louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02643602: Does Bicarbonate in Addition to Theophylline Reduce CIN?
Official title: Does Bicarbonate in Addition to Theophylline Reduce Contrast Induced Nephropathy Compared to Sodium Chloride?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiographic Contrast Agent Nephropathy
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Contrast-induced nephropathy (CIN) is the third most frequent cause of hospital-acquired acute renal failure. Different regimes in the prophylaxis of CIN have been investigated in the last years. Recent Meta-analysis show a reduced incidence of CIN when theophylline is administered to the patients especially in patients with already existing renal impairment. Furthermore hydration with bicarbonate seems to to be superior to hydration with sodium chloride alone. The combination of the two prophylaxis has not been investigated yet.

Aim of this prospective randomized trial is to investigate the effect of hydration with sodium bicarbonate compared to saline in addition to theophylline prophylaxis which all patients receive.


Eligibility criteria: Inclusion Criteria:

Increased risk for contrast induced nephropathy defined as:

* Serum creatinine level ≥ 1.1 mg/dl OR
* Serum creatinine level ≥ 0.8 mg/dl plus an additional risk factor like diabetes mellitus, renal failure in past medical history or nephrotoxic medication (aminoglycoside, vancomycin, amphotericin B, diuretic)

Exclusion Criteria:

* pre-existing renal replacement therapy
* unstable serum creatinine levels (difference of more than ±0.4 mg/dl within 3 days before contrast application)
* contraindications for theophylline or sodium bicarbonate (allergies, tachycardia, alkalosis, hypokalemia)
* additional interventions that might influence renal function

Primary outcomes:
measure: Contrast induced nephropathy
timeFrame: 48 hours
Secondary outcomes:
measure: Change of serum creatinine levels over time
timeFrame: 48 hours
measure: Change of creatinine clearance over time
timeFrame: 48 hours
measure: Change in blood pH
timeFrame: 48 hours
measure: Change in blood bicarbonate-concentration
timeFrame: 48 hours
measure: Change in blood sodium-concentration
timeFrame: 48 hours
measure: Change in urine pH
timeFrame: 48 hours
measure: Change in urine bicarbonate-concentration
timeFrame: 48 hours
measure: Change in urine pH sodium-concentration
timeFrame: 48 hours
measure: Incidence of patients with need for dialysis
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: 2. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München
name: Wolfgang Huber, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03002402: Feasibility and Acceptability of an Internet-based Cognitive-behavioral Treatment for Insomnia in Adults With Asthma
Official title: Feasibility and Acceptability of an Internet-based Cognitive-behavioral Treatment for Insomnia in Adults With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Insomnia Chronic
Keywords: asthma
insomnia
cognitive-behavioral treatment
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-12-23
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the proposed study are to explore changes in sleep and asthma outcomes from baseline to post-treatment in adults with asthma and comorbid insomnia who underwent Internet-based cognitive-behavioral treatment for insomnia (CBT-I).


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of moderate-severe persistent asthma
* Not well controlled asthma (score ≤ 19 on the Asthma Control Test)
* Age 18-75 years
* Meets criteria for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Insomnia Disorder
* At least moderate insomnia severity (score ≥ 10 on Insomnia Severity Index)
* Telephone number, email address, and reliable Internet access

Exclusion Criteria:

* History of bipolar or psychosis
* Substance abuse disorder within past 3 months
* Dementia or probable dementia diagnosis
* Plans to move or leave present source of care during the following 6 months.
* Non-English speaking, illiterate, or possesses sensory deficits

Primary outcomes:
measure: Insomnia severity
timeFrame: baseline and post-intervention (up to 9 weeks)
measure: Asthma control
timeFrame: baseline and post-intervention (up to 9 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Faith S Luyster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01725802: A Safety, Tolerability, and Plasma Concentration Study of Levodopa/Carbidopa Subcutaneous Solution (ND0612) in Parkinson's Disease (PD) Patients
Official title: A Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: NeuroDerm Ltd.
Sponsor class: INDUSTRY
First posted: 2012-11-14
Enrollment: 8
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this Phase I/IIa study, the effect of continuous subcutaneous administration of LD/CD solution (ND0612) on the safety and PK profile of LD will be examined.

Detailed description: Design: single center, double-blind, randomized, placebo-controlled, crossover study.

Study Drug: Subcutaneous (SC), ND0612 (LD/CD solution) or placebo (saline) to be administered via a continuously via the CRONO Five SC pump. A 1-week washout period will apply between the treatments.

Population: Eight (8) PD subjects.

Eligibility criteria: Main Inclusion Criteria:

* Men and women with idiopathic Parkinson's disease
* Subjects must experience motor fluctuations associated with LD/CD dosing
* Modified Hoehn and Yahr stage \< 5
* Subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy
* Women must be postmenopausal, surgically sterilized, or using adequate birth control. Women of childbearing potential must have a negative pregnancy test (serum beta-HCG) at screening.
* Subjects must be age 30 or older.
* Subjects must be willing and able to give informed consent.

Main Exclusion Criteria:

* Subjects with a clinically significant or unstable medical or surgical condition
* Subjects with clinically significant psychiatric illness.
* Pre-menopausal women, not using birth control method.
* Subjects who have taken experimental medications within 60 days prior to baseline.
* Subject who have undergone a neurosurgical intervention for Parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation).

Primary outcomes:
measure: Incidence and frequency of adverse events
timeFrame: up to 8 weeks
measure: Withdrawal rate
timeFrame: 2 days
Secondary outcomes:
measure: LD Half life (t½ ), time of LD plasma concentrations maintained above 1000 ng/ml, trough levels, Cmax, Tmax and AUC
timeFrame: Up to 2 days
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References:
Clinical trial NCT02604602: Coagulation Factors and Postpartum Hemorrhage
Official title: Peripartal Concentration of Coagulation Factors and Postpartum Hemorrhage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage
Keywords: PPH
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women before delivery

Brief summary: Objective is to analyze a possible association of coagulation factors peripartal with the occurrence of postpartum hemorrhage.


Eligibility criteria: Inclusion Criteria:

* pregnant women \> 22 weeks of gestation

Exclusion Criteria:

* age \< 18 years, no informed consent

Primary outcomes:
measure: occurrence of PPH
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich
Study officials:
affiliation: Division of Obstetrics, University Hospital of Zurich
name: Christian Haslinger, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05259202: Value of Fetal Scalp Lactate Sampling During Labour in Cases of Abnormal Fetal Heart Rate
Official title: Value of Fetal Scalp Lactate Sampling During Labour in Cases of Abnormal Fetal Heart Rate During Labor Over 60 Minutes Without a Significant ST-event
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Acidosis
Keywords: serious metabolic acidosis
T segment analysis
Blood samples
instrumental delivery
Apgar score
admission to a neonatal ward
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women monitored by STAN in active labour with singleton term fetus in cephalic presentation

Brief summary: ST-analysis of the foetal ECG (STAN®) is another second line technique for intrapartum foetal monitoring. Combining ST-analysis with standard CTG interpretation aims to identify hypoxic foetuses more accurately than CTG alone. The STAN® method identifies changes in the ST-interval of the foetal ECG that occur in the presence of foetalcentral hypoxia The aim of this studie is to investigate if the foetal lactate blood sampling is still useful when STAN® monitoring is already being used as a second line technique for intrapartum foetal monitoring if the fetal heart rate is abnormal without a significant ST event Nowadays in the Montpellier hospital's protocol, the investigators have to check the value of lactate sampling in case of le STAN doesn't detect an ST event.

So this studie can change the Montpellier hospital's protocol and avoid useless fetal blood sampling


Eligibility criteria: Inclusion criteria:

* patient with labor monitoring by ST segment analysis (STAN) according to current guidelines
* patient who received a fetal lactate sample for fetal heart rate classified as pathological for more than 60 minutes

Exclusion criteria:

* STAN guidelines not respected before installation and during work
* misclassification of fetal heart rate
* obstetrical complications during labor

Primary outcomes:
measure: the incidence of serious metabolic acidosis
timeFrame: day 1
Secondary outcomes:
measure: Number of the instrumental delivery
timeFrame: day 1
measure: Number of the neonatal outcome
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: WALTZING Aude
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03232502: Pharmacogenetics in Primary Care Psychotropics
Official title: Pharmacogenetics in Primary Care Psychotropics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Depression
Obsessive-Compulsive Disorder
Generalized Anxiety Disorder
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pragmatic trial of pharmacogenetic testing at the time of prescription for a selective serotonin reuptake inhibitor, tricyclic antidepressant or atypical antipsychotic. Does real time intervention improve patient outcomes?


Eligibility criteria: Inclusion Criteria:

* Over 18
* Prescribed a drug of interest for the first time

Exclusion Criteria:

* Previous pharmacogenetic testing available

Primary outcomes:
measure: Patient oriented outcome1- Clinical Improvement
timeFrame: 6 months
measure: Patient oriented outcome2- Adverse effects
timeFrame: 6 months
measure: Patient oriented outcome3- Time to Improvement
timeFrame: Up to 6 months
measure: Patient oriented outcome5- Visits
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04141202: Structured Physical Exercise in Short-term Inpatient Treatment of Substance Use Disorder
Official title: Structured Physical Exercise in Short-term Inpatient Treatment of Substance Use Disorder: Implications for Abstinence, Quality of Life, Physical- and Mental Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Substance-Related Disorders
Drug Abuse
Drug Dependence
Keywords: Exercise therapy
Exercise physiology
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 200
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: Diagnosed with substance use disorder.

Brief summary: In 2017, structured physical exercise with high intensity was implemented as a part of the treatment program at St. Olav Hospital Clinic of Substance Use and Addiction Medicine.

The objective of this study is to examine whether implementing structured physical exercise in the treatment program has implications for patients' physical and mental health and quality of life after completing a 3 month residential treatment program.

The results of this study will benefit substance use disorder patients in the future, and may have an impact on further implementation of physical exercise in addiction treatment clinics both nationally and internationally.


Eligibility criteria: Inclusion Criteria:

* Being an inpatient at the clinic

Exclusion Criteria:

-

Primary outcomes:
measure: Physical health
timeFrame: 18 months
measure: Physical health
timeFrame: 18 months
measure: Mental health
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital HF Klinikk for rus og avhengighetsmedisin
Study officials:
affiliation: St Olavs Hospital Klinikk for rus- og avhengighetsmedisin
name: Kristin Smedsrud
role: STUDY_DIRECTOR
References:
Clinical trial NCT01616602: Prone Versus Left-sided Colonoscopy in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Keywords: patients
presenting
elective
colonoscopy.
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
First posted: 2012-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: For obese patients, a randomized trial aimed at determining whether colonoscopy performance and patient comfort is improved if a patient is in the prone position (lay on their abdomen) versus the traditional left-sided position.


Eligibility criteria: Inclusion Criteria:

* BMI \>30kg/m2
* Elective Colonoscopy

Exclusion Criteria:

* Patients with prior colonic resection, strictures, or known colonic or intra-abdominal malignancy.
* Patients who are scheduled to have monitored or general anesthesia for their procedure.
* Emergency colonoscopy
* Inadequate preparation of the colon as assessed during colonoscopy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT06784921: To Investigate the Real-world Efficacy and Safety of Sacituzumab Govitecan for HER2 Negative Metastatic Breast Cancer Patients in China.
Official title: Real-World Patient Characteristics, Treatment Patterns, and Outcomes for Patients with HER2 Negative Metastatic Breast Cancer Treated with Sacituzumab Govitecan: a Retrospective Trial in China（SACIT-OUT）
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer Metastatic
Keywords: Breast cancer
Sacituzumab Govitecan
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient had a diagnosis of metastatic breast cancer, received at least two cycles of sacituzumab govitecan.

Brief summary: To investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.

Detailed description: This study will conduct a multicenter, open, prospective clinical trial to investigate the real-world efficacy and safety of Sacituzumab govitecan for HER2 negative metastatic breast cancer patients in China.

Eligibility criteria: Inclusion Criteria:

Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.

HER2-negative breast cancer(according to 2018 ASCO/CAP HER2 test guideline). 18-75 years old. ECOG PS 0～2. life expectancy is not less than 12 weeks. at least one measurable lesion according to RECIST 1.1. received at least two cycles of SG. Signed informed

Exclusion Criteria:

Patients who did not receive sacituzumab govitecan treatment for two or more cycles Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.

Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial History of neurological or psychiatric disorders Researchers believe that patients are not suitable for any other situation in this study.

Primary outcomes:
measure: PFS
timeFrame: from enrollment to progression or death (for any reason),assessed up to 100 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: from enrollment to progression or death (for any reason), assessed up to 100 months
measure: DoR
timeFrame: The first evaluation of CR or PR to progression or death (for any reason),assessed up to 100 months
measure: OS
timeFrame: from enrollment to death (for any reason).assessed up to 100 months
Other outcomes:
measure: adverse event
timeFrame: from enrollment to 30 days after the last dose administrate
Locations:
Study officials:
References:
Clinical trial NCT04080921: Stem Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis
Official title: The Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis at Vinmec International Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Encephalitis
Meningitis
Keywords: encephalitis
meningitis
neurological sequelae due
Lead sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 22
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in-patient with neurological sequelae due to encephalitis or meningitis

Detailed description: The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow-derived mononuclear cell in 22 patients with neurological sequelae due to encephalitis or meningitis at Vinmec International Hospital, Hanoi, Vietnam

Eligibility criteria: Inclusion Criteria:

* Neurological sequelae due to encephalitis or meningitis

Exclusion Criteria:

* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections

Primary outcomes:
measure: Change in Total Score of Gross Motor Function Measure (GMFM-88)
timeFrame: Baseline, 6 months, and 12 months after transplantation
measure: Change in Muscle Tone Assessed by Modified Ashworth Scale (MAS)
timeFrame: Baseline, 6 months, and 12 months after transplantation
Secondary outcomes:
measure: Number of adverse events
timeFrame: Through study completion, an average of 12 months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
affiliation: Vinmec Research Institute of Stem Cell and Gene Technology
name: Liem T Nguyen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bansal H, Singh L, Verma P, Agrawal A, Leon J, Sundell IB, Koka PS. Administration of Autologous Bone Marrow-Derived Stem Cells for Treatment of Cerebral Palsy Patients: A Proof of Concept. J Stem Cells. 2016;11(1):37-49.
citation: Nguyen LT, Nguyen AT, Vu CD, Ngo DV, Bui AV. Outcomes of autologous bone marrow mononuclear cells for cerebral palsy: an open label uncontrolled clinical trial. BMC Pediatr. 2017 Apr 12;17(1):104. doi: 10.1186/s12887-017-0859-z.