louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03181919: Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS
Official title: Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility Poly Cystic Ovary
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of the study is to compare between the step-up and conventional protocols in ovulation induction in infertile women with PCOS

Detailed description: The current study was conducted in private outpatient clinic after being approved by the medical ethics committee. The study is a prospective randomized study consisting of 90 Egyptian patients diagnosed as having infertility with pcos .

Sample size determination:

Group sample sizes of 42 and 42 achieve 80% power based on study finding carried out by (Galal et al., 2014) to detect a difference of 0.7 between the null hypothesis that both group means are 2.2 and the alternative hypothesis that the mean of group 2 is 1.5 with known group standard deviations of 1.5 and 0.6 and with a significance level (alpha) of 0.05000 using a two-sided Mann-Whitney test assuming that the actual distribution is uniform.

Sample size was calculated by PASS 11 Computer program for sample size calculation.

Taking into consideration 10% drop out rate, the sample size will be increased to 45 patients in group I and another 45 patients in group II.

Patients were divided into two groups with randomization sheet:

Group (I): includes 45 females taking Letrozole (old regimen).

Group (II): includes 45 females taking Letrozole 5 mg tab in a step-up protocol (new regimen).

Eligibility criteria: Inclusion Criteria:

* Age: 20 -37 years old.
* No conception for at least one year.
* Diagnosis of PCO as established by Rotterdam criteria, endometriosis diagnosed by laparoscope or unexplained infertility.

Exclusion Criteria:

* Age \< 20 and \> 35 years old.
* Uterine pathology e.g. fibroid or ovarian cyst.
* Hyperprolactinemia, hypo or hyperthyroidism.
* Impaired hepatic or renal function.
* History of hypersensitivity to study drugs.

Primary outcomes:
measure: Number of mature follicles
timeFrame: 2 weeks
Secondary outcomes:
measure: Pregnancy rate
timeFrame: one month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00537719: Scintigraphy Study to Assess Gastric Emptying in Healthy Subjects Given GSK716155 or Placebo.
Official title: A Single-Blind, Randomized, Placebo-Controlled Study in Healthy Men and Women to Determine the Effect of Single Subcutaneous Injections of GSK716155 on Gastric Emptying Time for Solid and Liquid Components of a Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: healthy
pharmacodynamics
glucagon-like peptide 1
pharmacokinetics
scintigraphy
radiation
albiglutide
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will use scintigraphy techniques to measure gastric emptying rate of liquid and solid food at baseline and after administration of GSK716155 or placebo.


Eligibility criteria: Inclusion Criteria:

* Healthy men or women, between the ages of 18 and 65, and have a Body Mass Index (BMI) of between 20 and 32.
* If female, the subject must be not be capable of having children.

Exclusion Criteria:

* Subjects must not use tobacco, nicotine, or illegal drugs of abuse, and must not take caffeine or alcohol for 24 hours before dosing and before each set of scintigraphy procedures.
* Subjects may not have HIV, hepatitis, elevated fasting blood sugar levels, high blood pressure, heart, lung, liver, gall bladder, gastrointestinal, pancreatic, or kidney disease, or untreated thyroid disease.
* Subjects must not have a history of alcohol abuse, must not take prescription or non-prescription drugs within 7 days of Day 1 and Day 8 of the study, and must not have previous exposure to any GLP-1 mimetic or exenatide.
* Prior radiation exposures must meet certain limits in order to participate in this study.

Primary outcomes:
measure: Change from baseline of the time to 50% gastric emptying (gastric emptying t½) of the solid and liquid components of a meal at 72 hours after dosing in healthy volunteers.
timeFrame: 3 Days
Secondary outcomes:
measure: Exploratory correlation of % contents remaining in stomach after a meal.GSK716155 concentration before meal & at the time gastric emptying is complete. Safety and tolerability parameters each visit.
timeFrame: 3 Days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.
Clinical trial NCT00250419: V930 First in Man (FIM) Study (V930-002)(COMPLETED)
Official title: A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V-930 in Patients With Cancers Expressing HER-2 and/or CEA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancers Expressing HER-2 and/or CEA
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-11-08
Enrollment: 26
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: To determine the safety/tolerability, and immunogenicity of an experimental vaccine given as intramuscular injections followed by electrostimulation in cancer patients.


Eligibility criteria: Inclusion Criteria:

* Patients must have stages II, III, or IV breast, colorectal, ovaria, of non-small cell lung cancer
* Patients will either be disease free following primary therapy or have advanced disease with a durable response (\>3 months) after standard therapy
* Tumor antigen HER-2 and/or CEA must be measurable in the blood or detected by Immunohistochemistry staining of the biopsies obtained from the primary tumor or metastasis

Exclusion Criteria:

* Patients with prior treatment with any HER-2 and/or CEA containing vaccine
* Patients who have significant cardiac disease
* Patients with autoimmune disorders
* Patients who are pregnant or lactating

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Diaz CM, Chiappori A, Aurisicchio L, Bagchi A, Clark J, Dubey S, Fridman A, Fabregas JC, Marshall J, Scarselli E, La Monica N, Ciliberto G, Montero AJ. Phase 1 studies of the safety and immunogenicity of electroporated HER2/CEA DNA vaccine followed by adenoviral boost immunization in patients with solid tumors. J Transl Med. 2013 Mar 8;11:62. doi: 10.1186/1479-5876-11-62.
Clinical trial NCT00185419: A Clinical Study on Yasmin® vs. Marvelon® in Chinese Women Requiring Contraception
Official title: An Open-Label, Randomised, Parallel-Group Comparison to Investigate the Efficacy of Yasmin® (30 µg Ethinylestradiol, 3mg Drospirenone) and Marvelon® (30 µg Ethinylestradiol, 150 µg Desogestrel) on Cycle Control in Healthy Chinese Women Over 13 Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 842
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effectiveness in terms of prevention of pregnancy and safety of the oral contraceptive Yasmin and Marvelon on cycle control in healthy Chinese women

Detailed description: The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:

* Healthy Chinese female requesting contraceptives

Exclusion Criteria:

* Vascular, metabolic, hepatic, renal, oncologic and other diseases

Primary outcomes:
measure: The primary efficacy variable is the comparison of cycle control from randomisation to cycle 13. This will be based on the number of subjects reporting at least 1 unexpected intracyclic bleeding episode between cycles 2 to 13.
timeFrame: 13 treatment cycles (1 cycle= 28 days)
Secondary outcomes:
measure: Weight changes
timeFrame: 13 treatment cycles
measure: Contraceptive reliability
timeFrame: 13 treatment cycles
measure: Effects on skin condition
timeFrame: 13 treatment cycles
measure: Changes in MDQ subscale scores
timeFrame: 13 treatment cycles
measure: Adverse Events
timeFrame: the whole study period
Other outcomes:
Locations:
city: ask Contact
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05567419: SARS-CoV-2 in Stools Compared to Respiratory Viral Strains.
Official title: SARS-CoV-2 in Stools Compared to Respiratory Viral Strains, in Patients Hospitalized for COVID-19.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2 Infection
Keywords: COVID-19; SARS-CoV-2
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalised patient for SARS-CoV-2 infection, nasopharyngeal PCR-confirmed (or any other sample) in Infectious diseases department and Intensive care unit, whatever the severity of the clinical form.

n=30

Sampling dates:

COVID-19 diagnostics day (d0), day-2, day-4, day-end of hospitalization, day-post hospitalization

Brief summary: The aim of the study is to characterize and to quantify SARS-CoV-2 strains in stools, in comparison with the viral strains in respiratory samples, from patients hospitalized for COVID-19. The methods will be standard ddPCR quantifying SARS-CoV-2 RNA and next generation sequencing-whole genome sequencing. The expected results will allow us to better understand SARS-CoV-2 dynamics and compartmentalization, both in the respiratory tract and in digestive-related tissues, according to the evolution of SARS-CoV-2 variants.


Eligibility criteria: Inclusion Criteria:

* Age: men or women of 18 years-old or more
* Clinical signs: hospitalised patient for SARS-CoV-2 infection, nasopharyngeal PCR-confirmed (or any other sample) (in: Infectious diseases department, Intensive care unit), whatever the severity of the clinical form.
* The subject gave his/her informed and writen consent, after complete explanations on the research schedule.
* Compulsory affiliation to a social security scheme.
* Previous medical examination, when a patient is admitted to the hospital, according to good clinical practices.

Exclusion Criteria:

* Subject corresponding to articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public health code:

  * pregnant woman, parturient or breastfeeding woman
  * Minor person
  * Person of full age under guardianship, curatorship, safeguard of justice
* Woman who wants to be pregnant during the study period
* Person in psychiatric care - articles L. 3212-1 and L. 3213-1 who do not fall under the article L. 1121-8 (without consent hospitalisation)

Primary outcomes:
measure: SARS-CoV-2 dynamics in stools.
timeFrame: 30 monthes
Secondary outcomes:
measure: SARS-CoV-2 in stools compared to the virus in wastewaters.
timeFrame: 30 monthes
measure: Modelization of SARS-CoV-2 load in stools and COVID-19 global frequency.
timeFrame: 30 monthes
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: Schvoerer
Study officials:
affiliation: University hospital Nancy, France
name: Evelyne ES Schvoerer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06933719: PRECEE2 Perinatal Research
Official title: Research Into Perinatal Care, Its Complications and Exposure to Multiple Factors (PRECEE2)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnancy Complications
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who gave birth at the CHUB between 01/01/2011 and 12/31/2025

Brief summary: The aim of this study is to analyze the relationship between complications and adverse pregnancy outcomes and exposure to environmental factors in women living in Franche-Comté who gave birth between 2011 and 2025 at Besancon University Hospital.


Eligibility criteria: Inclusion Criteria:

* Women who gave birth at the CHUB between 01/01/2011 and 12/31/2025
* who have not expressed any objection to the processing of their data.

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Subject is within the exclusion period of another study or is excluded from the "national volunteer file".
* Subject refusing the collection of his/her medical data.

Primary outcomes:
measure: pregnancy complications
timeFrame: at birth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05666219: Reversal of Complete Heart Block With Aminophylline in Inferior Wall Myocardial Infarction Patients
Official title: Assessing the Impact of Aminophylline in the Reversal of Complete Heart Block Secondary to Inferior Wall MI in Atropine Resistant Patients: An Open Label Non-randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Complete Heart Block
Inferior Wall Myocardial Infarction
Lead sponsor: National Institute of Cardiovascular Diseases, Pakistan
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An Open Label Non-randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: In this study, the investigator will evaluate the rate of reversal of complete heart block with aminophylline in atropine resistant patients with inferior wall myocardial infarction (MI)

Detailed description: Administration of Aminophylline can result in reversal of complete heart block in a significant number of atropine resistant patients with inferior wall MI. Hence, in this study our primary aim is to evaluate the rate of reversal of complete heart block with aminophylline in atropine resistant patients with inferior wall MI.

Eligibility criteria: Inclusion Criteria:

* Adult patients admitted with recent acute inferior wall myocardial infarction (MI)
* Hemodynamically stable blood pressure
* Complete heart block with Narrow QRS \< 120 ms and ventricular rate \>40/min persisting for at least 6 hours, resistant to atropine
* Temporary pacemaker (TPM) already placed
* Patient asymptomatic with a mean arterial pressure of greater than 65 mmHg with TPM rate placed at 40/min

Exclusion Criteria:

* Patients with cardiogenic shock
* Patients with preexisting permanent pacemaker and Implantable Cardioverter Defibrillator (ICD).
* Patients with a prior history of AV block
* Drugs with dromotropic effects (beta blocker, calcium channel blocker, inotropes)
* Known liver disease (cirrhosis, hepatitis)
* Hypothyroidism
* Unable to consent

Primary outcomes:
measure: Reversal of complete heart block
timeFrame: Within 1 hour of 2nd dose
Secondary outcomes:
measure: Improved conduction
timeFrame: Within 1 hour of 2nd dose
measure: Major adverse cardiac events (MACE)
timeFrame: Within 12 hours
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
name: Azam Shafquat, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01824719: A Registry Study on Reduning（a Chinese Medicine Injection）Used in Hospitals in China
Official title: a Study of Clinical Safety Monitoring and the Mechanism of Anaphylactic Reaction Used Reduning(a Chinese Medicine Injection)in Hospitals in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Upper Respiratory Tract Infection;
Acute Tracheobronchitis
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An anticipated sample size was caculated in this study, about 3000 Patients using Reduning injection from January to March 2013 in hospitals.

Brief summary: This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in January 2013.

The purpose of this study is to make a event monitoring to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.

Detailed description: It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Reduning injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood.

Eligibility criteria Patients who will use Reduning injection in selected hospitals.

Eligibility criteria: Inclusion Criteria:

* Patients using Reduning injection from January to March 2013

Exclusion Criteria:

-

Primary outcomes:
measure: Number of participants with anaphylactic reaction;the blood routine examination of participants with anaphylactic reaction
timeFrame: to assess Reduning's 'anaphylactic reaction' .during patients' hospital stay, administration information of Reduning will be registered every day. The registry procedure will last 3 month only for patients using Reduning
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Institute of Basic Research in Clinical Medicine
state: Beijing
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Xie Y Ming
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05364619: Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection
Official title: Qingre Huashi Granules Combined the Modified Dual Therapy for Helicobacter Pylori Infection Treatment in the Elderly Patient, a Multi-center, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Geriatic
Dual therapy
Bismuth-containing quadruple therapy
Qingre Huashi Decoction
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University International Hospital
name: Beijing Geriatric Hospital
name: Beijing Changping Integrative Medicine Hospital
First posted: 2022-05-06
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, randomized controlled trial. The aim of the study is to evaluate the efficacy and safety of the Qingre Huashi Granules combined the modified dual therapy (or called high dose dual therapy) for Helicobacter pylori infection specifically in geriatric patients, compared with the bismuth containing quadruple therapy. A total of 160 eligible patients will be enrolled in 4 hospitals. The eradication rate, symptoms, and the adverse events will be recorded and analyzed.


Eligibility criteria: Inclusion Criteria:

* Current Helicobacter pylori infection.
* Age ≥ 60 years.
* Diagnosed with syndrome of dampness-heat by Traditional Chinese Medicine.
* Signed the informed consent document.

Exclusion Criteria:

* History of Helicobacter pylori treatment.
* History of gastric surgery.
* Allergic to any medications involved in the intervention.
* Sever complications, such as lung dysfunction, uncontrolled hypertension, diabetes, cardiovascular disease, renal dysfunction (eGFR\<60ml/min'1.73m2) , malignant tumor，mental disorder.
* Taking medications that may be conflict to the intervention drugs.
* Failing to express symptoms, unwilling to cooperate.
* Taking any antibiotics within a month.

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: The 4th week after the treatment.
Secondary outcomes:
measure: 7-point Global Overall Symptom Scale
timeFrame: Baseline, the second and sixth week after the treatment, respectively.
measure: Efficacy Scale of the Dampness-heat syndrome
timeFrame: Baseline, the second and sixth week after the treatment, respectively.
measure: Adverse events rate
timeFrame: During the follow-up, up to 6 weeks.
Other outcomes:
measure: CYP2C19 Genotype
timeFrame: The sixth week after the treatment.
measure: Helicobacter pylori antibody test.
timeFrame: Baseline
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Changping Integrative Medicine Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University International Hospital
state: Beijing
Study officials:
References: