louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03899207: Acupressure and Training for Coping With PMS
Official title: Adiyaman University School of Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Acupressure
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 199
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomize control trail
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study was conducted to determine the effect of acupressure and training, given to women under the guidance of health belief model for coping with premenstrual syndrome, on the premenstrual symptoms and quality of life.

This study was conducted to as a randomized controlled trial. The population of the study was composed of all women with PMS registered in FHCs no. 4 and 14 located in the city center. The sample of the study consisted of women including 51 women in training +acupressure group, 55 women in training group and 57 women in control group. The data were collected with Participant Information Form, PMSS and WHOQOL-BREF in the study. Training and acupressure were administered to the acupressure + training group. Only the training for coping with premenstrual syndrome was given to the training group. The data collection forms were reapplied to all groups 12 weeks after the pretest.

Detailed description: Premenstrual Syndrome is an important collection of symptoms affecting approximately one-fifth of women in reproductive age.

Acupressure is an intervention found in the nursing intervention system and defined as applying constant and powerful pressure on certain/specific points of the body in order to reduce pain, provide relaxation and relief, and to prevent or reduce nausea. Many studies conducted in gynecology have shown that acupressure decreased menstrual distress, premenstrual symptoms, back pain in women experiencing dysmenorrhea, labor pain and nausea and vomiting during pregnancy. In addition, it was shown in the studies that training given for PMS decreased the premenstrual symptoms

Eligibility criteria: Inclusion Criteria:

Having regular menstruation (between 21-35 days),

not having any psychiatric diagnosis or any gynecological diseases

not using contraceptives,

not having tissue deformity in the extremities.

Exclusion Criteria:

having any psychiatric diagnosis having any gynecological diseases

Primary outcomes:
measure: The Effects of Health Belief Model-Based Training for Coping with Premenstrual Syndrome and Acupressure on Premenstrual Symptoms and Quality of Life
timeFrame: 10 month
Secondary outcomes:
Other outcomes:
Locations:
city: Adıyaman
country: Turkey
facility: DİDEM
city: Malatya
country: Turkey
facility: ınönü Universty
Study officials:
affiliation: World Health Organization
name: Didem Simsek Kucukkelepce, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00705107: Adherence to Treatment With PegIntron Pen Plus Rebetol in Treatment-naïve Adult Patients With Hepatitis C in Romania (Study P04247)
Official title: Evaluation of Adherence Rate in Patients Receiving PegIntron Pen / Rebetol for Hepatitis C
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C, Chronic
Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 267
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Treatment-naïve adult patients with hepatitis C treated with PegIntron pen and Rebetol receiving a patient assistance program at approximately 40 sites in Romania. Patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).

Brief summary: Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C. The objective of this study is to evaluate the proportion of patients who complete treatment with PegIntron pen and Rebetol while participating in a patient assistance program. The patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).


Eligibility criteria: Inclusion Criteria:

* Treatment-naïve patients with hepatitis C
* Patients treated with PegIntron pen and Rebetol
* Patients receiving patient assistance program

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Number of Subjects Who Completed Treatment.
timeFrame: Assessed at the end of the 48-week treatment.
Secondary outcomes:
measure: Average Length of Treatment.
timeFrame: Assessed at the end of treatment. The prescribed treatment duration was 48 weeks.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00534807: A Study of the Interaction of Rifampin and Vinflunine in Subjects With Advanced Cancer
Official title: Effect of Rifampin on the Pharmacokinetics of Intravenous (IV) Vinflunine in Subjects With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 0
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 test how vinflunine interacts with rifampin in the human body


Eligibility criteria: Inclusion Criteria:

* Cancer unresponsive to previous treatment
* Consent for genetic samples

Exclusion Criteria:

* Cancer of the blood
* Spread of cancer to the brain
* Moderate or severe nerve damage
* Low white blood cell counts and platelet counts
* Inadequate liver or kidney function
* Prior treatment with vinflunine
* Use of certain medications that might interfere with the metabolism of vinflunine

