louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05939284: Progesterone-Primed Ovarian Simulation in Controlled-ovarian Simulation of Infertile PCOS Patients
Official title: Progesterone-Primed Ovarian Stimulation Might be a Safe and Effective Alternative to GnRH-antagonist Protocol for Controlled-Ovarian Stimulation of Infertile PCOS Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PCOS
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-07-11
Enrollment: 238
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluated the safety and efficacy of the progesterone-primed ovarian stimulation (PPOS) coupled with gonadotropin (FSH) for infertile women with polycystic ovary syndrome (PCOS) who were assigned for ICSI and frozen blastocyst transfer.

200 infertile women were divided randomly into Group C, which received Cetrorelix injection (0.25 mg daily) on day-6, and Group S, which received oral dydrogesterone (20 mg/day) on day-2 of the menstrual cycle till the trigger day. All patients received an FSH injection of 225 IU daily from day-2 till triggering day. ICSI was performed and day-5 blastocysts underwent vitrification ultra-rapid cryopreservation till being transferred. Outcomes included the ability of PPOS to suppress the premature luteinizing hormone (LH) surge and prevent the development of ovarian hyperstimulation syndrome (OHSS), the incidence of profound LH suppression, the number of retrieved M2 oocyte and fertilization, chemical and clinical pregnancy rates, and the miscarriage rate.


Eligibility criteria: Inclusion Criteria:

* Infertile PCOS women;
* aged 20-35 years;
* had BMI \<35 kg/m2.

Exclusion Criteria:

* Women who were younger than 20 or older than 35 years,
* obese of grade II or III,
* had poor OR, other causes of infertility,
* had previous attempts of IVF, had a history of repeated pregnancy loss.

Primary outcomes:
measure: Success rate of PPOS in relation to Premature LH surge suppression
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
state: Ash Sharqia Governorate
Study officials:
References:
Clinical trial NCT02442284: A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection
Official title: An Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in US Veterans With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-VA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Cirrhosis
Hepatitis C Virus
Keywords: Chronic Hepatitis C
Interferon-Free
Hepatitis C Genotype 1
Hepatitis C Virus
Hepatitis C
Cirrhosis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-05-13
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.


Eligibility criteria: Inclusion Criteria:

* US military veteran currently receiving healthcare through the Veterans Health Administration
* Screening laboratory result indicating hepatitis C virus (HCV), genotype 1-infection
* Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and HCV RNA \> 1,000 IU/mL at the time of Screening or HCV RNA \> 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease)

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab)
* Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN, RBV or sofosbuvir
* Any current or past clinical evidence of Child-Pugh B or C classification
* Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to Screening or on an ultrasound performed at Screening for participants with cirrhosis

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last actual dose of study drug
Secondary outcomes:
measure: Percentage of Participants With Virologic Failure During Treatment
timeFrame: up to 12 weeks (for 12-week treatment group) or up to 24 weeks (for 24-week treatment group
measure: Percentage of Participants With Post-treatment Relapse
timeFrame: From the end of treatment through 12 weeks after the last dose of study drug
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) Among Participants With Ongoing Psychiatric Disorders
timeFrame: 12 weeks after the last actual dose of study drug
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02377102: Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis
Official title: Does Physical Therapy Prevent Total Knee Arthroplasty in Patients With End Stage Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 65
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: Purpose: For the target population of adult patients with end stage osteoarthritis, this randomized clinical trial will be used to evaluate the benefit of three months of physical therapy compared to no treatment in patients indicated for total knee arthroplasty.

Participants:Patients that are diagnosed with end stage osteoarthritis who are indicated for total knee arthroplasty.

Procedures: Patients will be randomized to either receive physical therapy or no treatment. They will be scheduled to return in 3 months for discussion of operative versus continued nonoperative treatment of their osteoarthritis.This will be determined by change in PROMIS (Patient Reported Outcome Measurement Information System) score and prevention of surgery.


Eligibility criteria: Inclusion Criteria:

* Adult patients with grade 3 and 4 (severe) osteoarthritis and indicated for primary total knee arthroplasty.

Exclusion Criteria:

* Age less than 18 y/o
* Any form of arthritis other than osteoarthritis (traumatic, rheumatic, etc)
* Previous knee surgery
* Inability to personally consent to or participate with therapy due to cognitive impairment, physical disability, intoxication or sedation
* known contraindications would include patients that will be unable to participate with therapy or who will put themselves at significant risk due to therapy (this could be either severe cardiac or respiratory impairment that prevents the patient from ambulating or mental impairment preventing the patients from following instructions

Primary outcomes:
measure: Prevention of surgical intervention questionnaire
timeFrame: 12 weeks
Secondary outcomes:
measure: PROMIS-(Patient Reported Outcomes Measurement Information System) Lower Extremity Function Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Orthopaedics
state: North Carolina
Study officials:
affiliation: UNC Orthopaedics
name: Daniel J Del Gaizo, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02652702: Study Comparing Circular Stapler-assisted Colostomy vs Hand-stitching Colostomy of Colorectal Cancer Patients
Official title: Randomized Clinical Trial Comparing the Safety and Efficiency of Circular Stapler-assisted Colostomy With Hand-stitching Colostomy for Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Carcinoma
Keywords: circular stapler-assisted colostomy
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Conventional hand-stitching colostomy involves extensive hand-stitching by the surgeon. There are significant variations in the outcome of surgery due to differences in the suture techniques of surgeons. The use of a circular stapler in colostomy seems more rapid and efficient colostomy than the conventional methods.But all those reports are single center retrospective cohort study，no randomized controlled trials have been carried out so far.The aim of this study is to comparing the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in patients with colorectal carcinoma.

Detailed description: It has been difficult to standardize the pull-out of the colon and the size, shape and sutures of the colostomy due to the different techniques employed and varying levels of skill of surgeons in different regions.Thus, various postoperative colostomy complications are inevitable after surgery. Surgeons have been looking for a simple and efficient way to standardize colostomy and reduce its complications.

So we want to compare the safety and efficiency of circular stapler-assisted colostomy with conventional hand-stitching colostomy in colorectal cancer patients.

Eligibility criteria: Inclusion Criteria:

* Receiving permanent colostomy because of colorectal cancer
* Age of ≥18 and ≤80

Exclusion Criteria:

* Not willing or incapable to comply with all study visits and assessments
* Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications

Primary outcomes:
measure: colostomy associated complications
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital Zhejiang University College of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT00000202: Buprenorphine Maintenance for Opioid Addicts - 1
Official title: Buprenorphine Maintenance for Opioid Addicts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Keywords: Opioid-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of buprenorphine and desipramine in treatment of opiate and cocaine dependence.


Eligibility criteria: Please contact site for information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Thomas R Kosten, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: J Nerv Mental Dis, 1993, 181(6) pp. 358-364; NIDA Res Mono 1993, 132:100 ; Am J Psychiatary 1993, 150:1755; Am J Addictions 1994, 3: 43-48; NIDA Res Mono 1994, 141:79; NIDA Res Mono 1995, in press.
Clinical trial NCT05397002: Patient Specific Intraoral Inverted-L Osteotomy Modified With Inferior Alveolar Nerve Relocation in Corrective Mandibular Surgery
Official title: Patient Specific Intraoral Inverted-L Osteotomy Modified With Inferior Alveolar Nerve Relocation in Corrective Mandibular Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class III Malocclusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bilateral sagittal split osteotomy (BSSO) is considered the main osteotomy design in corrective mandibular surgery, however abnormal anatomical configuration of the posterior mandible with rolled out inferior border and thin mandibular rami with cortically adherent inferior alveolar nerve may interfere with the utilization of this osteotomy. The aim of this study is to introduce a novel modification of the intraoral inverted L ramus osteotomy (ILRO) to overcome these limitations in mandibular setback surgery. preoperative CBCT was requested for virtual planning and fabrication of cutting and drilling guides. Cutting lines were outlined to be consisted of four cuts; lateral ostectomy to uncover and lateralize the inferior alveolar nerve (IAN), posterior cut run horizontally from the anterior border of the ramus to a point just above the mandibular foramen, two anterior vertical cuts run from the anterior end of the lateral ostectomy to the inferior mandibular border. The guide was removed and the osteotomy lines were completed then the mandibular setback was oriented and fixed using pre-bent plates osteosynthesis. Inferior alveolar nerve function was regained perfectly one year post-operatively. This procedure introduces a robust alternative to the BSSO osteotomy in some cases of mandibular setback surgery.


Eligibility criteria: Inclusion Criteria:

* Adult patients.
* patients with skeletal class III malocclusion.
* Patients with thin mandibular rami with minimal medullary bone.
* Patients with inferior alveolar nerve proximity to the buccal cortex.
* Patients with lateral bending of the inferior mandibular border at molar angle region.
* Patients with high mandibular foramen.

Exclusion Criteria:

* Patients with previous extensive jaw surgery.
* mandibular pathological lesions.
* Patients with temporomandibular joint dysfunction.

Primary outcomes:
measure: Neurosensory dysfunction of Inferior Alveolar Nerve
timeFrame: one year after surgical intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Cairo University
name: Mohammed Omara, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07022002: SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors
Official title: A Phase II Study to Evaluate the Safety and Efficacy of SSGJ-705 Monotherapy and Combination Therapy in Patients With Advanced HER2-Expressing Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Locally Advanced, Recurrent or Metastatic Malignancies
Keywords: advanced malignancies
Lead sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2025-06-15
Enrollment: 340
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: This study was an open-label phase Ⅱ study to evaluate the safety and efficacy of SSGJ-705 Monotherapy and Combination Therapy in patients with advanced HER2-Expressing Solid Tumors.

Detailed description: This study includes 2 Parts: Part 1 (705 monotherapy for advanced gastric cancer and breast cancer that have failed standard treatment), and Part 2 (705 in combination with chemotherapy for previously untreated advanced gastric cancer and lung cancer).

Eligibility criteria: Inclusion Criteria:

* Males and/or females over age 18.
* Histologically and/or cytologically documented local advanced or metastatic NSCLC/BC/GC/GEJC.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Expected survival \>3 months.
* Signed informed consent form.

Exclusion Criteria:

* Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity.
* Pregnant or nursing women or women/men who are ready to give birth.
* symptomatic central nervous system metastasis.
* Allergy to other antibody drugs or any excipients in the study drugs.
* Inadequate organ or bone marrow function.

Primary outcomes:
measure: ORR
timeFrame: 12 months
measure: Safety and tolerability
timeFrame: 12 months
Secondary outcomes:
measure: PFS
timeFrame: 24 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT01129102: Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea
Official title: Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysmenorrhea
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2010-05-24
Enrollment: 215
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.

Detailed description: The main objective of this study is to confirm the effectiveness and safety profile of NPC-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary dysmenorrhea).

Additionally we also investigate the differences of effectiveness of NPC-01 in comparison with IKH-01 in the treatment of secondary dysmenorrhea as a reference, because IKH-01 is already marketed at them.

To achieve these, closed testing procedure is used in this study. After confirming statistical differences between NPC-01 and Placebo in the total dysmenorrhea, stratified analysis is carried out for primary dysmenorrhea (NPC-01, Placebo), and secondary dysmenorrhea (NPC-01, IKH-01 and Placebo).

Eligibility criteria: Inclusion Criteria:

* dysmenorrhea

Exclusion Criteria:

* severe hepatopathy
* pregnant woman

Primary outcomes:
measure: Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)
timeFrame: 16weeks
Secondary outcomes:
measure: Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)
timeFrame: 16weeks
Other outcomes:
Locations:
Study officials:
affiliation: Nissay Hospital,Osaka,Japan
name: Naoki Terakawa, M.D.,Ph.D.
role: STUDY_DIRECTOR
References:
citation: Harada T, Momoeda M. Evaluation of an ultra-low-dose oral contraceptive for dysmenorrhea: a placebo-controlled, double-blind, randomized trial. Fertil Steril. 2016 Dec;106(7):1807-1814. doi: 10.1016/j.fertnstert.2016.08.051. Epub 2016 Oct 4.
Clinical trial NCT01014702: Prospective Clinical Trial of the LensAR Laser System
Official title: Prospective Clinical Trial of the LensAR Laser System in the Treatment of Cataracts of Different Grades of Maturity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Cataract
Keywords: Cataract
Capsulotomy
Capsulorrhexis
lens fragmentation
phacoemulsification
Lead sponsor: LensAR Incorporated
Sponsor class: INDUSTRY
First posted: 2009-11-17
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The LensAR Laser System is used to create an opening in the anterior capsule of the lens and fragments the cataractous lens. The study will evaluate clinical outcomes compared to the contra-lateral eye treated with conventional phacoemulsification surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects must sign and be given a copy of the written informed consent form
* Subjects must have elected to undergo lens extraction and IOL implantation and then elect to have the LensAR laser surgery as part of the procedure.
* Subjects must be willing and able to return for scheduled follow-up examinations for 6 months after surgery.
* Subjects must have central 7 mm of clear cornea without vascularization.

Exclusion Criteria:

* Subjects who have undergone previous corneal or intraocular surgery in the eye to be treated.
* Subjects with a history, signs or symptoms of ocular disease or atypical finding which would be contraindicated under standard of care for cataract surgery.
* Diabetic or hypertensive subjects with clinical evidence of retinal pathology.
* Subjects with macular degenerative pathology.
* Subjects with a history of steroid-responsive rise in IOP or uncontrolled glaucoma in either eye.
* Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
* Subjects with corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.

Primary outcomes:
measure: Completeness and ease of opening of capsulotomy
timeFrame: Day 0 (Surgery)
measure: Reduced need for ultrasound phacoemulsification compared to control eye
timeFrame: Day 0 (surgery)
measure: Rate of adverse events
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociacion para Evitar la Ceguera en Mexico IAP
Study officials:
References: