cyrilzakka/clinical-trials huggingface dataset:
A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia

Oesophageal atresia (EA) is a rare congenital anomaly whose prevalence varies between 1 and 2 per 5000 live births in Europe. This condition is characterised by an interruption of the oesophagus often associated with the presence of a tracheo-oesophageal fistula (FTE).

Although considerable progress has been made in the treatment of AE in recent years, the aetiology of this defect is still not fully understood and several theories have been put forward to explain this phenomenon. What they have in common is an abnormal separation of the primary oesophagus and trachea. The main goal of AE treatment is the closure of the FTE using surgical techniques.

This is a non-profit, multicentre longitudinal observational cohort study. This study will enrol patients who underwent surgery for oesophageal atresia during the period 2011-2021 and are still in follow-up at participating clinical centres.

The primary objective is to assess the incidence of musculoskeletal abnormalities, of any type, in the long term (4 years after surgery) in patients with oesophageal atresia treated surgically by two different approaches: postero-lateral thoracotomy and mini-thoracotomy with muscle preservation


Eligibility Criteria:
Inclusion Criteria:

* Patients with oesophageal atresia (type III according to Ladd's classification);
* Patients who underwent their first operation for oesophageal atresia in the period 2011-2021
* Signature of written informed consent and consent to the study and privacy.

Exclusion Criteria:

* Not signature of written informed consent and consent to the study and privacy.
Cryaoablation Assisted Partial Nephrectomy a Non Ischemic Approach

Patients with renal masses eligible to partial nephrectomy often require arterial ischemia to control or prevent blood loss during this surgical procedure. This study aims to determine the safety and efficacy of renal cryoablation at the tumor bed, as a substitute measure or technique vs total or selective arterial renal ischemia.

Nephron sparring surgery has emerged as the procedure of choice for most patients with renal tumors that are \>2 cm and harbor a greater than 50% exophitic component. In order to decrease blood loss surgeons may: 1- interrupt blood flow to the kidney, completely or selectively; 2-Use diuretics such as mannitol to dehydrate the kidney; 3-Ice externally the kidney - in open procedures - to decrease metabolism during ischemia.

The emergence of robotic surgery triggered a shift in the the surgical approach to partial nephrectomy and is commonly employed. A fundamental drawback of this technique is represented on the lack of cold ischemia. However, warm ischemia is commonly employed and requires dissection of the renal pedicle, which by itself puts the kidney at risk of loss.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ages between 45-90-year-old.
* Renal tumor ≤ 7 cm in the greatest extension, \>50% exophitic.

Exclusion Criteria:

* Prior renal surgery
* M1 Disease
Clinical Comparison of RPDs Retained by Conical and Galvanoformed Double Crowns.

The aim of this prospective clinical trial was to investigate the clinical performance and complication rate of RPDs (Removable partial dentures) retained on conventional conical double crowns in comparison to galvanoformed telscopic double crowns. Additionally the OHIP (Oral Health related Qualitiy of Life)and the abrasion of the teeth were investigated.


Eligibility Criteria:
Inclusion Criteria:

* Indication for RPDs retained by double crowns; 2 to 6 Abutment teeth;

Exclusion Criteria:

* limited contractual capability and absence of consent of the patient
Study on Obesity Intervention With Physical Exercise Among Students in Changping District, Beijing

The primary objective of this study is to assess the effectiveness of a school based physical activity programme on obesity and related health outcomes in young schoolchildren.


Eligibility Criteria:
Inclusion Criteria:

* Grade of 2 to 5 in elementary schools and grade of 1 to 2 in middle schools.

Exclusion Criteria:

* Suffering or any history of disabilities, cardiovascular diseases, asthma, metabolic diseases, etc.
Effectiveness of Proprioceptive Training on Dynamic Postural Balance During Pregnancy

The purpose of the present study was to measure the effect of proprioceptive training, short-term, on dynamic postural balance during pregnancy and after 8 weeks of follow-up.

Thirty-nine pregnant women were randomized to either the intervention group(n=20) , which would perform proprioceptive exercise, or the control group(n=19, no intervention) .

Improvement in the postural balance of pregnant women may be the improvement in joint mechanoreceptor activation present in the joint capsules, medial ligament, posterior cruciate ligament, and meniscus, which result in improved articular stabilization and, consequently, a possible increase in the musculature's ability to provide co-contraction.

Improved their postural control after the intervention may have been due to central and peripheral nervous system balance control circuits and strength gains, which showed improvements extending from the second to the third trimester . The maintenance of postural balance requires the integration of the visual, vestibular, and somatosensory systems.

At the spinal level, first level of motor control, nervous reflex movement patterns are received from higher levels of the nervous system. This provides for reflex splinting during conditions of abnormal stress about the joint and has significant implications for rehabilitation.The muscle spindles play a major role in the control of muscular movement by adjusting activity in the lower motor neurons.

The second level of motor control is the brain stem, where the joint afferent is relayed to maintain the posture and balance of the body. Information delivered to the brain stem emanates from the joint proprioceptors, the vestibular centers in the ears, and the eyes.The final aspect of motor control includes the highest level of CNS function (motor cortex, basal ganglia, and cerebellum)and is mediated by cognitive awareness of body position and movement. Movements that are repeated can be stored as central commands, and can be performed without continuous reference to consciousness. This better joint afferent between the peripheral and central nervous system control may be reflected in the improvement of balance during pregnancy, as observed in this study as a result of proprioceptive training delivered to pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Maternal age between 25 and 30 years,
* Gestational age was 20 weeks gestation,
* Body mass index not exceeding 30 kg/m2,
* Low risk pregnancy,
* Single fetus,
* Healthy sensory motor function in the lower limbs.

Exclusion Criteria:

* Gestational diabetes,
* Pre-eclampsia,
* Toxemia,
* Gestational hypertension,
* Previous abortion,
* High-risk pregnancy,
* Type I or Type II diabetes ,
* Any condition that could affect sensation,
* A leg or foot fracture or ankle or knee sprain within the last year,
* Current back or knee pain,
* Cardiovascular, neurologic, neuromuscular, or pulmonary disease,
* Vertigo, balance or any visual problems,or psychological illness.
* Current smokers,
* Currently taking any medication that would affect their ability to balance.
Multicomponent Lifestyle Intervention for Depression Supported With Digital Health Technologies to Promote Adherence

The proposed study will be a randomized, assessor-blind controlled trial embedding both outcome and process evaluations of a 6-week group LM intervention with/without self-tracking tools (Study I). The outcome evaluation will examine the effects of LM-S and LM alone vs. CAU, and the process evaluation will enhance the understanding of the causal assumptions that underpin LM to inform policy and clinical practice. Eligible participants with at least a moderate level of depression will be randomly assigned to the LM- S, LM alone, and CAU groups in a 1:1:1 allocation ratio. The study period will be 18 weeks. Assessments at baseline, week 7 (1-week post-intervention), and week 18 (12-week post-intervention) will be managed by an independent assessor (a research assistant, RA) who is blind to the group allocation. The proposed trial and the nested pilot study will follow the CONSORT and STROBE guidelines, respectively. The intervention will be provided free of charge.


Eligibility Criteria:
Inclusion Criteria:

1. at least 18 years of age
2. Cantonese language fluency and readability
3. a PHQ-9 score of at least 10, indicating a moderate level of depression
4. current DSM-IV diagnostic criteria of major depressive episode based on the Mini International Neuropsychiatric Interview (MINI)
5. possession of an internet-enabled mobile device (iOS or Android operating system)
6. willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria:

1. the presence of other current psychiatric disorders as assessed by the MINI
2. any medical or neurocognitive disorder(s) that makes participation unsuitable based on the team's clinical experience or interferes with adherence to the lifestyle modification (e.g., where exercise or a change in diet are not recommended by physicians)
3. current serious suicidal risk (non-fleeting intent or plan) as assessed by a PHQ-9 Item 9 score \> 2 (referral information to professional mental health services will be provided)
4. current involvement in lifestyle changes supervised by professionals
5. intake of medication or current participation in any psychotherapy for depression
6. pregnancy
7. hospitalization
8. current participation in any other trial(s).
Circuit Training and Aerobic Exercise Among Sedentary Elderly Population

To compare the effects of Circuit training and aerobic exercise on cardiopulmonary fitness among Sedentary elderly population


Eligibility Criteria:
Inclusion Criteria:

* Participants meeting the below criteria, shall be recruited in the study.
* Sedentary elderly people (Can perform 6 MWT without complication)
* Sedentary elderly population
* No regular exercise or gym activity since last 6 months

Exclusion Criteria:

* Already trained (any gym activity or regular exercise)
* Diagnosed cardiopulmonary disease
* Diabetes
* Any neurological complication
Quantitative Evaluation of Skin Shrinkage Caused by a Non-invasive Tightening Device

This study is being done to measure the amount of skin shrinkage caused by a non-invasive skin tightening device.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-60 y/o
* Mild to moderate laxity of arm skin
* Skin of Fitzpatrick levels I-III

Exclusion Criteria:

* Any active local arm infections
* Scarring or abnormalities in upper arm area
* Major systemic illnesses
* Any condition with delayed wound healing
* History of psychiatrist illnesses
Left Ventricular Mass Index Predicts Clinical Outcomes in Patients with Obstructive Hypertrophic Cardiomyopathy Undergoing Septal Myectomy

In this study, we aimed to analyze the association between left ventricular mass index and clinical outcomes to provide the potential indicator for worse survival.

This retrospective study aimed to determine the prognostic value of left ventricular mass index in predicting clinical outcomes, including all-cause death, new-onset or recurrent atrial fibrillation, and a composite endpoint of all-cause death, heart failure,permanent pacemaker implantation, new-onset or recurrent atrial fibrillation, and stroke.

Eligibility Criteria:
Inclusion Criteria:(1) Difficulty in relieving symptoms with medication or recurrent syncope. (2) Left ventricular outflow tract (LVOT) pressure gradient ≥ 50 mmHg at rest or with provocation and the maximum thickness of the septum is ≧ 15 mm.

Exclusion Criteria:

* (1) Combined right ventricular outflow tract obstruction requiring right ventricular outflow tract dissection. (2) Combined mitral or aortic valve organic lesions requiring valve replacement surgery. (3) Apical ventricular aneurysm formation requiring ventriculotomy. (4) Previous septal reduction therapy, including alcohol ablation or septal myectomy. (5) patients did not undergo cardiac magnetic resonance examination.
Amifostine in Treating Patients With Ovarian Epithelial Cancer Who Are Receiving Chemotherapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.

PURPOSE: Randomized phase III trial to study the effectiveness of amifostine in treating patients who have ovarian epithelial cancer and who are receiving chemotherapy.

OBJECTIVES: I. Determine if patients with ovarian epithelial cancer receiving chemotherapy have significantly fewer neurologic events when treated with amifostine. II. Compare amifostine vs no chemoprotection in terms of overall incidence of neuropathy, incidence of neutropenia, infection, and other myelosuppressive events (e.g., leukopenia, anemia, and thrombocytopenia), length of hospital stay due to infections, and quality of life in this patient population.

OUTLINE: This is a randomized, parallel, controlled, double blind study. Patients are randomized to one of two treatment arms. Arm I: Patients receive amifostine IV over 10 minutes, 30 minutes prior to chemotherapy. Arm II: Patients receive a placebo IV over 10 minutes, 30 minutes prior to chemotherapy. Treatment repeats every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to courses 1, 4, and 8, and then every 3 months for 1 year. Patients are followed monthly for 6 months.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed, surgically staged ovarian epithelial cancer Planned treatment with paclitaxel/carboplatinum chemotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 3 mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Other: At least 24 hours since prior antihypertensives
A Study of GFH018 in Patients With Advanced Solid Tumors

This is the first- in human study of GFH018 comprised of a dose escalation part and a dose expansion part in subjects with advanced solid tumors after single/multiple administration. The study is designed to explore the safety/tolerability, pharmacokinetics, and MTD of GFH018 and to define a RP2D of GFH018.


Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects must meet all the inclusion criteria listed below:

  1. Voluntarily participate in this clinical trial and are willing to sign informed consent forms.
  2. Male or female aged from 18-75 years old (inclusive).
  3. Diagnosed with histologically or cytologically confirmed advanced solid tumors.
  4. Evaluable lesions defined by RECIST v1.1.
  5. Eastern Cooperative Oncology Group performance status of 0 to 1.
  6. Subjects or their legal representatives are able to communicate well with Investigators and are willing to comply with the protocol and complete the study.

Exclusion Criteria:

* Eligible subjects should not meet any of the exclusion criteria listed below:

  1. With clinically significant cardiac diseases.
  2. With clinically significant digestive disorders.
  3. Other severe disease.
  4. Pregnant or lactating women.
  5. Other unfavorable situations for subjects to participate in the study judged by Investigators.
Ropivacaine Plus Magnesium Sulphate Infiltration

In the domain of endocrine gland surgery, thyroidectomy is the most common procedure. Patients report moderate to severe discomfort postoperatively, which is induced by a variety of mechanisms, the most common of which are cervical incision and surgical maneuvers. The other two causes are endotracheal intubation and neck overextension. Incisional pain, odynophagia, dysphagia, neck and shoulder pain have all been reported as sources of discomfort.However, it seems that this discomfort has a time limit, with a considerable decrease in pain scores that will last 24 to 36 hours. Pain is felt more profoundly within the first few hours after surgery, peaking at 6 hours, with patients requesting further analgesic medication.

Surgical wound infiltration can inhibit this procedure by preventing the alginate signal from reaching the incision site's receptors. According to the multimodal analgesia trends, magnesium sulfate can be added to the ropivacaine solution. Magnesium acts as an NMDA (N-methyl-D-aspartate) receptor antagonist, inhibiting cerebral sensitization to peripheral pain stimuli while reducing pre-existing hyperalgesia.

It becomes evident that this combination could contribute to attain the maximum analgesic efficacy. So, if any superiority of ropivacaine plus magnesium sulphate over ropivacaine could be demonstrated this would be very helpful in providing sufficient analgesic effects with a low incidence of adverse effects, while enhancing the option of one day surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Surgical indication for Total thyroidectomy
* Surgical indication forparathyroidectomy

Exclusion Criteria:

* Patients \< 18 years old
* Prior neck operation
* Lateral neck dissection
* Patient with history of chronic opioid use
* Patient with chronic pain syndromes
* Patient with allergy to ropivacaine
The Effect of Postpartum Kangaroo Father Care on Paternal Attachment

Objective: This study was conducted in a randomized controlled manner to determine the effect of kangaroo care (KC) on paternal attachment (PA).

Objective: This study was conducted in a randomized controlled manner to determine the effect of kangaroo care (KC) on paternal attachment (PA).

Design: The data for the study were collected using the introductory information form (IIF) and the father-infant attachment scale (FIAS). T test, Mann Whitney U test and Kruskal Wallis test were used for statistical analysis.

Participants and setting: A total of 90 fathers, including 45 in the intervention group and 45 in the control group who met the inclusion criteria of the study were included randomly.

Keywords: Kangaroo care; father; paternal attachment; Turkey.

Eligibility Criteria:
Inclusion Criteria:

* fathers who are aged 18 and 50,
* married,
* voluntarily agree to participate in the study,
* have healthy babies,
* live with their babies.

Exclusion Criteria:

* a history of chronic psychiatric illness
* antipsychotic medication use
* babies with premature / low birth weight / congenital anomalies
Prevention of Low Blood Pressure in Persons With Tetraplegia

The aim of this investigation is to determine the blood pressure response to NOS inhibition, with L-NAME, in persons with tetraplegia compared to non-SCI control subjects and to establish if blood pressure can be increased while upright in those with tetraplegia. If blood pressure is increased with NOS inhibition in persons with tetraplegia, this would improve our treatment of the condition of low blood pressure during seated postures in individuals with tetraplegia.

Despite disruption of central command of the vasculature during orthostatic maneuvers, individuals with tetraplegia are generally able to be seated in an upright position for long periods of time without developing symptoms of orthostatic intolerance. It must be appreciated however, that orthostatic hypotension may occur unpredictably in persons with chronic tetraplegia. This may result in a range of symptoms due to cerebral hypoperfusion from mild reduction in mental acuity to loss of consciousness. Nitric oxide (NO) is the most potent endogenous vasodilator which is synthesized by the enzyme NO synthase (NOS) and may be largely responsible for orthostatic hypotension in individuals with immobilizing conditions. Recent evidence suggests an up-regulation of inducible nitric oxide synthases (NOS) activity with prolonged exposure to hind limb suspension. The effects of NOS inhibition during orthostasis on blood pressure regulation in those with chronic tetraplegia may provide insight into effective pharmacological therapy to reduce or prevent pathologic orthostatic changes. Treatment with a NOS inhibitor may facilitate the process of mobilization in those with acute higher cord lesions.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 year olds.
* Non-ambulatory Chronic tetraplegia (1 year after acute SCI).

Exclusion Criteria:

* central nervous system disease (other than SCI) e.g., multiple sclerosis, amyotrophic lateral sclerosis, syringomyelia, tabes dorsalis;
* peripheral neuropathies;
* surgical sympathectomy;
* coronary heart and/or artery disease;
* anemia;
* hypertension;
* renal function abnormalities;
* diabetes mellitus;
* pituitary insufficiency;
* adrenal insufficiency;
* hypothyroidism; and
* medications known to affect the cardiovascular system.
Bioavailability Study of Fluconazole Tablets 200 mg Under Fasting Conditions

The objective of this study was an open-label, randomized, 2-way crossover to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Pfizer (Diflucan®) 200 mg fluconazole tablets under fasting conditions.

Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 18 healthy adult male volunteers. A total of 17 subjects completed the clinical phase of the study. In each period, subjects were housed from the morning dosing until after the 72-hour blood draw. Single oral 200 mg doses were separated by a washout period of 21 days.

Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

History or presence of significant:

• cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.

In addition, history or presence of:

* alcoholism or drug abuse within the past year;
* hypersensitivity or idiosyncratic reaction to fluconazole or other azoles. Subjects who have used any drugs or other substances known to be strong inhibitors of CYP (cytochrome P450) enzymes within 10 days prior to first dose.

Subjects who have used any drugs or other substances known to be strong inducers of CYP (cytochrome P450) enzymes within 28 days prior to first dose.

Subjects who have been on an abnormal diet (for whatever reason) during the 28 days prior to the first dosing.

Subjects who, through completion of the study, would have donated in excess of:

* 500 mL of blood in 14 days, or
* 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator),
* 1000 mL of blood in 90 days,
* 1250 mL of blood in 120 days,
* 1500 mL of blood in 180 days,
* 2000 mL of blood in 270 days,
* 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.