Primary outcomes:
measure: The Primary Outcome Measure of the effect of rifampin on the pharmacokinetics (PK) of intravenous (IV) vinflunine will be determined from the PK measurements
timeFrame: taken during Cycle 2 of study treatment, at approximately 4 weeks after the start of study treatment
Secondary outcomes:
measure: The Secondary Outcome Measures of the safety and tolerability of vinflunine when administered alone and with rifampin
timeFrame: determined after 2 complete 21-day Cycles of study treatment, at approximately 6 weeks after the start of study treatment
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Local Institution
state: Michigan
Study officials:
References:
Clinical trial NCT03743207: Preterm Infants May Better Tolerate Warmer Feeds
Official title: Preterm Infants May Better Tolerate Feeds at Temperatures Closer to Freshly Expressed Breast Milk- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity
Feeding Disorder Neonatal
Keywords: Prematurity
Enteral nutrition
Feeding tolerance
Temperature
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Feeding intolerance is frequent among preterm infants in neonatal intensive care units (NICUs). Although there are many studies about enteral nutrition strategies and content in preterm infants, no evidence-based standards exist for the optimal milk temperature for preterm infants. Therefore, in this study the investigators aimed to examine the effects of feeding temperature and the possible morbidities.

Detailed description: Feeding intolerance is one of the most frequent problems among preterm infants. These infants are fed with expressed breast milk or preterm formulas of which the temperature is not routinely measured. In this study, the investigators aimed to examine the effects of feeds with warm versus room temperature milk in preterm infants. Infants with a birth weight of ≤1500 g or gestational age of ≤ 34 weeks were included in the study and assigned to two different feeding temperature groups (22-24°C and 32-34°C). Some infants in both groups were exclusive breast milk fed and some received artificial milk. Feeding tolerance of patients in both groups and the consequences were evaluated.

Eligibility criteria: Inclusion Criteria:

* Infants born to birth weight of ≤1500 g
* Infants born to gestational age of ≤ 34 weeks

Exclusion Criteria:

* Genetic syndrome
* Gastrointestinal system anomalies
* Patients born small for their gestational age

Primary outcomes:
measure: Gastric residual volume in mililitres after every feeding
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Transition time to total enteral feeding
timeFrame: through study completion, an average of 6 months
measure: Daily weight gain
timeFrame: through study completion, an average of 6 months
measure: Need for anti reflux treatment
timeFrame: through study completion, an average of 6 months
measure: Body weight at discharge
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
affiliation: Ege University
name: Ozge Altun Koroglu, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01837407: Reconstruction of a Neurocutaneous Defect of the Proximal Phalanx With a Heterodigital Arterialized Nerve Pedicle Flap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Digital Injuries
Keywords: Soft tissue loss
nerve defect
dorsal branch of the proper digital nerve
heterodigital arterialized nerve pedicle flap
Composite Flap
nerve flap
nerve transfer
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2013-04-23
Enrollment: 9
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Complex digital injuries involving soft tissue loss and digital nerve defect pose challenging problems for hand surgeons. This study uses the heterodigital arterialized nerve pedicle flap including the dorsal branch of the digital nerve for reconstructing a digital neurocutaneous defect of the proximal phalanx.


Eligibility criteria: Inclusion Criteria:

* a neurocutaneous defect at the proximal phalanx
* a soft tissue defect on the volar, dorsal, and contiguous lateral aspects of adjacent fingers .associated digital nerve defect.

Exclusion Criteria:

* an injury involving the course of the arterial or venous pedicle; an injury involving donor site or donor nerve
* a soft tissue defect on the noncontiguous lateral aspects of adjacent fingers
* a nerve injury that is able to be repaired by primary neurorrhaphy

Primary outcomes:
measure: Static 2-point discrimination test
timeFrame: 18 months to 24 months
Secondary outcomes:
measure: Cold Intolerance Severity Score (CISS) questionnaire.
timeFrame: 18 months to 24 months
Other outcomes:
measure: Visual analog scale
timeFrame: 18 months to 24 months
Locations:
city: Tangshan
country: China
facility: The Second Hospital of Tangshan
state: Hebei
Study officials:
References:
citation: Chen C, Zhang X, Shao X, Gao S, Wang B, Liu D. Treatment of a combination of volar soft tissue and proper digital nerve defects using the dorsal digital nerve island flap. J Hand Surg Am. 2010 Oct;35(10):1655-1662.e3. doi: 10.1016/j.jhsa.2010.07.011.
citation: Chen C, Tang P, Zhang X. Reconstruction of a neurocutaneous defect of the proximal phalanx with a heterodigital arterialised nerve pedicle flap. Injury. 2014 Apr;45(4):799-804. doi: 10.1016/j.injury.2013.09.034. Epub 2013 Sep 27.
Clinical trial NCT01542307: Normobaric Oxygen (NBO) Therapy in Acute Migraine
Official title: Normobaric Oxygen (NBO) Therapy in Acute Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Keywords: migraine
oxygen therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.

Detailed description: A total of 40 adult subjects will be enrolled, male and female. Subjects will be consented to inhale either Normobaric Oxygen (NBO) or Room air for 30 minutes at the start of their migraine attacks. Outcomes will be assessed during and after gas treatment.

Eligibility criteria: Inclusion Criteria:

* Adult subjects with frequent migraine (at least 1 attack per month)

Exclusion Criteria:

* Secondary (non-migraine) headache
* Chronic obstructive pulmonary disease
* Pregnant

Primary outcomes:
measure: Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)
timeFrame: From baseline (0 minutes) to 30 mins
Secondary outcomes:
measure: Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)
timeFrame: Baseline (0 minutes) to 15 minutes
measure: Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)
timeFrame: Baseline (0 minutes) to 60 minutes
measure: Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS)
timeFrame: 60 minutes
measure: Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)
timeFrame: 60 minutes
measure: Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)
timeFrame: 60 minutes
measure: Final Nausea Score 0-1 on the Visual Analog Scale (VAS)
timeFrame: 60 minutes
Other outcomes:
measure: Post-gas Therapy Medication Use
timeFrame: 60 minutes
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Aneesh B Singhal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singhal AB, Maas MB, Goldstein JN, Mills BB, Chen DW, Ayata C, Kacmarek RM, Topcuoglu MA. High-flow oxygen therapy for treatment of acute migraine: A randomized crossover trial. Cephalalgia. 2017 Jul;37(8):730-736. doi: 10.1177/0333102416651453. Epub 2016 May 20.
Clinical trial NCT00797407: Effectiveness of Creatine in Preventing Muscle Aching From Cholesterol-Lowering Statin Drugs
Official title: Creatine Supplementation for the Prevention of Statin Myalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Aches
Cramps
Weakness
Keywords: Hydroxymethylglutaryl-CoA Reductase Inhibitors
Creatine
Adverse Effects
Muscle Toxicity
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine of creatine will prevent or treat the muscle toxicity side effect of statin drug therapy, whose symptoms are aching, cramping, and weakness. This is tested in patients who have had this side effect from 3 different statin drugs.

Detailed description: Muscle toxicity is the most common limiting side effect of statin therapy. Biochemical studies have suggested the presence of intramuscular creatine deficiency in patients with muscle toxicity. This is a test of oral creatine supplementation in statin intolerant subjects as a method of preventing the onset of this side effect as well as resolving these symptoms when present during statin therapy.

Eligibility criteria: Inclusion Criteria:

* hypercholesterolemia in need of aggressive treatment, defined as a high risk of a vascular event, thus subjects with diabetes, pre-diabetes, or known vascular disease
* intolerance (i.e. muscle toxicity symptoms) of at least 3 statin drugs, each confirmed on rechallenge

Exclusion Criteria:

* history of elevated CPK or rhabdomyolysis while taking a statin,
* CPK levels elevated above the normal range at baseline,
* pregnancy.
* renal insufficiency, defined as a serum creatinine ≥ 2.0 mg/dl.
* history of congestive heart failure.

Primary outcomes:
measure: Combined visual analog pain scales (0-10) for aching, cramping and weakness
timeFrame: baseline, after 5 days of creatine loading, after 6 weeks of creatine+statin, after up to 6 weeks on statin without creatine, after 4 days of rechallenge with creatine while still on statin
Secondary outcomes:
Other outcomes:
Locations:
city: Wooster
country: United States
facility: Wooster Family Health Center, Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: David A Shewmon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06145607: A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262
Official title: A Phase 1 Study to Evaluate Safety, Tolerability, and Food-Effect Following Administration of ABBV-CLS-7262 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Food effect
Pharmacokinetics
Lead sponsor: Calico Life Sciences LLC
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2023-11-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a randomized, three period, six sequence, single dose crossover design with ABBV-CLS-7262 in healthy adult subjects.

Detailed description: On Day 1 of each period, subjects will receive a single oral dose of ABBV-CLS-7262 administered according to the food regimen assigned. There will be a 4-day washout period between doses. Food regimens include administration after fasting, following a high-fat/high-calorie meal, or with apple sauce. Upon completion each subject will have taken a total of three doses of ABBV-CLS-7262, with one dose administered with each food regimen.

Eligibility criteria: Inclusion Criteria:

* Adult volunteers in general good health.
* Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures.
* Individuals between 18 and 55 years of age inclusive at the time of screening.
* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2.
* All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug.
* All female subjects who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female subjects must agree to not donate eggs during the study and for 30 days after the final dose of study drug.

Exclusion Criteria:

* Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures
* Pregnant or breastfeeding.
* Treatment with any other investigational treatment within 30 days

Primary outcomes:
measure: To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 taken with or without food.
timeFrame: Approximately Two Weeks
measure: To assess the pharmacokinetics following a single oral dose of ABBV-CLS-7262 administered with or without applesauce.
timeFrame: Approximately Two Weeks
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: Approximately Six Weeks
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: AbbVie Clinical Pharmacology Research Unit (ACPRU)
state: Illinois
Study officials:
References:
Clinical trial NCT02071407: A Clinical Trial of the Effect of Midazolam on the Cerebral Metabolism and Inflammatory Response in Patients With Moderate and Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
sedation
midazolam
Lead sponsor: Subei People's Hospital of Jiangsu Province
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 60
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: To explore the cerebral protective effect of midazolam in patients with traumatic brain injury, we will collect blood samples from patients treated with or without midazolam when the patient is admitted to ICU, 24 h, 48 h and 72 h after the admission before the use of midazolam for patients in group N1, and before the patient is treated with midazolam, 24 h， 48 h, 72 h after the use of midazolam for patients in group N2. Parameters of cerebral metabolism and inflammatory response will be obtained from the blood samples or the cerebrospinal fluid. With the aforementioned parameters, the relationship between clinical outcome and cerebral metabolism and inflammatory response will be detected with statistical method.


Eligibility criteria: Inclusion Criteria:

* Aged 18 or older;
* Hospitalized in ICU within 6 hours after the injury or after the operation;
* Traumatic brain injury is confirmed by computed tomography scan or magnetic resonance imaging, Glasgow Coma Scale is 3 to 12, and the patient should meet the diagnostic standard of severe traumatic brain injury;
* Informed consent is obtained.

Exclusion Criteria:

* Aged less than 18;
* Death is expected in 24 hours;
* History of neurological disease or history of drug abuse which may affect the outcome of the study;
* Failed to obtain Informed consent.

Primary outcomes:
measure: Cerebral metabolic parameters
timeFrame: from the admission to ICU to 72 h after the admission for Group N1 and before the use of midazolam to 72 h after the use for group N2
measure: Parameters of intracranial inflammatory response
timeFrame: from the admission to ICU to 72 h after the admission for Group N1 and before the use of midazolam to 72 h after the use for group N2
Secondary outcomes:
measure: Ramsay score
timeFrame: from the use of midazolam to 72 h after the use for group N2
measure: seizure
timeFrame: from the admission to ICU to 72 h after the admission
measure: one-week mortality
timeFrame: from the admission to ICU to one week after the admission
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Subei People's Hospital of Jiangsu Province
state: Jiangsu
Study officials:
References: