louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06261333: Quality of Life in Patients With Hemorrhagic Telangiectasia
Official title: Influence of Telangiectasia and Anemia on the Well-being and Quality of Life of Patients With Hereditary Hemorrhagic Telangiectasia (HHT).
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hereditary Hemorrhagic Telangiectasia
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from HHT

Brief summary: Hereditary Hemorrhagic Telangiectasia (HHT), also known as Osler's disease, is a genetic disorder that leads to abnormal blood vessel formations. It primarily affects blood vessels in the skin, mucous membranes, and internal organs. The disease can be clinically diagnosed using the Curaçao criteria (1. Positive family history of HHT, 2. Recurrent and spontaneous epistaxis, 3. Multiple typical telangiectasias, 4. Organ involvement with vascular malformations, especially in the liver, lungs, gastrointestinal tract, or brain); if a patient meets at least 3 criteria, the diagnosis of HHT can be established.

Patients with HHT often have telangiectasias on their faces. Additionally, many patients suffer from anemia, which can result in a pale and potentially tired appearance. Patients with HHT may be less satisfied with their appearance due to the aesthetic changes in their faces and may also experience psychosocial impairment. To further investigate this, various validated questionnaires (FACE-Q©, PROMIS-Profile-29+2, EQ5D), as well as routinely collected clinical data (e.g., laboratory values including hemoglobin levels, Curaçao criteria, smoking status, alcohol consumption, and the Epistaxis Severity Score (ESS)) will be used.


Eligibility criteria: Inclusion criteria:

* knowledge of german language
* Age above 17 years
* capable of giving consent
* Diagnosis of HHT (Curaçao criteria or genetic testing)

Exclusion criteria:

-Individuals not meeting the inclusion criteria.

Primary outcomes:
measure: Quality of Life and Patient Satisfaction measured using the FACE-Questionnaire
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Departement of Otorhinolaryngology - Head and Neck Surgery University Hospital Essen
state: NRW
Study officials:
References:
Clinical trial NCT00092833: Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED)
Official title: An Open-Label, Worldwide, Treatment Use Study to Provide Ezetimibe 10 Mg/Day to Patients With Homozygous Familial Hypercholesterolemia or Homozygous Sitosterolemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hypercholesterolemia, Familial
Lipid Metabolism, Inborn Errors
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 49
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
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 provide an investigational drug to patients with a specific type of hypercholesterolemia (high cholesterol) or sitosterolemia (unusually high absorption of non-cholesterol sterols) in a treatment use setting.


Eligibility criteria: Inclusion Criteria:

* Homozygous familial hypercholesterolemia or sitosterolemia

Exclusion Criteria:

* Patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study

Primary outcomes:
measure: Incidence of clinical and laboratory adverse experiences in in patients with homozygous FH or homozygous sitosterolemia taking ezetimibe 10 mg/day
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02369133: Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control
Official title: Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section; Dehiscence
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2015-02-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive paracetamol on postoperative pain scores, patient satisfaction, total morfin consumption and the incidence of morfin-related side effects in patients undergoing cesarean section.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 20-40 years,
* ASA physical status 1-2 who underwent elective cesarean surgery during general anesthesia were included in the study

Exclusion Criteria:

* A history of allergy to any of the study medications (opiod, general anesthetic agents or paracetamol),
* history of opioid or paracetamol use,
* hepatic or renal failure,
* any psychological disorders,
* complications during cesarean section and unable to use PCIA device were excluded from the study.

Primary outcomes:
measure: Postoperative pain scores measured by visual analog scale (VAS)
timeFrame: Postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01511133: Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™
Official title: Blinded Retrospective Laboratory Evaluations to Assess the Serologic Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in the Stool of Infants Aged 6 to 12 Weeks Following Administration of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus Vaccine (444563)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotavirus Infection
Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants
Keywords: Laboratory evaluations
infants
Porcine circovirus type 1 (PCV-1)
serologic response
human rotavirus (HRV) vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-01-18
Enrollment: 1
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants aged 6 to 12 weeks from 4 previously conducted clinical trials, who received 2 or 3 doses of either Rotarix™ or Placebo

Brief summary: This study aims to test the clinical samples (stool and serum) previously collected during clinical development of HRV vaccine, to identify if there is any evidence of PCV-1 replication and/or immune response to the PCV-1 in vaccinated infants.

Detailed description: Serum and stool samples collected from 4 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.

Eligibility criteria: Inclusion criteria:

* Subjects enrolled previously in randomized, double-blind and placebo-controlled studies 444563/022 (NCT00263666), 444563/033 (NCT00757770), 103477 (NCT00169455), and 104480 (NCT00137930);
* Infants aged 6 to 12 weeks at Dose 1 vaccinated with either HRV vaccine or placebo;
* Infants for whom sufficient residual volume of the stool samples at predetermined time points is available;
* Infants for whom sufficient residual volume of the pre and post vaccination blood samples is available.

Exclusion criteria:

- Not applicable

Primary outcomes:
measure: Presence of PCV-1 DNA and pattern of detection in the stool samples collected
timeFrame: At pre-defined time points after vaccination (3-7 time points up to day 45 after vaccination)
measure: Presence of serum anti-PCV-1 antibody
timeFrame: At pre and post vaccination time points (At Day 0 and 2 Months after last dose vaccination)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Han HH, Karkada N, Jayadeva G, Dubin G. Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix: A retrospective laboratory analysis. Hum Vaccin Immunother. 2017 Jan 2;13(1):237-244. doi: 10.1080/21645515.2016.1231262.
Clinical trial NCT05560633: Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring
Official title: The Feasibility of Nipple-sparing Mastectomy in Combined With Abdominal Free Flap Breast Reconstruction Without Skin Paddles for Flap Monitoring: a Single-center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast/Surgery
Keywords: breast cancer
DIEP
ms-TRAM
breast reconstruction
learning curve
nipple spring mastectomy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 147
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The eligibility of patients for free-TRAM/DIEP was based on the judgement of surgeons, preference of patients, and guideline recommendation as a standard-of-care. For NSM, patients should receive standard-of-care physical examination, ultrasound, mammogram and/or MRI assessment of the involved breast. Patients with clinical involvement of the nipple areola complex (NAC) were excluded

Brief summary: 1. Learning curve of ms-Tram and DIEP breast reconstructions surgery are important to guide the training of new surgeon.
2. Buried flap post operative monitoring without implantable doppler was seldom studied, a validated protocol reported.
3. The complication rates of the flap and oncological safety were studied.

Detailed description: Operative time and complication rate are employed to analysis the learning curve of the ms-Tram and DIEP surgery,which is meaningful for the new microsurgeon training.

Buried flap without the implatable doppler is very common condition all over the world, and the complication rate was evaluated as evidence of reliable of the validated monitoring protocol.

Complication rates were considered as different before and after the platue of the learning curve. Within the study of the learning curve, complication rates were reported.

Eligibility criteria: Inclusion Criteria:

* Female breast cancer patients with age \> 18 years
* Received autologous abdominal free-flap breast reconstruction (including muscle-sparing free TRAM or DIEP)

Exclusion Criteria:

* Breast conserving patient
* Implant-based breast reconstruction

Primary outcomes:
measure: Total flap failure rate
timeFrame: Through study completion， and average of 2.5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00237133: Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women
Official title: PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Locally Advanced Breast Cancer
Keywords: Breast cancer,
Letrozole,
Hormonal receptors
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR)


Eligibility criteria: Inclusion Criteria:

1. Postmenopausal women
2. Primary locally invasive breast cancer
3. Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with \> 10% positive malignant epithelial cells.
4. Post menopausal status
5. Tumor measurable by clinical examination, mammography and ultrasound

Exclusion Criteria:

1. Prior treatment with letrozole or tamoxifen.
2. Patients with bilateral breast tumors
3. Patients who are eligible for breast conserving surgery
4. Evidence of inflammatory breast cancer or distant metastasis.
5. Other concurrent malignant disease
6. Concomitant anti-cancer treatments such as chemotherapy

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Safety and tolerability of Letrozole
timeFrame: frequency and severity of the clinical adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: Barretos - SP
country: Brazil
facility: Novartis Investigative Site
city: Florianopolis - SC
country: Brazil
facility: Novartis Investigative Site
city: Fortaleza/CE
country: Brazil
facility: Novartis Investigative Site
city: Goiania/GO
country: Brazil
facility: Novartis Investigative Site
city: Jau -SP
country: Brazil
facility: Novartis Investigative Site
city: Porto Alegre/RS
country: Brazil
facility: Novartis Investigative Site
city: Ribeirao - SP
country: Brazil
facility: Novartis Investigative Site
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
city: Santo Andre
country: Brazil
facility: Novartis Investigative Site
city: Sao Paulo/SP
country: Brazil
facility: Novartis Investigative Site
city: Vitoria/ES
country: Brazil
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT04719533: Outcomes Following Pre-marking of Episiotomy Location
Official title: Short and Long Term Outcomes of Patients With and Without Pre-marked Episiotomy Location
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Episiotomy; Complications
Episiotomy Extended by Laceration
Episiotomy Infection
Keywords: episiotomy
episiotomy complications
premarked episiotomy
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized-controlled trial
Primary purpose: PREVENTION

Brief summary: To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.

Detailed description: Purpose: To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.

Hypothesis: Women following episiotomy following pre-marking of the location will suffer from fewer short- and long-term complications compared to those without pre-marked episiotomy location.

Study type: prospective randomized-controlled trial

Eligibility criteria: Inclusion Criteria:

* women 18 years of age or older who present in active labour to our center and consent to participate in the study

Exclusion Criteria:

* women under 18 years of age or those who do not or are unable to provide informed consent to participate in the study

Primary outcomes:
measure: Extended laceration of the episiotomy
timeFrame: Up to 1 hour following the episiotomy
measure: Third- and fourth-degree perineal tears
timeFrame: Up to 2 hours following the episiotomy
measure: Post-partum hemorrhage
timeFrame: Up to 6 weeks following delivery
measure: Blood transfusion requirement
timeFrame: Up to 5 days following delivery
measure: Episiotomy site infection
timeFrame: Up to 6 weeks following delivery
measure: Requirement of resuturing of episiotomy or evacuation of hematoma
timeFrame: up to 6 weeks following delivery
measure: Long-term symptoms related to episiotomy
timeFrame: Up to 5 years following delivery
measure: Perineal tears in subsequent deliveries
timeFrame: Up to 5 years following delivery
measure: Surgical correction of episiotomy
timeFrame: Up to 5 years following delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Sharon Davidesko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00737633: Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic Adults
Official title: An Open-Label, Non-Randomized Multicenter Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Providing and Maintaining Glycemic Control in Type 2 Diabetic Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetes
Keywords: Diabetes
Type 2 Diabetes
Diabetes Mellitus
Metabolic Diseases
Glucose Metabolism Disorders
Glycemic Control
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
Collaborators: name: Synteract, Inc.
name: Sentrx
First posted: 2008-08-19
Enrollment: 101
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an extension of a study that has been ongoing for 1 year. The purpose of this open label study is to see the how well type 2 diabetics respond to VI-0521(phentermine/topiramate) in controlling blood sugar and how safe VI-0521 is over an extended period of time. All subjects eligible to enroll into this study will receive study drug.


Eligibility criteria: Inclusion Criteria:

* Have completed the qualifying DM-230 trial
* If females of child-bearing potential, subjects must be using adequate contraception
* Provide written informed consent
* Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures
* Be greater than 80% compliant in study medication use during the last three visits for DM-230

Exclusion Criteria:

* Subjects who have developed one or more morbidities during the DM-230 trial that would pose a safety concern

Primary outcomes:
measure: Change in HbA1c From Baseline to Week 72
timeFrame: Baseline to 72 weeks
Secondary outcomes:
measure: Percent Weight Change From Baseline to Week 72
timeFrame: Baseline to 72 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Spring Valley
country: United States
facility: Research Site
state: California
city: Walnut Creek
country: United States
facility: Research Site
state: California
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Austin
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: VIVUS LLC
name: Barbara Troupin, MD, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT02012933: 3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome (LEMS) and Congenital Myasthenia (CM)
Official title: 3,4-Diaminopyridine for Lambert-Eaton Myasthenic Syndrome and Congenital Myasthenia
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Lambert-Eaton Myasthenic Syndrome (LEMS)
Congenital Myasthenia (CM)
Keywords: 3,4DAP, LEMS, CM
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Jacobus Pharmaceutical
First posted: 2013-12-17
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Lambert-Eaton Myasthenic Syndrome (LEMS) is a rare autoimmune disorder which affects the nerve-muscle junction. The major symptoms of LEMS are progressive muscle weakness. Many patients experience other symptoms like dry mouth or impotence. Congenital Myasthenia (CM) is an inherited disorder with similar affects and symptoms.

3,4-Diaminopyridine (DAP) is an experimental drug that has improved strength in some subjects with (LEMS). There are no other accepted treatments for LEMS and DAP has relatively few side effects.

Detailed description: Subjects with clinically confirmed LEMS or CM will receive 3,4-diaminopyridine (3,4 DAP) by mouth in slowly increasing doses. Treatment will begin with 5-10 mg three times a day. A common final dosage is 15-20 mg four or five times a day, as clinically needed, and if tolerated. The upper limit is a total of 100 mg/day. Subjects will be monitored for strength and side effects via routine clinic visits at intervals of one month for the first three months, then every three months for the first year, and at least every six months thereafter. Treatment will be continued indefinitely if a good clinical response is achieved and side effects are tolerable.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of LEMS or CM
* If female and over the age of 9, must have a negative pregnancy test, and, if premenopausal, must be willing to practice an effective form of birth control.
* Must be tested and found by ECG not to have a prolonged Q-Tc syndrome.
* Must agree to have a second ECG at the time of peak drug effect.

Exclusion Criteria:

* Known to have sensitivity to 3,4-DAP
* History of clinical seizures or evidence of seizure activity on screening EEG
* History of severe asthma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References: