louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05236478: Efficiency of an Optimized Care Organization for Fatigue Management for Patients With COVID-19.
Official title: Efficiency of an Optimized Care Organization for Fatigue Management for Patients With COVID-19.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Fatigue
Keywords: COVID-19
Fatigue
training
therapeutic education
physical activity
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute fatigue post-COVID-19

Brief summary: Length of hospitalization for COVID-19 infection may be increased due to the persistence of fatigue in 29-46% of cases. Its management is essential to prevent the chronic fatigue . Chronic fatigue syndrome affected between 30 and 40% of patients with SARS in 2003 or MERS in 2005 and persisted beyond 3 years. There is currently no specific treatment for acute or \<4 months asthenia. To avoid the transition to chronicity, some authors recommend respecting a long rest period. However, a program combining adapted physical activity and therapeutic patient education has already shown significant benefits for combating recent or semi-recent fatigue following a cardiovascular pathology and even during cancer treatments. Therefore, the existing care pathway for hospitalized patients with COVID-19 was adapted, combining exercise training and therapeutic patient education workshops.


Eligibility criteria: Inclusion Criteria:

* Patient living in the Loire region, France
* Patient showing post COVID-19 fatigue (RT PCR positive \<1 month)
* Non-intubated patient if hospitalization in intensive care (\<72h)
* Patient hospitalized in a Covid unit at the Saint Etienne Hospital

Exclusion Criteria:

* Patient hospitalized in intensive care \>72h
* Intubated and ventilated patient in intensive care
* Non-hospitalized patient and community-based medical follow-up

Primary outcomes:
measure: Fatigue evaluation
timeFrame: At 1 Month
Secondary outcomes:
measure: Quality of life (MOS-SF 12)
timeFrame: At 1 Month
measure: Aerobic performances
timeFrame: At 1 Month
measure: Anaerobic performances
timeFrame: At 1 Month
measure: Physical activity
timeFrame: At 1 Month
measure: return to work
timeFrame: At 1 Month
measure: previous activities
timeFrame: At 1 Month
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: David HUPIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00276978: Aripiprazole Augmentation Therapy in Treatment-resistant Depression
Official title: Aripiprazole Augmentation Therapy in Treatment-resistant Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Therapy-resistant Depression
Keywords: Therapy-resistant Depression
add-on therapy depression
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2006-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 20 therapy-refractory patients with major depression will be treated for 3 weeks with Aripiprazole 10 mg/d. Effectivity will be assessed using a pre-post comparison of different psychopathological rating scales and patient adherence.

Detailed description: This will be an open pilot study using pre-post comparison. 20 treatment-refractory patients with major depression diagnosed by DSM-IV will be included. Psychotic features of depression will be excluded by a score of 2 or less in the PANSS subscales P1, P3 and P6. Treatment resistance as defined by history of non-response to two antidepressants from different classes at an acceptable dose and period is confirmed retrospectively. If possible, treatment compliance should be confirmed by plasma level examination. After informed consent, visit 1 is performed on day 0 (inclusion criteria, history, demographics, physical examination, vital signs, HAMD, MADRS, CGI, BDI, lab). Study medication is started on day 1, the antidepressive therapy is continued at stable dose until the end of the study. Patients will receive an adjunctive augmentation therapy of 10 mg/d aripiprazole. Study visits will be performed on days 3, 7, 14 and 21 (visits 2-5: vital signs, HAMD, MADRS, CGI, BDI, lab). In addition to the HAM-D and MADRS scores, patients will perform a self-rating (BDI). Aripiprazole plasma levels will be measured at the end of the treatment period to assess compliance and to detect a putative correlation between drug plasma levels and efficacy.

Eligibility criteria: Inclusion Criteria:

* major depression without psychotic features (DSM-IV definition)
* therapy resistance (two courses of antidepressants from different classes for more than 3 weeks in adequate dose)
* HAM-D score greater/equal than 17
* age 18-70

Exclusion Criteria:

* bipolar disorder
* active alcohol or illicit drug use
* female without effective contraception
* severe medical conditions
* psychotic features

Primary outcomes:
measure: rate of response as defined by a more or equal 50 % reduction of baseline HAM-D (Hamilton Depression Rating scale)
timeFrame: 4 wks
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Dept. of Psychiatry, University of Freiburg
Study officials:
affiliation: Department of Psychiatry, University of Freiburg
name: Claus Normann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05616078: Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts
Official title: Laser Versus Cryotherapy for the Treatment of Recalcitrant Warts: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Warts
Lead sponsor: The 306 Hospital of People's Liberation Army
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate whether laser was superior to cryotherapy for recalcitrant warts

Detailed description: Patients with recalcitrant warts were randomized equally to receive laser or cryotherapy every 3 to 4 weeks, for a maximum of 4 sessions.The primary outcomes were the cure rate at 16 weeks; secondary outcomes included time to clearance of warts, patient satisfaction with the treatment and treatment-related adverse effects.

Eligibility criteria: Inclusion Criteria:

* Patients with HPV2/27/57-induced recalcitrant warts, including periungualor mosaic warts, common or plantar warts with a duration of longer than 1 year, and common or plantar warts previously received no more than two sessions of cryotherapy
* Total number of warts is ≤10 .
* Aged 18 years or older.

Exclusion Criteria:

* Patients are currently participating in another trial for the treatment of cutaneous warts.
* Patients have taken immunosuppressant drugs (such as oral corticosteroids) during the past three months.
* Patients have impaired healing eg due to diabetes, vitamin A deficiency, hyperthyroidism and hypothyroidism.
* Patients have autoimmune diseases (such as systemic lupus erythematosus, dermatomyositis, scleroderma or other diseases).
* Patients are pregnant or ready for pregnancies or breast-feeding.
* Patients have cold intolerance (such as cold urticaria, cryoglobulinaemia, cold agglutinin syndrome or Raynaud's syndrome).
* Patients have local pain intolerance.
* Patients have local hypoesthesia.
* Patients are unable to tolerate laser or cryotherapy.

Primary outcomes:
measure: cure rate at 16 weeks
timeFrame: 16 weeks since the initial treatment
Secondary outcomes:
measure: time to clearance of warts
timeFrame: 16 weeks since the initial treatment
measure: patient satisfaction with the treatment
timeFrame: 16 weeks since the initial treatment
measure: treatment-related adverse events
timeFrame: 16 weeks since the initial treatment
Other outcomes:
Locations:
Study officials:
affiliation: The 306 Hospital of People's Liberation Army
name: Shichao Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00525278: To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis
Official title: Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Seasonal Allergic Rhinitis (SAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis
Allergic
Seasonal
Keywords: Levocetirizine dihydrochloride
Xyzal tablets
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-09-05
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 to 60 years old, inclusive
* two-year history of allergic rhinitis due to tree, grass or weed pollen
* sufficient histamine-dependent symptoms of rhinitis during the selection week (T5SS ≥ 5)

Exclusion Criteria:

* An ear, nose or throat (ENT) infection
* asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
* atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment
* an associated ENT disease
* use of decongestants
* nasal or ocular topical treatment

Primary outcomes:
measure: Investigator rated T5SS (Total 5 symptom Score) over 2 weeks
timeFrame: 2 weeks
Secondary outcomes:
measure: Investigator's global efficacy evaluation at 2 weeks; the patient's mean T5SS and 5 individual symptoms (over the last 24 hours) over the first week and over the 2 weeks of treatment; the Symptoms Score Reducing Index (SSRI).
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00755378: AZD8529 Single Ascending Dose Study
Official title: Phase I, Single-Center, Randomized, Double-Blind, Placebo Controlled Single-Ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and PK of AZD8529 in Healthy Subjects Part B: A Randomized, Open Label Study to Assess the Effect of Food on AZD 8529
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Phase I
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-19
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after single ascending doses


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects aged 18 to 45 years (inclusive) on Day 1. Female subjects must be of non-child bearing potential.

Exclusion Criteria:

* Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of investigational prod
* Plasma donation within one month of screening or any blood donation/blood loss \> 500mL during the 3 months prior to screening
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Primary outcomes:
measure: To assess the safety and tolerability of single dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.
timeFrame: at each visit, at least daily, during the study.
Secondary outcomes:
measure: To characterize the pharmacokinetics of AZD8529 in plasma and urine.
timeFrame: Blood and urine samples will be taken during the study.
measure: To asses the effect of food on the safety and pharmacokinetic profile of AZD8529.
timeFrame: Safety assessments and blood and urine samples will be taken throughout the study.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: AstraZeneca Clinical Pharmacology Unit, US
name: Sylvan J Hurewitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01246271: Sub Urethral Sling With or With Out Anterior Repair
Official title: a Retrospective Cohort Recognize the Out Comes of SUS With or Without Anterior Vaginal Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Lead sponsor: Tabriz University
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 98
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: woman with stress urinary incontinence

Brief summary: There is a concern about choosing adequate surgical options for stress urinary incontinence associated with vaginal prolapsed and still lack of evidence can be observed. In this study we compared primary and secondary outcomes of single or combine surgery for SUI with pelvic organ prolapsed.


Eligibility criteria: Inclusion Criteria:

1. Patients must be female
2. Subjective evidence of stress predominant symptoms on symptom specific questionnaire
3. Stress incontinence on urodynamics
4. Patients must be capable of filling in the symptom diary
5. Prolapse beyond the introitus

Exclusion Criteria:

1. Patients who are medically unfit to undergo surgical intervention.
2. Patients who have undergone previous continence surgery
3. Patients with voiding dysfunction
4. Patients with recurrent urinary tract infection
5. Patients who are not sure that their family is complete

Primary outcomes:
measure: Urinary incontinence cure rate according ICIQ-UIsf
timeFrame: 3 month after surgery
Secondary outcomes:
measure: morbidity and complication
timeFrame: 3 month after surgery
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Urology department Imam Reza Hospital
Study officials:
References:
Clinical trial NCT00927771: Azelaic Acid Versus Hydroquinone in Melasma
Official title: Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Melanosis
Keywords: melanosis
melasma
azelaic acid
hydroquinone
Lead sponsor: Callender Center for Clinical Research
Sponsor class: OTHER
First posted: 2009-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of Azelaic Acid Gel to Hydroquinone Cream in the treatment of melasma.

Detailed description: Melasma is a chronic condition in which dark areas appear on the forehead, cheeks, and upper lips. Hydroquinone is a skin lightener (or fade cream) and is one of the most commonly used medications for the treatment of melasma. Azelaic acid gel is currently used to treat acne and rosacea.

Eligibility criteria: Inclusion Criteria:

* must have stable moderate-severe epidermal or mixed melasma involving the face
* all races
* males and females
* persons taking birth control medication, hormone replacement therapy or any other hormone altering medication may participate only if they have not started or stopped the medication within the last 3 months

Exclusion Criteria:

* if the person has only dermal melasma
* pregnancy, breastfeeding, a positive pregnancy test in the office or plans to become pregnant
* a known allergy or sensitivity ot azelaic acid or hydroquinone
* the use of photosensitizing medications (ex. tetracycline) within 3 months of the study.
* starting or stopping hormonal medication within 3 months
* chemical peels, microdermabrasion, or laser treatment within 6 months
* worsening or improving melasma

Primary outcomes:
measure: Improvement of melasma
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mitchellville
country: United States
facility: Callender Center for Clinical Research
state: Maryland
Study officials:
affiliation: Howard University
name: Valerie D Callender, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02062671: Renal Sympathetic Denervation for Reduction of Pain and Improvement of Insulin Sensitivity in Adult Polycystic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adult Polycystic Kidney Disease
Keywords: ADPKD
denervation
renal denervation
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 12
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: In patients with polycystic kidney disease, pain may be resistant to drug therapy and may reduce quality of life. This study investigate the effect of renal denervation on this pain.


Eligibility criteria: Inclusion Criteria:

* Pain limiting daily activities in spite of pain killers, ADPKD

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Pain
timeFrame: 6 months
Secondary outcomes:
measure: Quality of Life (QoL)
timeFrame: 6 months
Other outcomes:
measure: kidney function
timeFrame: 6 months
Locations:
city: Odense
country: Denmark
facility: Department of Nephrology
Study officials:
References:
Clinical trial NCT02676271: The Long Term Outcome of Varus Derotational Osteotomy for Legg-Calvé-Perthes' Disease
Official title: The Long Term Outcome of Varus Derotational Osteotomy for Legg-Calvé-Perthes' Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Legg-Calvé-Perthes Disease
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-02-08
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Forty patients (43 hips) who had undergone VDRO for LCPD who participated in a long term follow-up study a decade ago. All patients were treated in our institution during 1959 to 1983 with proximal VDRO.

Brief summary: Background: Varus derotation osteotomy (VDRO) is one of the most popular surgical treatments for Legg-Calvé-Perthes disease yet its long term results have not been assessed. Our purpose was to determine the long term clinical and radiographic outcomes of these patients.

Methods: Forty patients (43 hips) who had undergone VDRO for LCPD who participated in a long term follow-up study a decade ago were approached for the present study.

All patients were treated in our institution during 1959 to 1983 with proximal VDRO.

The patients were invited to for a medical interview and a physical examination. They were also asked to fill out questionnaires and to provide or undergo a standing anteroposterior (AP) pelvic and a lateral hip radiographs during the visit.

Patients were asked to self-grade their hip pain as none, mild, moderate or severe and to grade their back pain using the Visual Analogue Scale (VAS) between 0-10. Details regarding daily function, physical activity, work status and family history were obtained. All participants completed the Harris Hip Score (HHS) with a maximum score of 100 and the Short Form-36 which is composed of 8 sections and has a maximum score of 100.

The physical examination included an assessment of the hip range of motion, leg length discrepancy and the presence of a Trendelenburg sign.

Radiographic parameters evaluated were the Tonnis grade (with a score between 0-3), head size ratio, and the center-edge (CE) angle.


Eligibility criteria: Inclusion Criteria:

* All patients were treated in our institution during 1959 to 1983 with proximal VDRO and were examined a decade ago

Exclusion Criteria:

-

Primary outcomes:
measure: Clinical outcomes
timeFrame: a follow-up 42.5 years from surgery
measure: Clinical outcomes
timeFrame: a follow-up 42.5 years from surgery
measure: Radiographic outcomes
timeFrame: a follow-up 42.5 years from surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Haroffeh Medical center
Study officials:
affiliation: Tel Aviv University, Israel
name: Noam Shohat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01530971: Effect of Maternal and Neonatal Oxygenation
Official title: Effects of Neonate and Maternal Oxygenation in Low-dose Oxygen Supplement by Oxygen Cannula or Non- Supplement in Elective Cesarean Section: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peer Review, Research
Keywords: oxygen
pregnancy
caesarean section
anesthetic techniques
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 325
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intraoperative supplemental oxygen has been given for most parturients undergoing cesarean section under spinal anesthesia. However, evidences supporting the practice is not clear nowadays, especially for healthy parturients who are monitored continuously with pulse oximeter. Furthermore, hyperoxia may produce free radicles which could harm fetus and newborns.

Changing practice is not that easy. This study has been conducted to prove that supplemental oxygen is not necessary for healthy parturients during cesarean section.

Detailed description: Supplemental oxygen has been routinely given to parturients because doctors were concerned about desaturation. However, the evidences for giving oxygen was not strong, and the condition nowadays can be detected immediately with pulse oximeter which is a standard monitoring.

After this study finished, we will set a safety guideline for supplemental oxygen for healthy parturients undergoing elective cesarean section.

Eligibility criteria: Inclusion Criteria:

* Aged \> 18 years old.
* Term pregnancy (gestational age 37 -42 weeks).
* Singleton
* Elective cesarean section.

Exclusion Criteria:

* History of infertility
* Diabetes
* Hypertension or preeclampsia
* Heart disease
* Morbid obesity
* Premature rupture of membrane
* Placenta previa
* Preoperative oxygen saturation \< 95%

Primary outcomes:
measure: proportion of maternal desaturation
timeFrame: intraoperative period
Secondary outcomes:
measure: neonatal outcomes
timeFrame: intraoperative period
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
affiliation: Mahidol University
name: Arunotai Siriussawakul, MD.
role: PRINCIPAL_INVESTIGATOR
References: