication therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus Hospital
Study officials:
References:
Clinical trial NCT01128790: Pilot Study of Remote Ischemic Preconditioning in Heart Failure
Official title: Effect of Remote Ischemic Preconditioning on Exercise Capacity in Patients With Heart Failure: A Double Blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Left Ventricular Dysfunction
Keywords: exercise
remote ischemic preconditioning
heart failure
left ventricular dysfunction
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2010-05-24
Enrollment: 22
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: The purpose of this study is to determine the effect of remote ischemic preconditioning on exercise capacity in patients with heart failure.


Eligibility criteria: Inclusion Criteria:

* LV ejection fraction \<40%
* NYHA functional class II-IV
* Non ischemic cardiomyopathy
* Stable

Exclusion Criteria:

* recent cardiovascular hospitalization (within last 4 weeks)
* ischemic cardiomyopathy
* diabetes mellitus
* peripheral neuropathy
* ventricular assist device
* contraindications to exercise stress testing

Primary outcomes:
measure: Exercise performance - VO2, exercise time, exercise workload, anaerobic threshold
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
References:
citation: McDonald MA, Braga JR, Li J, Manlhiot C, Ross HJ, Redington AN. A randomized pilot trial of remote ischemic preconditioning in heart failure with reduced ejection fraction. PLoS One. 2014 Sep 2;9(9):e105361. doi: 10.1371/journal.pone.0105361. eCollection 2014.
Clinical trial NCT05776290: The Effect of Hyaluronic Acid Gel on Relieving Post-Implantation Pain
Official title: Evaluation of the Efficacy of a Hyaluronic Acid Gel in Relieving Post-Implantation Pain: A Split-Mouth Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Complication
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 11
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth design
Primary purpose: TREATMENT

Brief summary: Few previous studies have employed HA in the implant socket; instead, the majority have applied it topically to the area around dental implants after they have been placed. The application was done after suturing in these investigations. Therefore, the goal of the current study was to inject HA into the implant socket and onto the alveolar bone prior to implant insertion and suturing in order to preserve the HA for an extended period of time.

This study aims to use a visual analog scale (VAS) on the first, third, and tenth days following the surgical intervention to assess the efficacy of employing HA in dental implants in terms of pain reduction that may accompany dental implant surgery.


Eligibility criteria: Inclusion Criteria:

* bilateral tooth loss with a sufficient amount of bone volume
* no general problems
* good oral health
* age between 20 and 60 years

Exclusion Criteria:

* the use of immunosuppressive drugs and corticosteroids for long periods
* the existence of serious systemic disorders
* contraindications for local anesthesia or oral surgery
* pregnant women and nursing mothers
* patients receiving chemotherapy or radiation
* alcoholics and heavy smokers.

Primary outcomes:
measure: Change in the Perception of pain
timeFrame: First assessment: at 24 hours following the surgical procedure. Second assessment: at 72 hours following the surgical intervention. Third assessment will be made on the tenth day following the surgical intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Oral Medicine, Faculty of Dentistry, University of Damascus
Study officials:
affiliation: PhD student at the Department of Oral Medicine
name: Waseem Al-Khateeb, DDS MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00942864: Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)
Official title: An Open-label, Nonrandomized, Phase IIIb, Single Dose Study to Evaluated the Changes in Optical Coherence Tomography (OCT) and Fluorescein Angiography (FA) After Intravitreal Injection of Lucentis® in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Edema
Retinal Vein Occlusion
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-07-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of intravitreal Lucentis® (Ranibizumab) and investigate the anatomical and functional improvement following this treatment in patients with macular edema due to retinal vein occlusion (RVO).


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Patients with macular edema due to RVO (confirmed by fundus photography, fluorescein angiography, OCT)
* Male and female aged from 18 to 70
* Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/400 to 20/30 using ETDRS chart

Exclusion Criteria:

* Additional eye disease that could compromise VA
* Ocular inflammation
* Intraocular surgery ≤ 1 month before day 0
* Uncontrolled glaucoma
* Prior treatments with laser photocoagulation or other intervention for macular edema due to BRVO
* Patients aged under 18 or over 71
* Female patient in pregnancy or breast feeding
* Not suitable to regular follow up

Primary outcomes:
measure: The change in ETDRS visual acuity letter scores from baseline. The change in the 1-mm central retinal thickness as measured by OCT from baseline.
timeFrame: every 4 weeks (up to 52 weeks)
Secondary outcomes:
measure: The intraretinal structure changes in OCT. Progression of avascular area by FA. Number of additional treatments. Intraocular safety (endophthalmitis, uveitis, increase in intraocular pressure, etc).
timeFrame: every 4 weeks (up to 52 weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Dept. of ophthalmology, Kyung Hee University Medical Center
Study officials:
affiliation: Dept. ophthalmology, Kyunghee medical center
name: Seung-Young Yu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06032364: Stone Disease of the Urinary Tract in Children
Official title: Stone Disease of the Urinary Tract in Children: Clinical Presentation, Diagnostic Methods, Therapeutic Management, Evolution and Prognosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Lithiasis
Keywords: Urinary Lithiasis
Stone disease
Urolithiasis
Urinary Calculi
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged less than 18 years presenting with lithiasis of the urinary tree in one of the two departments concerned between 01/01/2010 and 12/31/2022

Brief summary: The incidence of stone disease of the urinary tract in children is increasingly increasing with a remarkable economic impact for its management.

This incidence is variable according to race, geographic region, socio-economic status and dietary habits.

Oxalo-calcium stones are the most common but the biochemical nature of urinary stones varies depending on the region where those of a phosphatic nature are characterized by a higher incidence in Europe.

The diagnosis is confirmed by imaging. The unprepared abdomen (ASP) has low diagnostic accuracy. The scanner is the reference tool but remains an irradiating examination.

Risk factors for disease recurrence include primarily the presence of an underlying urinary metabolic abnormality and young age. Urinary metabolic abnormalities vary from one study to another.

The understanding of lithogenesis, its evaluation as well as the therapeutic options is essential for adequate and adapted management in the pediatric population.


Eligibility criteria: Inclusion criteria:

* Patients aged less than 18 years.
* Both sexes.
* Subjects presenting with lithiasis of the urinary tree in one of the two departments concerned between 01/01/2010 and 12/31/2022
* Subject not opposing, after information, the reuse of their data for the purposes of this research.
* Holders of parental authority who do not object, after being informed, to the reuse of their child's data for the purposes of this research.

Exclusion criteria:

* Subject or holder of parental authority having expressed opposition to participating in the study.
* Non-usable patient files: insufficient data.

Primary outcomes:
measure: Study of the modalities of the therapeutic management of children with urinary stones, retrospective description of the evolutionary aspects and the risk factors associated with recurrence.
timeFrame: Files analysed retrospectively from January 01, 2010 to December 31, 2022 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pédiatrie 1 - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT01852864: Degarelix Before Radical Prostatectomy
Official title: A Study of the Early Biological Effects of Testosterone Suppression in Prostate Cancer Using Neoadjuvant Degarelix Prior to Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
Keywords: Prostate cancer
testosterone
castration
degarelix
proliferation
Lead sponsor: University of Cambridge
Sponsor class: OTHER
First posted: 2013-05-14
Enrollment: 40
Sex: MALE
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: BASIC_SCIENCE

Brief summary: The biological effects of castration on prostate cancers will be studies by administration of degarelix prior to radical prostatectomy.

The effects will be studied by analysis of gene expression and immunohistochemistry focusing on markers of proliferation and apoptosis of samples taken at the time of radical prostatectomy (7 days after administration of degarelix).

Tumours from patients treated with neo-adjuvant degarelix will be compared with tumours from patients who have not been medically castrated.


Eligibility criteria: Inclusion Criteria:

* Intermediate/high risk prostate cancer
* Patient eligible for and wanting surgery

Exclusion Criteria:

* Inability to consent
* Previous thromboembolism/arrhythmias
* contraindication to degarelix or surgery

Primary outcomes:
measure: proliferative index defined by immunohistochemistry for ki67
timeFrame: at surgery, 7 days after administration of degarelix
Secondary outcomes:
measure: Gene expression levels measured by microarray
timeFrame: At surgery 7 days after degarelix administration
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hopital NHS Trust
state: Cambridgeshire
Study officials:
affiliation: Cambridge University
name: David Neal, BSc MS FRCS
role: STUDY_CHAIR
References:
Clinical trial NCT03224364: Solo and Non-solo Approach for Laparoscopic Appendectomy (SOLOAP)
Official title: A Randomized Controlled Trial Comparing a Solo and Non-solo Approach for Laparoscopic Appendectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Appendicitis
Laparoscopic
Keywords: Solo surgery
Camera holder
Laparoscopic Appendectomy
Lead sponsor: Daejeon St. Mary's hospital
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the safety and feasibility of solo laparoscopic appendectomy, which is defined as the application of solo surgery to laparoscopic appendectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Detailed description: Laporoscopic appendectomy usually requires three surgeons, including an operator, a camera assistant, and other instrument assistant. Recent advancement of technology made it possible to develop the conveniently adjustable holders for camera and other laparoscopic instruments. The application of these instruments enables "solo-surgery" wherein an operation is driven by single surgeon. During surgery, human assistant(s) are helpful because of their instant assistance according to the operation's need. Therefore, the utilization of instruments instead of human assistants would be cumbersome. However, the utilization of instruments would be helpful by enabling operation-driven repositioning of the camera and instrument(s). Currently, no attempt has been made to objectively compare the merits and demerits of these two procedures. Therefore, this study was conducted to determine the safety and feasibility of solo laparoscopic appendectomy, which is defined as the application of solo surgery to laparoscopic appendectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).

Eligibility criteria: Inclusion Criteria:

1. The patients planned to undergo elective laparoscopic appendectomy
2. Benign gallbladder diseases requiring surgery
3. The patients who are indicated for single-port laparoscopic appendectomy.

Exclusion Criteria:

1. the patients with complicated cholecystitis
2. the patients with the gallbladder with a thickness more than 4mm.
3. the patients who are expected to have severe peritoneal adhesion.
4. the patients with malignant gallbladder diseases.
5. the patients whose operation appears to need human assistant(s)

Primary outcomes:
measure: Operation time
timeFrame: day 1
Secondary outcomes:
measure: Pain score
timeFrame: day 3
Other outcomes:
Locations:
Study officials:
affiliation: Daejeon St. Mary's hospital, the Catholic University of Korea, 222, Banpo-dong, Seocho-gu, Seoul, 06591, South Korea
name: Say-June Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004364: Study of Novel Types of Familial Diabetes Insipidus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Insipidus
Keywords: diabetes insipidus
endocrine disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Northwestern University
First posted: 1999-10-19
Enrollment: 5
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES:

I. Define the phenotype and genotype of previously unrecognized types of familial diabetes insipidus (FDI) in kindreds with atypical or novel forms of FDI.

Detailed description: PROTOCOL OUTLINE: Participants undergo a series of tests to determine the presence, absence, cause, natural history, clinical status, and mode of inheritance of their type of diabetes insipidus (DI). The studies include measurements of basal fluid intake and urine output, plasma vasopressin during standard fluid deprivation or waterload/saline infusion tests, and changes in water balance during a therapeutic trial of DDAVP. If clinically indicated, echocardiograms and assays of plasma catecholes and renin are also completed.

Linkage analysis is performed for all participants; kindreds with the Marfan-like syndrome are also studied for the fibrillin-1 genotype.

Participants determined to have DI are treated with desmopressin for 2 days.

Eligibility criteria: * Familial diabetes insipidus (DI) in atypical or novel form, e.g.: Dipsogenic DI Neurohypophyseal DI
* Affected and unaffected members of kindreds eligible

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Gary L. Robertson
role: STUDY_CHAIR
References:
Clinical trial NCT06957964: Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds: A Randomized Clinical Trial
Official title: Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Wound
Infection Prevention
Negative Pressure Wound Therapy
Lead sponsor: Gulab Devi Hospital
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total 70 participants meeting selection criteria will be enrolled in the study from operational theatre. They will be randomly divided in two groups by using lottery method. In group A, Negative Pressure Wound Therapy will be applied at end of procedure. In group B, no Negative Pressure Wound Therapy will be placed. They will be shifted to post-surgical wad for 72 hours and then will be discharged with prescription of standard antibiotics and will be followed-up in OPD for 30 days. If patient will develop surgical site wound infection, then it will be noted. If infection will not be cured with antibiotics course, then re-operation will be done. Patients complications will be managed as per hospital protocol. All this information will be recorded in proforma.


Eligibility criteria: Inclusion Criteria:

* Patients of age between 20 to 70 years, both genders
* Undergoing laparotomy under general anaesthesia
* ASA I-II

Exclusion Criteria:

* Patients who did not complete the follow up instructions
* Pregnant patients
* Patients already undergone a relook laparotomy, if their abdomen is left open or if unable to adhere

Primary outcomes:
measure: Surgical Site Infection
timeFrame: 03 Months
Secondary outcomes:
measure: Re Operation
timeFrame: 03 Months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Gulab Devi Hospital Lahore
state: Punjab
Study officials:
affiliation: Gulab Devi Hospital Lahore
name: Professor Dr Maratab Ali, MBBS FCPS
role: STUDY_DIRECTOR
References: