louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03814135: Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With Insomnia
Official title: Randomized, Double-blind, Double-dummy, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Doses of Hipnos Medication in the Treatment of Adults With Insomnia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Insomnia
Keywords: insomnia
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of three doses of Hipnos medication in adults with insomnia.


Eligibility criteria: Inclusion Criteria:

* Participants aged 50 years or more;
* Diagnosis of insomnia disorder according to criteria defined by the DSM-V;
* Sleep latency ≥ 20 minutes obtained through polysomnography performed prior to the randomization visit.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Known hypersensitivity to the formula components used during the clinical trial;
* Decompensated diabetes mellitus, hypothyroidism or hyperthyroidism;
* History of hepatic impairment;
* Current smoking;
* Pregnancy or risk of pregnancy and lactating patients;
* History of sleep-disordered breathing, sleep disorders associated with changes in circadian rhythm and severe neurological and psychiatric disorders;
* Diagnosis of clinical diseases that interfere with sleep;
* Participants who have used psychostimulant medications, antidepressants and/ or antipsychotic with sedative effects and/or antiepileptic;
* Participation in clinical trial in the year prior to this study.

Primary outcomes:
measure: Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment.
timeFrame: 4 weeks
Secondary outcomes:
measure: Incidence and severity of adverse events recorded during the study.
timeFrame: 5 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00581035: Study Evaluating the Safety and Ability to Produce Immune Response of Prevenar and Meningitec Given at the Same Time
Official title: A Randomised Open Label Phase 4 Study to Evaluate the Safety and Immunogenicity of Concomitant Prevenar and Meningitec Compared to Prevenar Alone and Meningitec Alone When Used as Part of the Routine Vaccination Series in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Meningococcal disease
pneumococcal disease
meningitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-27
Enrollment: 712
Sex: ALL
Minimum age (years): 42
Maximum age (years): 63
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immunogenicity of concomitant Prevenar and Meningitec compared to Prevenar alone and Meningitec alone when used as part of the routine vaccination series in healthy infants


Eligibility criteria: Inclusion Criteria:

* Healthy infants aged 6 to 9 weeks

Primary outcomes:
measure: The pneumococcal and meningococcal responses achieved after the infant series
timeFrame: 7 months
Secondary outcomes:
measure: The pneumococcal and meningococcal responses achieved after the toddler dose
timeFrame: 13 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05752435: Comparison of Therapeutic Efficacy Between Intralesional Bleomycin and Cryotherapy in Plantar Warts
Official title: Comparison of Therapeutic Efficacy Between Intralesional Bleomycin and Cryotherapy in Plantar Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Viral Wart
Lead sponsor: Combined Military Hospital Abbottabad
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial (RCT)
Primary purpose: TREATMENT

Brief summary: A randomized control trial to compare the efficacy difference between intralesional bleomycin and cryotherapy in treating plantar warts.

Detailed description: In spite of many available studies on bleomycin and cryotherapy in treating warts, little head-to-head research is carried out to compare the efficacy of these treatments. This study shows clear difference in the clearance of warts treated with intralesional bleomycin and cryotherapy.

Eligibility criteria: Inclusion Criteria

-healthy individuals of both genders between 18 to 50 years

Exclusion Criteria

* Pregnant and Lactating women
* history of vascular diseases/ chilblains
* Immunocompromised patients
* Treated previously for warts

Primary outcomes:
measure: comparative effecacy of intra lesional bleomycin vs cryotherapy in treating plantar warts within 30 days of treatment
timeFrame: 30 days of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: ABbottabad
country: Pakistan
facility: Adeel Siddiqui
state: KPK
Study officials:
affiliation: Combined Military Hospital Abbottabad
name: Adeel Dr Siddiqui, FCPS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00035841: Phase 2 Study of TLK286 in Metastatic Breast Cancer
Official title: Phase 2 Study of TLK286 in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Telik
Sponsor class: INDUSTRY
First posted: 2002-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
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 determine the effectiveness of TLK286 in treatment of metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of breast cancer
* Metastatic disease
* Measurable or evaluable disease
* No prior chemotherapy regimens
* Age at least 18 years
* Adequate liver and kidney function
* Adequate bone marrow function

Exclusion Criteria:

* Pregnant or lactating women
* Unstable medical conditions
* Chemotherapy within 14 days of TLK286
* Radiation therapy within 14 days of TLK286
* Hormonal therapy within 14 days of TLK286
* Immunotherapy within 14 days of TLK286
* CNS metastasis unless controlled by treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
Study officials:
References:
Clinical trial NCT06755541: Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study
Official title: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis (PBC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Primary Biliary Cholangitis (PBC)
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination with Ursodeoxycholic Acid in Subjects with Primary Biliary Cholangitis (PBC)


Eligibility criteria: Inclusion Criteria:

1. Must have given written informed consent (signed and dated)
2. Completed in a PBC study with fenofibrate(NCT05751967)
3. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

Exclusion Criteria:

1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results

Primary outcomes:
measure: Treatment emergent adverse events (TEAEs)
timeFrame: Through study completion, up to 120 Months
Secondary outcomes:
measure: Death
timeFrame: 120 months
measure: Liver transplantation
timeFrame: 120 months
measure: Normalization of ALP
timeFrame: 120 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT00545441: A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas
Official title: A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Fistula
Keywords: Anal fistula
fistula in ano
anorectal fistula
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Cook Biotech Incorporated
name: Cook Ireland, Ltd.
First posted: 2007-10-17
Enrollment: 86
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: The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.


Eligibility criteria: Inclusion Criteria:

* Over eighteen years old
* Clinical diagnosis of primary anal fistula categorized as transsphincteric, suprasphincteric, or extrasphincteric in nature
* Pre-placement of seton required for at least 6 weeks prior to surgical treatment
* Willing to sign informed consent and share data with study sponsor and Surgisis AFP manufacturer

Exclusion Criteria:

* Recurrent fistula tracts
* J-pouch fistulas
* Superficial fistulas
* Fistulas with active abscess, infection, or acute inflammation
* History of Chron's Disease
* History of Ulcerative Colitis
* History of HIV or other immune system disease
* History of collagen disease
* History of radiation to the anorectal region
* Allergies to pig tissue or pig products
* Religious or cultural objection to the use of pig tissue

Primary outcomes:
measure: Healing Success
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Krankenhaus Waldfriede
city: Giessen
country: Germany
facility: Justus-Liebig-Universitat Giessen
city: Hannover
country: Germany
facility: End-und Dickdarmzentrum Hannover
city: Mannheim
country: Germany
facility: Enddarmzentrum Mannheim
city: Regensburg
country: Germany
facility: Caritas-Krankenhaus St. Joseph
city: Wiesbaden
country: Germany
facility: St. Joseph Hospital
Study officials:
affiliation: Justus-Liebig-Universitat Giessen
name: Thilo Schwandner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03566641: Negative Pressure Wound Therapy vs Standard Care Dressing
Official title: A Comparison of Negative Pressure Wound Therapy vs Standard Care, for Vascular, Plastic and General Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Negative-Pressure Wound Therapy
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparing the rate of occurrence of surgical site infection, total hospital cost and length of stay between two groups: group 1 represents patients who receive Prevena for postoperative wound care and group 2 represents patients who receive standard care dressing for the same purpose.
Primary purpose: PREVENTION

Brief summary: A comparison between the efficacy of negative pressure wound therapy and the efficacy of standard care dressing

Detailed description: The aim of our study is to compare the efficacy of negative pressure wound therapy (Prevena) and standard clinical dressing in terms of prevention of postoperative surgical site infection, length of hospital stay, and total cost of hospitalization among vascular, plastic and general surgery patients.

Eligibility criteria: Inclusion Criteria:

* Consent for participation from the patient or his legal representative

Exclusion Criteria:

* Currently infected wounds
* Patients with history of immunosupression
* Pregnancy

Primary outcomes:
measure: Surgical site infection
timeFrame: 30-day postoperative period
Secondary outcomes:
measure: length of total hospital stay
timeFrame: 6 months
measure: cost of hospitalization
timeFrame: 6 months
measure: Rate of reoperation
timeFrame: 30-day postoperative period
Other outcomes:
Locations:
city: Toledo
country: United States
facility: UTMC
state: Ohio
Study officials:
affiliation: UTMC
name: munier nazzal, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06840041: Vaginal Microbiota and Post-cesarean SSI
Official title: The Relationship Between Vaginal Microbiota and Post-Cesarean Section Wound Infection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Site Infection
Cesarean Section; Complications, Wound, Infection (Following Delivery)
Keywords: cesarean section
SSI
vaginal microbiota
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will enroll pregnant women undergoing either elective or emergency cesarean section at or beyond 37 weeks of gestation. Participants must have a singleton pregnancy. Women with known immunodeficiency, chronic infections, or those who have received antibiotics within two weeks prior to delivery will be excluded. Additionally, women with ruptured membranes for more than 18 hours will be excluded to minimize the potential influence of prolonged exposure to mixed flora. The study aims to investigate the relationship between vaginal microbiota and post-cesarean section wound infection within this defined population.

Brief summary: The goal of this observational study is to investigate the relationship between vaginal microbiota composition and the development of post-cesarean section wound infection in women undergoing cesarean delivery. The main question it aims to answer is:

Is there a correlation between specific vaginal microbiota profiles and the incidence of post-cesarean section wound infection? Can specific bacterial taxa or diversity indices within the vaginal microbiota predict the risk of post-cesarean section wound infection?

Participants will:

Provide vaginal swab samples pre-operatively and post-operatively. Undergo standard post-cesarean section care and follow-up. Have wound assessment performed per standard of care, and have data collected regarding wound infection status.

Have demographic and clinical data collected, including but not limited to, antibiotic use, gestational age, and comorbidities.


Eligibility criteria: Inclusion Criteria:

* Pregnant women undergoing elective or emergency cesarean section (CS).
* Singleton pregnancy.
* Cesarean section performed at ≥ 37 weeks of gestation.

Exclusion Criteria:

* Use of antibiotics within two weeks prior to delivery.
* Known immunodeficiency.
* Chronic infections.
* Ruptured membranes for more than 18 hours.

Primary outcomes:
measure: Comparison of Vaginal Microbiota Composition and Surgical Site Infection (SSI) Incidence
timeFrame: 4 weeks after the surgery.
Secondary outcomes:
measure: Predictive Value of Specific Vaginal Bacterial Species for Surgical Site Infection (SSI).
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Hussein University Hospital
Study officials:
affiliation: Al-Azhar University
name: Muhamed Alhagrasy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02329041: Comparison of McGrath Series 5 and Airtraq Videolaryngoscope for Double-lumen Tube (DLT) Intubation
Official title: A Randomised Controlled Trial Comparing of McGrath Series 5 and Airtraq Videolaryngoscope for Double-lumen Tube Intubation in Patients With Low Airway Risk Index Score
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Thoracic Disease
Intubation Complication
Keywords: videolaryngoscope
double-lumen tube
intubation
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. We have compared it with traditional Macintosh laryngoscopefor double-lumen tube intubation. In this study, we will investigate its role in double-lumen tube intubation by comparison with another videolarygoscope.

Detailed description: The investigators designed a randomised controlled study to compare of McGrath Series 5 and Airtraq videolaryngoscope for DLT intubation in intubation time and the first attempt success rate.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Thoracic surgery required one lung ventilation

Exclusion Criteria:

* ASA physical status \>4
* Emergent operation
* planned tracheotomy
* difficult intubation predicted by a simplified airway risk index score

Primary outcomes:
measure: Intubation time
timeFrame: at intubation
Secondary outcomes:
measure: number of successful intubation at first attempt
timeFrame: at intubation
measure: total successful rate of DLT intubation
timeFrame: at intubation
Other outcomes:
measure: Airway evaluation with Cormack-Lehane Score
timeFrame: At intubation
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: yktian@tjh.tjmu.edu.cn
name: Yuke Tian, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01233141: Viennese Registry on Patients With Chronic Critical Limb Ischemia
Official title: Phase IV Hospital Based Registry to Explore the Outcome of Chronic Critical Limb Ischemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic (> 2 Weeks) Critical Ischemia With Skin Defect in Lower Limbs
Keywords: peripheral artery disease stage IV (Fontaine's classification) or stage 5 and 6 (Rutherford's classification
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary care centre

Brief summary: The rationale of this study is to establish a registry to detect and follow patients with CLI treated in Vienna. The Vienna CLI registry is meant to document the incidence, prevalence, and actual outcome of CLI patients in a real world setting and should serve as a tool for the evaluation of medical, endovascular and surgical interventions. It will help determining the prognosis of individual patients and have impact on economic and political decisions in Vienna concerning this disease and the related costs.

Detailed description: This is a prospective observational cohort study including consecutive patients with CLI. The study will be initiated as a single center evaluation and is intended to be step-wise expanded to a Vienna-wide systematic survey. The study will include patients with chronic critical limb ischemia and ischemic ulcerations as defined by Fontaine stage IV or Rutherford stages 5 \& 6. The study will include all patients presenting with CLI to the participating centers including inpatients and outpatients.

Patients will be followed up 1 month, 3 months, 6 months, 12 months and then every 6 months. The study will be continued at least until the 5 year data of the last included patient are available.

Eligibility criteria: Inclusion Criteria:

* Chronic (\> 2 weeks) critical limb ischemia in one or both of the lower extremities with necrosis and/or gangrene in the limb (peripheral artery disease IV according to Fontaine's classification or Rutherford stage 5 \& 6) of whatever genesis (atherosclerotic, aneurysmatic, embolic, inflammatory)
* ankle/brachial index \< 0.4 or toe pressure \< 30 mmHg
* Ability to give written informed consent

Exclusion Criteria:

* o Ulceration exclusively due to nonvascular causes like neuropathy (without coexisting hemodynamic impairment as defined above) or venous ulceration (without coexisting arterial impairment as defined above)

Primary outcomes:
measure: death
timeFrame: 5 years
measure: ipsilateral amputation rate
timeFrame: 5 years
measure: stroke
timeFrame: 5 years
measure: myocardial infarction
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: