louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06755528: Effect of Shockwaves on Fallopian Tubes Adhesion
Official title: Effect of Shockwaves on Fallopian Tubes Adhesion: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fallopian Tube Adhesion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of shock waves on fallopian tube adhesions.

Detailed description: Tubal factor infertility accounts for approximately 40% of the cases of female infertility. Identifiable causes of tubal infertility are post-infectious tubal damage, endometriosis-related adhesions, and postsurgical adhesion formation.

Although surgical management is considered as a common choice for treating blocked tubes or adhesion it has many complications such as: infection, creation of more scar tissue, damage to organs and bleeding.

Shock waves is a modality that exerts an anti-inflammatory action and regenerative effect as well biological model. Shock waves can be nowadays considered an effective, safe, versatile, repeatable, noninvasive therapy for the treatment of many musculo-skeletal diseases, and for some pathological conditions where regenerative effects are desirable, especially when some other noninvasive/conservative therapies have failed.

For these reasons and complications of surgery, This study aims to examine the effect of shockwaves therapy on fallopian tubes adhesion

Eligibility criteria: Inclusion Criteria:

* Their ages will be ranged from 25 to 35 years old.
* Their body mass index (BMI) will be less than 35kg/m².
* All women will be diagnosed with fallopian tubes adhesion by the physician.
* They have regular menstrual cycles.
* All Patients have secondary infertility and they have previous caesarean section).

Exclusion Criteria:

* Any gynecological diseases (uterine prolapse, retroversion flexion of the uterus or chronic pelvic pain).
* Leukemia or tumor (spinal or pelvic tumor).
* Diabetes mellitus, hypertension, heart diseases, cardiovascular diseases and skin diseases.

Primary outcomes:
measure: Assessment of Fallopian tube adhesions
timeFrame: 4 weeks
measure: Detection of Fallopian tube patency
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Al-Agoza Police Hospital
name: Nabil Fekry, PHD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Soheir El-kosery, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT03213028: Family Planning Service Delivery Integration For HIV Positive And At-Risk Women In Botswana: A Hybrid Type 2 Clinical Intervention And Implementation Strategy
Official title: Family Planning Service Delivery Integration For HIV Positive And At-Risk Women In Botswana: A Hybrid Type 2 Clinical Intervention And Implementation Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Planning
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: University of Botswana
First posted: 2017-07-11
Enrollment: 248
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this pilot study is to assess both implementation outcomes (acceptability, feasibility and adoption) and clinical efficacy (contraceptive method uptake by women wishing to avoid pregnancy) using a Hybrid Type 2 study design of a family planning program being piloted by the Cervical Cancer Prevention Program in Gabarone, Botswana.


Eligibility criteria: Inclusion Criteria:

1. Female
2. English or Setswana speaking
3. Receiving CCP services at the clinic
4. 18-45 years of age
5. Able to give informed consent to study procedures, as determined by research/clinic staff

Exclusion Criteria:

1. Pregnant

Primary outcomes:
measure: Provider acceptability rating
timeFrame: 6 months
measure: Provider rating of feasibility
timeFrame: 6 months
measure: Provider report of adoption of the intervention
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gabarone
country: Botswana
facility: Princess Marina Hospital
Study officials:
References:
Clinical trial NCT01144728: Initiation and Titration of Amaryl
Official title: AMIT Study - Amaryl M Initiation and Titration Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-06-16
Enrollment: 172
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

* To describe the conditions of initiation and titration of Amaryl M, according to previous treatment:
* initial dose
* titration scheme
* efficacy after 4 months assessed by HbA1C
* tolerability (number and severity of hypoglycaemia)

Secondary Objective:

* Fasting Plasma Glucose
* Weight evolution


Eligibility criteria: Inclusion criteria:

* Patients with Type 2 diabetes who have been treated with a stable dose (any dose) of :
* sulfonylurea monotherapy or
* metformin monotherapy or
* free combination of glimepiride and metformin with a stable dose (any dose)
* Body Mass Index (BMI) between 20 and 40 kg/m2
* HbA1c superior or egal to 7.5%
* FPG superior or egal 7 mmol/l

Exclusion criteria:

* Secondary or insulin-dependant diabetes
* Any severe chronic disease (hepatic, renal impairments)
* History of major cardiovascular event in the last 6 months
* Acute conditions with the potential to alter renal function such as: dehydratation, severe infection, shock, IV administration of iodinated contrast agents
* Allergy to sulfonylurea, metformin
* Drug or alcohol abuse
* Pregnancy, lactation

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Glycolysated Haemoglobin (HbA1c)
timeFrame: From baseline to Month 4
measure: Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%
timeFrame: Month 4
measure: Evolution of Fasting Plasma Glucose (FPG)
timeFrame: From baseline to Months 4
Secondary outcomes:
measure: Post Prandial Plasma Glucose (PPPG)
timeFrame: Month 4
measure: Number of patients for each start dose
timeFrame: At baseline
measure: Number of patients with different final doses
timeFrame: Month 4
measure: Rate of Symptomatic Hypoglycemia
timeFrame: During treatment period (4 months)
measure: Change in Weight
timeFrame: Month 4
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT05638828: A Study of RD14-01 in Patients With Advanced Solid Tumors
Official title: A Study of RD14-01 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Solid Tumor
Keywords: CAR-T Cell
ROR1
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 24
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: This study will evaluate the safety and tolerability of RD14-01, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ advanced solid tumors.

Detailed description: This single-arm, open-label, dose-escalation and dose-expansion study will evaluate the safety and tolerability of RD14-01, ROR1-targeting CAR T cells, in adults with ROR1+ advanced solid tumors. The dose-escalation phase will investigate 3 dose levels to the. The dose-expansion phase will enroll .

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. Patients with histologically or cytologically confirmed advanced solid tumor, who have progressive disease, have undergone systemic therapy for advanced disease, and for whom no standard therapy is available.
3. ROR1+ by central laboratory immunohistochemistry (IHC).
4. Adequate organ and marrow function.
5. At least one measurable lesion as per RECIST v1.1.
6. . Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
7. Ability to understand and provide informed consent.

Exclusion Criteria:

1. Prior treatment with any agent targeting ROR1
2. Presence of active central nervous system (CNS) metastasis
3. Impaired cardiac function or clinically significant cardiac disease
4. Untreated or active infection at the time of screening or leukapheresis
5. HIV-positive, active acute or chronic HBV or HCV, or active tuberculosis
6. Untreated or active infection at the time of screening or leukapheresis
7. Pregnant or breast-feeding females

Primary outcomes:
measure: DLT and MTD
timeFrame: up to 28 days
measure: TEAEs
timeFrame: up to 12 months
Secondary outcomes:
measure: ORR
timeFrame: up to 28 days
measure: DOR
timeFrame: up to 12 months
measure: PFS
timeFrame: up to 12 months
measure: OS
timeFrame: up to 12 months
measure: Maximum concentration of RD14-01 (Cmax) in peripheral blood (PB) samples
timeFrame: up to 12 months
measure: Time to Cmax (Tmax) of RD14-01 in peripheral blood (PB) samples
timeFrame: up to 12 months
measure: Persistence of RD14-01 CAR T cells in peripheral blood samples
timeFrame: up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Lin Shen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05113628: Methylene Blue Spray for Identification of Recurrent Laryngeal Nerve and Parathyroid Gland
Official title: Methylene Blue Spray for Identification of Recurrent Laryngeal Nerve and Parathyroid Glands During Thyroidectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methylene Blue
Recurrent Laryngeal Nerve Injuries
Parathyroid Gland
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-11-09
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Thyroidectomy is the procedure by which surgeons treat various thyroid diseases and is considered the commonest endocrinal surgery. Yet, it carries a risk for intraoperative complications. The most distressing complications are recurrent laryngeal nerve and parathyroid injuries. Methylene blue spray is a technique than can be used for easy identification of both recurrent laryngeal nerve and parathyroid glands so we can avoid their injuries.

Detailed description: Thyroid disorders constitute the second most common endocrine disease following diabetes mellitus. Thyroid surgery is one of the most frequently operated Head and Neck surgeries. Post-thyroidectomy complications are not uncommon. Parathyroids and Recurrent Laryngeal Nerve (RLN) are two of the complications of thyroidectomy that cause significant postoperative morbidity Due to the advances in thyroids surgeries, the occurrence of postoperative complications has been decreased, but when occurred, they cause lifelong handicap. The most important complications encountered are injury to the RLN and parathyroids. Meticulous dissection is a key factor in minimizing the occurrence of complications During thyroidectomy, careful dissection can protect the parathyroid glands and RLN. Various methods were used including capsular dissection, attention to protection of the arterial supply to parathyroids, avoiding unnecessary manipulation in the area of RLN Methylene blue spraying is a new technique that allows identification of both parathyroid glands and recurrent laryngeal nerves

Eligibility criteria: Inclusion Criteria:

* Age of 16 years and older.
* Both sexes.
* Patients who are candidate for thyroid surgery and euthyroid.

Exclusion Criteria:

* - Patients with hyper- or hypo-thyroid status.
* Patients who were unfit for surgery.
* Patients with unilateral or bilateral vocal cord palsy on preoperative indirect laryngoscopy
* Patients with thyroid malignancy by preoperative FNAC.
* Patients with hypersensitivity to methylene blue were excluded.

Primary outcomes:
measure: detection of the recurrent larngeal nerve unstained
timeFrame: one minute after dye application
measure: detection of the parathyroig glands
timeFrame: 3 minutes after dye application
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university hospitals
Study officials:
References:
Clinical trial NCT04949828: Effect of CREON on Exocrine Pancreatic Insufficiency (EPI) Symptoms
Official title: Observational Study Assessing for Effect of CREON on Symptoms of Exocrine Pancreatic Insufficiency (EPI) in Patients With EPI Due to Chronic Pancreatitis (CP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Keywords: Chronic pancreatitis
Exocrine Pancreatic Insufficiency
CREON
pancrelipase
ABT-SLV245
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-07-02
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with medical diagnosis of chronic pancreatitis (CP) and exocrine pancreatic insufficiency (EPI)

Brief summary: Exocrine Pancreatic Insufficiency (EPI) is a condition where pancreatic enzyme quantity or activity is reduced below threshold needed for normal digestion. Symptoms include bloating, flatulence, diarrhea and steatorrhea. This is an observational study assessing for effect of CREON on symptoms of EPI in participants with EPI due to chronic pancreatitis.


Eligibility criteria: Inclusion Criteria:

* Medical history of chronic pancreatitis (CP).
* Diagnosis of Exocrine Pancreatic Insufficiency (EPI).

Exclusion Criteria:

--History of cystic fibrosis, pancreatic cancer, pancreatic surgery, gastric bypass surgery, extensive bowel surgery, inflammatory bowel disease, celiac disease, irritable bowel syndrome

Primary outcomes:
measure: Change in Score of EPI Symptoms Domain Using an EPI Patient-Reported Outcomes Questionnaire
timeFrame: Up to 1 month
Secondary outcomes:
measure: Change in T-scores for Patient-Reported Outcomes Measurement and Information System(PROMIS) Questionnaires for Anxiety, Depression, and Fatigue
timeFrame: Up to 1 month
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Med /ID# 229530
state: California
city: Gainesville
country: United States
facility: University of Florida - Archer /ID# 227057
state: Florida
city: Baltimore
country: United States
facility: John Hopkins University /ID# 227061
state: Maryland
city: New York
country: United States
facility: NYU Langone Health /ID# 230818
state: New York
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center /ID# 227844
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine - Baylor Medical Center /ID# 227067
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02338128: The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients
Official title: The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorders Associated With Peritoneal Dialysis
Hyperuricemia
Keywords: peritoneal dialysis
hyperuricemia
cardiovascular
Febuxostat
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peritoneal dialysis patients with hyperuricemia

Brief summary: The purpose of this study is to determine whether Febuxostat could protect cardiovascular function of peritoneal dialysis patients by lowering serum uric acid.

Detailed description: Patients with more than 3-month-history of peritoneal dialysis and hyperuricemia. Use Febuxostat to control their serum uric acid for 1 year. To observe the cardiovascular events of patients, and compare and evaluate the changes of heart function, heart construction, serum cardiac markers and brain natriuretic peptide (BNP) levels before and after Febuxostat treatment.

Eligibility criteria: Inclusion Criteria:

- Peritoneal dialysis for more than 3 months with hyperuricemia.

Exclusion Criteria:

1. Acute hepatopathy or liver dysfunction (Aspartate transaminase and/or alanine aminotransferase exceed 2 times of normal range)
2. Heart failure (stage IV, NYHA), unstable angina, acute stroke
3. Severe lung disease or cancer
4. unable to sign the informed consent form or disagree following-up.

Primary outcomes:
measure: cardiovascular events (heart failure, myocardial infarction, unstable angina which need hospitalization，heart surgery, or death caused by cardiovascular disease.)
timeFrame: 1 year
Secondary outcomes:
measure: Serum uric acid
timeFrame: 1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month
measure: cardiovascular function (Heart construction and cardiac ejection fraction determined by echocardiography; blood test: cardiac markers including troponin,myoglobin and creatinine kinase, MB isoenzyme (CK-MB), brain natriuretic peptide)
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital
name: Ling Wang, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01221428: Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis
Official title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Ulcerative Colitis
Mesenchymal Stem Cells
Umbilical Cord
Keywords: Ulcerative colitis
Mesenchymal Stem Cells
Umbilical Cord
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2010-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 determine whether umbilical cord Mesenchymal Stem Cells of treatment for ulcerative colitis is safe and effective.

Detailed description: Ulcerative colitis is characterized as chronic and nonspecific inflammation of gastroenteritis tract．Nowadays，etiology and pathogenesis of UC have been unclear．Recent basic research has been revealed that stem cell can settle down in epithelium of gastroenteritis tract，which provide a hope for treating the disease.We hope umbilical cord Mesenchymal Stem Cells could not only address the need for epithelial cell replacement but also control of the autoimmune response to mocous membrane of colon.

Eligibility criteria: Inclusion Criteria:

* Male or female, 18 years of age or older.
* Ulcerative colitis described according to usual criteria.
* Refractoriness Ulcerative colitis or unefficient by using other therapy
* Signed informed consent form.

Exclusion Criteria:

* History of neoplasm or hematological disease
* Uncontrolled high blood pressure (\>180/110)
* Severe cardiac insufficiency (New York Heart Association \[NYHA\] IV) or ejection fraction\<30%
* Malignant ventricular arrythmia
* Deep venous thrombosis during the last 3 months
* Active bacterial infection
* Body mass index \> 35 Kg/m2
* Stroke or myocardial infarction during the last 3 months

Primary outcomes:
measure: the result of enteroscopy and pathological report
timeFrame: 3 months
Secondary outcomes:
measure: the clinical symptom (including stomachache,abdominal distention,bloody purulent stool)
timeFrame: 3 months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Stem Cell Research Center of Medical School Hospital of Qingdao University
state: Shandong
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: Gang Zhao, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03447028: Effect of TyG Index on Outcomes of Radical Prostatectomy
Official title: A Novel Prognostic Risk Factor for Patients Undergoing Radical Prostatectomy: Triglyseride-Glucose (TyG) Index
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Prostate Cancer
Insulin Resistance
Keywords: Triglyseride-Glucose index
prostate cancer
radical prostatectomy
metabolic syndrome
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 200
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing radical prostatectomy for prostate cancer between january 2007 and december 2012.

Brief summary: We investigate the association between Triglyserid-Glucose(TyG) index and prostate cancer in patients undergoing radical prostatectomy.

Detailed description: TyG index is calculated with special formula. Patients undergoing radical prostatectomy are divided two groups according to the cut-off level of 8.55 for TyG index.Groups were compared statistically in terms of oncological outcomes and survival.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing radical prostatectomy for prostate cancer

Exclusion Criteria:

* taking medicines for established diabetes and dyslipidaemia,
* presence of endocrinological disease,
* history of bariatric surgery,
* missing data and patients with uncontrolled follow-up

Primary outcomes:
measure: Oncological outcomes
timeFrame: 5 years
Secondary outcomes:
measure: Survival
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References: