louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00943761: A Study of Vaniprevir (MK-7009) in Participants With Chronic Hepatitis C Infection After Participation in Other Vaniprevir Studies (MK-7009-028)
Official title: A Phase II Open Label Study of MK-7009 Administered Concomitantly With Pegylated Interferon Alfa-2a and Ribavirin to Patients With Chronic Hepatitis C Infection After Participation in Other MK-7009 Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-07-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will provide vaniprevir 600 mg or 300 mg twice daily in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) to participants with chronic hepatitis C virus (HCV) infection who did not achieve viral eradication while participating in a prior vaniprevir clinical trial (MK-7009-004, NCT00518622; MK-7009-007, NCT00704405; MK-7009-009, NCT00704184; and MK-7009-029, NCT00954993).


Eligibility criteria: Inclusion criteria:

* Participant has participated in a prior vaniprevir clinical trial
* Participant agrees to use acceptable birth control method during treatment

Exclusion criteria:

* More than one year has passed since the participant was determined to be eligible for enrollment in protocol 028
* Participant discontinued vaniprevir and/or peg-IFN and/or RBV in the prior study due to a safety or tolerability issue
* Participant received any investigational therapy for HCV after participating in the prior study

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event
timeFrame: up to 72 weeks
measure: Number of Participants Who Experienced a Serious Adverse Event
timeFrame: up to 72 weeks
measure: Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
timeFrame: 48 weeks
measure: Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After the End of Treatment (SVR24)
timeFrame: 72 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04419961: Sexual Dysfunction and an Educational Program to Improve the Quality of Sexual Function in Vietnamese Pregnant Women in First Trimester
Official title: Sexual Dysfunction and an Educational Program to Improve the Quality of Sexual Function in Vietnamese Pregnant Women in First Trimester
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Sexual Dysfunction
Keywords: sexual dysfunction
pregnant women
education
Lead sponsor: National Hospital of Obstetrics and Gynecology
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sexual dysfunction is common in pregnant women (46.6%, 34.4%, and 73.3% in women in the first, second, and third trimester worldwide, respectively). These dysfunctions can persist after childbirth, affecting quality of life, marriage satisfaction, and family happiness. In Vietnam, a country heavily influenced by the Eastern traditions, sexual activity is considered private and only shared between husband and wife. Many women have wrong beliefs that having sexual intercouse during pregnancy will affect the safety of the fetus, and thus, are reluctant to engage in sexual activity with their husband. Interventions have been developed to improve the quality of sexual function in pregnant women.

In Vietnam, data of sexual dysfunction in pregnant women are somewhat limited, and there have been no programs to improve the sexual function for this population. Therefore, the study team plans to develop an educational program with aim to improve the quality of sexual function in Vietnamese pregnant women. This study aims to investigate the prevalence and associated factors of sexual dysfunction in first-trimester pregnant women and evaluate the effectiveness of the educational program.


Eligibility criteria: Inclusion Criteria:

* Pregnant women whose gestational age is less than or equal to 12 weeks.
* Currently living with husband/partner.
* No signs and symptoms of first trimester complications (eg, threated abortion).

Exclusion Criteria:

* Getting pregnant from in vitro fertilization or having a history of preterm birth.
* Having serious health conditions that require abortion.
* Illiterate, or having mental illness or incapacity.
* Having a fetus diagnosed with anomalies.
* Does not agree to participate.

Primary outcomes:
measure: Prevalence of sexual dysfunction in pregnant women
timeFrame: Baseline
measure: Change in the FSFI score from baseline to two months
timeFrame: Two months
Secondary outcomes:
measure: Change in knowledge and attitude at two months
timeFrame: Two months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: National Hospital of Obstetrics and Gynecology
Study officials:
affiliation: National Hospital of Obstetrics and Gynecology
name: Thanh C Phan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00749983: Effects of Creatine Supplementation in Women With Knee Osteoarthritis and Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Fibromyalgia
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-09-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 80
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 creatine associated or not to exercise training can improve physical performance in patients with knee osteoarthritis and fibromyalgia.


Eligibility criteria: Inclusion Criteria:

* Fulfill ACR criteria of knee osteoarthritis
* Fulfill ACR criteria of fibromyalgia

Exclusion Criteria:

* Athletes
* Drugs stable for at least three months before entering the study
* No limitations to resistance training

Primary outcomes:
measure: Physical function
timeFrame: 12 weeks
Secondary outcomes:
measure: Strength
timeFrame: 12 weeks
measure: Quality of life
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: Renal function
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo School of Medicine
Study officials:
References:
Clinical trial NCT06238583: Expanded Access to Provide Copanlisib for Patients With Cancer Who Are Experiencing a Positive Response, as Determined by Their Doctors
Official title: Copanlisib Expanded Access Program (EAP) for Patients Who, in the Opinion of Their Healthcare Provider, Are Deriving Benefit From Copanlisib Therapy
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-02-02
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this Expanded Access Program (EAP) is to allow patients to continue receiving treatment with copanlisib if they are currently having, in the opinion of their healthcare provider, an objective favorable response when taking copanlisib. Patients considering this access program should have no other therapeutic option, have not developed a disease and/or medical condition (including pregnancy), and/or have a toxicity that would conflict with continuing to receive copanlisib.


Eligibility criteria: Inclusion Criteria:

* Patient has provided written informed consent.
* Patient meets one of the following criteria:

  * Already enrolled and on treatment with copanlisib in Bayer-sponsored Study 17067 (CHRONOS-3), OR
  * Already enrolled and on treatment with copanlisib in an investigator-initiated research (IIR)/institution-sponsored collaborative study (ISCS), OR
  * Currently on copanlisib treatment prescribed by a healthcare provider.
* Patient is deriving an objective favorable response from copanlisib in the opinion of their healthcare provider.
* Patient has no suitable alternative treatments available.
* Women of childbearing potential and men must agree to use effective contraception when sexually active due to potential embryo-fetal toxicity for 1 month after the last dose.

Exclusion Criteria:

* Patients who may have developed a disease/condition/toxicity that would conflict with continuing to receive copanlisib treatment.
* Patients on treatment with rituximab (R) either alone or in combination with chemotherapy, including an alkylating agent (e.g. bendamustine \[R-B\] or cyclophosphamide, hydroxydoxorubicin, vincristine, prednisone \[R-CHOP\]) for relapsed indolent non-Hodgkin's lymphoma (iNHL).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Brazil
facility: Many Locations
city: Multiple Locations
country: Chile
facility: Many Locations
city: Multiple Locations
country: Hong Kong
facility: Many Locations
city: Multiple Locations
country: Hungary
facility: Many Locations
city: Multiple Locations
country: Ireland
facility: Many Locations
city: Multiple Locations
country: Malaysia
facility: Many Locations
city: Multiple Locations
country: Poland
facility: Many Locations
city: Multiple Locations
country: Romania
facility: Many Locations
city: Multiple Locations
country: Russian Federation
facility: Many Locations
city: Multiple Locations
country: Taiwan
facility: Many Locations
city: Multiple Locations
country: Ukraine
facility: Many Locations
Study officials:
References:
Clinical trial NCT01931683: Dosing Study of Remifentanil for Smooth Removal of the Laryngeal Mask Airway (LMA)
Official title: Effect-site Concentration of Remifentanil for Smooth Removal of the LMA From Propofol Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Drug Usage
Keywords: LMA removal
remifentanil
propofol
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2013-08-29
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators attempted to determine the optimal effect-site concentration of remifentanil for smooth removal of the LMA from propofol anesthesia.

Detailed description: At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to predetermined (initial concentration 1.0 ng/ml for the first patient). LMA removal was performed when the patients opened their eyes and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed.

Eligibility criteria: Inclusion Criteria:

* ASA I-II patients undergoing general anesthesia for short elective surgery (\<1 hr)

Exclusion Criteria:

* G-E reflux
* obesity (BMI\>30)
* anticipated difficult airway

Primary outcomes:
measure: smooth removal of LMA
timeFrame: from end of surgery to removal of LMA (participants will be followed for the emergence periods, an expected average of 15 min).
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
Study officials:
affiliation: Ajou University School of Medicine
name: Jong Yeop Kim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01626183: Studying RNA in Samples From Younger Patients With T-Cell Acute Lymphoblastic Leukemia
Official title: Molecular Taxonomy in Pediatric Cancer- IncRNA Expression in Primary T-ALL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: T-cell childhood acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-06-22
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients with diagnosed or relapsed T-ALL

Brief summary: RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer

PURPOSE: This laboratory study is looking into RNA in samples from younger patients with T-cell (T) acute lymphoblastic leukemia (ALL).

Detailed description: OBJECTIVES:

* Characterization of the transcriptomic landscape in diagnosis and relapse of T-cell acute lymphoblastic leukemia (ALL) and the direct comparison with corresponding physiological samples (human thymus).
* Perform high-throughput transcriptome ribonucleic acid (RNA) sequencing using matched diagnostic T-precursor pediatric ALL samples (peripheral blood or bone marrow).

OUTLINE: Archived peripheral blood and bone marrow samples are analyzed for long non-coding RNA (IncRNA) expression and sequencing.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Peripheral blood and bone marrow samples from pediatric patients with diagnosed and relapsed T-ALL

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Identification and characterization of IncRNA of pediatric T-cell acute lymphoblastic leukemia
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Iannis Aifantis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04267783: Prediction of Uterine Atony After Vaginal Delivery by Elastography
Official title: Prediction of Uterine Atony After Vaginal Delivery by Shear Wave Elastography: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Keywords: postpartum hemorrhage
uterine atony
shear wave
elastography
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women above 37 weeks of gestation without known risk factors for postpartum hemorrhage who have vaginal births in our centre will be eligible for this study

Brief summary: Prospective study evaluating the feasibility of shear-wave elastography of the uterus during the third stage of labour and following placental delivery. The investigators hypothesize that the stiffness of the myometrium can be measured by using shear-wave technology. This study involves 30 patients with a healthy pregnancy and spontaneous vaginal delivery. One co-investigator will carry out measurements at the uterine fundus, at three different time points: after fetal delivery, after placental delivery and 30 minutes after placental delivery.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* cephalic presentation
* maternal age \> 18 years old
* nulliparous
* healthy uncomplicated pregnancy
* gestational age between 37-42 weeks of gestation
* spontaneous labour and delivery
* uncomplicated progression of labour (cervical dilatation at \>1 cm/h)
* administration of less than 3 units of oxytocin during the second stage of labour
* patient having read, accepted and signed the consent form

Exclusion Criteria:

* antepartum hemorrhage in the present pregnancy
* protracted second stage of labour (more than two hours from full dilatation to delivery)
* more than 30 minutes of active pushing
* BMI \> 35 kg/m2
* distance from skin to uterus \> 8 cm
* age \> 35 years old
* instrumental deliveries
* bleeding disorders
* polyhydramnios
* diabetes
* pre-eclampsia
* high blood pressure
* use of anticoagulant medications
* clinical chorioamnionitis
* placental abnormality (low-lying or abruption)
* fetal macrosomia
* uterine fibroids
* uterine anomalies
* previous uterine scar
* multiple pregnancy
* placental retention
* inability to follow procedures or insufficient knowledge of project language
* inability to give consent
* refusal to participate

Primary outcomes:
measure: Stiffness of the myometrium
timeFrame: Third labor stage to 30 minutes post placenta delivery
Secondary outcomes:
measure: Blood loss
timeFrame: Two hours following the childbirth
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
state: Vaud
Study officials:
References:
Clinical trial NCT06597383: The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly
Official title: The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly ( RAPSODIA )
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acromegaly
Keywords: somatostatin analogues
pasireotide
pegvisomant
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: University of Turin, Italy
name: University of Padova
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acromegaly treated with second-line medical therapy.

Brief summary: This is an observational, retrospective, national multicenter study aimed to evaluate the impact and efficacy of Time To Switch (TTS) from first-line to second-line medical therapy in Acromegaly.

Detailed description: The study will retrospectively collect clinical, laboratory and anamnestic data of approximately 100 patients evaluated at the UOs involved in the study in last 5 years and 6 months.

Acromegalic patients which neurosurgical intervention was not completely effective or contraindicated or rejected by the patient and for which first-line medical therapy with first-generation somatostatin analogues (octreotide LAR or lanreotide) did not result in disease control and switched to second-line medical therapy will be enrolled. The TTS is the time defined in days and months from the observation that disease is no longer biochemically controlled, defined by the presence of GH levels ≥1 μg/L and IGF-1\>1.3×ULN (upper limit of normal), during 1st line therapy, and the start of 2nd line therapy line.

Eligibility criteria: Inclusion Criteria:

* Adult men and women (age ≥ 18 years) affected by acromegaly, including those of childbearing age
* Patients inadequately controlled with first generation somatostatin analogues (GH ≥1 μg/L and IGF-1 \>1.3×ULN)
* Second line medical treatment (Pasireotide; Pegvisomant only; combination Pegvisomant + 1st generation SSA) after use of first-line medical treatment
* At least 12 months of follow up during 2nd line therapy
* Signature of the informed consent to the study

Exclusion Criteria:

* age ≤18 years
* Pregnant and/or breastfeeding women
* Patients unable to understand and sign the Informed Consent

Primary outcomes:
measure: Evaluate the impact of TTS on disease control in acromegalic patients defined by IGF-1 levels <1.3xULN
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Andrea Giustina
Study officials:
References:
Clinical trial NCT00743483: Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency
Official title: An Open Label, Exploratory Study on the Effect of rhBSSL on the Fat Absorption in Patients With Cystic Fibrosis and Pancreatic Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Keywords: cystic fibrosis
pancreatic insufficiency
bucelipase alfa
bile salt stimulating lipase
BSSL
coefficient of fat absorption
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2008-08-28
Enrollment: 15
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: The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and pancreatic insufficiency following treatment with BSSL

Detailed description: In this open study, patients will enter a baseline period of 6 days where the pancreatic enzyme therapy will be discontinued and a standard diet given. After the baseline period, patients will enter a treatment period of 6 days where a fixed dose of BSSL will be administered. The primary efficacy measurements will be made by collecting stool during the last three days of each period.

Eligibility criteria: Inclusion Criteria:

* Patients with cystic fibrosis and pancreatic insufficiency who are able to refrain from their ongoing pancreatic enzyme treatment for a period of 7 days and are able to produce stools \>= 5 times per week

Primary outcomes:
measure: The Absolute Difference Between Baseline and Treatment Coefficient of Fat Absorption (CFA)
timeFrame: Final 3 days of baseline and treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Gdansk
country: Poland
facility: Specjalistyczny Zespól Opieki Zdrowotnej nad Matka i Dzieckiem w Gdansku
city: Poznan
country: Poland
facility: Uniwersytet Medyczny im. K. Marcinkowskiego
city: Rabka-Zdroj
country: Poland
facility: Oddzialu Terenowego Instytutu, Gruzlicy i Chorob Pluc w Rabce-Zdroju
Study officials:
affiliation: Swedish Orphan Biovitrum
name: Jean-Pierre Isal, MD, PhD
role: STUDY_DIRECTOR
affiliation: Erasmus Medical Center, Rotterdam, Netherlands
name: Janneke Langendonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04241783: Relationship of Mindfulness, Artistic Activities and Quality of Life
Official title: University of Bojnord
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Lead sponsor: University of Bojnord
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of women working in workshops of carpet weaving in Bojnourd in 2018 that were selected by cluster sampling from 5 workshops.

Brief summary: Methods: This study has the descriptive-correlational method and the statistical population was all artistic females of Bojnord city in 2018. In this study, 200 women of carpet weavers were selected by cluster random sampling. Participants filled out researcher-made questionnaires on how to do artistic activities, mindfulness, and quality of life. Data were analyzed using the Pearson correlation coefficient and hierarchical regression (moderator).


Eligibility criteria: Inclusion Criteria:

* be female, having 21 -60 years old, to work in workshops of weaving carpet, be literacy

Exclusion Criteria:

* be male, having under 21, upper 60, no work in workshops of weaving carpet , having psychotic disorders, be illiteracy

Primary outcomes:
measure: quality of life
timeFrame: 3 day
measure: mindfulness
timeFrame: 3 day
measure: artistic activities
timeFrame: 3 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bojnourd
country: Iran, Islamic Republic of
facility: university of Bojnord
state: North Khorasan
Study officials:
References: