louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01005069: Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus
Official title: Phase-II Clinical Study: A Randomized, Double Blind, Dose Ranging, and Controlled Study to Evaluate the Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes mellitus
DLBS-32
fasting plasma glucose
insulin resistance
Lead sponsor: Dexa Medica Group
Sponsor class: INDUSTRY
First posted: 2009-10-30
Enrollment: 72
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: The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the management of subjects with type-II-diabetes mellitus and to determine the minimal effective dose of DLBS 32 for subjects with type-II-diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Fasting capillary blood glucose of 127-249 mg/dL at screening
* BMI \>= 18.5 kg/m\^2 or waist circumference of \>= 90 cm (male) or \>= 80 cm (female)
* Normal liver function
* Normal renal function
* OHA-naive type-II-diabetic patients

Exclusion Criteria:

* Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
* Uncontrolled hypertension
* History of or current treatment with insulin
* Current treatment with systemic corticosteroids or herbal (alternative) medicines
* History of renal and/or liver disease
* Pregnant or breast feeding females

Primary outcomes:
measure: Reduction of venous Fasting Plasma Glucose from baseline
timeFrame: every 2-week interval over 6 weeks of treatment
Secondary outcomes:
measure: Reduction of 2h-post-prandial plasma glucose from baseline
timeFrame: six weeks
measure: Change of homeostasis model assessment of insulin resistance (HOMA-IR) from baseline
timeFrame: six weeks
measure: Change of high sensitivity C-reactive protein (hs-CRP) from baseline
timeFrame: six weeks
measure: Liver Function, Renal Function, Adverse events
timeFrame: six weeks
measure: Change in HbA1c from baseline
timeFrame: six weeks
measure: Change in lipid profile from baseline
timeFrame: six weeks
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Sanglah Hospital Denpasar
state: Bali
city: Jakarta Pusat
country: Indonesia
facility: RSUD Tarakan
state: DKI Jakarta
Study officials:
affiliation: Division of Endocrinology and Metabolic Disease University of Udayana / Sanglah Denpasar Hospital
name: Ketut Suastika, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of internal medicine, RSUD Tarakan
name: Nuniek E Nugrahini, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01385969: LMA Cuff Pressure and LMA-induced Complications
Official title: Using the Natural Recoil of the Inflating Syringe as a Safety Valve to Limit LMA Cuff Pressure and Decrease LMA-Induced Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sore Throat
Dysphagia
Dysphonia
Keywords: overinflation of LMAs
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo a surgical procedure less than 2 hours in duration

Brief summary: The purpose of this study is to determine if using 20 mL B.Braun syringes to inflate LMAs and allowing them to recoil will put the pressure of the LMA cuff within the safety range. It will also determine if remaining within this safety range has an effect on complications after surgery..


Eligibility criteria: Inclusion Criteria:

* Registered Mayo Clinic in Florida patients scheduled to undergo a surgery
* Planned use of LMA during surgery
* between the ages of 18-99
* short duration (\<2 hours elective surgery)

Exclusion Criteria:

* recent history of upper respiratory tract infection
* intra-cavitary or laparoscopic procedure
* risk of pulmonary aspiration
* known difficult airway
* history of gastric reflux
* BMI \> 40
* lateral or prone positions
* oral or nasal surgery

Primary outcomes:
measure: Pressure of the syringe after inflation of the LMA cuff
timeFrame: after inflation, 1 hour into surgery
Secondary outcomes:
measure: Number of patients with dysphagia and/or dysphonia
timeFrame: 1, 2, and 24 hours after surgery
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Christopher Robards, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05565469: Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location
Official title: Correlation Between Abdominal Wall Stimulation and Neurostimulator Tip Location
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neurostimulator; Complication
Neuropathy
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this prospective interventional study, we look at the level of tip of the DTM neurostimulator and the presence of abdominal wall stimulation in patients


Eligibility criteria: Inclusion Criteria:

* Patients with a DTM neurostimulator for Failed Back Surgery Syndrome (FBSS) at the thoracic level

Exclusion Criteria:

* Patients younger than 18 years of age
* Patients who are not able to exercise their will.
* Inability to understand the Dutch language

Primary outcomes:
measure: Abdominal stimulation
timeFrame: up to 15 minutes after start of the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jessa Hospital
name: Mark Plazier, dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04533269: A Study of Topical Arnica & Ledum on Bruise Reduction in HNV
Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Arnica Montana and Ledum Palustre Formulation on Mechanically Induced Bruising in Healthy Normal Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bruise, Contusion
Lead sponsor: Cearna, Inc.
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Subjects will have a bruise induced. A pad containing either a placebo or active will be applied to the bruise. Photographs will be taken over the following days to record bruise healing.

Detailed description: This is a randomized, double-blind, placebo-controlled, crossover, multicenter study that will be used to evaluate the difference in bruise reduction efficacy between active remedy and placebo when a mechanical bruise is induced. The trial will be conducted at 5-8 sites with up to 150 subjects. Each subject will be injured two times using the same bruise-inducing mechanism, and the resulting bruises will be treated with active remedy or placebo-infused pads that will be identical in appearance. Subjects and study investigators will be blinded to the order of treatment assignment. Subjects will be asked to come to the clinic for photographic assessments of the bruise. Each subject will be randomly assigned to have a placebo or active remedy pad applied over each mechanically induced bruise on Day 1. The pad will be applied by study staff immediately after bruise induction (within 5 minutes). The pad will cover the bruised area completely, and then sealed with Tegaderm. All procedures, including bruise induction, treatment, and photography, will be administered by study staff who are blinded to treatment type. All photographs will be rated according to standardized criteria by blinded, trained study investigators after the completion of all subject data collection.

Eligibility criteria: Inclusion Criteria:

* Fitzpatrick skin type 1-3
* BMI 25 kg/m2
* Self described bruisers
* Intact skin in the target area, free of markings, blemishes and hair

Exclusion Criteria:

* Use of recreational drugs, steroids, pain medications, other homeopathic remedies, anticoagulant therapies, antiplatelet therapy
* Known history of dermal sensitivity, serious illness, hematological abnormality, impaired wound healing
* Inability to forego application of topical products in the target area
* Hair removal by laser, wax or chemicals within one week prior to Day 1
* Avoid tanning beds
* History of allergy to topical gels, Arnica or Ledum
* Active wound or infection in the target area
* History of keloids or hypertrophic scarring
* History of collagen or vascular disease
* History of organ transplant

Primary outcomes:
measure: Efficacy
timeFrame: 11 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04383769: Differentiated Service Delivery for Antiretroviral Therapy
Official title: Differentiated Service Delivery for Antiretroviral Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 5000
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: Data officer will collect secondary data regarding ART refill, laboratory test, counseling, doctor visit for HIV-related conditions, such as adverse drug reaction, opportunistic infections, and comorbidities, from the medical records already existed in the hospital and community-based organization systems and entered into the case report form. The identity of the clients will be untraceable since UL, which is a unique letter code assigned to each participant using Thai initials and date of birth translated into English alphabets, will be used as an individual identifier. The data will be collected prospectively for 24 months and retrospectively for up to 5 years from the screening date.

Brief summary: This study is a prospective observational cohort. The target study population is PLHIV who receive ART at hospitals and community-based organizations (CBOs) in Chiang Mai, Ubon Ratchathani, Chonburi, and Songkhla. Participants will receive ART service in the same standard as in the hospital setting. Secondary data will be collected from the medical records already existed in the hospital and CBO systems.

Detailed description: DSD-ART service at the Hospital

* Medical examination: All clients who receive ART service at the hospital and agree to participate in the research project will be interviewed to collect personal information and receive physical and laboratory examination in order to assess eligibility in research participation. If ineligible, the clients will be referred to the standard of care.
* Preparation and DSD-ART service offer: PLHIV who are eligible to participate in the research will receive counselling to assess the supports the clients need and will be offered various models of DSD-ART service. The clients may choose the model that is most suitable to their lifestyle.

Eligibility criteria: Inclusion Criteria:

1. Thai citizenship
2. Age ≥ 18
3. HIV positive
4. Received ART for at least 6 months at a participating hospital (Except for After hour ART clinic model that will allow participants who receive ART less than 6 months into service)

Exclusion Criteria:

N/A

Primary outcomes:
measure: differentiated service delivery for antiretroviral therapy (DSD-ART)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chon Buri
country: Thailand
facility: 3. Swing Dic,
Study officials:
affiliation: Institute of HIV Research and Innovation (IHRI)
name: Nittaya Phanuphak, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01826669: Chest Wall Muscle Stretching and Acute Effects in Chronic Obstructive Pulmonary Disease
Official title: Chest Wall Muscle Stretching and Acute Effects on Volume Variation of Thoracoabdominal Wall and Electromyographic Activity in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The study hypothesis is chest wall muscle stretching increase distribution of volume variation of thoracoabdominal wall and reduce electromyographic activity of respiratory muscles in patients with Chronic Obstructive Pulmonary Disease.

Detailed description: Randomized controlled trial involving patients with Chronic Obstructive Pulmonary Disease evaluated before and immediately after a program of stretching muscles of the rib cage or after resting with time similar to the intervention, as volume variation of thoracoabdominal wall by optoelectronic plethysmography and on the electromyographic activity of accessory muscles of respiration.

Eligibility criteria: Inclusion Criteria:

* clinical and functional diagnosis of Chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2009),
* forced expiratory volume in one second (FEV1) less than 80% predicted post-bronchodilator;
* clinical stability during the study,
* both sexes,
* age above 40 years,
* body mass index (BMI) between 18.5 and 29.9 kg / m²;
* smoking history,
* symptoms of cough,
* dyspnea or hypersecretion,
* ex-smokers for at least three months.

Exclusion Criteria:

* Disease exacerbation for at least eight weeks,
* patients with other respiratory diseases,
* cardiovascular or osteoarticular and
* participants in pulmonary rehabilitation programs.

Primary outcomes:
measure: Distribution of volume variation of thoracoabdominal wall and electromyographic activity of respiratory muscles
timeFrame: 1 hour
Secondary outcomes:
measure: Respiratory rate, minute volume, expiratory time, inspiratory time, relation inspiratory time/ total time
timeFrame: 1 hour
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: UFPE
state: Pernambuco
Study officials:
References:
Clinical trial NCT03107169: Treatment of Initial Clostridium Difficile Infection
Official title: Fecal Microbiota Transplant Versus Vancomycin for Treatment of Initial Clostridium Difficile Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clostridium Difficile Infection
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 10
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: Investigators designed an open, two-arm study to compare oral vancomycin with a fecal microbiota transplant (FMT) from a fecal donor-unrelated donor mix (FURM) as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients.

Detailed description: Investigators designed an open, two-arm study to compare oral vancomycin with an FMT-FURM as treatments for the first Clostridium difficile infection (CDI) episode among hospitalized patients. From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Specimens are cultured to isolate C. difficile, and C. difficile are assessed for the presence of genes encoding enterotoxin (tcdB), cytotoxin (tcdA), the binary toxin A (cdtA), binary toxin B (cdtB), and deletions within the negative regulator of toxin A and B production (tcdC) by polymerase chain reaction (PCR). The minimum inhibitory concentrations (MICs) of ciprofloxacin, moxifloxacin, erythromycin, clindamycin, vancomycin, metronidazole, linezolid, fidaxomicin, and tetracycline against C. difficile are measured using the agar dilution method. Fecal samples and FMT-FURM are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic sequencing.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of CDI (first episode)
* Older than 18 years old

Exclusion Criteria:

* Patients younger than 18 years old

Primary outcomes:
measure: Decrease in number of evacuations
timeFrame: up to a 2 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06069869: Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial
Official title: Individually Randomized Crossover Trial of Multiple Micronutrient Supplementation (MMS) Iron Dosages During Pregnancy in Tanzania
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Pregnancy Related
Keywords: Acceptability
Multiple Micronutrient Supplementation
Iron
Tanzania
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: Ifakara Health Institute
name: Harvard School of Public Health (HSPH)
name: Muhimbili University of Health and Allied Sciences
name: Africa Academy for Public Health
name: Columbia University
First posted: 2023-10-06
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will be randomized to one of 6 sequence orders to receive the three MMS regimens first, second or third in order (e.g., 30, 45, then 60 mg; or 45, 30, then 60 mg; or 45, 60 then 30 mg etc.).
Primary purpose: PREVENTION

Brief summary: This is an individually randomized cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron.


Eligibility criteria: Inclusion Criteria:

* Attending first ANC visit at the study clinic
* Pregnant women ≤ 15 weeks of gestation
* Aged ≥ 18 years
* Intending to stay in Dar es Salaam for the duration of study
* Provides informed consent

Exclusion Criteria:

* Severe anemia (defined as Hb \<8.5 g/dL per Tanzania standard of care)
* Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
* Concurrent participation in other nutritional supplementation trial

Primary outcomes:
measure: Acceptability of MMS formulations
timeFrame: At one month of taking each regimen
Secondary outcomes:
measure: Most preferred MMS formulation
timeFrame: At three months (after taking all three regimens)
measure: Side effects of MMS formulations
timeFrame: At one month At one month of taking each regimen
measure: Adherence
timeFrame: At one month of taking each regimen
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Blair Wylie, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Ifakara Health Institute
name: Honorati Masanja, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Africa Academy for Public Health
name: Alfa Muhihi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Muhimbili University of Health and Allied Sciences
name: Andreas Pembe, MD, MMed, PhD, FCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: The George Washington University
name: Emily R Smith, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard University
name: Christopher R Sudfeld, ScD, ScM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03273569: PDIUC Protocol for Placental Accreta
Official title: Preplacental Delivery Intervention for Uterine Conservation Protocol: a Novel Approach for Management of Placenta Accreta
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placenta Accreta
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Women with placenta accreta at the time of Cesarean delivery
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean delivery indicated for placenta accreta.

Detailed description: Placenta accreta is a morbid obstetric condition that describes variable non-physiologic invasion of the placenta into the the uterine wall. The incidence of placenta accreta, as a serious cause of postpartum hemorrhage, has substantially increased secondary to increase the rate of Cesarean delivery. Placenta accreta is primarily managed by peripartum hysterectomy prior to delivery of the placenta to avoid uncontrolled bleeding. However, in addition to the surgical risks, hysterectomy is psychologically morbid to many women particularly younger women and women with low parity. Therefore, several conservative options were studied to provide an alternative for hysterectomy in these women. Our study is designated to evaluate a proposed protocol of multi-step interventions to reduce the anticipated amount of bleeding prior to delivery of the placenta.

Eligibility criteria: Inclusion Criteria:

* Women with diagnosis of placenta accreta (US or MRI based diagnosis)
* Women who decline hysterectomy
* Pregnancy at 28 weeks of gestation or beyond
* Women who accept to participate in the study

Exclusion Criteria:

* Emergency Cesarean delivery (women with active bleeding)
* Women with cardiac diseases
* Women with coagulopathy

Primary outcomes:
measure: Uterine conservation
timeFrame: Intra-operative (during the time of Cesarean delivery)
Secondary outcomes:
measure: Primary postpartum hemorrhage
timeFrame: From delivery of the fetus to 1 hour after delivery of the fetus
measure: Severe primary postpartum hemorrhage
timeFrame: From delivery of the fetus to 1 hour after delivery of the fetus
measure: Bladder injury
timeFrame: Intra-operative (during the time of Cesarean delivery)
measure: Bowel injury
timeFrame: Intra-operative (during the time of Cesarean delivery)
measure: Surgical site infection
timeFrame: Up to 2 weeks after Cesarean delivery
measure: Drop in hemoglobin level
timeFrame: Hemoglobin is checked 1 hour prior to Cesarean delivery and again postoperative (24 and 72 hours after Cesarean delivery)
Other outcomes:
Locations:
Study officials:
References: