louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00000295: Progesterone Treatment in Female Smokers - 12
Official title: Progesterone Treatment in Female Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Minnesota
First posted: 1999-09-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate progesterone effects in female smokers

Detailed description: Limited research has been done on the effects of gender and menstrual cycle in response to drugs of abuse in humans. The main goal of this pilot study is to investigate the safety and tolerability of progesterone treatment in female nicotine users. In addition, plasma progesterone levels reached with a single 200 mg dose of progesterone treatment will be measured. The study will be a double-blind placebo controlled, crossover trial in which 12 female smokers who are in the early follicular phase of their menstrual cycle will be enrolled. Druing the experimental sessions, subjects will be given a single 200 mg dose of micronized progesterone or placebo and multiple blood samples will be obtained to measure the plasma levels of progesterone. Starting 2 hours after progesterone or placebo treatment, subjects will have a self-administration period that will last around 2.5 hours. We hypothesize that administration of 200 mg of progesterone will achieve plasma progesterone concentrations similar to those found in the luteal phase of the menstrual cycle, 3-30 ng/ml.

Eligibility criteria: Inclusion Criteria:

Female subjects aged 21-45 years with a smoking history of at least 20 cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests. Not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods other than hormonal contraceptives.

Exclusion Criteria:

History of heart disease, peripheral vascular disease, COPD, liver diseases, abnormal vaginal bleeding, suspected or known breast malignancy, or any other medical condition which physician investigator deems inappropriate for subject participation. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history. Amenorrhea. Current use of oral or other types of hormonal contraceptives. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products. Known allergy to progesterone or peanuts.

Primary outcomes:
measure: Behavioral
measure: Subjective
measure: Biochemical
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06462495: Head-to-head Comparison of [18F]F-PSMA-N5 With [18F]F-PSMA-1007 PET/CT in PCa Diagnosis, Recurrence, and Metastasis
Official title: Head-to-head Comparison of [18F]F-PSMA-N5 With [18F]F-PSMA-1007 PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Prostate Cancer
PET/CT
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-17
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[18F\]F-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[18F\]F-PSMA-1007.

Detailed description: \[18F\]F-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[18F\]F-PSMA-1007 PET/CT.

Eligibility criteria: Inclusion Criteria:

* Aged from 18 to 90 years old;
* Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
* Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
* simultaneous \[18F\]F-PSMA-N5 and \[18F\]F-PSMA-1007 examinations within two weeks;
* Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
* Sign informed consent.

Exclusion Criteria:

* Patients who cannot cooperate with the examination;
* Concurrent malignant tumors;
* Previous alcohol allergy;
* Patients with liver and kidney dysfunction;
* Other circumstances deemed by the investigator to be inappropriate for trial participation.

Primary outcomes:
measure: Standard uptake value(SUV)
timeFrame: 30 days
Secondary outcomes:
measure: Diagnostic efficacy
timeFrame: 30 days
measure: Number of lesions
timeFrame: 30 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
name: Qiang Xie
role: STUDY_CHAIR
References:
Clinical trial NCT05146895: A Cohort Study of Hyperthermia and Imiquimod for the Treatment of Flat Warts
Official title: Evaluation of Local Hyperthermia for the Treatment of Flat Warts After 4 Months: a Single-center, Single-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Human Papilloma Virus
Keywords: hyperthermia
human papillomavirus virus
flat warts
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: flat warts are a superficial viral skin disease, extremely common in childhood.Treatment of warts is often difficult and involves different destructive procedures.Although several pharmacological and physical topical treatments are available (keratolytic agents, electrosurgery, cryotherapy, carbon dioxide laser), results are often unsatisfactory in terms of efficacy (frequent recurrence) and cosmetic outcome (scars, inflammatory reactions, transient or permanent hyper- or hypopigmentation).

Mild local Hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. It has been utilised in the treatment of some neoplasm, fungal and HPV infections. Investigators' study found that local hyperthermia at 44°C could cleared HPV in more than half of the patients with plantar warts. Investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate HPV.So the purpose of the study is to evaluation local hyperthermia in the treatment of flat warts Appropriate control arms were designed for different conditions.


Eligibility criteria: Inclusion Criteria:

* 12-65 years old;
* diagnosis confirmed;
* signed informed consent

Exclusion Criteria:

* Pregnant woman;
* Local or systematic treatment within 3 months;
* Comorbidity of other severe gynecological inflammation,
* Infection, or tumor;
* Comorbidity of other serious illnesses;
* No guarantee of timely treatment and follow-up

Primary outcomes:
measure: clearance rates of HPV
timeFrame: 3 months after the last time of treatment
Secondary outcomes:
measure: effective rates of HPV
timeFrame: 3 months after the last time of treatment
Other outcomes:
Locations:
city: Shenyang
country: China
facility: the First Hospital of China Medical University
Study officials:
References:
Clinical trial NCT04868695: Subjective and Objective Outcome of ESS in CRSwNP
Official title: Subjective and Objective Outcom Eof Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis With Nasal Polyps
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CRS
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: (A): Beidseitige Fronto-Spheno-Ethmoidektomie mit Erweiterung des natürlichen Zuganges zur Stirnhöhle (Draf Typ II): Unter einem Draf Typ II Zugang versteht man die Erweiterung des natürlichen Zuganges zur Stirnhöhle mit Entfernung des Bodens der Stirnhöhle zwischen der Lamina papyracea zur Augenhöhle und der mittleren Nasenmuschel.

(B): Beidseitige Fronto-Spheno-Ethmoidektomie mit maximaler Erweiterung des Zuganges zur Stirnhöhle (Draf Typ III): Unter einem Draf Typ III verste. (C) Beidseitige Spheno-Ethmoidektomie: Abtragung des Processus uncinatus, die Eröffnung der Kieferhöhle, die Eröffnung des vorderen und hinteren Siebbeinsystems und die Eröffnung der Keilbeinhöhle.

Detailed description: (A): Beidseitige Fronto-Spheno-Ethmoidektomie mit Erweiterung des natürlichen Zuganges zur Stirnhöhle (Draf Typ II): Unter einem Draf Typ II Zugang versteht man die Erweiterung des natürlichen Zuganges zur Stirnhöhle mit Entfernung des Bodens der Stirnhöhle zwischen der Lamina papyracea zur Augenhöhle und der mittleren Nasenmuschel.

(B): Beidseitige Fronto-Spheno-Ethmoidektomie mit maximaler Erweiterung des Zuganges zur Stirnhöhle (Draf Typ III): Unter einem Draf Typ III verste. (C) Beidseitige Spheno-Ethmoidektomie: Abtragung des Processus uncinatus, die Eröffnung der Kieferhöhle, die Eröffnung des vorderen und hinteren Siebbeinsystems und die Eröffnung der Keilbeinhöhle.

Eligibility criteria: Inclusion Criteria:

* Symptomatic CRSwNP patients without improvement after conservative treatment for at least 6 months Extent of disease at least Davos Polyp Score ≥ 4 points Age 18-65 years Signed consent

Exclusion Criteria:

* Previous sinunasal surgery High resolution paranasal sinus CT shows other pathology (e.g. mucocele) Incapable of judgement

Primary outcomes:
measure: Nasal Polyp Score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Zurich University Hospital
Study officials:
References:
Clinical trial NCT05864014: Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.
Official title: Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hetrombopag for the Treatment of Chemotherapy-induced Thrombocytopenia in Adults With Solid Tumors.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Chemotherapy-Induced Thrombocytopenia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of current study is to evaluate the efficacy and safety of hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Men and women, 18-75 years of age;
2. Participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents;
3. Participant experienced thrombocytopenia and chemotherapy delay;
4. ECOG performance status 0-1;
5. Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x ULN for participants without liver metastases or 5.0 x ULN for participant with liver metastases);
6. Adequate renal function; serum creatinine \< 1.5 x ULN or eGFR≤60 ml/min（Cockcroft-Gault）

Exclusion Criteria:

1. Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
2. Participant has serious bleeding symptoms;
3. History of allergy to the study drug;
4. Participant with HIV;
5. Pregnant or lactating women;
6. Participant has received any experimental therapy within 4 weeks prior to screening
7. Other conditions that may affect participant's safety or trial evaluations per investigator's discretion

Primary outcomes:
measure: The proportion of treatment responders.
timeFrame: Randomization up to 80 days
Secondary outcomes:
measure: Duration from the commencement of treatment to a platelet count ≥100×109/L;
timeFrame: Randomization up to 30 days
measure: Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy and;
timeFrame: Randomization up to 160 days
measure: Proportion of subjects without serious bleeding events;
timeFrame: Randomization up to 190 days
measure: Number of adverse events (AEs)/serious adverse events (SAEs)
timeFrame: Randomization up to 190 days
Other outcomes:
Locations:
city: Haerbin
country: China
facility: Hematology Tumor Research Center of Harbin First Hospital
state: Heilongjiang
Study officials:
References:
Clinical trial NCT04512014: Perioperative Lactate Kinetics in Patient Undergoing Major Liver Surgery
Official title: Evaluation of Lactate Levels in as a Risk Factor for Posthepatectomy Liver Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Failure, Acute
Lead sponsor: Institutul Clinic Fundeni
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients undergoing major liver failure in our institution

Brief summary: Major liver surgery is associated with increased incidence of perioperative complications and increased mortality if these are not addressed quickly in a high dependency intensive care unit. Of these, posthepatectomy liver failure (PHLF) represents one of the most important cause of postoperative unfavourable outcome. The present study investigates the correlation between lactate levels and PHLF. Lactate levels were collected at six specific timepoints: preoperative, pre-dissection phase, post-dissection phase, end of surgery and 24-hours and 48-hours in the postoperative period.


Eligibility criteria: Inclusion Criteria:

* patients undergoing major liver surgery for primary or secondary tumours

Exclusion Criteria:

* unsigned patient consent
* death within 24 hours
* need for perioperative renal replacement therapy
* underlying liver disease (e.g. liver cirrhosis)
* other causes of raised lactate levels (e.g. shock)

Primary outcomes:
measure: lactate levels (mmol/L) in patients with PHLF
timeFrame: early postoperative period (48 hours)
Secondary outcomes:
measure: mortality
timeFrame: 30 days mortality
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
Study officials:
affiliation: Fundeni Clinical Institute
name: Dana Tomescu, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT01388114: Clinical Evaluation of e- Ab Sensor - Based Real-time Diagnosis of Serum Procalcitonin Level
Official title: Clinical Evaluation of e- Ab Sensor - Based Real-time Diagnosis of Serum Procalcitonin Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: Procalcitonin Measurement
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop a real-time diagnostic technique with e- Ab sensor for serum PCT level measurement will offer a test with lower cost, and increase the applicability of serum Procalcitonin (PCT) level in daily clinical practice.

Detailed description: Sepsis is a clinical syndrome with complex interactions between microorganism, host immune, inflammatory and coagulation response. The mortality rate associated with septic shock is high, up to 40-70%. Currently, the diagnosis of sepsis depends on microbial infection and systemic inflammatory response syndrome, which lacks sensitivity and specificity. Accordingly, Society of Critical Care Medicine (SCCM) offered new recommendations about the diagnosis of sepsis in 2001, which included the serum level of procalcitonin (PCT). Increased PCT levels through the clinical course correlated with higher mortality in critically-ill patients. On the other hand, recent studies also showed PCT levels could guide the antibiotic treatment in patients with sepsis or lower respiratory tract infection. Besides usage in sepsis population, serum PCT level could also be used for aids in diagnosis of bacterial infection and for guide of antibiotic treatment in acute exacerbation of chronic obstructive airway disease. However, current method of PCT assay depends on the Kryptor system developed by BRAHMS, Germany, with the functional sensitivity of 60 pg/mL. Each assay costs 1300 NT dollars, which is too expensive for serial follow-up of serum PCT levels. A real-time diagnostic technique with e- Ab sensor for serum PCT level measurement will offer a test with lower cost, and increase the applicability of serum PCT level in daily clinical practice. Here, the investigators conduct a study to develop a real-time diagnostic technique with e- Ab sensor for serum PCT level measurement in patients with sepsis.

Eligibility criteria: Inclusion Criteria:

* Patients who are admitted to medical intensive care units

Exclusion Criteria:

* Patients who refuse consent

Primary outcomes:
measure: Performance of e- Ab sensor for serum PCT level measurement
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hosital
Study officials:
affiliation: National Taiwan Universtiy Hospital
name: Chao-Chi Ho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02766114: Carpal Tunnel Release Through Mini Transverse Approach
Official title: Carpal Tunnel Release Through Mini Transverse Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Carpal Tunnel Release
Carpal Tunnel Surgery
Carpal Tunnel Transverse Approach
CTS
Keywords: CTS
Carpal tunnel syndrome
Carpal tunnel release
Mini incision of carpal tunnel release
Cosmetic surgery of carpal tunnel syndrome
endoscopic carpal tunnel surgery
Carpal Tunnel Release Through Mini Transverse Approach
Dr. Sayed Issa's Approach
CTRMTA
OCTR
ECTR
Open Carpal Tunnel Release
Endoscopic Carpal Tunnel Release
Syria
Cosmetic
Safety
Rehabilitation,
Complications
Surgery
Satisfaction
Lead sponsor: Issa, Abdulhamid Sayed, M.D.
Sponsor class: INDIV
First posted: 2016-05-09
Enrollment: 43
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm length.

Detailed description: Carpal tunnel release through a small approach on the distal wrist crease, it is about 1.5 cm, the benefits of this technique is less surgical traumatic and more tender, it takes less time for rehabilitation, so the patient can work next day of operation, and it has very cosmetic and gentle scar in results and outcome.

Eligibility criteria: Inclusion Criteria:

* Patients presented with Carpal Tunnel Syndrome refractory to conservative treatment
* Participant cooperation sufficient to operate under local anesthesia

Exclusion Criteria:

* Un controlled diabetes mellitus type 1 and 2
* Patients with non controlled Vascular hypertension
* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
* Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
* Patients with history of Carpal Tunnel release surgery failure

Primary outcomes:
measure: Proportion of patients with post surgical trauma
timeFrame: Up to eight weeks
Secondary outcomes:
measure: Duration of rehabilitation period
timeFrame: Up to three weeks
measure: Proportion of patients with cosmetic scar
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Aleppo
country: Syrian Arab Republic
facility: Dr. Sayed Issa's Clinic
Study officials:
References:
Clinical trial NCT01717014: Radial Reload Open LAR Case Series
Official title: Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Anterior Resection
Proctosigmoid Resection
Rectal Cancer
Keywords: rectal cancer
stapler
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
Collaborators: name: Duke University
name: Providence Medical Research Center
name: University of South Florida
First posted: 2012-10-30
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate the safety and feasibility of the Radial Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires relating to the function of the device.


Eligibility criteria: Inclusion Criteria:

1. The subject is able to understand and sign Informed Consent Form.
2. The subject is between 18-85 years of age.
3. The subject is anticipated to undergo a resection of the rectum with anastomosis below the peritoneal reflection for the treatment of rectal cancer.
4. The subject is anticipated to undergo mobilization and stapling of the rectum through an open incision.

Exclusion Criteria:

1. Any female patient, who is pregnant, suspected pregnant, or nursing.
2. The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
3. The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.

Primary outcomes:
measure: Staple Line
timeFrame: Operative
measure: Distal Margins
timeFrame: Operative
Secondary outcomes:
measure: Usability: Visibility
timeFrame: Operatively
measure: Usability: Access
timeFrame: Operatively
measure: Usability: Manueverability
timeFrame: Operatively
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Spokane
country: United States
facility: Providence Medical Center
state: Washington
Study officials:
References: