cyrilzakka/clinical-trials huggingface dataset:
Arthroscopic-Assisted Reduction of Hip Dislocation Via Sub-Adductor and Anterolateral Portals

This study aims to present our arthroscopic-assisted surgical technique's reliability as a successful treatment for DDH, achieving reduction without the potential sequelae associated with open reduction techniques.

Developmental dysplasia of the hip (DDH) encompasses a spectrum of pathological conditions including dislocation, subluxation, and deformities of the femoral head and acetabulum. The optimal surgical approach for DDH remains a subject of debate. The goal of successful treatment is achieving a stable concentric reduction and preventing future subluxation or dislocation.The aim of this study is to introduce the reliability of our arthroscopic-assisted surgical technique as a successful treatment for DDH that can achieve reduction with avoidance of sequelae which may be experienced following open reduction techniques.

Eligibility Criteria:
Inclusion Criteria:

- Patients with DDH in this study

Exclusion Criteria:

- Previous surgical treatment and those with teratologic or neuromuscular dislocations
Desk Cycling Work Performance Evaluation

This lab study is evaluating the feasibility of accomplishing productive office work while simultaneously pedaling a compact desk-based cycling device.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* Ability to type without looking at the keyboard
* Native English speaker
* Normal hearing
* Spend 6 or more hours per day sitting
* Less than 150 minutes of physical activity per week

Exclusion Criteria:

* Positive response on the Physical Activity Readiness Questionnaire indicating that low intensity pedaling could present safety risks
* Pregnancy
* Body mass index less than 18 or greater than 35
Lymphedema Prevention in Breast Cancer

OBJECTIVE: To find out the effectiveness of early application of Manual Lymph Drainage in the prevention of upper limb lymphedema after breast surgery and axillary lymphadenectomy in women with breast cancer.

DESIGN: Randomized, controlled and single blinded clinical trial. Five years duration. Patients were randomly assigned to one of these groups: Experimental group: Manual Lymph Drainage + training in means of prevention; Control group: just training in means of prevention. In both groups several physical therapy assessments were undertaken: 1st before surgery; 2nd 3 month after surgery; 4th, 5th, 6th, 7th, 8th and 9th after 6, 12, 24, 36, 48 and 60 months.

SUBJECTS: Women with breast cancer treated with breast surgery including axillary lymphadenectomy in Provincial Hospital of Toledo, provided that there is no contraindication for manual lymph drainage, and after reading, understanding and freely signing an informed consent form.

SAMPLE SIZE: A total of 150 subjects were included in the study (57 subjects in experimental group and 93 in control group), assuming a 20% of drop-outs and at least 25% reduction, with a statistical power of 75%.

DATA ANALYSIS: To find out the effectiveness of intervention the investigators will compare the rate of lymphedema in both groups by means of a logistic regression analysis, in which the main factor is the intervention group. Other factors aimed to control the effect of the intervention will also be included. In order to compare the rate of appearance of lymphedema in both groups, a survival analysis will also be included.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of breast cancer.
* Undergoing unilateral surgery with axillary lymph-node dissection.

Exclusion Criteria:

* Bilateral breast cancer.
* Systemic disease.
* Locoregional recurrence.
* Any contraindication to physical therapy.
Active Elements of Digital Single-session Interventions

Depression is a leading cause of disability in young adults. However, access to care is limited due to structural and psychological barriers. Single-session interventions (SSIs) are structured programs designed to maximize the therapeutic output in one interaction between the patient and the provider or a program. Project ABC, a single-session intervention (SSI), has been shown to be effective in reducing depressive symptoms. Project ABC is based on four components-psychoeducation, testimonials, saying is believing exercises, and action planning. However, it is unclear what are the effects of the individual components.

The primary aim of this study is to calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on Patient Health Questionnaire-8 (PHQ-8) scores at 8-week follow-up.

The secondary aims of this study are to:

1. calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on PHQ-8 scores at immediate post-treatment and 2-week follow-up.
2. calculate the interaction effects, if any, among the candidate components on PHQ-8 scores at immediate post-treatment, 2-week, and 8-week follow-up.
3. calculate the main and interaction effects of the candidate components on measures of hopelessness, autonomy, relatedness, and competence.
4. determine if the effects of the candidate components on PHQ-8 are mediated by measures of autonomy, relatedness, and competence.

Additionally, the exploratory aim of this study is to determine if common factors, like credibility of the intervention and expectations to improve, can lead to symptom change.


Eligibility Criteria:
Inclusion Criteria:

* Located in the United States
* Baseline Patient Health Questionnaire-8 (PHQ-8) score \>= 10
* Able to read and write English
* Able to access to the internet via a computer, tablet or smartphone for the next eight weeks

Exclusion Criteria:

* Participants who have participated in another related study on depression from our laboratory via the same participant recruitment platform in the past two months
* Participants who have submitted gibberish in open response questions
Effect of Materials for Subcuticular Suture (Quill vs. Monocryl) on Complications After Liver Resection

This study investigates the effect of materials used in subcuticular suture on patients' outcomes after surgery. The prevention of surgical site wound infection is important to decrease the length of hospital stay and the post-operative risk of incisional hernia, especially in patients undergoing open hepatectomy (surgical removal of the liver). The purpose of this study is to compare the impact of the use of Quill versus Monocryl for subcuticular suture on patients' outcomes after surgery.

PRIMARY OBJECTIVE:

I. To investigate the impact of materials for subcuticular suture (Quill versus \[vs.\] Monocryl) on complications after liver resection.

OUTLINE:

Patients' medical records are reviewed retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>= 18 years of age undergoing liver resection at MD Anderson Cancer Center from June 1, 2020 through January 31, 2021

Exclusion Criteria:

* Patients who have a history of previous abdominal surgery will be excluded
* Pregnant women will not be included in this chart review
Digital Analysis of Primary Teeth Dimensions in a Group of Egyptian Children (4-6 Years)

Tooth size (Mesiodistal, Buccolingual and Occluso-gingival) has an important role in pediatric dentistry as it helps for fabrication of appropriate sizes of zirconia crowns for primary anterior teeth and Stainless-Steel crowns for primary posterior teeth. Tooth size differs among and within populations.


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 4-6 years
2. Fully erupted first and second primary molars
3. Sound interproximal \& buccal / lingual walls with or without minimal occlusal pits \& fissure incipient caries.
4. No previous interproximal \& buccal / lingual restorations
5. Intact mesial and distal marginal ridge

Exclusion Criteria:

1. Children with gross carious lesions.
2. Children with hypo-mineralization, hypoplasia and fracture.
3. Children with mental disability.
Study of 3D Radiotherapy With or Without Erlotinib (Tarceva®) in Patients With Localized Non-Small Cell Lung Cancer

A phase II, multicenter, randomized trial of 3D Radiotherapy versus 3D Radiotherapy and erlotinib (Tarceva®) in patients with localized-unresectable (IA-IIIB) non-small cell lung cancer non susceptible for chemotherapy treatment, to compare safety and toxicity profile, and the progression-free survival in both arms of treatment (3D Radiotherapy versus 3D Radiotherapy + erlotinib) in patients who have not received previous chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to any specific procedure of the protocol.
* Histologically confirmed diagnosis of non small cell lung cancer.
* Unresectable (IA-IIIB) non-small cell lung cancer.
* Patients non susceptible for chemotherapy treatment
* Measurable disease according to RECIST criteria
* Age \> 18 years.
* ECOG performance status \< 2.
* Adequate bone marrow, hepatic, renal and respiratory function.
* Patients capable of following an adequate therapeutic compliance and accessible for a correct follow-up.
* Women at a fertile age must have a negative serum or urine pregnancy test within the 7 days prior to the beginning of the treatment.
* Patients of both genders at a fertile age, including those women having their last menstruation within the two previous years, must follow effective contraceptive measures.

Exclusion Criteria:

* Prior chemotherapy or radiotherapy.
* History of other curatively treated malignancy and no evidence of disease within the past 5 years except squamous cell skin cancer, or resected cervix carcinoma.
* Pregnant or lactating women.
* Any other severe disease or clinical conditions, as, but not only:

  1. Unstable cardiopathy despite treatment, myocardial infarction within the 6 months before entering the study
  2. Uncontrolled active infection
  3. Uncontrolled peptic ulcer, unstable diabetes mellitus or any other contraindication for treatment with corticosteroids.
  4. Autoimmune diseases.
* Concomitant treatment with any other antineoplastic therapy.
* Prior experimental pharmacological agent within the 3 weeks prior to the inclusion of the study.
* Prior treatment with EGFR targeted therapies.
* Erlotinib known hypersensibility.
* Any radiotherapy treatment contraindication.
* History of significant neurological or psychiatric disorders, including epileptic seizures.
* Any significant ophthalmologic impairment of the eye surface (Use of contact lenses is not recommended)
* Inability to take oral medication and surgical procedures affecting the absorption or implying intravenous or parenteral feeding.
* Any other underlying severe process affecting the ability to take part in the study.
Randomised Study to Compare the Effect of r-Hu-EPO Administration With Transfusion of Red Blood Cell Concentrates and Also With the Administration of Polyvitamins in Anemic and Tired Patients Presenting a Bad Prognostic in Middle Course

Randomised study to compare the effect of r-Hu-EPO administration with transfusion of Red Blood cell concentrates and also with the administration of polyvitamins in anemic and tired patients presenting a bad prognostic in middle course.


Eligibility Criteria:
Inclusion Criteria:

* Both sexes
* 18-70 yrs
* metastatic or locally advanced cancer
* Life expectancy \> 3 months
* hemoglobin between 7 and 10 g/100ml
* no contraindication to r-Hu-EPO
* with written informed consent at entry time
Evaluation of the Cobas® 4800 HPV Test for the Detection of High-grade Cervical Disease

This study provided data on the performance of the Cobas® 4800 HPV Test for identifying histologically confirmed high-grade cervical disease. The baseline, cross-sectional phase was conducted in approximately 45,000 women undergoing routine cervical cancer screening, of whom approximately 7,400 were selected to undergo colposcopy and biopsy/endocervical curettage (ECC) at baseline. These subjects included women with cytology that is 'not normal' and a selection of those with 'normal' cytology who entered a follow-up phase and underwent cytological evaluation annually for 3 years. In this follow-up phase, colposcopy and biopsy/ECC were performed only in women with cervical cytology considered 'not normal' at any of the annual follow-up visits.


Eligibility Criteria:
Inclusion Criteria:

* Females ≥ 21 years of age presenting for routine cervical cancer screening.
* An intact cervix.
* Willing and able to undergo colposcopy and biopsy and endocervical curettage within 8 weeks after study Visit 1.

Exclusion Criteria:

* Known pregnancy at study Visit 1.
* Presenting for colposcopy at study Visit 1.
* Any condition resulting in increased risk of bleeding at biopsy.
* Hysterectomy.
* Known history of ablative or excisional therapy to the cervix within the preceding 12 months.
Antidepressants and Bone Mineral Density

The aim of this five arm randomized trial was thus to compare selective serotonin reuptake inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the primary endpoint being bone mineral density, and secondary endpoints being bone turnover markers.

These results have overt clinical implications. They suggest a noxious effect, particularly of selective serotonin reuptake inhibitor (SSRI) antidepressants, on bone. Osteoporosis and fracture is overtly the problem of the elderly. However, the process of skeletal consolidation begins in childhood and the corresponding phase of demineralisation proceeds at a glacial pace and lasts throughout adulthood, as a consequence antidepressant therapy is likely to have a substantive impact on a phenomenon likely to manifest decades hence. It is known that numerically small changes in bone mineral density are associated with a substantial increase in fracture risk. Because the SSRIs have only been in widespread use for two decades, it is plausible that the consequences of this adverse effect are yet to emerge. These data consequently suggest a recalibration of the risk/benefit ratio of this class of agents and additionally beg the question of the potential role of screening for bone mineral density in this at-risk population group.

Eligibility Criteria:
Inclusion Criteria:

* Participants needed to have a primary diagnosis of depression with Zung Self Rated Depression Scale (SDS) \> 53, and Hamilton Depression Scale (HAMD) ≥20.

Exclusion Criteria:

* The patients with hyperparathyroidism, myeloma or other disorders known to affect bone metabolism
* Use of estrogen
* Calcitonin drugs
* Previous antidepressant or other psychiatric drug use or prior treatment history
Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:

* Smoking history of at least 20 pack years
* Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) \< 80% predicted and \>or= 30% of predicted normal value
* Post-bronchodilator FEV1/FVC \< 70%

("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)

Exclusion Criteria:

* Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception
* Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in
* Patients requiring oxygen therapy for chronic hypoxemia (typically \>15h/day)
* Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period
* Concomitant pulmonary disease
* Asthma history (eosinophils \> 400/mm3; symptoms prior to age 40). Includes history of childhood asthma
* History of long QTc syndrome or QTc interval \> 450 ms for males and \>470 ms for females
* Patients who have a clinically significant condition or a clinically relevant laboratory abnormality
* History of reactions to sympathomimetic amines or inhaled medication
* Inability to use the dry powder devices or perform spirometry
* Irregular day/night, wake/sleep cycles, e.g. shift workers
* Certain medications for COPD and allied conditions such as long acting bronchodilators must not be used prior to Visit 1 and for a pre-specified minimum washout period
* Patients unable or unwilling to complete a patient diary

Other protocol-defined inclusion/exclusion criteria may apply.
Role of Hypofractionated Radiotherapy With Concurrent Gemcitabine in Treatment of Urinary Bladder Carcinoma

Estimate the response to modified hypofractionated radiotherapy concurrent with Gemcitabine in urinary bladder cancer patients .

Estimate local control, relapse free survival, overall survival and bladder preservation rate. Evaluate the toxicity of a modified hypofractionated chemoradiotherapy protocol for patients with invasive bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

- Pathologically confirmation of transitional cell carcinoma . Non metastatic invasive bladder cancer (TNM0) Any age group ≥ 18 years. Non pregnant female patients.

Exclusion Criteria:

- Other pathology than Transitional cell carcinoma Metastatic Patient Age less than 18 years
Safety, Tolerability, and Efficacy Study of MB07803 Administered to Patients With Type 2 Diabetes Mellitus

The purpose of this study is to collect important information regarding the safety, tolerability, and efficacy of MB07803 when administered for 28 days in patients with type 2 diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* Fasting plasma glucose between 120 - 270 mg/dL at screening
* HbA1c measurements between 6.0 - 10% at screening
* Females who are surgically sterile (i.e. women who have had a hysterectomy or tubal ligation). Females who are postmenopausal for at least 12 consecutive months and documented by blood follicular stimulating hormone (FSH) greater than or equal to 40 mlU/mL.Females of childbearing potential must be willing to use an approved double-barrier method of birth control (e.g. condom plus spermicide ;IUD plus spermicide) from the time of signing the informed consent form through 4 weeks following the last dose of study drug.
* Body mass index (BMI) in the range of 18.5 - 37 kg/m2 Patients with a BMI in the range of 37.5 - 40 kg/m2 who in the Investigator's opinion, are in good health and satisfy the eligibility criteria, will be considered on a case-by case basis
* Written informed consent

Exclusion Criteria:

* Type 1 diabetes mellitus
* Type 2 diabetes mellitus with a history of diabetic ketoacidosis or ketosis-prone
* Use of thiazolidinediones (TZDs)
* Currently on more than two oral hypoglycemic agent
* History of outpatient insulin use
* Clinically significant history of cardiac disease within 6 months of informed consent
XLCART001 Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects

The trial is a single arm, single-center, non-randomized clinical trial which is designed to evaluate the efficacy and safety of XLCART001 in treatment of relapsed/refractory/high-risk B-cell malignancy subjects


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years, male and female,
* Confirmed as CD19-positive B cell lymphoma/leukemia by immunohistochemistry or flow cytometry
* No effective treatment
* Patients must have a measurable or evaluable disease at the time of enrollment.
* Adequate organ system function including:

  * ALT/AST \< 3 upper limit of normal; Total Bilirubin \< 2.5 upper limit of normal
  * Creatinine \< 2 upper limit of normal
  * Oxygen saturation ≥ 95%
  * Left ventricular ejection fraction ≥ 40%
  * Number of neutrophil ≥ 0.75×10\^9/L, number of platelet ≥ 50×10\^9/L
* At least 4 weeks from receiving previous treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatments)
* No contraindications of peripheral blood apheresis
* Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures
* ECOG score 0-2, expected survival ≥ 12 weeks

Exclusion Criteria:

* Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
* Uncontrollable active infection within four week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons
* Subjects with any autoimmune disease or any immune deficiency disease
* Have a history of allergy to antibodies or cellular products
* Participated in any other clinical trial within four weeks
* Used of systemic steroids within four weeks (using inhaled steroids or ≤ 20mg/d prednison are exceptions)
* Have mental diseases
* Have history of drug addiction
* The investigators believe that any increase in the risk of the subject or interference with the results of the trial