louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03025165: A Comparison of Different Community Models of ART Delivery Amongst Stable HIV+ Patients in Two Urban Settings in Zambia
Official title: A Comparison of Different Community Models of ART Delivery Amongst Stable HIV+ Patients in Two Urban Settings in Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
First posted: 2017-01-19
Enrollment: 2526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the virological and clinical outcomes of patients participating in community models of ART delivery to the standard of care in an urban setting in Zambia.

Detailed description: The outcomes of this study will be measured in a prospective cohort of adult patients enrolled into ART care in two urban communities participating in the HPTN 071 (PopART) trial. The two community models are: 1) adherence clubs, groups of 20-25 stable patients who receive ART care in the community every 3 months, and 2) home-based ART delivery in which a community health worker delivers ART care to an individual at home every 3 months. The standard of care is delivery of ART care at the local clinic.

Eligibility criteria: Inclusion Criteria:

18 years or older On first-line ART and retained in care for more than 6 months Virologically suppressed World Health Organization (WHO) stage I and II at time of screening Reside within the clinic catchment area Willing to provide written informed consent and accept Community HIV-care Provider (CHiPs) intervention

Exclusion Criteria:

-

Primary outcomes:
measure: Viral Suppression
timeFrame: One year after beginning participation in the program
Secondary outcomes:
measure: Viral suppression at 24 months
timeFrame: Two years after beginning participation in the program
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Zambart
Study officials:
affiliation: Zambart
name: Mohammed Limbada, MBCHB, MScID
role: PRINCIPAL_INVESTIGATOR
References:
citation: Limbada M, Macleod D, Situmbeko V, Muhau E, Shibwela O, Chiti B, Floyd S, Schaap AJ, Hayes R, Fidler S, Ayles H; HPTN 071 (PopART) study team. Rates of viral suppression in a cohort of people with stable HIV from two community models of ART delivery versus facility-based HIV care in Lusaka, Zambia: a cluster-randomised, non-inferiority trial nested in the HPTN 071 (PopART) trial. Lancet HIV. 2022 Jan;9(1):e13-e23. doi: 10.1016/S2352-3018(21)00242-3. Epub 2021 Nov 26.
citation: Limbada M, Bwalya C, Macleod D, Floyd S, Schaap A, Situmbeko V, Hayes R, Fidler S, Ayles H; HPTN 071 (PopART) Study Team. A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study. Trials. 2021 Jan 12;22(1):52. doi: 10.1186/s13063-020-05010-w.
Clinical trial NCT03825666: Can Simple Perioperative Measures Improve Quality of Recovery Following Ambulatory Laparoscopic Surgery in Females?
Official title: Can Simple Perioperative Measures Improve Quality of Recovery Following Ambulatory Laparoscopic Surgery in Females? An Open Prospective Randomised Study, Comparing Nutritional Preoperative Drink and Chewing Gum During Recovery to Standard Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Recovery
Keywords: quality of recovery
PONV
PDNV
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to assess whether it was possible to improve patients' self-assessed quality of recovery and reduce the level of post-operative nausea and vomiting in female patient undergoing laparoscopic cholecystectomy by simple perioperative measures in the form of a preoperative 200 ml nutritional drink and chewing gum during early recovery.

Patients were randomised to an active group receiving the intervention, and controls provided with standard care only. Patients were followed by questionnaire interviews preoperatively and at 2, 24 and 48 hours after surgery.

Detailed description: Abstract One major goal in modern perioperative anaesthesia care is to facilitate a rapid, yet safe recovery process, with focus on improving time to regained consciousness and subsequent resuming of activities of daily living. Laparoscopic cholecystectomy and gynaecological laparoscopy are a "high volume" procedure commonly performed in young females expecting rapid resumption of health.

The aim of this study was to assess whether it was possible to improve patients' self-assessed quality of recovery and reduce the level of post-operative nausea and vomiting in female patient undergoing laparoscopic cholecystectomy by simple perioperative measures in the form of a preoperative 200 ml nutritional drink and chewing gum during early recovery.

Methods Patients were randomised to an active group receiving the intervention, and controls provided with standard care only. Patients were followed by questionnaire interviews preoperatively and at 2, 24 and 48 hours after surgery. The Quality of Recovery scale (QoR) 15 items and 5 additional questions around gastro-intestinal symptoms were self-assessed by patients at each occasion.

Eligibility criteria: Inclusion Criteria:

* ASA 1-2

Exclusion Criteria:

* ASA 3-4, obese

Primary outcomes:
measure: Quality of recovery, QoR15, (Quality of Recovery 15)
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02722265: Long-term Study of CS-3150 as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension
Official title: Open-label, Multicenter, Interventional, Dose Titration Study to Assess the Long-term Study of CS-3150 2.5mg and 5mg Alone as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Keywords: Essential hypertension
Long-term treatment
Mineralocorticoid receptor antagonist
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-03-29
Enrollment: 368
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To examine antihypertensive effect, pharmacodynamics, and safety of long-term administration of CS-3150 as monotherapy and in combination with calcium channel blocker or renin-angiotensin system inhibitor in patients with essential hypertension.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 20 years or older at informed consent
* Subjects with essential hypertension, who do not receive any antihypertensive drugs or receive calcium channel blocker, angiotensin converting enzyme ACE inhibitor, or angiotensin-II receptor blockade ARB during run-in period (Sitting systolic blood pressure SBP ≥ 140 mmHg and \< 180 mmHg, Sitting diastolic blood pressure DBP ≥ 90 mmHg and \< 110 mmHg, and mean 24hr SBP ≥ 130 and DBP ≥ 80 mmHg)

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* Diabetes mellitus with albuminuria
* Serum potassium level \< 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive ACE inhibitor, or ARB)
* Reversed day-night life cycle including overnight workers
* estimated glomerular filtration rate eGFR \< 60 mL/min/1.73 m\^2.

Primary outcomes:
measure: change from baseline in sitting systolic and diastolic blood pressure
timeFrame: week 0 (baseline) to end of weeks 12, 28, and 52
Secondary outcomes:
measure: Change from baseline in 24-hr ambulatory blood pressure monitoring (ABPM)
timeFrame: week 0 (baseline) to end of weeks 12, 28, and 52
Other outcomes:
Locations:
city: Osaka
country: Japan
Study officials:
affiliation: Daiichi Sankyo Co., Ltd.
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: Ichikawa S, Tsutsumi J, Sugimoto K, Yamakawa S. Antihypertensive Effect of Long-Term Monotherapy with Esaxerenone in Patients with Essential Hypertension: Relationship Between Baseline Urinary Sodium Excretion and Its Antihypertensive Effect. Adv Ther. 2022 Oct;39(10):4779-4791. doi: 10.1007/s12325-022-02282-3. Epub 2022 Aug 17.
Clinical trial NCT03435965: PROM by AmnioQuick Duo+ in Egyptian Women
Official title: Dilemma for Diagnosis of Amniotic Fluid Leakeage by AmnioQuickDuo+
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PROM (Pregnancy)
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
name: National Research Centre, Egypt
First posted: 2018-02-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: - pregnant ladies with PROM from 20- 37 weeks came to the hospital to confirm PROM

Brief summary: Preterm premature rupture of the membranes (PPROM) is responsible for one-third of all preterm births. Optimum treatment relies on accurate diagnosis and gestational age. The diagnosis of PPROM is made by a combination of examination, patient history and some simple tests.

Detailed description: Premature rupture of the fetal membranes (PROM) is the rupture of the amniotic membranes with release of the amniotic fluid prior to the onset of labour. PROM may be subdivided into term -PROM (TPROM, i.e. PROM after 37 weeks of gestation) and preterm PROM (PPROM, i.e. PROM prior to 37 weeks of gestation). PPROM occurs in approximately 3% of pregnancies and is responsible for a third of all preterm births.The diagnosis of PPROM is made by examination , patient history and simple testing. Patient history has an accuracy of 90% for the diagnosis of PPROM

Eligibility criteria: Inclusion Criteria:

* pregnant ladies with PROM from 20- 37 weeks

Exclusion Criteria:

* Gestational Age \>37 wks Non reassuring CTG Signs of chorioamnonitis ( Fever , maternal or fetal tachycardia , Foul cervical discharge , uterine tenderness or high TLC ) Antepartum hemorrhage

Primary outcomes:
measure: number of participants who was diagnosed with leakage of liqour by AmnioQuickDuo+
timeFrame: within a week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasralainy Hospital
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
name: Mahmoud Alalfy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01293266: Effect of Propofol and Sevoflurane on Lactate During Anesthesia for Pediatric Heart Catheterisation
Official title: Effect of Propofol and Sevoflurane on Base Excess, pH and Lactate in Pediatric Heart Catheterisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Acidosis
Keywords: Propofol
Metabolic Acidosis
Pediatric Cardiology
Anesthesia
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2011-02-10
Enrollment: 40
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Propofol is routinely used for general anesthesia during pediatric heart catheterisation. Propofol infusion syndrome (PRIS) is a rare, but often fatal complication mainly defined by bradycardia with progress to asystolia during propofol infusion. Metabolic acidosis is regarded as an early warning sign of PRIS. In this study the effect of propofol and sevoflurane on serum base excess, pH and lactate are examined during pediatric heart catheterisation.

Detailed description: In this prospective randomised study 40 children are anesthetised for pediatric heart catheterisation with propofol (N = 22) or sevoflurane (N = 18) with ethic committee approval. Base excess, pH and lactate were measured by blood gas analysis at the beginning, during and at the end of the procedure. Changes relative to baseline were analysed by paired t-Test with correction for multiple testing. The study was powered to detect a difference of 1.5 mmol/l for base excess and lactate.

Eligibility criteria: Inclusion Criteria:

* Indication for heart catheterization under general anesthesia

Exclusion Criteria:

* Participation in another study
* Preexisting metabolic acidosis
* Contraindication against Propofol

Primary outcomes:
measure: Serum Lactate
timeFrame: 4 hours
Secondary outcomes:
measure: pH and base excess
timeFrame: Hours
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein, Campus Kiel
state: Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Berthold Bein, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01078766: Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic Cerebral Palsy (CP)
Official title: Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic CP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Hand Function
Keywords: cerebral palsy
Lead sponsor: Alyn Pediatric & Adolescent Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2010-03-02
Enrollment: 9
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The combination of the constraint-induced movement therapy (CIMT) method as a complement to hand arm bimanual training (HABIT) will improve the frequency and quality of cooperative hand use and function in children with hemiplegic CP.


Eligibility criteria: Inclusion Criteria:

* active wrist extension/dorsiflexion of at least 20;
* MACS 1-3;
* GMFCS 1-2;
* enrolled in regular or remedial level education with ability to understand instructions and participate without parent presence.

Exclusion criteria:

* seizures;
* severely increased muscle tone; or hemi arm to good;
* orthopedic surgery on the upper extremity;
* botulin toxin injections within the past half year to the upper extremity;
* inability to understand instructions or cognitive/behavior/concentration.

Primary outcomes:
measure: Assisting Hand Assessment
timeFrame: twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program
Secondary outcomes:
measure: Jebsen-Taylor Test of Hand Function
timeFrame: twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program
measure: The Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program
measure: Muscle strength
timeFrame: twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05917366: Effect of Manipulation on Coccydynia
Official title: The Effectiveness of Manipulation in Combination With Exercise for Patients With Coccydynia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coccyx Disorder
Pelvic Floor; Weak
Stretch
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 46
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the efficacy of manipulation combined with exercise as a treatment for patients with coccydynia.

Detailed description: Subject: Coccydynia is a painful condition characterized by inflammation and discomfort in the coccyx region, commonly known as the tailbone. It can significantly affect an individual's quality of life by impairing their ability to sit, stand, or engage in daily activities. Various treatment approaches have been explored to alleviate the symptoms of coccydynia, including manipulation techniques and exercise interventions. However, to date, there is a scarcity of research investigating the combined effects of manipulation and exercise for patients with coccydynia.

Purpose: The purpose of this study is to evaluate the efficacy of combining manipulation techniques with exercise interventions for patients diagnosed with coccydynia, a painful condition affecting the coccyx region. Despite the debilitating impact of coccydynia on daily activities and quality of life, there is a limited understanding of the optimal treatment approach for this condition. This study aims to address this knowledge gap by investigating the potential benefits of combining manipulation and exercise in managing coccydynia.

Eligibility criteria: Inclusion Criteria:

* chronic (3 months) coccydynia
* age over 25 and under 60 years
* no ongoing antidepressant treatment
* no medicolegal litigation or occupational-accident etiology

Exclusion Criteria:

* undergoing an operation aimed at the anal area
* those with additional diseases such as radiculopathy etc.

Primary outcomes:
measure: Change from baseline in Pain at 4 weeks and 6 months
timeFrame: Baseline measurement before the treatment programs begin (pre-intervention), post-intervention at week 4, and 6 months follow-up
measure: Change from baseline in Paris questionnaire at 4 weeks and 6 months
timeFrame: Baseline measurement before the treatment programs begin (pre-intervention), post-intervention at week 4, and 6 months follow-up
measure: Change from baseline in The Oswestry Disability Index at 4 weeks and 6 months
timeFrame: Baseline measurement before the treatment programs begin (pre-intervention), post-intervention at week 4, and 6 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: KTO Karatay University
Study officials:
affiliation: KTO KARATAY UNIVERSTESI
name: Bayram Sönmez ÜNÜVAR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02052765: AnalyST & Brugada Syndrome - Feasibility Study
Official title: AnalyST & Brugada Syndrome - Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brugada Syndrome
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Brugada syndrome is characterized by a ST shift on the surface ECG, and a specific morphology of the Twave. This ECG abnormality is called a type 1-ECG, and is variable in time. Patients presenting a Brugada syndrome are exposed to sudden cardiac death, although it's difficult to predict patients at high risk. It is suspected that the type 1-ECG burden might be correlated to the ventricular fibrillation risk of these patients, but there is no mean to record the ECG over a long period of time.

The objective of the study is to evaluate the correlation between ST elevation on the electrocardiogram (ECG) and ST shift on the intracardiac electrograms (EGM) recorded with the AnalyST ICD, to assess the ability of the device to detect the type 1-ECG. Patients enrolled in the study are patients already implanted with a defibrillator for their Brugada syndrome. During an Ajmalin test, which unmasks the type 1-ECG, both intracardiac EGM and surface ECG will be compared to assess the detection of the typical ST-shift by the ICD.

Detailed description: To evaluate the correlation between ST elevation on the ECG and ST shift on the intracardiac EGM recorded with the AnalyST ICD, patients enrolled will have to be already diagnosed as presenting the Brugada Syndrome. They will undergo an ajmaline test, to unmask the type 1-ECG, characteristic from the Brugada syndrome.During the test, both surface ECG and intracardiac signal will be continuously recorded; then the signals will be compared in terms of amplitude of the ST shift, duration of the shift, and recovery period.

Eligibility criteria: Inclusion Criteria:

* Patients with Brugada syndrome and previous positive Ajmalin test

Primary outcomes:
measure: ST shift correlation
timeFrame: Acute testing - 4h after the beginning of the ajmaline test.
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Hopital Laennec
Study officials:
affiliation: Hopital Laennec
name: Vincent Probst, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03114566: Collection and Generation of Antigen-specific T-lymphocyte Cell Lines From Primary, Third-party, Related, and Unrelated Donors
Official title: Collection and Generation of Antigen-specific T-lymphocyte Cell Lines From Primary, Third-party, Related, and Unrelated Donors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy
Keywords: transplant donor
HLA typed
17-211
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transplant donors and healthy HLA typed volunteers

Brief summary: The purpose of this study is to obtain lymphocyte collections from normal healthy volunteer donors in order to create Good Manufacturing Practice grade banks of virus-specific and tumor-reactive T-cells of defined HLA type and restricting HLA allele readily available for therapeutic use.


Eligibility criteria: Inclusion Criteria:

* Donors must satisfy standards including those set forth by FACT (Foundation for the Accreditation of Cellular Therapy) and the criteria specified in FDA 21 Code of Federal Regulations (CFR) 1271. Specifically, screening for risk factors for communicable disease as well as infectious disease screening by serologic and PCR testing as outlined below. Including testing for IV, Hepatitis B, Hepatitis C, HTLV I and II, CMV, EBV, and toxoplasmosis, westnile virus, syphilis, varicella zoster, and Chagas disease.
* Donors must be typed for HLA-A, B, C, DR and DQ at high resolution.
* Donors accrued at MSKCC must have a hemoglobin value \> 10g/dl
* Donors must be capable of undergoing, at least, a single standard 2 blood volume leukapheresis or a donation of one unit of whole blood
* Donors must weight \>/= 25 kg

Exclusion Criteria:

* HTLV/HIV (+) or Hepatitis B or C positive donors
* Donors who are pregnant

Primary outcomes:
measure: Generation of T-cells
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Susan Prockop, MD
role: PRINCIPAL_INVESTIGATOR
References: